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Photo :EpiPen JR 2-Pak
foremost EpiPen JR 2-Pak Generic Name: epinephrine injection (EP i NEF rin) Brand Name: Adrenaclick Two-Pack, Adrenalin, Auvi-Q, EpiPen 2-Pak, EpiPen JR 2-Pak, EPIsnap Overview Side Effects Dosage Interactions Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons What is EpiPen JR 2-Pak (epinephrine injection)? Epinephrine is a chemical that narrows blood vessels and opens airways in the lungs. These effects can reverse severe low blood pressure, wheezing, severe skin itching, hives, and other symptoms of an allergic reaction. Epinephrine injection is used to treat severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens. Epinephrine is also used to treat exercise-induced anaphylaxis. Epinephrine auto-injectors may be kept on hand for self-injection by a person with a history of an severe allergic reaction. Epinephrine injection may also be used for purposes not listed in this medication guide. Slideshow 7 First Aid Kit Must Haves For Your Medicine Cabinet What is the most important information I should know about EpiPen JR 2-Pak (epinephrine injection)? Seek emergency medical attention after any use of epinephrine to treat a severe allergic reaction. After the injection you will need to receive further treatment and observation. What should I discuss with my healthcare provider before using EpiPen JR 2-Pak (epinephrine injection)? Before using epinephrine, tell your doctor if any past use of this medicine caused an allergic reaction to get worse. To make sure epinephrine injection is safe for you, tell your doctor if you have: heart disease or high blood pressure; asthma; Parkinson's disease; depression or mental illness; a thyroid or adrenal gland disorder; or diabetes (you may need to adjust your dose of insulin or other diabetes medication after using epinephrine injection). It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether epinephrine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication. How should I use EpiPen JR 2-Pak (epinephrine injection)? Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Epinephrine is injected into the skin or muscle of your outer thigh. In an emergency, this injection can be given through your clothing. Your medicine may also come with a "trainer pen." The trainer pen contains no medicine and no needle. It is only for non-emergency use to practice giving yourself an epinephrine injection. Do not use a trainer pen to treat an allergic reaction. The auto-injector device is a disposable single-use system that comes with patient instructions for safe and effective use. Do not inject this medicine if you do not understand these instructions. Do not remove the safety cap until you are ready to use the auto-injector. Never put your fingers over the injector tip when removing the safety cap or after the safety cap has been removed. To use an epinephrine auto-injector: Form a fist around the auto-injector with the tip pointing down. Pull off the safety cap. Place the tip against the fleshy portion of your outer thigh. You may give the injection directly through your clothing. Push the auto-injector firmly against your thigh to release the needle that injects the dose of epinephrine. Hold the auto-injector in place for 10 seconds after activation. Remove the auto-injector from your thigh and massage the area gently. Carefully re-insert the used device needle-first into the carrying tube. Re-cap the tube and take it with you to the emergency room so that anyone who treats you will know how much epinephrine you have received. Use an auto-injector only one time. Do not try to reinsert an auto-injector a second time if the needle has come out of your skin before the full 10 seconds. If the needle is bent from the first use, it may cause serious injury to your skin. Seek emergency medical attention after any use of epinephrine to treat a severe allergic reaction. The effects of epinephrine may wear off after 10 or 20 minutes. You will need to receive further treatment and observation. Do not use epinephrine injection if it has changed colors or has particles in it, or if the expiration date on the label has passed. Call your pharmacist for a new prescription. Store at room temperature away from moisture, heat, and light. Do not refrigerate or freeze this medication, and do not store it in a car. What happens if I miss a dose? Since epinephrine is normally used only as needed in an emergency, you are not likely to be on a dosing schedule. Do not use repeat doses of epinephrine without a doctor's advice. What happens if I overdose? Seek emergency medical attention right away after any use of epinephrine injection. Symptoms of an epinephrine overdose may include worsened breathing trouble, sudden numbness or weakness on one side of the body, slurred speech, problems with vision or balance, or dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure). What should I avoid while using EpiPen JR 2-Pak (epinephrine injection)? Do not inject epinephrine into a vein or into the muscles of your buttocks, or it may not work as well. Inject it only into the fleshy outer portion of the thigh. Accidentally injecting epinephrine into your hands or feet may result in a loss of blood flow to those areas, and resulting numbness. EpiPen JR 2-Pak (epinephrine injection) side effects Before using epinephrine, tell your doctor if any past use of this medicine caused an allergic reaction to get worse. Call your doctor at once if you notice pain, swelling, warmth, redness, or other signs of infection around the area where you gave an injection. Common side effects may include: fast or pounding heartbeats; pale skin, sweating; nausea and vomiting; dizziness; weakness or tremors; throbbing headache; or feeling nervous, anxious, or fearful. 