old enough Sitavig (Buccal mucosa) the child

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abruptly Sitavig (Buccal mucosa) Generic Name: acyclovir (Buccal mucosa route) ay-SYE-kloe-vir Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons Commonly used brand name(s) In the U.S. Sitavig Available Dosage Forms: Tablet Therapeutic Class: Antiviral Pharmacologic Class: Viral DNA Polymerase Inhibitor Chemical Class: Guanosine Nucleoside Analog Slideshow Prednisone: 12 Things You Should Know Uses For Sitavig Acyclovir buccal tablet is used to treat the symptoms of herpes simplex virus infection on the lips and around the mouth (cold sores) in adults with normal immune systems. Although this medicine will not cure herpes simplex, it may help the sores to heal faster and relieve some of the pain and discomfort. Acyclovir is an antiviral agent (treats a virus). This medicine is available only with your doctor's prescription. Before Using Sitavig 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 acyclovir buccal tablets in the pediatric population. Safety and efficacy have not been established. Use in younger children is not recommended due to the potential risk of choking. Geriatric Although appropriate studies on the relationship of age to the effects of acyclovir buccal tablets have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding Studies in women suggest that this medication poses minimal risk to the infant when used during 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 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. Foscarnet 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. Fosphenytoin Mycophenolate Mofetil Mycophenolic Acid Phenytoin Valproic Acid 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. 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: Allergy to milk protein concentrate Should not be used in patients with this condition. Weak immune system This medicine may not be safe to use in patients with this condition. Proper Use of Sitavig Use this medicine exactly as directed by your doctor to benefit your condition as much as possible. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. This medicine is only for cold sores on the lips and around the mouth . To use: Peel the blister back to remove the tablet. Do not push the tablet through the blister as this may damage the tablet. Use this medicine within 1 hour after you have the first symptom of a cold sore, such as itching, redness, burning, or tingling, and before a cold sore begins. Place the tablet in the mouth, on the upper gum above the incisor tooth, with a clean, dry finger. Press on the upper lip lightly for 30 seconds to ensure adhesion. For comfort, place the rounded side of the tablet facing the upper gum The tablet will dissolve slowly during the day. Do not crush, chew, suck, or swallow the tablet. Apply the tablet on the same side of the mouth with the cold sores symptoms. You may eat and drink while the tablet is in placed on your upper gums. Drink more liquids if your mouth becomes dry while using this medicine. Avoid chewing gums, touching or pressing the tablet after it is placed, wearing upper dentures, or brushing your teeth while using this medicine. Do not remove the tablet if it sticks to your upper gum. If the tablet does not stick or falls off of your upper gum within the first 6 hours that you have applied, use the same tablet and place it back onto your upper gum. If it still does not stick, replace it with a new tablet. If you swallow the tablet within the first 6 hours of applying it, drink a glass of water and place a new tablet on your upper gum. Do not reapply a new tablet if it falls out or if you swallow it after it has been placed 6 hours or longer. 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 buccal dosage form (tablets): For cold sores: Adults 50 milligrams (mg) as a single dose. Children Use and dose must be determined by your doctor. Use in younger children is not recommended due to the potential risk of choking. 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 Sitavig It is very important that your doctor check your progress after you use this medicine to see if it is working properly. If your symptoms do not improve within a few days, or if they become worse, check with your doctor. Sitavig 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: Less common Canker sores pain in the gums sores, ulcers, or white spots on the tongue or inside the mouth 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 Flushing or redness of the skin rash unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness unusually warm skin 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 Sitavig (acyclovir) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Espaรฑol 8 Reviews Add your own review/rating Drug class: purine nucleosides Consumer resources Sitavig Other brands: Zovirax Professional resources Sitavig (FDA) Acyclovir Sodium (AHFS Monograph) Related treatment guides Cold Sores} 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 Drug Class Purine nucleosides Related Drugs Cold Sores acyclovir , valacyclovir , Valtrex , Zovirax , famciclovir , Famvir , Denavir , tetracaine topical , benzocaine topical , Orabase , Zovirax Ointment , Zovirax Cream , Pontocaine , penciclovir topical , benzyl alcohol topical , Xerese , Kank-a , More... Sitavig Rating 8 User Reviews 8.6 /10 8 User Reviews 8.6 Rate it! Related Questions & Answers How long after taking sitavig should I wiat before getting the shingle shot? Read more questions} } wind up


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our children Sitagliptin and Metformin Tablets Generic Name: Sitagliptin and Metformin Tablets sit a GLIP tin & met FOR min Brand Name: Janumet Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Warning Rarely, metformin may cause an acid health problem in the blood (lactic acidosis). The risk of lactic acidosis is higher in people with kidney problems and in people who take certain other drugs like topiramate. The risk is also higher in people with liver problems or heart failure, in older people (65 or older), or with alcohol use. If lactic acidosis happens, it can lead to other health problems and can be deadly. Lab tests to check the kidneys may be done while taking this medicine (sitagliptin and metformin tablets). Talk with the doctor. Call your doctor right away if you have signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast or slow heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps. Do not take this medicine if you have a very bad infection, low oxygen, or a lot of fluid loss (dehydration). If you have liver disease, talk with your doctor. Talk with your doctor before you drink alcohol. If you are having an exam or test with contrast or have had one within the past 48 hours, talk with your doctor. Tell all of your health care providers that you take this medicine (sitagliptin and metformin tablets). This includes your doctors, nurses, pharmacists, and dentists. Uses of Sitagliptin and Metformin Tablets: It is used to lower blood sugar in patients with high blood sugar (diabetes). Slideshow Ladies A Moment: 10 Health Screenings That All Women Need What do I need to tell my doctor BEFORE I take Sitagliptin and Metformin Tablets? If you have an allergy to sitagliptin, metformin, or any other part of this medicine. 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: Acidic blood problem, kidney disease, liver disease, or type 1 diabetes. If you have had a recent heart attack or stroke. If you are not able to eat or drink like normal, including before certain procedures or surgery. This is not a list of all drugs or health problems that interact with this medicine (sitagliptin and metformin tablets). 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 this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. What are some things I need to know or do while I take Sitagliptin and Metformin Tablets? Tell all of your health care providers that you take this medicine (sitagliptin and metformin tablets). This includes your doctors, nurses, pharmacists, and dentists. Do not drive if your blood sugar has been low. There is a greater chance of you having a crash. Check your blood sugar as you have been told by your doctor. Have blood work checked as you have been told by the doctor. Talk with the doctor. Low blood sugar can happen. The chance of low blood sugar may be raised when this medicine is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices. It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor. Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss. Follow the diet and workout plan that your doctor told you about. If you have been taking this medicine (sitagliptin and metformin tablets) for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine stops working well. Do not take more than ordered. A skin reaction called bullous pemphigoid has happened with drugs like this one. Sometimes, people have had to go to the hospital. Call your doctor right away if you have blisters or if your skin starts to break down. Heart failure has happened in people taking drugs like this one. Tell your doctor if you have ever had heart failure or kidney problems. Call your doctor right away if you feel very tired or you have shortness of breath, a big weight gain, or swelling in the arms or legs. If you are 65 or older, use this medicine (sitagliptin and metformin tablets) with care. You could have more side effects. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine 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 (Sitagliptin and Metformin Tablets) best taken? Use this medicine (sitagliptin and metformin tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take with meals. Do not split or break tablet. Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well. To gain the most benefit, do not miss doses. What do I do if I miss a dose? 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. 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. Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain. Chest pain or pressure. Fever or chills. Sore throat. Very bad and sometimes deadly pancreas problems (pancreatitis) have happened with this medicine (sitagliptin and metformin tablets). This could happen at any time during care. Signs of pancreatitis include very bad stomach pain, very bad back pain, or very upset stomach or throwing up. Call your doctor right away if you have any of these signs. It is common to have stomach problems like upset stomach, throwing up, or loose stools (diarrhea) when you start taking this medicine. If you have stomach problems later during care, call your doctor right away. This may be a sign of an acid health problem in the blood (lactic acidosis). A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes. Drugs like this one may cause joint pain that can be very bad and disabling. Call your doctor right away if you have very bad joint pain or any joint pain that does not go away. What are some other side effects of Sitagliptin and Metformin Tablets? 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 any of these side effects or any other side effects bother you or do not go away: Belly pain. Upset stomach or throwing up. Loose stools (diarrhea). Gas. Feeling tired or weak. Headache. Sore throat. Stuffy nose. Runny nose. 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 Sitagliptin and Metformin Tablets? Store at room temperature. 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. This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (sitagliptin and metformin tablets) is refilled. If you have any questions about this medicine, please talk with the doctor, 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 (sitagliptin and metformin tablets) 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine (sitagliptin and metformin tablets). 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 this medicine. Review Date: November 1, 2017 Next Side Effects Print this page Add to My Med List More about metformin/sitagliptin Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Espaรฑol 47 Reviews Add your own review/rating Drug class: antidiabetic combinations Consumer resources Metformin and sitagliptin Sitagliptin and Metformin Extended-Release Tablets Sitagliptin and metformin (Advanced Reading) Other brands: Janumet , Janumet XR Professional resources Sitagliptin and Metformin (Wolters Kluwer) Related treatment guides Diabetes, Type 2} 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 Metformin / sitagliptin Rating 47 User Reviews 6.6 /10 47 User Reviews 6.6 Rate it! Manufacturer Macleods Pharmaceuticals Limited Drug Class Antidiabetic combinations Related Drugs Diabetes, Type 2 metformin , insulin aspart , glipizide , glimepiride , Januvia , pioglitazone , Victoza , Actos , Tradjenta , Glucophage , glyburide , Janumet , Invokana , Amaryl , Welchol , Onglyza , sitagliptin , Trulicity , Jardiance , Lantus , Farxiga , Levemir , Tresiba , Glucotrol , Bydureon , More...} } gives you


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to combustible [30:<60 mL/minute) which may result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia; unstable and/or insulin-dependent (type 1) diabetes mellitus (IDDM); history of ketoacidosis (with or without coma); history of lactic acidosis, regardless of precipitating factors; acute or chronic excessive alcohol intake; severe hepatic disease; cardiovascular collapse and disease states associated with hypoxemia (eg, cardiorespiratory insufficiency) which are often associated with hyperlactacidemia; use during stress conditions (eg, severe infection, trauma, surgery) and the recovery phase thereafter; severe dehydration; breast-feeding; pregnancy Dosing: Adult Diabetes mellitus, type 2: Oral: Initial doses should be based on the current dose of sitagliptin and metformin; titrate gradually per glycemic response. Total daily dose should be administered in 2 equally divided doses (immediate-release tablets) or once daily (extended-release tablets). Maximum dose: Sitagliptin 100 mg/metformin 2,000 mg per day. Patients already on metformin: Initial: Sitagliptin 100 mg/day plus current daily dose of metformin. Patients currently on metformin 1,700 mg/day (eg, 850 mg twice daily) may receive an initial dose of sitagliptin 100 mg/metformin 2,000 mg per day. Patients not on metformin: Initial: Sitagliptin 100 mg/metformin 1,000 mg per day. Conversion from immediate release to extended release: Convert using same total daily dose (up to the maximum recommended dose), but adjust frequency as indicated for immediate (twice daily) or extended (once daily) release products. Dosage adjustment for concomitant therapy: Patients receiving concomitant insulin and/or insulin secretagogues (eg, sulfonylureas) may require dosage adjustments of these agents. Dosing: Geriatric Refer to adult dosing. The initial and maintenance dosing should be conservative, due to the potential for decreased renal function (monitor). Dosing: Renal Impairment eGFR> 45 mL/minute/1.73 m 2 : No dosage adjustment necessary; monitor renal function at least annually. eGFR 30 to 45 mL/minute/1.73 m 2 : Use is not recommended for initiation of therapy; if eGFR falls to <45 mL/minute/1.73 m 2 during therapy, consider benefits/risks of continuing therapy and limit sitagliptin dose to 50 mg once daily (immediate-release products available will not accommodate this dose and are not recommended). eGFR> <30 mL/minute/1.73 m 2 : Use is contraindicated. Dosing: Hepatic Impairment The manufacturer recommends to avoid metformin since liver disease is considered a risk factor for the development of lactic acidosis during metformin therapy. However, continued use of metformin in diabetics with liver dysfunction, including cirrhosis, has been used successfully and may be associated with a survival benefit in carefully selected patients; use cautiously in patients at risk for lactic acidosis (eg, renal impairment, alcohol use) (Brackett 2010; Zhang 2014). Use of sitagliptin in patients with severe hepatic impairment has not been studied. Administration Oral: Administer with meals, at the same time each day (preferably with the evening meal for extended-release tablets). Swallow extended-release tablets whole; do not split, crush, or chew; do not split or divide immediate release tablets. Dietary Considerations Should be taken with meals (to decrease GI upset). Take at the same time each day. Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral part of therapy. Monitor for signs and symptoms of vitamin B 12 and/or folic acid deficiency; supplementation may be required. Storage Store at 20 C to 25 C (68 F to 77 F); excursions permitted to 15 C to 30 C (59 F to 86 F). Drug Interactions Abemaciclib: May increase the serum concentration of MetFORMIN. Monitor therapy Alcohol (Ethyl): May enhance the adverse/toxic effect of MetFORMIN. Specifically, alcohol may potentiate the risk of lactic acidosis Avoid combination Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Monitor therapy BuPROPion: May increase the serum concentration of OCT2 Substrates. Monitor therapy Carbonic Anhydrase Inhibitors: May enhance the adverse/toxic effect of MetFORMIN. Specifically, the risk of developing lactic acidosis may be increased. Exceptions: Brinzolamide; Dorzolamide. Monitor therapy Cephalexin: May increase the serum concentration of MetFORMIN. Monitor therapy Cimetidine: May increase the serum concentration of MetFORMIN. Management: Consider alternatives to cimetidine in patients receiving metformin due to a potential for increased metformin concentrations and toxicity (including lactic acidosis). Consider therapy modification Dalfampridine: MetFORMIN may increase the serum concentration of Dalfampridine. Dalfampridine may increase the serum concentration of MetFORMIN. Monitor therapy Digoxin: SITagliptin may increase the serum concentration of Digoxin. Monitor therapy Dofetilide: MetFORMIN may increase the serum concentration of Dofetilide. Monitor therapy Dolutegravir: May increase the serum concentration of MetFORMIN. Management: Limit the daily metformin dose to 1,000 mg when used together with dolutegravir. Metformin dose adjustments may also be needed upon discontinuation of dolutegravir. Monitor patient response to metformin closely. Consider therapy modification Glycopyrrolate (Systemic): May increase the serum concentration of MetFORMIN. Monitor therapy Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy Insulins: Dipeptidyl Peptidase-IV Inhibitors may enhance the hypoglycemic effect of Insulins. Management: Consider a decrease in insulin dose when initiating therapy with a dipeptidyl peptidase-IV inhibitor and monitor patients for hypoglycemia. Consider therapy modification Iodinated Contrast Agents: May enhance the adverse/toxic effect of MetFORMIN. Renal dysfunction that may be caused by iodinated contrast agents may lead to metformin-associated lactic acidosis. Management: Management advice varies. Refer to the full drug interaction monograph content for details. Exceptions: Diatrizoate Meglumine; Diatrizoate Sodium; Ethiodized Oil. Consider therapy modification Isavuconazonium Sulfate: May increase the serum concentration of MetFORMIN. Monitor therapy LamoTRIgine: May increase the serum concentration of MetFORMIN. Management: The lamotrigine Canadian product monograph states that coadministration of these drugs is not recommended. Monitor therapy Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy Ombitasvir, Paritaprevir, and Ritonavir: May enhance the adverse/toxic effect of MetFORMIN. Specifically, the risk for lactic acidosis may be increased. Monitor therapy Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir: May enhance the adverse/toxic effect of MetFORMIN. Specifically, the risk for lactic acidosis may be increased. Monitor therapy Ondansetron: May increase the serum concentration of MetFORMIN. Monitor therapy Patiromer: May decrease the serum concentration of MetFORMIN. Management: Administer metformin at least 3 hours before or 3 hours after patiromer. Consider therapy modification Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy Prothionamide: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy Quinolones: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolones may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy Ranolazine: May increase the serum concentration of MetFORMIN. Management: Limit the metformin dose to a maximum of 1700 mg/day when used together with ranolazine 1000 mg twice daily. Consider therapy modification Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy Sulfonylureas: Dipeptidyl Peptidase-IV Inhibitors may enhance the hypoglycemic effect of Sulfonylureas. Management: Consider a decrease in sulfonylurea dose when initiating therapy with a dipeptidyl peptidase-IV inhibitor and monitor patients for hypoglycemia. Consider therapy modification Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy Topiramate: May enhance the adverse/toxic effect of MetFORMIN. Monitor therapy Trimethoprim: May increase the serum concentration of MetFORMIN. Monitor therapy Trospium: MetFORMIN may decrease the serum concentration of Trospium. Monitor therapy Vandetanib: May increase the serum concentration of MetFORMIN. Monitor therapy Verapamil: May diminish the therapeutic effect of MetFORMIN. Monitor therapy Adverse Reactions Also see individual agents. 1% to 10%: Central nervous system: Headache (6%) Gastrointestinal: Diarrhea (8%), nausea (5%), abdominal pain (3%), vomiting (2%) Respiratory: Upper respiratory tract infection (6%)> <1% (Limited to important or life-threatening): Hypersensitivity reaction (including anaphylaxis, angioedema, skin rash, urticaria, hypersensitivity angiitis, exfoliative skin conditions [including Stevens-Johnson syndrome]), lactic acidosis, pancreatitis (including hemorrhagic or necrotizing), pemphigoid, renal failure, renal insufficiency, severe arthralgia (FDA Safety Alert, Aug 28, 2015) ALERT: U.S. Boxed Warning Lactic acidosis: Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio, and metformin plasma levels generally >5 mcg/mL. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), age 65 years, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information. If metformin-associated lactic acidosis is suspected, immediately discontinue sitagliptin/metformin and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. Warnings/Precautions Concerns related to adverse effects: Arthralgia: Severe and disabling arthralgia has been reported with DPP-IV inhibitor use; onset may occur within one day to years after treatment initiation and may resolve with discontinuation of therapy. Some patients may experience a recurrence of symptoms if DPP-IV inhibitor therapy resumed. Bullous pemphigoid: DPP-4 inhibitor use has been associated with development of bullous pemphigoid; cases have typically resolved with topical or systemic immunosuppressive therapy and discontinuation of DPP-4 inhibitor therapy. Advise patients to report development of blisters or erosions. Discontinue therapy if bullous pemphigoid is suspected and consider referral to a dermatologist. Hypersensitivity reactions: Rare hypersensitivity reactions (including anaphylaxis, angioedema and/or severe dermatologic reactions, such as Stevens-Johnson syndrome) have been reported in postmarketing surveillance; discontinue if signs/symptoms of hypersensitivity reactions occur. Events have generally been noted within the first 3 months of therapy, and may occur with the initial dose. Use with caution if patient has experienced angioedema with other DPP-IV inhibitor use. Lactic acidosis: [US Boxed Warning]: Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset is often subtle, accompanied by nonspecific symptoms (eg, malaise, myalgias, respiratory distress, somnolence, abdominal pain); elevated blood lactate levels (>5 mmol/L); anion gap acidosis (without evidence of ketonuria or ketonemia); increased lactate:pyruvate ratio; metformin plasma levels generally >5 mcg/mL. Risk factors for lactic acidosis include patients with renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), 65 years, having a radiologic study with contrast, surgery and other procedures, hypoxic states (eg, acute heart failure), excessive alcohol intake, and hepatic impairment. Discontinue immediately if acidosis is suspected; prompt hemodialysis is recommended. Lactic acidosis should be suspected in any patient with diabetes receiving metformin with evidence of acidosis but without evidence of ketoacidosis. Discontinue metformin in patients with conditions associated with dehydration, hypoperfusion, sepsis, or hypoxemia. Temporarily discontinue therapy in patients with restricted food and fluid intake. The risk of accumulation and lactic acidosis increases with the degree of impairment of renal function. Pancreatitis: Cases of acute pancreatitis (including hemorrhagic and necrotizing with some fatalities) have been reported with use. Monitor for signs/symptoms of pancreatitis; discontinue use immediately if pancreatitis is suspected and initiate appropriate management. Use with caution in patients with a history of pancreatitis as it is not known if this population is at greater risk. Renal effects: Worsening renal function, including acute renal failure, sometimes requiring dialysis has been reported with sitagliptin. Vitamin B 12 concentrations: Long-term metformin use is associated with vitamin B 12 deficiency; monitor vitamin B 12 serum concentrations periodically with long-term therapy. Monitoring of B 12 serum concentrations should be considered in all patients receiving metformin and in particular those with peripheral neuropathy or anemia (ADA 2017c). Disease-related concerns: Cardiovascular disease: Use metformin with caution in patients with congestive heart failure requiring pharmacologic management, particularly in patients with unstable acute heart failure; risk of lactic acidosis may be increased secondary to hypoperfusion. In cardiovascular outcome trials of patients with type 2 diabetes and atherosclerotic cardiovascular disease, treatment with other DPP-4 inhibitors has been associated with heart failure. Use sitagliptin with caution in patients at risk for heart failure (eg, history of heart failure or renal impairment) and monitor for signs and symptoms of heart failure during therapy; consider discontinuation if heart failure develops. In a scientific statement from the American Heart Association, sitagliptin and metformin have been determined to be agents that may exacerbate underlying myocardial dysfunction (magnitude: major) (AHA [Page 2016]). However, in one large randomized, double-blinded trial in patients with type 2 diabetes and established cardiovascular disease (history of major CAD, ischemic cerebrovascular disease, or atherosclerotic peripheral arterial disease), the occurrence of the primary composite cardiovascular outcome (cardiovascular death, nonfatal MI, nonfatal stroke, or hospitalization for unstable angina) with sitagliptin was found to be noninferior to placebo. In addition, the rate of hospitalization for heart failure did not differ between the two groups (Green 2015; McGuire 2016). Hepatic impairment: Use is not recommended in patients with hepatic impairment due to potential for lactic acidosis. Renal impairment: Metformin and sitagliptin are substantially excreted by the kidney; assess renal function prior to initiation of therapy and periodically thereafter using estimated glomerular filtration rate (eGFR). The risk of metformin accumulation and lactic acidosis increases with degree of renal impairment. Initiation of therapy is not recommended if eGFR is between 30 to 45 mL/minute/1.73 m 2 and is contraindicated in patients with eGFR <30 mL/minute/1.73 m 2 . Use of concomitant medications that may affect renal function (ie, affect tubular secretion) may also affect metformin disposition. Metformin should be withheld in patients with dehydration and/or prerenal azotemia. Stress-related states: It may be necessary to discontinue metformin and administer insulin if the patient is exposed to stress (fever, trauma, infection, surgery). Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Dosage forms specific issues: Extended release tablet: Incompletely dissolved tablets passed in stool have been reported; assess the adequacy of glycemic control in patients who repeatedly observe tablets in their stool. Special populations: Elderly: Use with caution; risk of metformin associated lactic acidosis increases with age. Other warnings/precautions: Appropriate use: Not indicated for use in patients with insulin-dependent diabetes mellitus (IDDM) (type 1) or in patients with diabetic ketoacidosis (DKA). Ethanol use: Instruct patients to avoid excessive acute or chronic ethanol use; ethanol may potentiate metformin's effect on lactate metabolism. Iodinated contrast: Discontinue metformin at the time of or before iodinated contrast imaging procedures in patients with an eGFR 30 to 60 mL/minute/1.73 m 2 ; or with a history of hepatic disease, alcoholism, or heart failure; or in patients who will receive intra-arterial iodinated contrast. Reevaluate eGFR 48 hours after imaging procedure; restart if renal function is stable. Alternatively, the American College of Radiology (ACR) guidelines recommend that metformin may be used prior to or following administration of iodinated contrast media in patients with no evidence of acute kidney injury (AKI) and with an eGFR 30 mL/minute/1.73 m 2 ; ACR guidelines recommend temporary discontinuation of metformin in patients with known AKI or severe chronic kidney disease (stage IV or V [ie, eGFR> <30 mL/minute/1.73 m 2 ]) or who are undergoing arterial catheter studies (ACR 2015). Patient education: Diabetes self-management education (DSME) is essential to maximize the effectiveness of therapy. Surgical procedures: Metformin should be withheld 24 hours before surgery (all other oral hypoglycemic agents should be withheld the morning of surgery or procedure) (ADA 2017d). Resume only after normal intake resumed and normal renal function is verified. Monitoring Parameters HbA 1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2017a]), serum glucose, hematologic parameters (eg, hemoglobin/hematocrit, red blood cell indices) at least annually; hepatic function, renal function (eGFR) should be performed prior to initiation of therapy and at least annually (more often in patients at risk of developing renal impairment; every 3 to 6 months if eGFR 45 to> <60 mL/minute/1.73 m 2 ; every 3 months if eGFR 30 to> <45 mL/minute/1.73 m 2 [Lipska 2011]); vitamin B 12 (periodically with long-term treatment) and folate (if megaloblastic anemia is suspected); signs/symptoms of heart failure Pregnancy Risk Factor B Pregnancy Considerations Animal reproduction studies have not been conducted with this combination. See individual agents. Health professionals are encouraged to report any prenatal exposure to sitagliptin/metformin combination by contacting Merck s pregnancy registry (1-800-986-8999). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience abdominal pain, nausea, vomiting, diarrhea, flatulence, loss of strength and energy, headache, rhinitis, or rhinorrhea. Have patient report immediately to prescriber signs of heart problems (cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps) signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating), signs of a pancreas problem (pancreatitis; severe abdominal pain, severe back pain, severe nausea, vomiting), signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), skin blisters, skin breakdown, angina, chills, pharyngitis, severe joint pain, persistent joint pain, or tablet shell in stool (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about metformin/sitagliptin Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Espaรฑol 47 Reviews Add your own review/rating Drug class: antidiabetic combinations Consumer resources Metformin and sitagliptin ... +3 more Professional resources Other brands: Janumet , Janumet XR Related treatment guides Diabetes, Type 2> ]} 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 Metformin / sitagliptin Rating 47 User Reviews 6.6 /10 47 User Reviews 6.6 Rate it! Manufacturer Macleods Pharmaceuticals Limited Drug Class Antidiabetic combinations Related Drugs antidiabetic combinations Janumet , Kombiglyze XR , Jentadueto , Invokamet , Glucovance , ActoPlus Met Diabetes, Type 2 metformin , insulin aspart , glipizide , glimepiride , Januvia , pioglitazone , Victoza , Actos , Tradjenta , Glucophage , glyburide , Janumet , Invokana , Amaryl , Welchol , Onglyza , sitagliptin , Trulicity , Jardiance , Lantus , Farxiga , Levemir , Tresiba , Glucotrol , Bydureon , More...} } cord


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this may increasingly sitagliptin and simvastatin (Oral route) sit-a-GLIP-tin FOS-fate, sim-va-STAT-in Overview Side Effects Interactions Pregnancy Reviews More Support Group Q & A Commonly used brand name(s) In the U.S. Juvisync Available Dosage Forms: Tablet Therapeutic Class: Antihyperlipidemic Pharmacologic Class: Sitagliptin Slideshow Cholesterol. Get Your Fats Straight! Uses For sitagliptin and simvastatin Sitagliptin and simvastatin combination is used together with a proper diet and exercise to treat type 2 diabetes. It is also used together with a proper diet to treat high cholesterol and triglyceride (fats) levels in the blood. sitagliptin and simvastatin may help prevent medical problems caused by clogged blood vessels such as heart attacks and strokes. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood. Simvastatin belongs to the group of medicines called statins. It works to reduce the amount of cholesterol in the blood by blocking the production of cholesterol. sitagliptin and simvastatin was available only with your doctor's prescription. The Juvisync product will no longer be marketed in the United States as of September 26, 2013, but may be available in other countries. Before Using sitagliptin and simvastatin 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 sitagliptin and simvastatin, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to sitagliptin and simvastatin 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 sitagliptin and simvastatin 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 sitagliptin and simvastatin combination in the elderly. However, elderly patients are more likely to have age-related kidney or muscle problems, which may require caution and an adjustment in the dose for patients receiving sitagliptin and simvastatin combination. Pregnancy Pregnancy Category Explanation All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. Breast Feeding Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using sitagliptin and simvastatin. 