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trade show Angiomax Generic Name: bivalirudin (bye VAL i roo din) Brand Name: Angiomax Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Pricing & Coupons What is Angiomax (bivalirudin)? Bivalirudin is an anticoagulant (thrombin inhibitor) that helps prevent the formation of blood clots. An unwanted blood clot can occur with certain heart or blood vessel conditions. Bivalirudin is used to prevent blood clots in people with severe chest pain or other conditions who are undergoing a procedure called angioplasty (to open blocked arteries). Bivalirudin may also be used for purposes not listed in this medication guide. Slideshow Shingles: Settling The Score What is the most important information I should know about Angiomax (bivalirudin)? You should not receive bivalirudin if you are allergic to it, or if you have any major bleeding from a surgery, injury, or other medical trauma. Tell your doctor if you are using blood thinners or receiving any other medications to treat or prevent blood clots. Bivalirudin can make it easier for you to bleed even from a minor injury. What should I discuss with my health care provider before receiving Angiomax (bivalirudin)? You should not receive bivalirudin if you are allergic to bivalirudin, or if you have any major bleeding from a surgery, injury, or other medical trauma. To make sure bivalirudin is safe for you, tell your doctor if you have: heart disease; kidney disease; a bleeding or blood clotting disorder, such as hemophilia; or if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests. Tell your doctor if you are pregnant or plan to become pregnant. Bivalirudin is not expected to be harmful to an unborn baby. However, aspirin is sometimes given with bivalirudin, and taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Tell your doctor if you are pregnant before you are treated with bivalirudin and aspirin. It is not known whether bivalirudin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. How is Angiomax (bivalirudin)given? Bivalirudin is injected into a vein through an IV. You will receive this injection during your angioplasty procedure in a clinic or hospital setting. The medicine must be given throughout the entire procedure. Your doctor may want you to continue receiving bivalirudin for up to 20 hours after your angioplasty procedure. Bivalirudin is usually given together with aspirin. Because bivalirudin keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it may be easier for you to bleed even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop. What happens if I miss a dose? Because you will receive bivalirudin in a clinical setting, you are not likely to miss a dose. What happens if I overdose? Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. What should I avoid after receiving Angiomax (bivalirudin)? Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth. Avoid drinking alcohol. It may increase your risk of bleeding in your stomach or intestines. Angiomax (bivalirudin) side effects Get emergency medical help if you have signs of an allergic reaction : hives; difficult breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers right away if you have: a light-headed feeling, like you might pass out; easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; any bleeding that will not stop; slow heartbeats; little or no urinating; signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing; signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs; or increased blood pressure--severe headache, blurred vision, pounding in your neck or ears. Common side effects may include: headache, anxiety; nausea, vomiting; pelvic pain, back pain; sleep problems (insomnia); or pain or irritation where the injection was given. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Side Effects (complete list) What other drugs will affect Angiomax (bivalirudin)? Tell your doctor about all your current medicines and any you start or stop using, especially medications to treat or prevent blood clots, such as: heparin, warfarin (Coumadin, Jantoven); argatroban, dabigatran, fondaparinux, lepirudin, rivaroxaban; abciximab, eptifibatide, tirofiban; dalteparin, enoxaparin, tinzaparin; anagrelide, cilostazol, clopidogrel, dipyridamole, eltrombopag, oprelvekin, prasugrel, romiplostim, ticagrelor, ticlopidine; or alteplase, reteplase, tenecteplase, urokinase. This list is not complete. Other drugs may interact with bivalirudin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Next Side Effects Print this page Add to My Med List More about Angiomax (bivalirudin) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 1 Review Add your own review/rating Generic Availability Drug class: thrombin inhibitors Consumer resources Angiomax Angiomax (Advanced Reading) Professional resources Angiomax (AHFS Monograph) Angiomax (FDA) Related treatment guides Angina Percutaneous Coronary Intervention Where can I get more information? Your doctor or pharmacist can provide more information about bivalirudin. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright 1996-2012 Cerner Multum, Inc. Version: 2.05. Last reviewed: January 19, 2017 Date modified: December 03, 2017 Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer The Medicines Company Drug Class Thrombin inhibitors Related Drugs Percutaneous Coronary Intervention Plavix , clopidogrel , bivalirudin , Integrilin , cangrelor , eptifibatide , More... Angina aspirin , amlodipine , carvedilol , metoprolol , atenolol , Norvasc , nitroglycerin , propranolol , Nitrostat , Coreg , More... Angiomax Rating 1 User Review 10 /10 1 User Review 10 Rate it! Help and Support Looking for answers? Ask a question or go join the Angiomax support group to connect with others who have similar interests. really appropriate


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Photo :The Little-Known Benefits of Pregnancy
what was causing Home Pregnancy Pregnancy Guide Benefits of Pregnancy The Little-Known Benefits of Pregnancy We're all familiar with the negative aspects of pregnancy: stretch marks , morning sickness, discomfort , complications , and risks. But what about the positives of pregnancy? Despite the bad rep the experience of pregnancy seems to get, most women report a positive pregnancy experience. Here are some of the little discussed reasons why pregnancy is a positive experience. Stellar Pregnany Sex During the second semester, there's an increased blood flow to the pelvic area, making your genitals a lot more sensitive. This, for many, means greater sensitivity during sex and a higher likelihood of orgasm. Some women even experience their first orgasm during pregnancy, and some even start to have multiple orgasms. Pregnancy hormones and androgens also kick in to heat up your libido and make you feel sexier. During the first trimester you may feel too nauseous and fatigued, and during the thirds trimester you may feel too bulky and uncomfortable to really feel the libido change, but during your second semester watch out! Make sure to take this special time to reconnect with your partner before baby comes. Even if you're not up for sex, create intimacy by asking your partner to rub your back, neck, shoulders, or feet, or have a warm bath together. When the mood is right, don't worry about sex during pregnancy hurting the baby - it won't. Unless you have a complicated pregnancy, you can have sex up until delivery time. Menstrual Cramps Be Gone An end to pregnancy means a start to menstrual periods again, but there's often a welcome change. Many women find that after pregnancy their menstrual cramps are mush less severe or they even disappear all together. Scientists think that childbirth may eliminate some of the prostaglandin receptor sites in the uterus. Prostaglandins are the hormones that cause the uterus to contract and they play a role in menstrual pain. Fewer receptor sites means fewer cramps. Healthful Pregnacy Habits Pregnancy is a great motivator for healthy diet and lifestyle changes, since mom knows that what she puts in her body she's also exposing her baby to. Experts say pregnancy is one of the strongest inspirations for quitting smoking and getting fresh air and exercise . New health and eating habits also last past the pregnancy, creating a healthier lifestyle for you and your family. Heightened Pregnancy Senses Your sense of taste and smell increase during pregnancy. The same mechanism that makes you nauseous and morning sick in early pregnancy is what makes food seem especially appetizing and flavorful later on. Experts say that the phenomenon may have a protective effect for the baby; Mom's sensitive nose steers her towards foods good for Baby and away from foods and environments (like tainted foods and cigarette smoke) that are harmful to Baby. The "radar nose" is likely from high levels of estrogen during pregnancy. Cancer Risk Decrease It's been well documented that pregnancy produces a protective effect against breast and ovarian cancers. Studies have confirmed that the more pregnancies you go through, and the younger you start having children, the more your risk is reduced. We aren't sure why quite yet, but there are a number of theories. One possibility is that women who ovulate less over a lifetime are at a lower risk of ovarian cancer than those who ovulate more (ovulation stops during pregnancy - that's nine fewer ovulations for every pregnancy). Some experts say that breastfeeding is the key to the breast cancer shield offered by pregnancy, even though those that don't breastfeed get the same hormonal stimulation of their breast tissue as those who do. Soaring Confidence Pregnancy is the ultimate do-it-yourself project, so it's no surprise that it can also be a major confidence builder - after all, look what you can make! Women with low-risk pregnancies realize they can still do lots of activities, even with extra stress on their bodies. Women also gain a new-found sense of strength and resiliency after labor and childbirth. And you're less likely to worry about the little things when you realize that you're actually creating a new person and delivering her into the world. You've experienced the phenomena of creation that connects you to past and future generations. Login to comment Log in or sign up Forgot Password? Username: Password: CANCEL (0 Comments) Login to add a comment Post a comment You must be logged in to comment. possibly