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 EpiPen JR 2-Pak (epinephrine injection)? Other drugs may interact with epinephrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using. Next Side Effects Print this page Add to My Med List More about EpiPen JR 2-Pak (epinephrine) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: adrenergic bronchodilators Consumer resources Other brands: Adrenalin , Auvi-Q , Adrenaclick , Adrenalin Chloride , ... +3 more Professional resources Epinephrine (AHFS Monograph) Epinephrine Injection (FDA) Other Formulations EpiPen EpiPen 2-Pak Epipen Jr Related treatment guides Allergic Reactions Anaphylaxis Oral Allergy Syndrome Pupillary Dilation Where can I get more information? Your doctor or pharmacist can provide more information about epinephrine injection. 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: 9.01. Date modified: December 03, 2017 Last reviewed: September 01, 2017} Generics for EpiPen: What Are Your Options? Learn more about Epipen costs, generics and alternatives for treatment of severe life-threatening allergies (anaphylaxis): Epipen Costs & Alternatives Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug WADA Class Anti-Doping Classification Drug Class Adrenergic bronchodilators Catecholamines Vasopressors Related Drugs Anaphylaxis promethazine , EpiPen , Phenergan , epinephrine , EpiPen 2-Pak , Adrenalin , More... Allergic Reactions prednisone , promethazine , loratadine , triamcinolone , diphenhydramine , Benadryl , More... Oral Allergy Syndrome EpiPen , epinephrine , EpiPen 2-Pak , Adrenalin , Auvi-Q , More... Pupillary Dilation EpiPen , epinephrine , atropine ophthalmic , phenylephrine ophthalmic , scopolamine ophthalmic , EpiPen 2-Pak , More... EpiPen JR 2-Pak 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 EpiPen JR 2-Pak support group to connect with others who have similar interests.} } find out


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prospective customers [2:] 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 Drug Class Antidotes Related Drugs Radiation Emergency potassium iodide , SSKI , prussian blue , More... Radiogardase Rating No Reviews - Be the first! 10 /10 No Reviews - Be the first! 10 Rate it! chronic


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Photo :BeeGentle Gel
and have become BeeGentle Gel Generic Name: benzocaine Dosage Form: gel Side Effects Dosage Professional Interactions Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. Product Information BeeGentle is a water-insoluble topical anesthetic containing 20% benzocaine which forms an insoluble film upon contact with moist tissue. The film releases benzocaine at a constant rate over a 20-30 minute period. The anesthetic adheres to soft tissue forming a white film that remains in place until physically removed or until slowly dissolved by saliva. This unique time-release benzocaine anesthetic provides longer lasting anesthesia versus conventional water-soluble products. BeeGentle has an ethanol based solvent and is honey flavored. Not for use on patients with known sensitivity or allergies to benzocaine or other similar caine substances. Not for use in pulpectomy procedures or application to exposed roots. Ensure the material has had time for the solvent to evaporate and profound anesthesia has occurred. For topical use only. Do not inject. Do not store above 100 F (38 C). Do not freeze. Do not use beyond indicated shelf life. Do not use if the packaging has been damaged or if the seals are found to be broken or open. Shelf Life: 2 years Twist on ViscoTip brush tip for easy application. Apply a generous coat of varnish to the treatment site. Wait 2 minutes after application before administering any injections or proceeding with the procedure. BeeGentle will release benzocaine for 20-30 minutes. Remove with wet gauze or allow saliva to dissolve. NOTES: If the material needs to be removed from the application site, use a dry cotton pellet or swab to work the material free. To reduce the amount of anesthesia, use a dry brush, cotton pellet or swab to thin out the layer of varnish or work the material free. Back page of Complete Instructions: Caution: Federal law restricts this device to sale by or on the order of a licensed professional. Disclaimer: CAO Group believes this information to be accurate and is offered only for the benefit of its customers for use of the product under proscribed conditions. This document is not to be considered a warranty or guarantee of product performance, and CAO Group is not legally bound to such claims based on this document. Manufactured by CAO (China) Medical Equipment Co,. Ltd. for CAO Group. Inc. P 877.236.4408 F 