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 sitagliptin and simvastatin, 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 sitagliptin and simvastatin 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. Amprenavir Atazanavir Boceprevir Clarithromycin Cobicistat Cyclosporine Danazol Darunavir Erythromycin Fosamprenavir Gemfibrozil Idelalisib Indinavir Itraconazole Ketoconazole Lopinavir Mibefradil Mifepristone Nefazodone Nelfinavir Paritaprevir Posaconazole Ritonavir Saquinavir Telaprevir Telithromycin Tipranavir Voriconazole Using sitagliptin and simvastatin 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. Acenocoumarol Amiodarone Amlodipine Azithromycin Balofloxacin Besifloxacin Bezafibrate Carbamazepine Ceritinib Ciprofibrate Ciprofloxacin Clofibrate Colchicine Conivaptan Dabigatran Etexilate Dalfopristin Daptomycin Delavirdine Diltiazem Eliglustat Eltrombopag Enoxacin Eslicarbazepine Acetate Fenofibrate Fenofibric Acid Fleroxacin Fluconazole Flumequine Fusidic Acid Gatifloxacin Gemifloxacin Lanreotide Levofloxacin Lomefloxacin Lomitapide Lumacaftor Moxifloxacin Nadifloxacin Niacin Norfloxacin Octreotide Ofloxacin Pasireotide Pazopanib Pazufloxacin Pefloxacin Prulifloxacin Quinupristin Ranolazine Risperidone Rufloxacin Simeprevir Sparfloxacin Tadalafil Thioctic Acid Tosufloxacin Verapamil Warfarin Using sitagliptin and simvastatin 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. Acebutolol Albiglutide Alitretinoin Atenolol Betaxolol Bisoprolol Bosentan Carteolol Carvedilol Celiprolol Clopidogrel Dasatinib Digoxin Dronedarone Efavirenz Esmolol Fosphenytoin Interferon Beta Labetalol Levobunolol Levothyroxine Metipranolol Metoprolol Nadolol Nebivolol Oat Bran Oxcarbazepine Oxprenolol Pectin Penbutolol Phenytoin Pindolol Practolol Propranolol Rifampin Sotalol St John's Wort Ticagrelor Timolol 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 sitagliptin and simvastatin with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use sitagliptin and simvastatin, or give you special instructions about the use of food, alcohol, or tobacco. Cranberry Juice Grapefruit Juice Other Medical Problems The presence of other medical problems may affect the use of sitagliptin and simvastatin. Make sure you tell your doctor if you have any other medical problems, especially: Alcohol use, excessive or history of or Chinese ancestry or Gallbladder stones or Hypothyroidism (an underactive thyroid), uncontrolled or Kidney disease or Liver disease, history of or Pancreas problems, history of Use with caution. May cause side effects to become worse. Angioedema (swelling of the face, lips, tongue, throat, arms, or legs) with sitagliptin or other DPP-4 inhibitors, history of Use with caution. May increase the risk of this condition occurring again. Diabetic ketoacidosis (high ketones and acid in the blood) or Kidney disease, severe or Liver disease, active or Type 1 diabetes Should not be used in patients with these conditions. Electrolyte disorders, severe or Endocrine disorders, severe or Epilepsy (seizures), not well-controlled or Hypotension (low blood pressure) or Major surgery or trauma, recent or Metabolic disorders, severe or Sepsis (severe infection in the blood) Patients with these conditions may be at risk for muscle or kidney problems. Muscle pain, tenderness, or weakness, history of Use with caution. May make these conditions worse. Proper Use of sitagliptin and simvastatin Take sitagliptin and simvastatin only as directed by your doctor . Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. sitagliptin and simvastatin should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand. Your doctor will give you instructions about diet, exercise, testing your blood sugar, and adjusting your dose when you are sick. Carefully follow your doctor's instructions . Swallow the tablet whole. Do not break, crush, or chew it. If you are taking diltiazem (Cardizem ), dronedarone (Multaq ), or verapamil (Calan , Isoptin , Verelan ) together with sitagliptin and simvastatin, your dose of Juvisync should not be higher than 100 milligrams (mg) of sitagliptin and 10 mg of simvastatin per day, unless otherwise directed by your doctor. Do not use more than 100 mg of sitagliptin and 20 mg of simvastatin per day together with amiodarone (Cordarone ), amlodipine (Norvasc ), lomitapide (Juxtapid ), or ranolazine (Ranexa ) . When used together with higher doses of Juvisync , these medicines may increase your risk of muscle injury and could result in kidney problems. Avoid drinking grapefruit juice while you are taking sitagliptin and simvastatin. Grapefruit juice may increase your risk of muscle injury and could result in kidney problems. Do not drink large amounts of alcohol with sitagliptin and simvastatin. This could cause unwanted effects on the liver. Dosing The dose of sitagliptin and simvastatin 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 sitagliptin and simvastatin. 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 oral dosage form (tablets): For type 2 diabetes and high cholesterol: For patients who are not taking sitagliptin or simvastatin: Adults At first, 100 milligrams (mg) of sitagliptin and 40 mg of simvastatin combination once a day in the evening. Your doctor may adjust your dose as needed. Children Use and dose must be determined by your doctor. For patients who are already taking simvastatin: Adults At first, 100 milligrams (mg) of sitagliptin and the dose of simvastatin you are already taking. It is taken once a day in the evening. Your doctor may adjust your dose as needed. Children Use and dose must be determined by your doctor. Missed Dose If you miss a dose of sitagliptin and simvastatin, 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 sitagliptin and simvastatin It is very important that your doctor check your progress at regular visits . This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects. Using sitagliptin and simvastatin while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Do not use sitagliptin and simvastatin if you are also taking any of the following medicines: boceprevir (Victrelis ), cobicistat-containing products (Stribild ), cyclosporine (Gengraf , Neoral , Sandimmune ), danazol (Danocrine ), gemfibrozil (Lopid ), nefazodone (Serzone ), telaprevir (Incivek ), certain antibiotics (such as clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole, Nizoral ), or medicines to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir, Crixivan , Kaletra , Lexiva , Norvir , Prezista , Reyataz ). Using these medicines together with sitagliptin and simvastatin combination may increase your risk of muscle injury and could result in kidney problems . Chinese patients who are taking large amounts of niacin (greater than or equal to 1 gram or 1000 milligrams per day) together with sitagliptin and simvastatin may have an increased risk for muscle injury. Talk to your doctor if you are Chinese or have Chinese ancestry and take large amounts of niacin (Niacor , Niaspan ). You may need a different dose of sitagliptin and simvastatin. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM). Myopathy is more common when high doses of simvastatin (eg, 80 milligrams) are used, but some people get myopathy with lower doses. Call your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems. Call your doctor right away if you have dark-colored urine, a general feeling of tiredness or weakness, a headache, light-colored stools, loss of appetite, stomach pain, upper right stomach pain, vomiting, weight loss, or yellow eyes or skin. These could be symptoms of liver damage. Tell your doctor right away if you have sudden and severe stomach pain, nausea, vomiting, fever, or lightheadedness. These may be symptoms of pancreatitis (swelling and inflammation of the pancreas). sitagliptin and simvastatin may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using sitagliptin and simvastatin. sitagliptin and simvastatin may cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, take certain medicines, or take sitagliptin with another type of diabetes medicine (eg, insulin, glimepiride, metformin, or pioglitazone). Symptoms of low blood sugar must be treated before they cause you to pass out (unconsciousness). People feel different symptoms with low blood sugar . It is important that you learn which symptoms you usually have so you can treat it quickly. Symptoms of low blood sugar include anxiety, behavior changes similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headaches that continue, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness. If symptoms of low blood sugar occur, check your blood sugar level. If you have low blood sugar, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drinks, or sugar dissolved in water. Glucagon is a medicine that is used in emergency situations when severe symptoms, such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. The members of your family should also know how to use glucagon. There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes with a list of all your medicines. Make sure any doctor or dentist who treats you knows that you are using sitagliptin and simvastatin. You may need to stop using sitagliptin and simvastatin if you have major surgery, a major injury, or you develop other serious health problems. 