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exceptional Sinemet CR (Oral) Generic Name: carbidopa and levodopa (Oral route) kar-bi-DOE-pa, lee-voe-DOE-pa Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Drug Images Support Group Q & A Pricing & Coupons Commonly used brand name(s) In the U.S. Parcopa Rytary Sinemet 10-100 Sinemet 25-100 Sinemet 25-250 Sinemet CR In Canada Sinemet 100/10 Sinemet 100/25 Sinemet 250/25 Sinemet CR 100/25 Sinemet CR 200/50 Available Dosage Forms: Tablet, Extended Release Capsule, Extended Release Tablet Tablet, Disintegrating Therapeutic Class: Antiparkinsonian Pharmacologic Class: Decarboxylase Inhibitor Slideshow Misdiagnosis: Righting The Wrong Uses For Sinemet CR Carbidopa and levodopa combination is used to treat Parkinson's disease, sometimes called shaking palsy or paralysis agitans. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord). Extended-release carbidopa and levodopa (Rytary ) is also used to treat parkinsonism caused by encephalitis, or parkinsonism caused by carbon monoxide or manganese poisoning. Dopamine is a naturally occurring substance in the brain that helps provide control of movement and activities such as walking and talking. In patients with Parkinson's disease, there is not enough dopamine in some parts of the brain. Levodopa enters the brain and helps replace the missing dopamine, which allows people to function better. By increasing the amount of dopamine in the brain, levodopa helps control symptoms and helps you to perform daily activities such as dressing, walking, and handling utensils. This medicine is available only with your doctor's prescription. Before Using Sinemet CR In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies have not been performed on the relationship of age to the effects of levodopa and carbidopa combination in the pediatric population. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Rytary in the elderly. Although appropriate studies on the relationship of age to the effects of Lodosyn have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of Lodosyn in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving Lodosyn . No information is available on the relationship of age to the effects of carbidopa and levodopa combination in geriatric patients. Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Interactions with Medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Amisulpride Bromopride Clorgyline Furazolidone Iproniazid Isocarboxazid Linezolid Methylene Blue Moclobemide Nialamide Pargyline Phenelzine Procarbazine Sulpiride Toloxatone Tranylcypromine Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Bupropion Isoniazid Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Droxidopa Fosphenytoin Indinavir Iron Kava Metoclopramide Phenylalanine Phenytoin Spiramycin Tyrosine Interactions with Food/Tobacco/Alcohol Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. High Protein Food Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Asthma or Depression, history of or Dyskinesia (abnormal muscle movements) or Endocrine disease or Heart attack, history of or Heart or blood vessel disease, severe or Heart rhythm problems (eg, ventricular tachycardia) or Kidney disease or Liver disease or Lung disease, severe or Peptic ulcer, history of or Psychosis (mental disorder), or history of or Wide-angle glaucoma (eye pressure problem) Use with caution. May make these conditions worse. Melanoma (skin cancer), suspicious or a history of or Narrow angle glaucoma (eye pressure problem) or Skin lesions, undiagnosed (rashes that involve changes in color or texture of the skin) Should not be used in patients with these conditions. Phenylketonuria (PKU) The oral disintegrating tablet contains phenylalanine, which can make this condition worse. Proper Use of carbidopa and levodopa This section provides information on the proper use of a number of products that contain carbidopa and levodopa. It may not be specific to Sinemet CR. Please read with care. Take this medicine exactly as directed , and every time that you are supposed to take it. It is important that you do not stop taking your medicine unless ordered by your doctor. It is also important to not start taking other medicines for your Parkinson's disease without first talking with your doctor . You may experience a wearing-off effect towards the end of the dosing interval. You should tell your doctor if you have problems with this that affect your every day life. Your doctor may want to adjust your dose. Since protein may interfere with the body's response to carbidopa and levodopa, high protein diets should be avoided. Intake of normal amounts of protein should be spaced equally throughout the day, or taken as directed by your doctor. If you are taking multivitamin tablets or plan to start taking them, discuss this first with your doctor. Iron salts (in vitamins) may keep this medicine from working properly. Sinemet tablet or Parcopa disintegrating tablet begins to release its ingredients 30 minutes after you take it. Swallow the extended-release capsule or sustained release tablet whole. Do not crush, break, or chew it. If you have trouble swallowing the extended-release capsules : The capsules can be opened and the contents can be sprinkled on 1 to 2 tablespoons of applesauce. This mixture must be swallowed immediately without chewing. If you are using the disintegrating tablet , make sure your hands are dry before you handle the tablet. Do not remove the tablet from the bottle until you are ready to take it. Place the tablet on the top of your tongue, where it will melt quickly. Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. Dosing The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For Parkinson's disease: For oral dosage form (extended-release capsules): Adults For patients starting on carbidopa and levodopa treatment: At first, one capsule three times a day for the first 3 days. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 10 capsules per day. For patients taking carbidopa and levodopa already: At first, 3 or 4 capsules three times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 10 capsules per day. Children Use and dose must be determined by your doctor. For oral dosage form (disintegrating tablets): Adults For patients starting on carbidopa and levodopa treatment: At first, one tablet three or four times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 8 tablets per day. For patients taking levodopa already: Levodopa should be discontinued at least 12 hours before starting Parcopa . The starting dose is one tablet three or four times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 8 tablets per day. Children Use and dose must be determined by your doctor. For oral dosage form (sustained release tablets): Adults For patients switching from Sinemet to Sinemet CR: The starting dose is based on the amount of Sinemet you are currently taking per day. Your doctor may adjust your dose as needed. For patients taking levodopa already: Levodopa should be discontinued at least 12 hours before starting Sinemet CR. The starting dose is one tablet two times a day. Your doctor may adjust your dose as needed. For patients not taking levodopa: At first, one tablet two times a day. Your doctor may adjust your dose as needed. Children Use and dose must be determined by your doctor. For oral dosage form (tablets): Adults For patients starting on carbidopa and levodopa treatment: At first, one tablet three or four times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day. For patients taking levodopa already: Levodopa should be discontinued at least 12 hours before starting Lodosyn plus levodopa or Sinemet . The starting dose is one tablet three or four times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day. For patients taking carbidopa and levodopa already: 25 milligrams (mg) of Lodosyn per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day. Children Use and dose must be determined by your doctor. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Precautions While Using Sinemet CR It is very important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects. Do not take this medicine if you have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine, tranylcypromine, Nardil , Parnate ) in the past 2 weeks. Do not stop taking this medicine without first checking with your doctor . Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Check with your doctor right away if you are having convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS). This medicine may cause dizziness, drowsy, trouble in controlling movements, or trouble in concentrating or seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well . It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away. If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability. It is possible that a dark color (red, brown, or black) may appear in saliva, urine, or sweat after taking this medicine. The color may cause some of your garments to become discolored. This is normal and nothing to worry about. It is possible that you may become nauseous, especially when you are first starting your medicine. Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine. Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Sinemet CR Side Effects Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: More common Twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs Less common Bladder pain bloody or cloudy urine chest pain confusion difficult, burning, or painful urination discouragement feeling sad or empty frequent urge to urinate inability to move the eyes increased blinking or spasms of the eyelid irritability lack of appetite loss of interest or pleasure lower back or side pain seeing, hearing, or feeling things that are not there sticking out of tongue tiredness trouble concentrating trouble in breathing, speaking, or swallowing trouble sleeping uncontrolled twisting movements of the neck, trunk, arms, or legs unusual facial expressions Incidence not known Anxiety black, tarry stools bluish color blurred vision changes in skin color chest discomfort chills convulsions cough or hoarseness dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position dry mouth false beliefs that cannot be changed by facts fast, irregular, pounding, or racing heartbeat or pulse feelings about hurting oneself or others fever with or without chills general feeling of tiredness or weakness high fever hyperventilation increased in sexual ability, desire, drive, or performance increased interest in sexual intercourse increased sweating large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs loss of bladder control lower back or side pain nausea pain pain or discomfort in the arms, jaw, back, or neck restlessness seeing, hearing, or feeling things that are not there severe muscle stiffness shaking sore throat sores, ulcers, or white spots on the lips or in the mouth swelling of the foot or leg swollen glands tenderness tiredness unusual bleeding or bruising unusual tiredness or weakness unusually pale skin vomiting Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Less common