801.256.9287 4628 West Skyhawk Drive, West Jordan, UT 84084-4501 U.S.A. www.caogroup.com SAL-CAI001C.1/22SEP2010 BACK PANEL OF INTRO KIT OUTER PACKAGING Manufactured by CAO (China) Medical Equipment Co., Ltd. for CAO Group, Inc. 4628 West Skyhawk Drive West Jordan, UT 84084 U.S.A. 877-236-4408 (tel) 801-256-9287 (fax) www.caogroup.com PACKAGE CONTENTS: 3) 3cc preloaded syringes 2) packs of 25 ViscoTips See package insert for dosage information. Rx Only. Dispose of properly after use. For complete safety information see product MSDS. Do not use if the packaging has been damaged, or if the safety seals are found to be broken. REORDER # 006-00094 STORAGE: [32 F/0 C to 100 F/38 C] TO REORDER: Henry Schein 1.800.372.4346 EXPIRATION DATE: [lot and date label] [BARCODE #: 872320000745] PAK-CT0001C.1/22SEP2010 BACK PANEL OF REFILL KIT OUTER PACKAGING Manufactured by CAO (China) Medical Equipment Co., Ltd. for CAO Group, Inc. 4628 West Skyhawk Drive West Jordan, UT 84084 U.S.A. 877-236-4408 (tel) 801-256-9287 (fax) www.caogroup.com PACKAGE CONTENTS: 20) 3cc preloaded syringes 2) packs of 25 ViscoTips See package insert for dosage information. Rx Only. Dispose of properly after use. For complete safety information see product MSDS. Do not use if the packaging has been damaged, or if the safety seals are found to be broken. REORDER # 006-00095 STORAGE: [32 F/0 C to 100 F/38 C] TO REORDER: Henry Schein 1.800.372.4346 EXPIRATION DATE: [lot and date label] [BARCODE #: 872320000752] PAK-CT0002C.1/22SEP2010 BACK PANEL OF BULK KIT OUTER PACKAGING Manufactured by CAO (China) Medical Equipment Co., Ltd. for CAO Group, Inc. 4628 West Skyhawk Drive West Jordan, UT 84084 U.S.A. 877-236-4408 (tel) 801-256-9287 (fax) www.caogroup.com See package insert for dosage information. Rx Only. Dispose of properly after use. For complete safety information see product MSDS. Do not use if the packaging has been damaged, or if the safety seals are found to be broken. REORDER # 006-00096 STORAGE: [32 F/0 C to 100 F/38 C] NET QTY: 30mL TO REORDER: Henry Schein 1.800.372.4346 EXPIRATION DATE: [lot and date label] [BARCODE #: 872320000769] PAK-CT0003D.1/22SEP2010 SIDE PANEL OF INTRO KIT OUTER PACKAGING BeeGentle Honey Flavored Topical Anesthetic Ingredients: Ethyl alcohol, benzocaine, proprietary polymer thickener, water/eau, honey flavor, sucralose NDC# 1406000203 SIDE PANEL OF REFILL KIT OUTER PACKAGING BeeGentle Honey Flavored Topical Anesthetic Ingredients: Ethyl alcohol, benzocaine, proprietary polymer thickener, water/eau, honey flavor, sucralose NDC# 1406000204 SIDE PANEL OF BULK KIT OUTER PACKAGING BeeGentle Honey Flavored Topical Anesthetic Ingredients: Ethyl alcohol, benzocaine, proprietary polymer thickener, water/eau, honey flavor, sucralose NDC# 1406000202 BeeGentle Honey Flavored Topical Anesthetic Introductory Kit Rapid, Easy Topical Anesthesia You Can See. Net Qty: 3) 3cc prefilled syringes Active Ingredient: Benzocaine, 20% BeeGentle Honey Flavored Topical Anesthetic Refill Kit Rapid, Easy Topical Anesthesia You Can See. Net Qty: 20) 3cc prefilled syringes Active Ingredient: Benzocaine, 20% BeeGentle Honey Flavored Topical Anesthetic Bulk Kit Rapid, Easy Topical Anesthesia You Can See. Net Qty: 30mL Active Ingredient: Benzocaine, 20% BEEGENTLE TOPICAL ANESTHETIC benzocaine gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:14060-002 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 210 mg in 1 g Inactive Ingredients Ingredient Name Strength Water Alcohol Product Characteristics Color Score Shape Size Flavor HONEY (Honey Flavor (artificial)) Imprint Code Contains Packaging # Item Code Package Description 1 NDC:14060-002-03 3 SYRINGE, PLASTIC (SYRINGE) in 1 KIT 1 3 g in 1 SYRINGE, PLASTIC 2 NDC:14060-002-04 20 SYRINGE, PLASTIC (SYRINGE) in 1 KIT 2 3 g in 1 SYRINGE, PLASTIC 3 NDC:14060-002-02 1 BOTTLE, PLASTIC (BOTTLE) in 1 PACKAGE 3 30 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/01/2010 Labeler - CAO Group, Inc. (102422578) Registrant - CAO Group, Inc. (102422578) Revised: 10/2010 CAO Group, Inc. Next Interactions Print this page Add to My Med List More about BeeGentle (benzocaine topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: topical anesthetics Consumer resources Professional resources Benzocaine topical (AHFS Monograph) Benzocaine Gel (FDA) Other brands: Topex , Benzo-Jel , Topical Anesthetic Dental Gel , Sting Relief , ... +6 more Related treatment guides Oral and Dental Conditions FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical anesthetics Related Drugs topical anesthetics lidocaine topical , Lidoderm , Emla , cocaine topical Oral and Dental Conditions benzocaine topical , Orajel , hydrogen peroxide topical , Orabase , Anbesol , Hurricaine , Topex , Cepacol Ultra , Trocaine , Benzo-Jel , Zilactin-B , OraMagic Plus , Dent-O-Kain , Kank-a , More... BeeGentle Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! massacre


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Photo :Definity