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. sitagliptin and simvastatin 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 Anxiety blurred vision chills cold sweats confusion cool, pale skin depression dizziness fainting fast or irregular heartbeat headache increased hunger nausea nightmares seizures shakiness slurred speech unusual tiredness or weakness Less common Bladder pain bloody or cloudy urine difficult, burning, or painful urination dry mouth flushed, dry skin frequent urge to urinate fruit-like breath odor increased thirst increased urination loss of consciousness lower back or side pain stomachache sweating swelling troubled breathing unexplained weight loss vomiting Rare Bloating constipation dark-colored urine fever indigestion loss of appetite muscle cramps or spasms muscle pain, tenderness, wasting, or weakness pains in the stomach, side, or abdomen, possibly radiating to the back yellow eyes or skin Incidence not known Agitation black, tarry stools bleeding gums blistering, peeling, or loosening of the skin burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chest pain decreased urine output diarrhea difficulty with moving difficulty with swallowing feeling of warmth hives increased sensitivity of the skin to sunlight irritability joint or muscle pain large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs lethargy pinpoint red spots on the skin rapid weight gain red, irritated eyes red, sore, or itching skin red skin lesions, often with a purple center redness of the face, neck, arms, and occasionally, upper chest seizures severe sunburn skin rash sore throat sores, ulcers, or white spots on the lips or in the mouth sores, welts, or blisters on the skin swollen glands swollen joints tightness in the chest unsteadiness or awkwardness unusual bleeding or bruising weakness in the arms, hands, legs, or feet 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: More common Body aches or pain cough that produces mucus ear congestion loss of voice runny or stuffy nose sneezing Less common Burning feeling in the chest or stomach dizziness or lightheadedness feeling of constant movement of self or surroundings pain or tenderness around the eyes and cheekbones sensation of spinning skin rash that is encrusted, scaly, and oozing tenderness in the stomach area trouble with sleeping Incidence not known Acid or sour stomach being forgetful belching decreased interest in sexual intercourse excess air or gas in the stomach or intestines full feeling hair loss heartburn inability to have or keep an erection loss in sexual ability, desire, drive, or performance passing gas problems with memory stomach discomfort, upset, or pain thinning of the hair 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 simvastatin/sitagliptin Side Effects During Pregnancy Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: antidiabetic combinations Consumer resources Other brands: Juvisync Professional resources Related treatment guides Cardiovascular Risk Reduction Diabetes, Type 2 High Cholesterol High Cholesterol, Familial Heterozygous High Cholesterol, Familial Homozygous} Drug Status Availability Discontinued X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Antidiabetic combinations Antihyperlipidemic combinations Related Drugs Cardiovascular Risk Reduction simvastatin , Zocor , ramipril , Victoza , telmisartan , Altace , More... High Cholesterol atorvastatin , simvastatin , Crestor , Lipitor , Zocor , Zetia , More... Diabetes, Type 2 metformin , insulin aspart , glipizide , glimepiride , Januvia , pioglitazone , More... High Cholesterol, Familial Homozygous atorvastatin , simvastatin , Crestor , Lipitor , Zocor , rosuvastatin , More... 1 more conditions... Simvastatin / sitagliptin Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Help and Support Looking for answers? Ask a question or go join the simvastatin / sitagliptin support group to connect with others who have similar interests.} } among the best


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major Sitavig Generic Name: acyclovir (oral) (a SYE klo veer) Brand Name: Sitavig, Zovirax Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons What is acyclovir? Acyclovir is an antiviral drug. It slows the growth and spread of the herpes virus in the body. Acyclovir will not cure herpes, but it can lessen the symptoms of the infection. Acyclovir is used to treat infections caused by herpes viruses, such as genital herpes, cold sores, shingles, and chicken pox. Acyclovir may also be used for purposes not listed in this medication guide. Slideshow Men's Health Month And Movember: Raising The Profile Of Men's Health One Stache At A Time What is the most important information I should know about acyclovir? 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 taking acyclovir? You should not take this medicine if you are allergic to acyclovir or valacyclovir (Valtrex). You should not take acyclovir buccal tablets (Sitavig) if you are allergic to milk proteins. To make sure acyclovir is safe for you, tell your doctor if you have: kidney disease; or a weak immune system (caused by disease or by using certain medicine). Acyclovir is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Herpes can be passed to your baby during childbirth if you have a genital lesion when your baby is born. If you have genital herpes, it is very important to prevent herpes lesions during pregnancy. Take your medicine as directed to best control your infection. Acyclovir passes into breast milk and may harm a nursing infant. Do not take this medication without telling your doctor if you are breast-feeding a baby. Do not give an acyclovir buccal tablet to a young child or choking could occur. How should I take acyclovir? Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Treatment with acyclovir should be started as soon as possible after the first appearance of symptoms (such as tingling, burning, blisters). Shake the oral suspension ( liquid ) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. To take the buccal tablet (Sitavig): Keep the tablet in its blister pack until you are ready to take it. Use a dry finger to remove the tablet. Do not chew or swallow a buccal tablet. Place the flat side of the tablet against your upper gum, behind your lip and above your canine tooth. Place the tablet on the same side of the mouth as your cold sore. Close your mouth and gently press on the outside of your lip over the tablet, holding it in place for 30 seconds. Avoid touching or pressing on the tablet once it is in place. Allow the tablet to dissolve in your mouth throughout the day. You may eat and drink normally while the buccal tablet is in place. During the first 6 hours of wearing time: If the tablet falls off or does not stick well, you may replace it with a new tablet. If you accidentally swallow the tablet, drink a glass of water and put a new tablet in place. Tell your doctor if you have any changes in weight. Acyclovir doses are based on weight (especially in children and teenagers), and any changes may affect the dose. Drink plenty of water while you are taking acyclovir to keep your kidneys working properly. Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely treated. Acyclovir will not treat a viral infection such as the flu or a common cold. Lesions caused by herpes viruses should be kept as clean and dry as possible. Wearing loose clothing may help to prevent irritation of the lesions. Store at room temperature away from moisture and heat. What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take 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. Overdose symptoms may include agitation, seizure (convulsions), or loss of consciousness. What should I avoid while taking acyclovir? Avoid brushing your teeth, chewing gum, or wearing an upper denture while you have a buccal tablet in your mouth. You may rinse your mouth gently. Drink plenty of liquids to prevent dry mouth. Herpes infections are contagious and you can infect other people, even while you are being treated with acyclovir. Avoid letting infected areas come into contact with other people. Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent passing the infection to others. Taking this medicine will not prevent you from passing genital herpes to your sexual partner. Avoid sexual intercourse while you have active lesions or the first symptoms of an outbreak. Genital herpes may still be contagious through "viral shedding" from your skin, even if you have no symptoms. Acyclovir 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. Call your doctor at once if you have: easy bruising or bleeding, purple or red pinpoint spots under your skin; or signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath. Common side effects may include: nausea, vomiting; diarrhea; general ill feeling; headache; or mouth pain while using an acyclovir buccal tablet. 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 acyclovir? Acyclovir can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve). Other drugs may interact with acyclovir, 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 Sitavig (acyclovir) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Espaรฑol 8 Reviews Add your own review/rating Drug class: purine nucleosides Consumer resources Sitavig Sitavig (Advanced Reading) Other brands: Zovirax Professional resources Sitavig (FDA) Acyclovir Sodium (AHFS Monograph) Related treatment guides Cold Sores Where can I get more information? Your pharmacist can provide more information about acyclovir. 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: 5.08. Date modified: December 03, 2017 Last reviewed: February 17, 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 Drug Class Purine nucleosides Related Drugs Cold Sores acyclovir topical , valacyclovir , Valtrex , Zovirax , famciclovir , Famvir , Denavir , tetracaine topical , benzocaine topical , Orabase , Zovirax Ointment , Zovirax Cream , Pontocaine , penciclovir topical , benzyl alcohol topical , Xerese , Kank-a , More... Sitavig Rating 8 User Reviews 8.6 /10 8 User Reviews 8.6 Rate it! Related Questions & Answers How long after taking sitavig should I wiat before getting the shingle shot? Read more questions} } worthwhile