Acid or sour stomach back or shoulder pain belching body aches or pain burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings diarrhea difficulty having a bowel movement (stool) ear congestion headache heartburn indigestion loss of voice muscle cramps nasal congestion runny nose sneezing stomach discomfort, upset, or pain unusual dreams weight loss Incidence not known Abdominal or stomach distress bad, unusual, or unpleasant (after) taste belching change in taste dark sweat double vision enlarged pupils feeling of warmth hair loss or thinning of the hair lack or loss of strength redness of the face, neck, arms, and occasionally, upper chest seeing double skin rash, hives or welts, itching Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Side Effects (complete list) The information contained in the Truven Health Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Truven Health products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Truven Health and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, TRUVEN HEALTH MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Truven Health does not assume any responsibility or risk for your use of the Truven Health products. Copyright 2017 Truven Health Analytics, Inc. All Rights Reserved. Next Side Effects Print this page Add to My Med List More about Sinemet CR (carbidopa / levodopa) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 3 Reviews Add your own review/rating Generic Availability Drug class: dopaminergic antiparkinsonism agents Consumer resources Sinemet CR Other brands: Rytary , Parcopa , Duopa Professional resources Sinemet CR (FDA) Levodopa/Carbidopa (AHFS Monograph) Other Formulations Sinemet Related treatment guides GTP-CH Deficiency Neuroleptic Malignant Syndrome Parkinson's Disease Restless Legs Syndrome} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Merck & Co., Inc. Drug Class Dopaminergic antiparkinsonism agents Related Drugs Parkinson's Disease Exelon , ropinirole , pramipexole , Sinemet , Requip , benztropine , carbidopa / levodopa , Mirapex , More... Neuroleptic Malignant Syndrome carbidopa , Sinemet , carbidopa / levodopa , Lodosyn , Parcopa , More... GTP-CH Deficiency carbidopa , Sinemet , carbidopa / levodopa , Lodosyn , Parcopa , More... Sinemet CR Rating 3 User Reviews 7.7 /10 3 User Reviews 7.7 Rate it! Sinemet CR Images Sinemet CR 50 mg / 200 mg (SINEMET CR 521) View all images Related Questions & Answers Can I take my Sinement CR tabs perscribed 3 times a day TO WORK EVENLY DURING MY DAYTIME HOURS? I take a combination of sinemet and sinemet cr. sometimes it takes 2 hours or more to take effect? My mom has in the last year gotten agressively worse. I am concerned that she is not tolerating the? Parkinson's Disease - Does anyone suffer from dark saliva (taking Sinemet CR)? Is it safe to take Kalms Night tablets (1 each night) to help sleep problems while taking sinemet CR Read more questions} } service provider


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sparsely Docusate and Senna Generic Name: Docusate and Senna (DOK yoo sate & SEN na) Brand Name: Doc-Q-Lax, Dok Plus, Geri-Stool, Peri-Colace, Senexon-S, ...show all 10 brand names. Senna Plus, Senna S, SennaLax-S, Senokot-S, SenoSol-SS Overview Side Effects Dosage Interactions Pregnancy More User Reviews Drug Images Support Group Q & A Compare Alternatives Pricing & Coupons Uses of Docusate and Senna: It is used to treat hard stools (constipation). What do I need to tell my doctor BEFORE I take Docusate and Senna? If you have an allergy to docusate, senna, or any other part of docusate and senna. If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs. If you have any of these health problems: Bowel block, belly pain, upset stomach, rectal bleeding, throwing up, or change in bowel habits lasting >2 weeks. If you are taking mineral oil. This is not a list of all drugs or health problems that interact with this medicine. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take docusate and senna with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. Slideshow Type 1 Diabetes: Symptoms, Treatments, and Breakthroughs What are some things I need to know or do while I take Docusate and Senna? Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists. Do not use docusate and senna for more than 1 week unless told to do so by your doctor. Do not use other laxatives or stool softeners unless told to do so by the doctor. If you have rectal bleeding or you do not have a bowel movement after using this medicine, talk with your doctor. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using docusate and senna while you are pregnant. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby. How is this medicine (Docusate and Senna) best taken? Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely. Follow how to take docusate and senna as you have been told by your doctor. Do not use more than you were told to use. Take at bedtime if taking once a day. Take with a full glass of water. Do not take other drugs within 2 hours of this medicine. What do I do if I miss a dose? If you take docusate and senna on a regular basis, take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses. Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor. Dosage Information (comprehensive) What are some side effects that I need to call my doctor about right away? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. What are some other side effects of Docusate and Senna? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch. Side Effects (complete list) If OVERDOSE is suspected: If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. How do I store and/or throw out Docusate and Senna? Store at room temperature. Protect from heat. Store in a dry place. Do not store in a bathroom. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Check with your pharmacist about how to throw out unused drugs. Consumer Information Use and Disclaimer If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor. Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about docusate and senna, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about docusate and senna. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using docusate and senna. Review Date: November 1, 2017 Next Side Effects Print this page Add to My Med List More about docusate/senna Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Español 13 Reviews Add your own review/rating Drug class: laxatives Consumer resources Docusate and senna Other brands: Senna Plus , Senna S , Senokot S , Peri-Colace , ... +7 more Related treatment guides Constipation, Acute Drug Status OTC Availability Over the counter N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Docusate / senna Rating 13 User Reviews 8.0 /10 13 User Reviews 8.0 Rate it! Manufacturer Sunrise Pharmaceutical, Inc. Drug Class Laxatives Related Drugs Constipation, Acute MiraLax , polyethylene glycol 3350 , lactulose , docusate / senna , GlycoLax , Generlac , Kristalose , Senokot S , Constulose , PEG3350 , Peri-Colace , Enulose , ClearLax , Sennalax-S , Senexon-S , GaviLAX , Doculax , Purelax , Doc-Q-Lax , More... Docusate / senna Images Docusate / senna systemic docusate sodium 50 mg / sennosides 8.6 mg (TCL 131 ) View all images unhurt


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service provider Jump to: Symptoms Treatment Finding a Therapist Major depression is one of the most common mental disorders in the United States, affecting 6.7% (16.1 million) adults aged 18 and over. 1 Major depression can appear at any age, but the likelihood of onset increases with puberty and peaks in the twenties. 2 Symptoms of major depressive disorder Major depression isn t limited to feeling sad. In fact, symptoms can vary and include both emotional and physical changes. Common symptoms of depression can include the following: Frequent crying and feelings of overwhelming sadness Feelings of hopelessness and worthlessness Changes in sleep patterns Irritability or anger Changes in eating patterns, including significant weight loss or gain Loss of pleasure in normal activities Psychosomatic complaints including headaches, muscle aches, and gastrointestinal distress Difficulty concentrating Thoughts of suicide The symptoms of major depression can make it difficult to attend to normal daily activities and can negatively impact employment or schooling, relationships or social functioning, and other areas of functioning. 3 For these reasons, it can be a challenge for someone suffering from major depression to seek help and follow through on treatment. Article continues below Worried you or someone you care about may be depressed? Take our 2-minute Depression quiz to see if you may benefit from further diagnosis and treatment. Take Depression Quiz How to find help Major depressive disorder is treatable with professional care, though success rates and length of treatment will vary depending on the severity of the depression. Understanding available treatments and how to find help make the process less overwhelming. Treatment Although treatment is individualized, several standard treatments are recommended: Cognitive Behavioral Therapy Process-oriented talk therapy Medication Family therapy Hospitalization if necessary Residential treatment if necessary Alternative treatments (nutrition plans, exercise plans, meditation or mindfulness strategies) How to find the right therapist Having confidence in your therapist plays an essential role in establishing a connection. To find the best therapist for you, it is recommended that you speak to more than one therapist. Be prepared to ask potential therapists questions that include both practical matters and treatment strategies. Consider these questions when you speak to potential therapists: Do you accept my insurance? Do you specialize in children, adults, families, or all three? What experience do you have treating major depressive disorder? If I need medication, can you prescribe it for me or refer me to someone who can? What are your credentials? What is your treatment approach? How will you help me overcome depression? How long do you expect treatment to last? What happens if I don t start feeling better in the typical timeframe? Are there things I can do on my own to improve my treatment outcome in addition to therapy? How many sessions a month do you typically provide for someone with depression? What if I can no longer afford the cost of treatment? Do you provide sliding scale rates? Once you have your list of questions, it s time to seek out referrals. If you know other people in your area who suffer (or have suffered) from depression, ask them. Word of mouth can be a great way to find a good match. If this is not possible, begin with your physician. It s always a good idea to get a physical if you suspect major depressive disorder because some medical problems can cause similar symptoms. If medical conditions are ruled out as a cause of the symptoms of depression, ask your primary care physician for a list of referrals for therapists. If you still need further recommendations, your insurance carrier, local hospitals, and outpatient clinics have referral systems in place. You can also search for a therapist online at one of the resources listed on our Mental Health Resources page. Article Sources 1. National Institute of Mental Health, Major Depression Among Adults, retrieved from https://www.nimh.nih.gov/health/statistics/prevalence/major-depression-among-adults.shtml. 2. American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition , American Psychiatric Publishing, Washington, D.C., 2013: Page 165. 3. Ibid., page 161. Last Updated: Dec 4, 2017 package