previous couple of Definity Generic Name: perflutren (per FLOO tren) Brand Name: Definity, Optison Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Pricing & Coupons What is Definity (perflutren)? Perflutren is an ultrasound contrast agent that is used to improve the quality of an echocardiogram (ultrasound of the heart). Perflutren works by changing the way ultrasound waves travel within your heart. This helps the ultrasound portray a sharper image of your heart. Perflutren is used to allow certain segments of the heart to be seen more clearly on an echocardiogram. Perflutren may also be used for purposes not listed in this medication guide. Slideshow Sexual Health Q+A: Your Questions Answered What is the most important information I should know about Definity (perflutren)? You should not be treated with perflutren if you have a genetic heart condition called "cardiac shunt." In rare cases, serious or fatal reactions may occur during the injection or shortly afterward. Tell your caregiver right away if you feel dizzy, nauseated, light-headed or short of breath, or if you have a severe headache, pounding in your ears, chest pain, fast or slow heartbeats, wheezing, or shallow breathing. You may be more likely to have a serious reaction if you have severe or uncontrolled heart problems (congestive heart failure, a recent heart attack, serious heart rhythm disorder). What should I discuss with my healthcare provider before receiving Definity (perflutren)? You should not be treated with perflutren if you are allergic to it, or if you have: a genetic heart condition called "cardiac shunt"; or if you are allergic to blood products or to a medicine that contains albumin. To make sure perflutren is safe for you, tell your doctor if you have: a congenital heart defect; a lung condition that has recently become worse; or if you have ever had an allergic reaction during a blood transfusion. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether perflutren passes into breast milk or if it could harm a nursing baby. However, if you are breast-feeding a baby, use a breast pump to empty your milk supply one time after you are treated with perflutren. Throw out the milk you collect during this time and do not feed it to your baby. Perflutren is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication. How is Definity (perflutren)given? Perflutren is injected into a vein through an IV. A healthcare provider will give you this injection just before the start of your echocardiogram. Your heart rate, breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 30 minutes after you receive perflutren. This is to make sure you do not have an allergic reaction to the medicine. What happens if I miss a dose? Since perflutren is given with an echocardiogram, you will not be on a regular dosing schedule. What happens if I overdose? Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. What should I avoid after receiving Definity (perflutren)? Follow your doctor's instructions about any restrictions on food, beverages, or activity. Definity (perflutren) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives, skin redness, itching; warmth, redness, numbness, or tingly feeling; wheezing, trouble breathing, tight feeling in your chest or throat; swelling of your face, lips, tongue, or throat. In rare cases, serious or fatal reactions may occur during the injection or shortly afterward. Tell your caregivers right away if you have: a light-headed feeling, like you might pass out; severe dizziness, or a cold sweat; chest pain, wheezing, trouble breathing; fast or slow heartbeats; severe headache, blurred vision, pounding in your neck or ears, anxiety, confusion; or slow heart rate, weak pulse, fainting, weak or shallow breathing. You may be more likely to have a serious reaction if you have severe or uncontrolled heart problems (congestive heart failure, a recent heart attack, serious heart rhythm disorder). Common side effects may include: headache, dizziness; flushing (warmth, redness, or tingly feeling); nausea; chest pain; pain in your side or lower back; or pain, swelling, or irritation where the injection was given. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Side Effects (complete list) What other drugs will affect Definity (perflutren)? Other drugs may interact with perflutren, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using. Next Side Effects Print this page Add to My Med List More about Definity (perflutren) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 1 Review Add your own review/rating Drug class: ultrasound contrast media Consumer resources Definity Definity (Advanced Reading) Other brands: Optison Professional resources Definity (FDA) Related treatment guides Echocardiography Where can I get more information? Your doctor or pharmacist can provide more information about perflutren. 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: 3.02. Date modified: December 03, 2017 Last reviewed: September 06, 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 Ultrasound contrast media Related Drugs Echocardiography perflutren , Optison , More... Definity Rating 1 User Review 1 User Review Not Rated - Be the first! Help and Support Looking for answers? Ask a question or go join the Definity support group to connect with others who have similar interests. yule


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manicure Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when Delestrogen is administered to a nursing woman. H. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Large and repeated doses of estrogen over an extended period of time may accelerate epiphyseal closure. Therefore to your doorstep