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information [33:<12 years of age is not recommended. 117 118 Possible increased severity of CNS effects in children compared with adults. a (See Nervous System Effects under Cautions.) Avoid use of caffeine and sodium benzoate injection in neonates; sodium benzoate may produce kernicterus. a Use caffeine citrate with caution in premature neonates with impaired renal or hepatic function, cardiovascular disease, or seizure disorders (see Cardiac Effects and also Nervous System Effects, under Cautions; also see Special Populations under Dosage and Administration). 115 Consider possible need for monitoring serum caffeine concentrations (see General under Dosage and Administration). 115 Monitor blood glucose concentrations periodically; hypoglycemia and hyperglycemia reported in neonates. 115 Long-term follow-up studies have not shown caffeine administration in premature neonates to adversely affect neurologic development or growth. 115 Hepatic Impairment Pharmacokinetics of caffeine citrate not evaluated in premature neonates with hepatic impairment; use with caution. 115 (See Hepatic Impairment under Dosage and Administration.) Renal Impairment Pharmacokinetics of caffeine citrate not evaluated in premature neonates with renal impairment; use with caution. 115 (See Renal Impairment under Dosage and Administration.) Common Adverse Effects CNS stimulation (e.g., insomnia, restlessness, nervousness, mild delirium), GI irritation (e.g., nausea, vomiting, gastric irritation). a In neonates with apnea of prematurity: Rash, feeding intolerance, sepsis, necrotizing enterocolitis. 115 Interactions for Caffeine; Caffeine and Sodium Benzoate Injection; Caffeine Citrate Appears to be metabolized principally by CYP1A2. 115 Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes Pharmacokinetic interactions likely with drugs metabolized by CYP1A2 or with CYP1A2 inducers or inhibitors. 115 Specific Drugs and Laboratory Tests Drug or Test Interaction Comments Anticonvulsants (phenobarbital, phenytoin) Possible increased elimination of caffeine and decreased serum caffeine concentrations 115 Possible increased metabolism of phenobarbital 120 Increased caffeine dosage may be required 115 ฮฒ-Adrenergic agonists May increase cardiac inotropic effects 120 a Cimetidine Possible decreased elimination of caffeine and increased serum caffeine concentrations 115 Reduced caffeine dosage may be required 115 Disulfiram Potential inhibition of caffeine metabolism and substantially decreased clearance of caffeine; 103 possible exaggerated or prolonged caffeine effects 103 104 Clinical importance unknown 103 104 Ketoconazole Possible decreased elimination of caffeine and increased serum caffeine concentrations 115 a Reduced caffeine dosage may be required 115 a Ketoprofen Possible decreased urine volume 115 Clinical importance unknown 115 Tests for serum urate False-positive elevations of serum urate as measured by the Bittner method 120 a Tests for urinary 5-hydroxyindoleacetic acid (5-HIAA) Slight increase in urine 5-HIAA concentrations 120 a Tests for urinary catecholamines and vanillylmandelic acid (VMA) Slight increase in urine concentrations of VMA and catecholamines; possible false-positive results on tests for pheochromocytoma and neuroblastoma 120 a Avoid caffeine intake during test 120 Theophylline Interconversion between caffeine and theophylline reported in premature neonates 115 Concurrent use not recommended in premature neonates 115 Monitor serum caffeine concentrations prior to initiating caffeine therapy in neonates previously treated with theophylline 115 Caffeine; Caffeine and Sodium Benzoate Injection; Caffeine Citrate Pharmacokinetics Absorption Caffeine and caffeine citrate are well absorbed following oral administration. a Absorption following oral administration may be more rapid than that following IM injection of caffeine and sodium benzoate. a Absolute bioavailability of orally administered caffeine in preterm neonates not fully determined. 115 Onset Following oral administration of 100 mg of caffeine (as coffee), peak plasma concentrations reached after 50 75 minutes. a Following oral administration of 10 mg/kg of caffeine to preterm neonates, mean time to peak plasma concentration was 0.5 2 hours. 115 Food Feeding formula does not affect time to peak plasma concentration in infants. 115 Plasma Concentrations Serum caffeine concentrations >50 mcg/mL associated with serious toxicity. 115 Distribution Extent Rapidly distributed into body tissues; readily crosses the blood-brain barrier. 115 120 Concentrations in the CSF of preterm neonates approximates plasma concentration. 115 Readily crosses the placenta and is distributed into milk. 115 a Mean volume of distribution in infants is slightly larger than that in adults (0.6 L/kg). 115 Plasma Protein Binding Approximately 17 36% in adults; data not available for neonates or infants. 115 120 Elimination Metabolism Metabolized in the liver, principally via CYP1A2, to 1-methyluric acid, 1-methylxanthine, and 7-methylxanthine. 115 120 May induce own metabolism; clinical importance of autoinduction is unknown. 120 a Neonates: Limited hepatic metabolism due to immature hepatic enzyme systems. 115 Interconversion between caffeine and theophylline reported. 115 (See Specific Drugs and Laboratory Tests under Interactions.) Metabolism of caffeine by 9 months of age approximates that seen in adults. 115 Elimination Route Adults: Excreted principally in urine as metabolites (> <1% recovered in urine as unchanged drug). 120 a Neonates: Excreted principally in urine as unchanged drug (approximately 86%). 115 Mean fraction excreted unchanged in urine in infants is inversely related to gestational/postconceptional age; 115 by 9 months of age, fraction excreted as unchanged drug approximates that seen in adults. 115 Half-life Adults: 3 5 hours. 120 a Neonates: Approximately 3 4 days. 115 Elimination slower in young infants than in adults because of immature hepatic and/or renal function. 115 Mean half-life in infants is inversely related to gestational/postconceptional age; 115 by 9 months of age, half-life approximates that seen in adults. 115 Special Populations Pharmacokinetics in neonates with renal or hepatic insufficiency not evaluated. 115 Stability Storage Oral Tablets Room temperature. 117 118 Solution 15 30°C. 115 Caregivers should store vials of the oral solution in the child-resistant container provided by the manufacturer. 115 Parenteral Caffeine Citrate Injection 15 30°C. 115 Caffeine and Sodium Benzoate Injection 15 30°C. 120 Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Solution Compatibility (for Caffeine Citrate) Compatible Amino acids 8.5% Dextrose 5 or 50% in water Fat emulsion 20%, IV Drug Compatibility (for Caffeine Citrate) Admixture Compatibility Compatible Calcium gluconate Dopamine HCl Fentanyl citrate Heparin sodium Actions Competitively inhibits phosphodiesterase, the enzyme that degrades cyclic 3 ,5 -adenosine monophosphate (AMP), increasing levels of intracellular cyclic AMP. 120 a Stimulates all levels of the CNS. 120 a Stimulates the cerebral cortex and produces a more rapid and clearer thought flow, wakefulness or arousal in fatigued patients; also improves psychomotor coordination. a Stimulates medullary vagal, vasomotor, and respiratory centers in slightly larger doses, promoting bradycardia, vasoconstriction, and increased respiratory rate. 120 a Produces a positive inotropic effect on the myocardium and a positive chronotropic effect at the SA node, causing transient increases in heart rate, force of contraction, cardiac output, and heart work. 115 120 a Constricts cerebral vasculature; also directly dilates peripheral blood vessels, decreasing peripheral vascular resistance. 