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carefully Home Pregnancy Problems Complications with Baby Spina Bifida Spina Bifida Spina bifida is the one of the most common birth defects in the United States, affecting one in every two thousand live births. Also called a cleft spine, spina bifida is a birth defect that affects the backbone and spinal cord. It is the most common neural tube defect (NTD). A neural tube is the embryonic structure that develops into the brain and spinal cord. Causes of Spina Bifida Up to 95% of spina bifida cases are isolated birth defects , meaning that the majority of cases do not have a genetic link. In the majority of cases the cause of the defect is unknown, however, babies whose mothers had fevers during pregnancy have a greater chance of being born with spina bifida. Women who have taken valproic acid to decrease the frequency of seizures caused by epilepsy are also more likely to give birth to babies with spina bifida, as are women with diabetes. Folic acid deficiency can also lead to neural tube defects. How Itï s Detected Prenatal tests can be conducted to detect birth defects. A maternal serum alpha-fetoprotein (AFP) test is taken between 16 and 18 weeks; the level of AFP in the mother's blood is tested and if high levels of it are found in two subsequent tests, a diagnosis can be confirmed. An ultrasound, or amniocentesis (in which a needle inserted in the uterus collects fluid and tests for AFP) can also be used to detect the disease. Detecting the disease as early as possible is crucial because it allows doctors to provide support and information to pregnant women. Future surgeries can also be planned before the birth. Types of Spina Bifida There are three types of Spina Bifida, ranging from mild to severe: Spina Bifida Occulta: Characterized as an opening in one, or more, vertebrae of the spinal column. There is no evident damage to the spinal cord. Most children born with this form of Spina Bifida donï t have health problems. Meningocele: The spinal cord is intact, but the meninges (sac), which protects it, is pushed out through the opening in the vertebrae. The meninges can be replaced with minimal damage to the spinal cord. Myelomeningocele: The most extreme form of spina bifida, in which a section of the spinal cord protrudes through the back. Seventy to ninety per cent of babies born with myelomeningocele have hydrocephalus, a large amount of fluid on the brain. This condition requires surgery, where a shunt is inserted to drain fluid. Learning problems are particularly frequent as a result of this type of spina bifida, as are problems with mobility and paralysis. Quality of Life and Survival Rate There are many physical and social problems associated with spina bifida. Paralysis is common in extreme manifestations of the disease. Depression is another symptom, as are learning disabilities (particularly with reading and math). Attention deficit hyperactivity disorders (ADHD) are also common, as are bladder and bowel control problems. Treatment In the past, babies born with spina bifida died shortly after birth. Today, early surgery is usually recommended and is often performed within the first forty-eight hours of birth. Surgery increases the survival rate, and many spina bifida patients live well into adulthood, however, children with spina bifida typically require several operations during their childhood to correct defects, particularly in the hips, feet and spine. Prevention Women should ensure they get enough folic acid while pregnant in order to prevent spina bifida. A daily dose of 0.4 milligrams of folic acid is recommended and should be taken for at least three month before getting pregnant and throughout the first trimester . Folic acid is found in foods such as eggs, dark leafy vegetables and orange juice. Multivitamins can also be used to ensure that the recommended daily dose is reached. Taking the proper amount of folic acid while pregnant can prevent up to 70% of neural tube defects, including spina bifida. Login to comment Log in or sign up Forgot Password? Username: Password: CANCEL (0 Comments) Login to add a comment Post a comment You must be logged in to comment. common


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close to (*this news item will not be available after 12/31/2017) Monday, October 2, 2017 MONDAY, Oct. 2, 2017 (HealthDay News) -- As news pours in from Las Vegas on the record level of carnage inflicted by a shooter at yet another crowded public event, psychiatrists urge young people and their parents to not give way to fear. Media reports say retiree Stephen Paddock, of Mesquite, Nev., killed at least 58 people and injured more than 500 at a crowded country music festival on the Las Vegas strip late Sunday. Police later found Paddock dead in his hotel room near the scene of the shooting. The horrific killings come on the heels of other senseless tragedies perpetrated on young people who were simply enjoying a night out. Twenty-two attendees at an Ariana Grande concert were killed in Manchester, U.K., this past May, and 49 revelers were shot down in 2016 at the Pulse nightclub in Orlando, Fla. In the aftermath of these bloody and random attacks on young people at festive gatherings, the nerves of young would-be concertgoers or club attendees are bound to be frayed, psychiatrists say. Certainly, "for those attending the concert in Las Vegas, their life will be marked as 'before' or 'after' the concert," said Dr. Victor Fornari. He directs child and adolescent psychiatry at Zucker Hillside Hospital, in Glen Oaks, N.Y. "For those who were injured or lost a loved one, the impact of the event may be traumatic," Fornari said. "Trauma coupled with loss may lead to a traumatic bereavement, often colored by so many complex emotions." And for those who witnessed the attack but survived, the psychological impact can be severe, he said. At these moments, the close support of family is key, as is the services of a trained trauma counselor, Fornari said. And what about the millions of young Americans who simply learned of the carnage via media? According to Fornari, people should remember that thousands of concerts and other group events occur nationwide every day, and the chances of encountering violence at any one event remain extremely slim. "Parents need to recognize that attending a concert is generally a safe event," he said. "The acts of violence we have seen are rare events, and should not interfere with young people from attending concerts." Dr. Matthew Lorber, a psychiatrist at Lenox Hill Hospital in New York City, agreed. "It is natural for parents to be fearful [after such events], but they have to be careful to not teach teens to be afraid of everything, but rather teach teens smart safety precautions," he said. "You do not want your children to be afraid of going out to crowded events for the rest of their lives, and even worse have them avoiding doing it out of fear," Lorber said. "The long-term effects of being exposed to these fear-invoking events can be traumatic, and it is important for parents to limit teens' exposures, and have an open dialogue answering all questions." Agreeing with Fornari, Lorber stressed that for the average young American, "these events are very rare, and the chances of something happening at an event they are at are almost zero." And how should concerned parents address the fears of younger children? According to Lorber, "It is inappropriate to talk about these things to children under 8, although at times they cannot be avoided because of peers talking about them. In that case, parents should address children's concerns, but reinforce that they are safe, their parents will protect them, and there are many more good people in the world who try and help others." SOURCES: Victor Fornari, M.D., director, child and adolescent psychiatry, Zucker Hillside Hospital, Glen Oaks, N.Y., and Cohen Children's Medical Center, New Hyde Park, N.Y.; Matthew Lorber, M.D., psychiatrist, Lenox Hill Hospital; Washington Post ; The New York Times HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Child Mental Health Parenting Recent Health News of favor


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prompted Docuprene Tablets Generic Name: docusate sodium Dosage Form: tablet Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. DOCUPRENE Active Ingredient (in each tablet) Purpose Sodium Dioctyl Sulfosuccinate 100mg Stool Softner Each tablet contains 8 mg. of Sodium Inactive Ingredients Croscamellose Sodium, Dicalcium Phosphate, Magnesium Silicate, Magnesium Stearatem Microcrystalline Cellulose, Pharmceutical Glaze, Silica, Sodium Benzoate and Stearic Acid. Uses: For the prevention of dry hard stools For relief of occasional constipation This product generally produces bowel movement with 12 to 72 hours. Warnings Do not use laxative products for longer that one week unless directed to do so by a doctor and if you are presently taking mineral oil, unless told to do so by a doctor. Ask a doctor before use if you have: Abdominal pain, nausea, vomiting, noticed a sudden change in or you fail to have a bowel movement after use. These could be signs of a serious condition. If pregnant or breast-feeding , ask a doctor before use. Other Information Store at room temperature 68- 77 degrees F For Questions or Comments Please email: info pnarx.com or Call: 877-329-2592 Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away. Adults and children 12 years of age and older: Take 1 or 2 tablets daily Children Under 12 years of age: Do not use, Consult a doctor before use. NDC 45861-0201-60 DOCUPRENE 100 mg Sodium Dioctyl Sulfosuccinate 60 Tablets Made in USA Patent Pending Manufactured For Pharmaceutica America Glendale CA DOCUPRENE docusate sodium tablet Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45861-201 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 8 Product Characteristics Color white (White) Score no score Shape ROUND Size 11mm Flavor Imprint Code CPC513 Contains Packaging # Item Code Package Description 1 NDC:45861-201-60 60 TABLET (TABLET) in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part334 06/16/2010 Labeler - Pharmaceutica North America, Inc. (962739699) Establishment Name Address ID/FEI Operations Contract Pharmacal Corporation 057795122 manufacture Revised: 06/2010 Pharmaceutica North America, Inc. Next Interactions Print this page Add to My Med List More about Docuprene (docusate) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: laxatives Consumer resources Docuprene oral/rectal Professional resources Docusate Sodium (FDA) Other brands: Doc-Q-Lace Related treatment guides Constipation FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Drug Class Laxatives Related Drugs laxatives MiraLax , Colace , docusate , polyethylene glycol 3350 , senna , Metamucil Constipation MiraLax , Colace , docusate , polyethylene glycol 3350 , magnesium oxide , senna , Amitiza , Metamucil , Linzess , bisacodyl , Dulcolax , psyllium , Senokot , linaclotide , FiberCon , Citrucel , GlycoLax , Dulcolax Stool Softener , Doc-Q-Lace , lubiprostone , Milk of Magnesia , methylcellulose , More... Docuprene Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! fee