the handcrafted Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when Delestrogen is administered to a nursing woman. H. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Large and repeated doses of estrogen over an extended period of time may accelerate epiphyseal closure. Therefore of goods
 
Photo :Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when Delestrogen is administered to a nursing woman. H. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Large and repeated doses of estrogen over an extended period of time may accelerate epiphyseal closure. Therefore
put forward periodic monitoring of bone maturation and effects on epiphyseal centers is recommended in patients in whom bone growth is not complete. I. Geriatric Use Clinical studies of estradiol valerate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In the Women's Health Initiative Memory Study that you're the


cops Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when Delestrogen is administered to a nursing woman. H. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Large and repeated doses of estrogen over an extended period of time may accelerate epiphyseal closure. Therefore growing older

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inquisitive about Drugs: Me - Me Drugs and medications listed by brand and/or generic name starting with the letter 'M'. Popular Drugs starting with 'M' Macrobid Magnesium Meclizine Melatonin Meloxicam Metformin Methadone Methocarbamol Methotrexate Methylprednisolone Metoclopramide Metoprolol Metronidazole MiraLax Mirtazapine Mobic Morphine Motrin Mucinex Myrbetriq Alphabetical results: 901 to 1000 of 2130 Filter Show all Generic names only Brand names only Professional only Consumer only Methergine Methergine (Methylergonovine Injection) Methergine (Methylergonovine Tablets) methimazole Methimazole methimazole Methimazole Methimazole Methimazole methionine Methitest Methitest Methitest Methocarbamol methocarbamol Injection methocarbamol Methocarbamol Methocarbamol Methocarbamol Injection Methocarbamol Injection Methocarbamol Tablets methohexital Methohexital Methotrexate methotrexate Oral, Injection methotrexate Methotrexate Methotrexate Injection Methotrexate Injection Methotrexate Injection (Subcutaneous) Methotrexate Oral Solution Methotrexate Sodium Methotrexate Sodium Methotrexate Tablets methoxsalen methoxsalen Injection methoxsalen Topical methoxsalen Methoxsalen Methoxsalen (Systemic) Methoxsalen (Topical) Methoxsalen (Topical) Methoxsalen Extracorporeal Solution Methoxsalen Hard-Gelatin Capsules Methoxsalen Soft-Gelatin Capsules methoxy polyethylene glycol-epoetin beta Injection Methoxy Polyethylene Glycol-Epoetin Beta Methoxy Polyethylene Glycol-Epoetin Beta methscopolamine Methscopolamine Methscopolamine Methscopolamine Methscopolamine Bromide methsuximide methsuximide Methsuximide Methsuximide methyclothiazide methyclothiazide Methyclothiazide Methyclothiazide methyl aminolevulinate topical methyl aminolevulinate Topical application Methyl Aminolevulinate Methyl Aminolevulinate Methyl Salicylate and Menthol Cream and Ointment Methyl Salicylate and Menthol Lotion methyl salicylate topical Methyl Salicylate, Menthol, and Camphor Methyl Salicylate, Menthol, and Capsaicin Cream and Ointment Methyl Salicylate, Menthol, and Capsaicin Lotion Methyl Salicylate, Menthol, and Capsaicin Patch Methyl Salicylate, Menthol, Lidocaine, and Capsaicin methylcellulose Methylcellulose Powder and Powder Packets Methylcellulose Tablets methyldopa Methyldopa methyldopa Oral, Intravenous Methyldopa Methyldopa methyldopa and hydrochlorothiazide Methyldopa and Hydrochlorothiazide Methyldopa and Hydrochlorothiazide Methyldopa and Hydrochlorothiazide Methyldopa Tablets Methyldopate Methyldopate methyldopate hydrochloride methylene blue injection Methylene Blue methylene blue Oral, Intravenous Methylene Blue Methylene Blue Methylene Blue Injection methylergonovine oral and injection methylergonovine methylergonovine Injection Methylergonovine Methylergonovine Injection Page 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Browse all Medications A B C D E F G H I J K L M N O P Q R S T U V W X Y Z FDA Consumer Updates Depression: FDA-Approved Medications May Help Dealing with ADHD: What You Need to Know Making Decisions for Your Health: Getting the Info You Need FDA: Cutting-Edge Technology Sheds Light on Antibiotic Resistance More FDA updates lately


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one way 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 Drug Class Antidotes Related Drugs antidotes naltrexone , atropine , naloxone , acetylcysteine , leucovorin Radiation Emergency potassium iodide , SSKI , prussian blue , More... Radiogardase Rating No Reviews - Be the first! 10 /10 No Reviews - Be the first! 10 Rate it! obligations