120 a Overall effect on heart rate and BP depends on whether CNS or peripheral effects predominate. 120 a Stimulates voluntary skeletal muscle, increasing the force of contraction and decreasing muscular fatigue. 120 a Stimulates gastric acid secretion from parietal cells. 120 a Increases renal blood flow and GFR; decreases proximal tubular reabsorption of sodium and water, resulting in mild diuresis. 120 a Advice to Patients Risk of adverse CNS and cardiac effects if excessive doses are taken. 115 Risk of necrotizing enterocolitis in premature infants; importance of informing clinician if signs of GI intolerance (e.g., abdominal distention, vomiting, bloody stools) or lethargy develops. 115 a Importance of informing clinician if premature infant continues to experience apneic events despite caffeine therapy; do not increase dosage without advice of clinician. 115 a Importance of adhering to directions for use of caffeine citrate oral solution, including directions for storage, measurement and withdrawal of the prescribed dose, and administration. 115 Provide copy of manufacturer s patient information. 115 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease). 115 Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. a Importance of informing patients of other important precautionary information. (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name Caffeine Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets 100 mg* 200 mg* Tablets, film-coated 200 mg* No Doz Maximum Strength Caplets (with povidone and propylene glycol) Novartis Vivarin GlaxoSmithKline Also commercially available in combination with analgesics, antacids, antihistamines, antipyretics, antitussives, belladonna alkaloids, diuretics, ergotamine tartrate, expectorants, nasal decongestants, skeletal muscle relaxants, sympathomimetics, and vitamins. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name Caffeine and Sodium Benzoate Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral Injection 250 mg/mL (equivalent to caffeine anhydrous 125 mg/mL and sodium benzoate 125 mg/mL)* Caffeine and Sodium Benzoate Injection American Regent, Bedford Caffeine Citrate Routes Dosage Forms Strengths Brand Names Manufacturer Oral Solution 20 mg/mL (equivalent to 10 mg/mL caffeine anhydrous) Cafcit MeadJohnson Caffeine Citrate Oral Solution Paddock, PharmaForce Parenteral Injection 20 mg/mL (equivalent to 10 mg/mL caffeine anhydrous) Cafcit MeadJohnson Caffeine Citrate Injection American Regent, Paddock, PharmaForce Bulk Powder AHFS DI Essentials. Copyright 2017, Selected Revisions November 20, 2012. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. † Use is not currently included in the labeling approved by the US Food and Drug Administration. References 100. Council on Scientific Affairs. Caffeine labeling. JAMA . 1984; 252:803-6. [PubMed 6748182] 101. Robertson D, Wade D, Workman R et al. Tolerance to the humoral and hemodynamic effects of caffeine in man. J Clin Invest . 1981; 67:1111-7. [PubMed 7009653] 102. Robertson D, Hollister AS, Kincaid D et al. Caffeine and hypertension. Am J Med . 1984; 77:54-60. [PubMed 6377891] 103. Beach CA, Mays DC, Guiler RC et al. Inhibition of elimination of caffeine by disulfiram in normal subjects and recovering alcoholics. Clin Pharmacol Ther . 1986; 39:265-70. [PubMed 3948467] 104. Mangini RJ, ed. Drug interaction facts. St. Louis: JB Lippincott Co; 1986(Jul):123a. 105. Aranda JV, Cook CE, Gorman W. Pharmacokinetic profile of caffeine in the premature newborn infant with apnea. J Pediatr . 1979; 94:663-8. [PubMed 430317] 106. Murat I, Moriette G, Blin MC et al. The efficacy of caffeine in the treatment of recurrent idiopathic apnea in premature infants. J Pediatr . 1981; 99:984-9. [PubMed 7310594] 107. Brouard C, Moriette G, Murat I et al. Comparative efficacy of theophylline and caffeine in the treatment of idiopathic apnea in premature infants. Am J Dis Child . 1985; 139:698-700. [PubMed 4014092] 108. Le Guennec JC, Billon B, Paré C. Maturational changes of caffeine concentrations and disposition in infancy during maintenance therapy for apnea of prematurity: influence of gestational age, hepatic disease, and breast-feeding. Pediatrics . 1985; 76:834-40. [PubMed 4058995] 109. Anwar M, Modestin H, Mojica N et al. Effect of caffeine on pneumogram and apnoea of infancy. Arch Dis Child . 1986; 61:891-5. [PubMed 3767418] 110. Spitzer AR, Fox WW. Infant apnea. Pediatr Clin North Am . 1986; 33:561-81. [PubMed 3714338] 111. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to June 28, 1996. Rockville, MD; 1996 Jul. 112. Cerulli J, Lomaestro BM, Malone M. Update on the pharmacotherapy of obesity. Ann Pharmacother . 1998; 32:88-102. [PubMed 9475827] 113. Astrup A, Toubro S, Christensen NJ et al. Pharmacology of thermogenic drugs. Am J Clin Nutr . 1992; 55:246-8S. 114. Food and Drug Administration. Dietary supplements containing ephedrine alkaloids. Proposed rule. [21 FR Part 111] Fed Regist . 1997; 62:30678-724. 115. Mead Johnson and Co. Cafcit (caffeine citrate) injection and oral solution prescribing information. Evansville, IN: 2003 May. 116. Matchar DB, Young WB, Rosenberg JH et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. St. Paul, MN; 2001. From the American Academy of Neurology web site. 117. GlaxoSmithKline Consumer Healthcare. Vivarin (caffeine) tablets patient information. Pittsburgh, PA; 2003. From website. Accessed 2007 May 17. 118. Novartis Consumer Health, Inc. Maximum Strength NoDoz (caffeine) tablets patient information. Parsippany, NJ; 2007. 119. Caffeine. In: Briggs GG, Freeman RK, Yaffe SJ, eds. Drugs in pregnancy and lactation: a reference guide to fetal and neonatal risk. 7th ed. Philadelphia: Lippincott, Williams & Wilkins; 2005:201-7. 120. American Regent Laboratories, Inc. Caffeine and sodium benzoate injection prescribing information. Shirley, NY: 1998 Nov. 121. Watson Laboratories, Inc. Butalbital, acetaminophen, caffeine, and codeine phosphate capsules prescribing information. Corona, CA; 2007 Jan. a. AHFS drug information 2007. McEvoy GK, ed. Caffeine. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2478-2481. b. Forest Pharmaceuticals, Inc. Esgic-Plus (butalbital, acetaminophen, and caffeine) capsules prescribing information. St. Louis, MO; 2002 Aug. c. Mikart, Inc. Butalbital, acetaminophen, and caffeine tablets prescribing information. Atlanta, GA; 2002 Aug. d. Novartis Consumer Health, Inc. Excedrin Tension Headache (acetaminophen and caffeine) tablets patient information. Parsippany, NJ; 2007. e. Mikart, Inc. Ergotamine tartrate and caffeine tablets prescribing information. Atlanta, GA; 2005 Feb. f. Actavis Elizabeth LLC. Butalbital, aspirin, and caffeine tablets prescribing information. Elizabeth, NJ; 2006 Jan. g. Novartis Consumer Health, Inc. Excedrin Migraine (acetaminophen, aspirin, and caffeine) tablets patient information. Parsippany, NJ; 2007. h. GlaxoSmithKline. Original Formula BC (aspirin, caffeine, and salicylamide) powder patient information. Pittsburgh, PA; 2007. i. Mikart, Inc. Butalbital, acetaminophen, and caffeine tablets prescribing information. Atlanta, GA; 2002 Aug. j. Watson Laboratories, Inc. Butalbital, aspirin, and caffeine capsules prescribing information. Corona, CA; 2006 Mar. k. Watson Laboratories, Inc. Butalbital, aspirin, caffeine, and codeine phosphate capsules prescribing information. Corona, CA; 2007 Jan. l. Novartis Consumer Health, Inc. Extra Strength Excedrin (acetaminophen, aspirin, and caffeine) tablets patient information. Parsippany, NJ; 2007. m. Novartis Pharmaceuticals Corporation. Cafergot (ergotamine tartrate and caffeine) suppositories prescribing information. East Hanover, NJ. Undated. Available from website. Accessed 2007 Dec 5. n. AHFS drug information 2007. McEvoy GK, ed. Ergotamine tartrate. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1359-61. o. Insight Pharmaceuticals. Anacin Max Strength (aspirin and caffeine) tablets patient information. Langhorne, PA. Undated. Available from website. Accessed 2007 Dec 12. p. Mikart, Inc. Butalbital, acetaminophen, and caffeine capsules prescribing information. Atlanta, GA; 2003 Feb. Next Interactions Print this page Add to My Med List More about caffeine/sodium benzoate Side Effects During Pregnancy Drug Interactions Support Group Pricing & Coupons 0 Reviews Add your own review/rating Drug class: CNS stimulants Consumer resources Caffeine and sodium benzoate Injection (Advanced Reading) Related treatment guides Respiratory Failure> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug WADA Class Anti-Doping Classification Manufacturer American Regent, Inc. Drug Class CNS stimulants Related Drugs Respiratory Failure nitric oxide , INOmax , caffeine / sodium benzoate , More... Caffeine / sodium benzoate Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } a petroleum


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