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the stainless steel Taltz Prefilled Syringe Generic Name: ixekizumab (IX ee KIZ ue mab) Brand Name: Taltz Autoinjector, Taltz Prefilled Syringe Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Pricing & Coupons What is Taltz Prefilled Syringe (ixekizumab)? Ixekizumab is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation. Ixekizumab is used to treat moderate to severe plaque psoriasis (raised, silvery flaking of the skin) in adults. Ixekizumab may also be used for purposes not listed in this medication guide. Slideshow 2016 New Drug Approvals: The Year That Was What is the most important information I should know about Taltz Prefilled Syringe (ixekizumab)? Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. What should I discuss with my healthcare provider before using Taltz Prefilled Syringe (ixekizumab)? You should not use ixekizumab if you are allergic to it. To make sure ixekizumab is safe for you, tell your doctor if you have: an active or recent infection; Crohn's disease, ulcerative colitis; or tuberculosis (or if you have close contact with someone who has tuberculosis). It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether ixekizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. Ixekizumab is not approved for use by anyone younger than 18 years old. How is Taltz Prefilled Syringe (ixekizumab)given? Before you start treatment with ixekizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Ixekizumab is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. This medicine is not used daily. The first 7 doses are usually given once per week. Then an injection is given once every 4 weeks. Follow your doctor's instructions. Your care provider will show you the best places on your body to inject ixekizumab. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Do not give an injection into a skin area with active psoriasis, or skin that is red, bruised, or tender. Ixekizumab should appear as a clear to light-yellow liquid. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medication. Do not shake the syringe or injection pen. Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets. Ixekizumab can lower blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Store this medicine in the original container in a refrigerator. Protect from light and do not freeze. Do not use the medicine if it has become frozen. Before injecting your dose, take the injection pen or prefilled syringe out of the refrigerator and leave it at room temperature for 30 minutes. Do not heat the medicine in a microwave or under hot water, and do not leave it in direct sunlight. Each single-use injection pen or prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left after injecting your dose. What happens if I miss a dose? Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Taltz Prefilled Syringe (ixekizumab)? Do not receive a "live" vaccine while using ixekizumab, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine. Do not share this medicine with another person, even if they have the same symptoms you have. Taltz Prefilled Syringe (ixekizumab) side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: fever, chills, sweating, muscle pain, weight loss; diarrhea (may be bloody), stomach cramps; painful skin sores; cough, shortness of breath, cough with red or pink mucus; sores or white patches in your mouth or throat (yeast infection or "thrush"); increased urination, pain or burning when you urinate; eye swelling, redness, crusting or drainage (may be signs of infection); or signs of a fungal infection (rash or red patches, itching, burning, cracked skin, hair loss). Common side effects may include: pain or redness where the medicine was injected; nausea; ear infection; or cold symptoms such as stuffy nose, sneezing, sore throat. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Side Effects (complete list) What other drugs will affect Taltz Prefilled Syringe (ixekizumab)? Other drugs may interact with ixekizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. Next Side Effects Print this page Add to My Med List More about Taltz (ixekizumab) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons 37 Reviews Add your own review/rating Drug class: interleukin inhibitors Consumer resources Taltz Taltz Autoinjector Taltz (Advanced Reading) Professional resources Taltz (AHFS Monograph) Taltz (FDA) Related treatment guides Plaque Psoriasis Where can I get more information? Your pharmacist can provide more information about ixekizumab. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01. Date modified: December 03, 2017 Last reviewed: April 07, 2016} Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Eli Lilly and Company Drug Class Interleukin inhibitors Related Drugs Plaque Psoriasis Humira , dexamethasone , methylprednisolone , betamethasone topical , Enbrel , Remicade , Otezla , adalimumab , calcipotriene topical , infliximab , etanercept , Cosentyx , Taclonex , Dovonex , Calcitrene , apremilast , Tremfya , Renflexis , Enstilar , secukinumab , Inflectra , Siliq , Erelzi , ixekizumab , More... Taltz Rating 37 User Reviews 7.6 /10 37 User Reviews 7.6 Rate it! Related Questions & Answers How does Taltz work? Taltz - How to have the dose and it costs?? Just started on taltz, started to get side effects but skin is better, do I need to stop? Read more questions} } most well known


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and feminine Jump to: What is a Concussion? Symptoms Concussion Research Treatment In the past few years, research about concussions and their link with depression, even suicide, in pro football players has understandably concerned parents of young athletes. Should they fear that their active young athletes may be jeopardizing their future health and setting themselves up for depression? In most cases, no, says Keith Yeates, PhD, professor of psychology, pediatrics and clinical neurosciences at the University of Calgary in Alberta. The vast majority of kids do recover pretty much on their own from concussion, he says. While the recovery period varies from person to person, most people talk about four weeks to twelve as a recovery timetable, says Yeates, who has researched the problem extensively. Concussions don t impact the kids as much as you [may] think, says Tim McGuine, PhD, ATC, a distinguished scientist at the University of Wisconsin School of Medicine and Public Health. He has a large database of 2,000 high school athletes he is following to study the impact of concussion on quality of life, including depression. So far, he has not found differences in depression between athletes who suffer a concussion and those who do not. Although long-term ill effects from concussions are not common, parents should should arm themselves with some facts. What is a Concussion? A concussion is a mild traumatic brain injury, caused by a blow, bump or jolt to the head that disrupts the brain s normal function. Not all blows or bumps cause a TBI, however. And a TBI, when it does occur, can be mild. According to the Centers for Disease Control and Prevention, TBI, as concussions are known medically, was the diagnosis in more than 282,000 hospitalizations and 2.5 million emergency department visits in 2013 (for people of all ages). From 2001 to 2012, the CDC says, the rate of ED visits for injuries related to sports or recreation related concussion more than doubled among children ages 19 and younger, the agency says. Another study, by FAIR Health, found that the increase in youth concussion grew 500% from 2010 to 2016. As to which sports are most likely to lead to concussions? Surveys and studies have come up with different results. But a study released in 2017 by the American Academy of Orthopaedic Surgeons has found that girls soccer teams suffered more concussions than even boys football. Boys baseball and girls volleyball had the greatest increase in concussions during the 10 years studied. What Are the Symptoms? Symptoms vary, and not all are present in each person. The symptoms can be grouped as physical, cognitive, emotional and sleep-related, according to experts at Nationwide Children s Hospital. Physical include headache, dizziness, problems with balance, vomiting and nausea, fatigue and light sensitivity. Cognitive include feeling foggy mentally, a feeling of being slow and difficult with concentrating, remembering or focusing. Emotional issues include irritability, sadness, nervousness and being more emotional than is usual. The emotional issues occur only occasionally, Yeates says, and are less likely to occur immediately. Instead, they can increase or become more noticeable with time. The usual timeline, frankly, doesn t involve significant emotional issues. Physical symptoms are much more common and more frequent, as are cognitive symptoms. Sleep problems include difficulty falling asleep or sleeping more or less than is usual. The symptoms sometimes come on right with the injury, but in other youth can take up to 48 hours or more. That s why it is crucial to monitor your child for up to 48 hours, looking out for danger signs that signal the concussion might be more serious. These include: a severe or increased headache, double vision, unequal pupils, convulsion, drowsiness that increases, clear fluid or blood discharge from the nose or ears, vomiting that is projectile or frequent, neck stiffness, severe personality changes, weakness in the arms or