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was resolute Benzo-Jel Generic Name: benzocaine Dosage Form: gel, dentifrice Side Effects Dosage Professional Interactions Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. Directions for Use: 1. Using the pull tab, peel open the lidding material first exposing the cotton tip applicator and then the individual reservoir of Benzo-Jel. 2. Using the cotton tip applicator, apply Benzo-Jel to the desired mucosa. Warnings: Keep out of reach of children. Do not use on people with known allergies to benzocaine. Slideshow Chronic Pain Management: A Healthcare Professional's Guide Storage: Store Benzo-Jel at controlled room temperature, between 59 and 86 F (15 and 30 C). Caution: Federal law (USA) prohibits dispensing without a prescription. Ingredients: Active: Each gram of 20% Benzocaine gel contains 200mg of Benzocaine USP Inactive: Strawberry: Polyethylene Glycol 400, Polyethylene Glycol 3350, Sucralose, flavor, FD&C Red # 40 Bubble Gum: Polyethylene Glycol 400, Polyethylene Glycol 3350, Sucralose, flavor, D&C Red # 28 Mint: Polyethylene Glycol 400, Polyethylene Glycol 3350, Sucralose, flavors, D&C Green # 5 For professional use only. REORDER # S: Strawberry (#112-7286) Bubble Gum (#112-7287) Mint (#112-7288) NDC # 0404-0742-01 (Strawberry) NDC # 0404-0743-01 (Bubble Gum) NDC # 0404-0741-01 (Mint) Distributed by (in US only): HENRY SCHEIN, INC. 135 DURYEA ROAD MELVILLE, NY 11747 USA MADE IN USA 246001 Rev Date: 05/2015 Package Label Benzo-Jel benzocaine gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0404-0742 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 200 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 400 Polyethylene Glycol 3350 Sucralose Fd&c Red No. 40 Product Characteristics Color RED Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0404-0742-01 100 CUP, UNIT-DOSE in 1 CARTON 1 .56 g in 1 CUP, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/03/2015 Benzo-Jel benzocaine gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0404-0743 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 200 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 400 Polyethylene Glycol 3350 Sucralose D&c Red No. 28 Product Characteristics Color PINK Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0404-0743-01 100 CUP, UNIT-DOSE in 1 CARTON 1 .56 g in 1 CUP, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/03/2015 Benzo-Jel benzocaine gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0404-0741 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 200 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 400 Polyethylene Glycol 3350 Sucralose D&c Red No. 28 Product Characteristics Color GREEN Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0404-0741-01 100 CUP, UNIT-DOSE in 1 CARTON 1 .56 g in 1 CUP, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/03/2015 Labeler - Henry Schein, Inc. (012430880) Revised: 06/2015 Henry Schein, Inc. Next Interactions Print this page Add to My Med List More about Benzo-Jel (benzocaine topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: topical anesthetics Consumer resources Professional resources Benzo-Jel Banana (FDA) Benzocaine topical (AHFS Monograph) Other brands: Topex , Topical Anesthetic Dental Gel , Sting Relief , BeeGentle , ... +6 more Related treatment guides Aphthous Ulcer Oral and Dental Conditions Pain FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical anesthetics Related Drugs topical anesthetics lidocaine topical , Lidoderm , Emla , cocaine topical Oral and Dental Conditions benzocaine topical , Orajel , hydrogen peroxide topical , Orabase , Anbesol , Hurricaine , Topex , Cepacol Ultra , More... 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the proper Defibrotide Sodium Class: Antithrombotic Agents, Miscellaneous Brands: Defitelio Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Introduction Defibrotide sodium is an antithrombotic agent. Uses for Defibrotide Sodium Defibrotide sodium has the following uses: Defibrotide sodium is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). 1 Slideshow Diabetic Nerve Pain: Symptoms And Treatment Defibrotide Sodium Dosage and Administration General Defibrotide sodium is available in the following dosage form(s) and strength(s): Injection: 200 mg/2.5 mL (80 mg/mL) in a single-patient-use vial. 1 Dosage It is essential that the manufacturer s labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary: Administer defibrotide sodium 6.25 mg/kg every 6 hours given as a 2-hour intravenous infusion. 1 Treat for a minimum of 21 days. If after 21 days signs and symptoms of VOD have not resolved, continue treatment until resolution. 1 Cautions for Defibrotide Sodium Contraindications Concomitant administration with systemic anticoagulant or fibrinolytic therapy. 1 Known hypersensitivity to defibrotide sodium or to any of its excipients. 1 Warnings/Precautions Hemorrhage Defibrotide sodium increased the activity of fibrinolytic enzymes in vitro , and it may increase the risk of bleeding in patients with VOD after hematopoietic stem-cell transplantation (HSCT). Do not initiate defibrotide sodium in patients with active bleeding. Monitor patients for signs of bleeding. If patients on defibrotide sodium develop bleeding, discontinue defibrotide sodium, treat the underlying cause, and provide supportive care until the bleeding has stopped. 1 Concomitant use of defibrotide sodium and a systemic anticoagulant or fibrinolytic agent (not including use for routine maintenance or reopening of central venous lines) may increase the risk of bleeding. Discontinue anticoagulants and fibrinolytic agents prior to defibrotide sodium treatment, and consider delaying the start of defibrotide sodium administration until the effects of the anticoagulant have abated. 1 Hypersensitivity Reactions Hypersensitivity reactions have occurred in less than 2% of patients treated with defibrotide sodium. These reactions include rash, urticaria, and angioedema. One case of an anaphylactic reaction was reported in a patient who had previously received defibrotide sodium. Monitor patients for hypersensitivity reactions, especially if there is a history of previous exposure. If a severe hypersensitivity reaction occurs, discontinue defibrotide sodium, treat according to the standard of care, and monitor until symptoms resolve. 1 Specific Populations Pregnancy Risk Summary: There are no available data on defibrotide sodium use in pregnant women. When administered to pregnant rabbits during the period of organogenesis at doses that were comparable to the recommended human dose based on body surface area, defibrotide sodium decreased the number of implantations and viable fetuses. Advise pregnant women of the potential risk of miscarriage. 1 The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. 1 Animal Data: Embryo-fetal toxicity assessment was attempted in rats and rabbits, but was not possible because of high maternal mortality, abortion, and fetal resorption at all doses. Pregnant rats were administered defibrotide sodium from gestational day (GD) 6 to 15 at 0, 240, 1200, and 4800 mg/kg/day by continuous intravenous infusion over 24 hours or at 60, 120, and 240 mg/kg/day by 2-hour infusions 4 times per day. Pregnant rabbits were administered defibrotide sodium at 0, 30, 60, or 120 mg/kg/day from GD 6 to 18 by 2-hour infusions 4 times per day. 1 In another study in pregnant rabbits, 3 separate subgroups of animals were treated with doses of 80 mg/kg/day defibrotide sodium administered by 2-hour infusions 4 times per day for 5 days each in a staggered manner during the organogenesis period. The dose of 80 mg/kg/day is approximately equivalent to the recommended clinical dose on a mg/m 2 basis. Subgroup 1 was dosed from GD 6 to 10, subgroup 2 was dosed from GD 10 to 14, and subgroup 3 was dosed from GD 14 to 18. An increased incidence of unilateral implantation was observed in defibrotide sodium-treated animals. Treatment with defibrotide sodium resulted in a decreased number of implantations and viable fetuses. 1 Lactation There is no information regarding the presence of defibrotide sodium in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions, including bleeding in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with defibrotide sodium. 1 Pediatric Use The safety and effectiveness of defibrotide sodium have been established in pediatric patients. Use of defibrotide sodium is supported by evidence from an adequate and well-controlled study and a dose finding study of defibrotide sodium in adult and pediatric patients with VOD with evidence of renal or pulmonary dysfunction following HSCT. The clinical trials enrolled 66 pediatric patients in the following age groups: 22 infants (1 month up to less than 2 years), 30 children (2 years up to less than 12 years), and 14 adolescents (12 years to less than 17 years). The efficacy and safety outcomes were consistent across pediatric and adult patients in the clinical trials. 1 Juvenile Animal Toxicity Data: A juvenile toxicity study in 21-day-old rats was conducted with intravenous bolus administration of defibrotide sodium at 40, 150, or 320 mg/kg/day for 4 weeks. A delayed mean age of preputial separation was observed at all doses, suggesting a delay in onset of male puberty. The dose of 40 mg/kg/day is approximately 0.4 times the clinical dose on a mg/m 2 basis for a child. The relevance of this finding for the onset of male puberty in humans is unknown. 1 Geriatric Use Clinical studies of defibrotide sodium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 1 Common Adverse Effects The most common adverse reactions (incidence 10% and independent of causality) with defibrotide sodium treatment were hypotension, diarrhea, vomiting, nausea, and epistaxis. 1 Drug Interactions Specific Drugs It is essential that the manufacturer s labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights: Defibrotide sodium may enhance the activity of antithrombotic/fibrinolytic drugs. 1 Actions Mechanism Of Action The mechanism of action of defibrotide sodium has not been fully elucidated. In vitro , defibrotide sodium enhances the enzymatic activity of plasmin to hydrolyze fibrin clots. Studies evaluating the pharmacological effects of defibrotide sodium on endothelial cells (ECs) were conducted primarily in the human microvascular endothelial cell line. In vitro , defibrotide sodium increased tissue plasminogen activator (t-PA) and thrombomodulin expression, and decreased von Willebrand factor (vWF) and plasminogen activator inhibitor-1 (PAI-1) expression, thereby reducing EC activation and increasing EC-mediated fibrinolysis. Defibrotide sodium protected ECs from damage caused by chemotherapy, tumor necrosis factor-α (TNF-α), serum starvation, and perfusion. 