legs, numbness in extremities or the face. What the Research Shows While the research about pro athletes is scary, Yeates says worry about suicide occurring after youth concussion is usually unfounded. I wouldn t be worried about suicide unless you have a kid with a previous history of depression and suicidal ideation [thoughts], he says. I wouldn t be worried about clinical depression unless there is a previous history of psychiatric problems [such as depression]. With his colleagues, Yeates evaluated 30 previously published studies on outcomes after traumatic brain injuries, including concussion, in youth. They found that both psychological and psychiatric problems were more common after the concussion if the child had to be hospitalized, in those youth with previous psychiatric illness and with previous concussions. While some previous research has found that concussion in youth increases their risk overall of depression, Yeates says the studies have flaws in their methods. For their own research, Yeates team had a reassuring conclusion: for most, evidence suggests that problems don t persist beyond the typical recovery period. In one study, McGuine polled 973 high school athletes on quality of life and depression symptoms. Of the total, 261 reported they had had at least one concussion in the past two years or so. He found no differences in depression or quality of life between the groups. While a small percentage do have problems, he says by and large most don t. And, he adds, it isn t just athletes with concussion who may get down after the injury. He sees it, too, for instance, with athletes who have ankle sprains and can t return to play. What s the Best Course of Action? If you suspect a concussion, your child should be seen by a health care provider. Don t try to assess the injury yourself. Be sure the provider is up to date on concussions, as practices on how to manage them have evolved based on research, Yeates says. Many practices, such as keeping children in a dark room, are outdated, he says. In fact, Yeates says, that could have contributed to emotional issues after the injury. McGuine agrees. He recommends light activity as tolerated, usually four or five days later. The idea of no screen time, no school, not activity, that is going away. However, your child should not return to sports until cleared by a health care provider, experts agree. Yeates tells parents not to expect instant recovery. Some youth have symptoms that persist for two, three, even four weeks or longer. Management of concussion has changed as research has evolved, so it s important to find a health care provider who has kept up, experts agree. If symptoms don t resolve in four weeks, get a referral to a neuropsychologist, a neurologist or a sports medicine doctor, Yeates says, someone who knows about concussions. Article Sources 1. Nationwide Children s Hospital, A Parent s Guide to Concussions. http://www.nationwidechildrens.org/parents-guide-to-concussions 2. Centers for Disease Control and Prevention, TBI: Get the Facts. https://www.cdc.gov/traumaticbraininjury/get_the_facts.html 3. Emery, CA, et. al. A Systematic Review of Psychiatric, Psychological, and Behavioral Outcomes following Mild Traumatic Brain Injury in Children and Adolescents, Canadian Journal of Psychiatry, May 2016. https://www.ncbi.nlm.nih.gov/pubmed/27254800 4. FAIRHealth, Concussions in Children and Young Adults, 2016. http://www.fairhealth.org/servlet/servlet.FileDownload?file=01532000001niEG 5. CDC: A Fact Sheet for Youth Sports Parents. https://www.cdc.gov/headsup/pdfs/youthsports/parents_eng.pdf 6. American Academy of Orthopaedic Surgeons, press release, March 14, 2017. http://aaos-annualmeeting-presskit.org/2017/research-news/concussions_hsu/ 7. Tim McGuine, PhD, ATC, distinguished scientist, Sports Medicine Program, University of Wisconsin School of Medicine and Public Health, Madison. 8. National Athletic Trainers Association Meeting, June 26-9, 2017, Houston. Last Updated: Dec 5, 2017 to steer


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to make a choice from Crinone Generic Name: progesterone Dosage Form: vaginal gel Crinone 4% and Crinone 8% (progesterone gel) PHYSICIAN INFORMATION For Vaginal Use Only Rx only Content Updated: August 2014 Crinone Description Crinone (progesterone gel) is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system, which is contained in single use, polypropylene vaginal applicators. The carrier vehicle is an oil in water emulsion containing the water swellable, but insoluble polymer, polycarbophil. The progesterone is partially soluble in both the oil and water phase of the vehicle, with the majority of the progesterone existing as a suspension. Physically, Crinone has the appearance of a soft, white to off-white gel. The active ingredient, progesterone, is present in either a 4% or an 8% concentration (w/w). The chemical name for progesterone is pregn-4-ene-3,20-dione. It has an empirical formula of C 21 H 30 O 2 and a molecular weight of 314.5. The structural formula is: Progesterone exists in two polymorphic forms. Form 1, which is the form used in Crinone, exists as white orthorhombic prisms with a melting point of 127-131 C. Each applicator delivers 1.125 grams of Crinone gel containing either 45 mg (4% gel) or 90 mg (8% gel) of progesterone in a base containing glycerin, light mineral oil, polycarbophil, carbomer homopolymer Type B, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone - Clinical Pharmacology Progesterone is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. Progesterone is essential for the development of decidual tissue, and the effect of progesterone on the differentiation of glandular epithelia and stroma has been extensively studied. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain the pregnancy. Normal or near-normal endometrial responses to oral estradiol and intramuscular progesterone have been noted in functionally agonadal women through the sixth decade of life. Progesterone administration decreases the circulatory levels of gonadotropins. Pharmacokinetics Absorption Due to the sustained release properties of Crinone, progesterone absorption is prolonged with an absorption half-life of approximately 25 to 50 hours, and an elimination half-life of 5 to 20 minutes. Therefore, the pharmacokinetics of Crinone are rate-limited by absorption rather than by elimination. The bioavailability of progesterone in Crinone was determined relative to progesterone administered intramuscularly. In a single dose crossover study, 20 healthy, estrogenized postmenopausal women received 45 mg or 90 mg progesterone vaginally in Crinone 4% or Crinone 8%, or 45 mg or 90 mg progesterone intramuscularly. The pharmacokinetic parameters (mean standard deviation) are shown in Table 1. TABLE 1 Single Dose Relative Bioavailability Crinone 4% 45 mg Intramuscular Progesterone Crinone 8% 90 mg Intramuscular Progesterone C max - maximum progesterone serum concentration C avg 0-24 - average progesterone serum concentration over 24 hours AUC 0-96 - area under the drug concentration versus time curve from 0-96 hours post dose T max - time to maximum progesterone concentration t 1/2 - elimination half-life F - relative bioavailability C max (ng/mL) 13.15 6.49 39.06 13.68 14.87 6.32 53.76 14.9 C avg 0-24 (ng/mL) 6.94 4.24 22.41 4.92 6.98 3.21 28.98 8.75 AUC 0-96 (ng hr/mL) 288.63 273.72 806.26 102.75 296.78 129.90 1378.91 176.39 T max (hr) 5.6 1.84 8.2 6.43 6.8 3.3 9.2 2.7 t 1/2 (hr) 55.13 28.04 28.05 16.87 34.8 11.3 19.6 6.0 F (%) 27.6 19.8 The multiple dose pharmacokinetics of Crinone 4% and Crinone 8% administered every other day and Crinone 8% administered daily or twice daily for 12 days were studied in 10 healthy, estrogenized postmenopausal women in two separate studies. Steady state was achieved within the first 24 hours after initiation of treatment. The pharmacokinetic parameters (mean standard deviation) after the last administration of Crinone 4% or 8% derived from these studies are shown in Table 2. TABLE 2 Multiple Dose Pharmacokinetics Assisted Reproductive Technology Secondary Amenorrhea Daily Dosing 8% Twice Daily Dosing 8% Every Other Day Dosing 4% Every Other Day Dosing 8% C max (ng/mL) 15.97 5.05 14.57 4.49 13.21 9.46 13.67 3.58 C avg (ng/mL) 8.99 3.53 11.6 3.47 4.05 2.85 6.75 2.83 T max (hr) 5.40 0.97 3.55 2.48 6.67 3.16 7.00 2.88 AUC 0-t (ng hr/mL) 391.98 153.28 138.72 41.58 242.15 167.88 438.36 223.36 t 1/2 (hr) 45.00 34.70 25.91 6.15 49.87 31.20 39.08 12.88 Distribution Progesterone is extensively bound to serum proteins (~ 96-99%), primarily to serum albumin and corticosteroid binding globulin. Metabolism The major urinary metabolite of oral progesterone is 5β-pregnan-3α, 20α-diol glucuronide which is present in plasma in the conjugated form only. Plasma metabolites also include 5β-pregnan-3α-ol-20-one (5β-pregnanolone) and 5α-pregnan-3α-ol-20-one (5α-pregnanolone). Excretion Progesterone undergoes both biliary and renal elimination. Following an injection of labeled progesterone, 50-60% of the excretion of progesterone metabolites occurs via the kidney; approximately 10% occurs via the bile and feces, the second major excretory pathway. Overall recovery of labeled material accounts for 70% of an administered dose, with the remainder of the dose not characterized with respect to elimination. Only a small portion of unchanged progesterone is excreted in the bile. Clinical Studies Assisted Reproductive Technology In a single-center, open-label study (COL1620-007US), 99 women (aged 28-47 years) with either partial (n = 84) or premature ovarian failure (n = 15) who were candidates to receive a donor oocyte transfer as an Assisted Reproductive Technology ("ART") procedure were randomized to receive either Crinone 8% twice daily (n = 68) or intramuscular progesterone 100 mg daily (n = 31). The study was divided into three phases (Pilot, Donor Egg and Treatment). The first phase of the study consisted of a test Pilot Cycle to ensure that the administration of transdermal estradiol and progesterone would adequately prime the endometrium to receive the donor egg. The second phase was the Donor Egg Cycle during which a fertilized oocyte was implanted. Crinone 8% was administered beginning the evening of Day 14 of the Pilot and Donor Egg cycles. Subjects with partial ovarian function also underwent a Pre-Pilot Cycle and a Pre-Donor Egg Cycle during which time they were administered only leuprolide acetate to suppress remaining ovarian function. The Pre-Pilot Cycle, Pilot Cycle, Pre-Donor Egg Cycle, and Donor Egg Cycle each lasted approximately 34 days. The third phase of the study consisted of a 10-week treatment period to maintain a pregnancy until placental autonomy was achieved. Sixty-one women received Crinone 8% as part of the Pilot Cycle to determine their endometrial response. Of the 55 evaluable endometrial biopsies in the Crinone 8% group performed on Day 25 to 27, all were histologically "in-phase", consistent with luteal phase biopsy specimens of menstruating women at comparable time intervals. Fifty-four women who received Crinone 8% and had a histologically "in-phase" biopsy received a donor oocyte transfer. Among these 54 Crinone-treated women, clinical pregnancies (assessed about week 10 after transfer by clinical examination, ultrasound and/or ß-hCG levels) occurred in 26 women (48%). Seventeen women (31%) delivered a total of 25 newborns, seven women (13%) had spontaneous abortions and two women (4%) had elective abortions. In a second study (COL1620-F01), Crinone 8% was used in luteal phase support of women with tubal or idiopathic infertility due to endometriosis and normal ovulatory cycles, undergoing in vitro fertilization ("IVF") procedures. All women received a GnRH analog to suppress endogenous progesterone, human menopausal gonadotropins, and human chorionic gonadotropin. In this multi-center, open-label study, 139 women (aged 22-38 years) received Crinone 8% once daily beginning within 24 hours of embryo transfer and continuing through Day 30 post-transfer. Clinical pregnancies assessed at Day 90 post-transfer were seen in 36 (26%) of women. Thirty-two women (23%) delivered newborns and four women (3%) had spontaneous abortions. (See PRECAUTIONS, Pregnancy ) Secondary Amenorrhea In three parallel, open-label studies (COL1620-004US, COL1620-005US, COL1620-009US), 127 women (aged 18-44) with hypothalamic amenorrhea or premature ovarian failure were randomized to receive either Crinone 4% (n = 62) or Crinone 8% (n = 65). All women were treated with either conjugated estrogens 0.625 mg daily (n = 100) or transdermal estradiol (delivering 50 mcg/day) twice weekly (n = 27). Estrogen therapy was continuous for the entire three 28-day cycle studies. At Day 15 of the second cycle (six weeks after initiating estrogen replacement), women who demonstrated adequate response to estrogen therapy (by ultrasound) and who continued to be amenorrheic received Crinone every other day for six doses (Day 15 through Day 25 of the cycle). In cycle 2, Crinone 4% induced bleeding in 79% of women and Crinone 8% induced bleeding in 77% of women. In the third cycle, estrogen was continued and Crinone was administered every other day beginning on Day 15 for six doses. On Day 24 an endometrial biopsy was performed. In 53 women who received Crinone 4%, biopsy results were as follows: 7% proliferative, 40% late secretory, 19% mid secretory, 13% early secretory, 7% atrophic, 6% menstrual endometrium, 6% inactive endometrium and 2% negative endometrium. In 54 women who received Crinone 8%, biopsy results were as follows: 44% late secretory, 19% mid secretory, 11% early secretory, 19% atrophic, 5% menstrual endometrium and 2% "oral contraceptive like" endometrium. Indications and Usage for Crinone Assisted Reproductive Technology Crinone 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency. Secondary Amenorrhea Crinone 4% is indicated for the treatment of secondary amenorrhea. Crinone 8% is indicated for use in women who have failed to respond to treatment with Crinone 4%. Contraindications Crinone should not be used in individuals with any of the following conditions: Known sensitivity to Crinone (progesterone or any of the other ingredients) Undiagnosed vaginal bleeding Liver dysfunction or disease Known or suspected malignancy of the breast or genital organs Missed abortion Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders Warnings The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately. Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses. No adequate evidence is available to show that they are effective for this purpose. Precautions General The pretreatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear. In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, nonfunctional causes should be considered. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken. Because progestogens may cause some degree of fluid retention, conditions which might be influenced by this factor (e.g., epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation. The pathologist should be advised of progesterone therapy when relevant specimens are submitted. Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree. A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen-progestin combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progestin therapy. Information for Patients The product should not be used concurrently with other local intravaginal therapy. If other local intravaginal therapy is to be used concurrently, there should be at least a 6-hour period before or after Crinone administration. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after usage. Drug Interactions No drug interactions have been assessed with Crinone. Carcinogenesis, Mutagenesis, Impairment of Fertility Nonclinical toxicity studies to determine the potential of Crinone to cause carcinogenicity or mutagenicity have not been performed. The effect of Crinone on fertility has not been evaluated in animals. Pregnancy [See CLINICAL STUDIES, Assisted Reproductive Technology ] Crinone 8% has been used to support embryo implantation and maintain pregnancies through its use as part of ART treatment regimens in two clinical studies (studies COL1620-007US and COL1620-F01). In the first study (COL1620-007US), 54 Crinone-treated women had donor oocyte transfer procedures, and clinical pregnancies occurred in 26 women (48%). The outcomes of these 26 pregnancies were as follows: one woman had an elective termination of pregnancy at 19 weeks due to congenital malformations (omphalocele) associated with a chromosomal abnormality; one woman pregnant with triplets had an elective termination of her pregnancy; seven women had spontaneous abortions; and 17 women delivered 25 apparently normal newborns. In the second study (COL1620-F01), Crinone 8% was used in the luteal phase support of women undergoing in vitro fertilization ("IVF") procedures. In this multi-center, open-label study, 139 women received Crinone 8% once daily beginning within 24 hours of embryo transfer and continuing through Day 30 post-transfer. Clinical pregnancies assessed at Day 90 post-transfer were seen in 36 (26%) of women. Thirty-two women (23%) delivered newborns and four women (3%) had spontaneous abortions. Of the 47 newborns delivered, one had a teratoma associated with a cleft palate; one had respiratory distress syndrome; 44 were apparently normal and one was lost to follow-up. Geriatric Use The safety and effectiveness in geriatric patients (over age 65) have not been established. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Nursing Mothers Detectable amounts of progestins have been identified in the milk of mothers receiving them. The effect of this on the nursing infant has not been determined. Adverse Reactions Assisted Reproductive Technology In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Crinone 8% twice daily, treatment-emergent adverse events occurring in 5% or more of the women are shown in Table 3. TABLE 3 Treatment-Emergent Adverse Events in 5% of Women Receiving Crinone 8% Twice Daily Study COL1620-007US (n = 61) Body as a Whole Bloating 7% Cramps NOS 15% Pain 8% Central and Peripheral Nervous System Dizziness 5% Headache 13% Gastro-Intestinal System Nausea 7% Reproductive, Female Breast Pain 13% Moniliasis Genital 5% Vaginal Discharge 7% Skin and Appendages Pruritus Genital 5% In a second clinical study of 139 women using Crinone 8% once daily for luteal phase support while undergoing an in vitro fertilization procedure, treatment-emergent adverse events reported in 5% of the women are shown in Table 4. TABLE 4 Treatment-Emergent Adverse Events in 5% of Women Receiving Crinone 8% Once Daily Study COL1620-F01 (n = 139) Body as a Whole Abdominal Pain 12% Perineal Pain Female 17% Central and Peripheral Nervous System Headache 17% Gastro-Intestinal System Constipation 27% Diarrhea 8% Nausea 22% Vomiting 5% Musculo-Skeletal System Arthralgia 8% Psychiatric Depression 11% Libido Decreased 10% Nervousness 16% Somnolence 27% Reproductive, Female Breast Enlargement 40% Dyspareunia 6% Urinary System Nocturia 13% Secondary Amenorrhea In three studies, 127 women with secondary amenorrhea received estrogen replacement therapy and Crinone 4% or 8% every other day for six doses. Treatment-emergent adverse events during estrogen and Crinone treatment that occurred in 5% or more of women are shown in Table 5. TABLE 5 Treatment-Emergent Adverse Events in 5% of Women Receiving Estrogen Treatment and Crinone Every Other Day Studies COL1620-004US, COL1620-005US, COL1620-009US Estrogen + Crinone 4% n = 62 Estrogen + Crinone 8% n = 65 Body as a Whole Abdominal Pain 3 (5%) 6 (9%) Appetite Increased 3 (5%) 5 (8%) Bloating 8 (13%) 8 (12%) Cramps NOS 12 (19%) 17 (26%) Fatigue 13 (21%) 14 (22%) Central and Peripheral Nervous System Headache 12 (19%) 10 (15%) Gastro-Intestinal System Nausea 5 (8%) 4 (6%) Musculo-Skeletal System Back Pain 5 (8%) 2 (3%) Myalgia 5 (8%) 0 (0%) Psychiatric Depression 12 (19%) 10 (15%) Emotional Lability 14 (23%) 14 (22%) Sleep Disorder 11 (18%) 12 (18%) Reproductive, Female Vaginal Discharge 7 (11%) 2 (3%) Resistance Mechanism Upper Respiratory Tract Infection 3 (5%) 5 (8%) Skin and Appendages Pruritus Genital 1 (2%) 4 (6%) Overdosage There have been no reports of overdosage with Crinone. In the case of overdosage, however, discontinue Crinone, treat the patient symptomatically, and institute supportive measures. As with all prescription drugs, this medicine should be kept out of the reach of children. Crinone Dosage and Administration Assisted Reproductive Technology Crinone 8% is administered vaginally at a dose of 90 mg once daily in women who require progesterone supplementation. Crinone 8% is administered vaginally at a dose of 90 mg twice daily in women with partial or complete ovarian failure who require progesterone replacement. If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10 to 12 weeks. Secondary Amenorrhea Crinone 4% is administered vaginally every other day up to a total of six doses. For women who fail to respond, a trial of Crinone 8% every other day up to a total of six doses may be instituted. It is important to note that a dosage increase from the 4% gel can only be accomplished by using the 8% gel. Increasing the volume of gel administered does not increase the amount of progesterone absorbed. How is Crinone Supplied Crinone is available in the following strengths: 4% gel (45 mg) in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator contains 1.3 g of gel and delivers 1.125 g of gel. NDC 52544-255-24: 6 Single-use prefilled applicators. 8% gel (90 mg) in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator contains 1.3 g of gel and delivers 1.125 g of gel. NDC 52544-256-12: 15 Single-use prefilled applicators. Each applicator is wrapped and sealed in a foil overwrap. Store at 20-25ºC (68-77ºF). [See USP controlled room temperature.] Keep out of reach of children. Rx only For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Distributed By: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Content Updated: August 2014 202084-01 PATIENT INFORMATION Crinone 4% and Crinone 8% (progesterone gel) For Vaginal Use Only Please read this information carefully before you start to use Crinone and each time your prescription is renewed, in case anything has changed. This leaflet does not take the place of discussions with your doctor. If you still have any questions, ask your doctor or healthcare provider. What is Crinone? Crinone is medicine that contains the female hormone called progesterone. What is Crinone used for? Crinone 4% and Crinone 8% are used to treat the absence of a menstrual period in a woman who has previously had a menstrual period. Progesterone is one of the hormones that allows women to have regular menstrual periods. When you do not produce enough progesterone, menstrual irregularities can occur. Crinone may be prescribed to increase your progesterone. Crinone 8% is also used as part of a program for women who are undergoing fertility treatments to get pregnant. Progesterone is one of the hormones that helps to prepare the lining of your uterus so that it is ready to receive and nourish a fertilized egg and to continue a pregnancy. If you are undergoing ART treatment and your doctor has determined your body does not produce enough progesterone on its own, Crinone may be prescribed to increase your progesterone. If pregnancy occurs, Crinone may be supplemented for 10 to 12 weeks until production of progesterone by the placenta is adequate. Who should not use Crinone? Do not start using Crinone if you: Are allergic to progesterone, progesterone-like drugs, or any of the inactive ingredients in the gel (ask a pharmacist if you are not sure about the inactive ingredients in Crinone). Have unusual vaginal bleeding which has not been evaluated by a doctor. Have or have had a liver disease. Have or have had cancer of the breast or genital organs. Have had a miscarriage and your physician suspects some tissue is still in the uterus. Have or have had blood clots in the legs, lungs, eyes, or elsewhere. What are the possible side effects of Crinone? Serious side effects include: Blood clots. Progestational drug products may increase your chance of having blood clots in your blood vessels. Blood clots can cause: blood vessel problems (thrombophlebitis) stroke loss of your arm or leg blood clot in your lungs (pulmonary embolus) heart attack death Birth defects. Abdominal wall defect and cleft palate have been reported with Crinone use in early pregnancy. It is not known if these defects were caused by Crinone. Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: Pains in the calves or chest, a sudden shortness of breath or coughing blood indicating possible clots in the legs, heart, or lungs. Severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg indicating possible clots in the brain or eye. Common side effects include: abdominal pain perineal pain (the perineum is the area between the vagina and the rectum) cramps bloating headache fatigue increased appetite contstipation diarrhea nausea joint pain depression mood swings sleep disorder nervousness decreased libido breast enlargement excessive urination at night vaginal discharge upper respiratory tract infection These are not all the possible side effects of Crinone. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I use Crinone? Use as directed by your healthcare provider. Read the Instructions for Use included in this leaflet for information on the right way to use Crinone. Additional information about Crinone You may see a small amount of white discharge that may look like a vaginal discharge. This discharge may be caused by gel that can remain in your vagina, even several days after use. Gel discharge from your vagina is normal, but if you are concerned, talk to your healthcare provider. If you miss a dose of Crinone, use it as soon as you remember. Do not use more Crinone than the dose prescribed by your doctor. Talk to your healthcare provider about whether to use other vaginal medicines when you are using Crinone. General information about the safe and effective use of Crinone Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Crinone for another condition. Your doctor has prescribed this drug for you and you alone. Do not give this drug to anyone else, even if they have the same condition. Keep Crinone out of the reach of children This leaflet provides the most important information about Crinone. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Crinone that is written for health professionals. You can get more information by calling the toll free number 1-888-776-4358 or visit www.Crinoneusa.com . What are the ingredients in Crinone? Crinone contains either 45 mg (4% gel) or 90 mg (8% gel) of progesterone in a base containing glycerin, light mineral oil, polycarbophil, carbomer homopolymer Type B, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. How should I store Crinone? Store Crinone at room temperature between 68 F to 77 F (20 C to 25 C). Do not use Crinone after the expiration date printed on the box. INSTRUCTIONS FOR USE Crinone 4% and Crinone 8% ("KRI-noan") (progesterone gel) For Vaginal Use Only You will need the following supplies: See Figure A. Step 1. Remove the applicator from the sealed wrapper. Open the sealed wrapper and remove the applicator. Do not remove the twist-off cap at this time. See Figure B. Step 2. Insert the plunger into the open end of the applicator. See Figure C. Hold the applicator on each side and push the plunger into the applicator until the plunger snaps into place. You will see about 1 inch of the plunger outside of the applicator. Step 3. Remove the cap. See Figures D and E. Remove the cap from the tip of the applicator by twisting it counterclockwise. Do not push the plunger while you are removing the cap. This could cause some gel to come out. Step 4. Prepare to insert the applicator. See Figure F. Choose the position that is most comfortable for you. For example, lying down on your back with your knees bent. Step 5. Insert the applicator. See Figure G. After you are in a comfortable position, gently insert the rounded tip of the applicator into your vagina. Step 6. Push the plunger. See Figure H. While the applicator is inserted in your vagina, push the plunger to release the gel into your vagina. Step 7. Remove the applicator from your vagina and throw it away in your household trash. It is normal for a small amount of gel to be left in the applicator. You will still get the right dose of medicine. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Rx only For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Distributed By: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Content Updated: August 2014 202084-01 PRINCIPAL DISPLAY PANEL Crinone 4% (progesterone gel) Carton x 6 Single-Use Prefilled Applicators NDC 52544-283-24 Crinone 4% (progesterone gel) Carton x 6 Single-Use Prefilled Applicators NDC 52544-283-24 PRINCIPAL DISPLAY PANEL Crinone 8% (progesterone gel) Carton x 15 Single-Use Prefilled Applicators NDC 52544-284-12 Crinone 8% (progesterone gel) Carton x 15 Single-Use Prefilled Applicators NDC 52544-284-12 PRINCIPAL DISPLAY PANEL Crinone 4% (progesterone gel) Carton x 6 Single-Use Prefilled Applicators NDC 52544-255-24 Crinone 4% (progesterone gel) Carton x 6 Single-Use Prefilled Applicators NDC 52544-255-24 PRINCIPAL DISPLAY PANEL Crinone 8% (progesterone gel) Carton x 15 Single-Use Prefilled Applicators NDC 52544-256-12 Crinone 8% (progesterone gel) Carton x 15 Single-Use Prefilled Applicators NDC 52544-256-12 Crinone progesterone gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52544-283 Route of Administration VAGINAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROGESTERONE (PROGESTERONE) PROGESTERONE 45 mg in 1.125 g Inactive Ingredients Ingredient Name Strength GLYCERIN MINERAL OIL POLYCARBOPHIL CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) HYDROGENATED PALM OIL SORBIC ACID WATER Packaging # Item Code Package Description 1 NDC:52544-283-24 6 APPLICATOR in 1 CARTON 1 1.125 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020701 05/13/1997 Crinone progesterone gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52544-284 Route of Administration VAGINAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROGESTERONE (PROGESTERONE) PROGESTERONE 90 mg in 1.125 g Inactive Ingredients Ingredient Name Strength GLYCERIN MINERAL OIL POLYCARBOPHIL CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) HYDROGENATED PALM OIL SORBIC ACID WATER SODIUM HYDROXIDE Packaging # Item Code Package Description 1 NDC:52544-284-02 2 APPLICATOR in 1 CARTON 1 1.125 g in 1 APPLICATOR 2 NDC:52544-284-12 15 APPLICATOR in 1 CARTON 2 1.125 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020701 05/13/1997 Crinone progesterone gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52544-255 Route of Administration VAGINAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROGESTERONE (PROGESTERONE) PROGESTERONE 45 mg in 1.125 g Inactive Ingredients Ingredient Name Strength GLYCERIN LIGHT MINERAL OIL POLYCARBOPHIL CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) HYDROGENATED PALM OIL SORBIC ACID WATER SODIUM HYDROXIDE Packaging # Item Code Package Description 1 NDC:52544-255-24 6 APPLICATOR in 1 CARTON 1 1.125 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020701 05/13/1997 Crinone progesterone gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52544-256 Route of Administration VAGINAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROGESTERONE (PROGESTERONE) PROGESTERONE 90 mg in 1.125 g Inactive Ingredients Ingredient Name Strength GLYCERIN LIGHT MINERAL OIL POLYCARBOPHIL CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) HYDROGENATED PALM OIL SORBIC ACID WATER SODIUM HYDROXIDE Packaging # Item Code Package Description 1 NDC:52544-256-12 15 APPLICATOR in 1 CARTON 1 1.125 g in 1 APPLICATOR 2 NDC:52544-256-02 2 APPLICATOR in 1 CARTON 2 1.125 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020701 05/13/1997 Labeler - Actavis Pharma, Inc. (119723554) Revised: 08/2014 Actavis Pharma, Inc. Print this page} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More} } surgical procedure


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