1 Advice to Patients Patient Counseling Information Hemorrhage : Advise patients and caregivers that defibrotide sodium may increase the risk of bleeding (hemorrhage). Instruct patients to immediately report any signs or symptoms suggestive of hemorrhage (unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision). 1 Hypersensitivity Reactions : Ask patients if they have been treated with defibrotide sodium previously. Instruct patients on the risk of allergic reactions, including anaphylaxis. Describe the symptoms of allergic reactions, including anaphylaxis, and instruct the patient to seek medical attention immediately if they experience such symptoms. 1 Additional Information AHFS First Release . For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity. 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. Defibrotide Sodium Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral Injection, Solution 80 mg /1 mL Defitelio Jazz Pharmaceuticals Inc. AHFS Drug Information. Copyright 2017, Selected Revisions September 13, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Jazz Pharmaceuticals, Inc.. DEFITELIO (defibrotide sodium) INTRAVENOUS prescribing information. 2016 Mar. Next Interactions Print this page Add to My Med List More about defibrotide Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: miscellaneous coagulation modifiers Consumer resources Defibrotide Defibrotide Intravenous (Advanced Reading) Professional resources Other brands: Defitelio Related treatment guides Hepatic Veno-Occlusive Disease} 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 N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Miscellaneous coagulation modifiers Related Drugs Hepatic Veno-Occlusive Disease defibrotide , Defitelio , More... Defibrotide Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } is essential


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that you can think of Delestrogen Generic Name: estradiol valerate Dosage Form: injection Side Effects Dosage Professional Interactions Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer ). CARDIOVASCULAR AND OTHER RISKS Estrogens and progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular disorders ). The Women s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies ). The Women s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies ). Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer ). CARDIOVASCULAR AND OTHER RISKS Estrogens and progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular disorders ). The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies ). The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies ). Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Delestrogen Description Delestrogen (estradiol valerate injection, USP) contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg estradiol valerate in a vehicle containing 5 mg chlorobutanol (chloral derivative/preservative) and sesame oil; 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg benzyl alcohol (preservative), and castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol, and castor oil. Estradiol valerate is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula: C23H32O3 MW 356.50 Slideshow 15 Prostate Cancer Facts You Simply Can't Ignore Delestrogen - Clinical Pharmacology Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level. The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone by peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women. Pharmacokinetics Absorption Estrogens used in therapy are well absorbed through the skin, mucous membranes, and gastrointestinal tract. When applied for a local action, absorption is usually sufficient to cause systemic effects. When conjugated with aryl and alkyl groups for parenteral administration, the rate of absorption of oily preparations is slowed with a prolonged duration of action, such that a single intramuscular injection of estradiol valerate or estradiol cypionate is absorbed over several weeks. Distribution The distribution of exogenous estrogens is similar to that of endogenous estrogens. Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in the blood largely bound to sex hormone binding globulin (SHBG) and albumin. Metabolism Exogenous estrogens are metabolized in the same manner as endogenous estrogens. Circulating estrogens exist in a dynamic equilibrium of metabolic interconversions. These transformations take place mainly in the liver. Estradiol is converted reversibly to estrone, and both can be converted to estriol, which is the major urinary metabolite. Estrogens also undergo enterohepatic recirculation via sulfate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the gut followed by reabsorption. In postmenopausal women, a significant proportion of the circulating estrogens exist as sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formation of more active estrogens. When given orally, naturally-occurring estrogens and their esters are extensively metabolized (first pass effect) and circulate primarily as estrone sulfate, with smaller amounts of other conjugated and unconjugated estrogenic species. This results in limited oral potency. By contrast, synthetic estrogens, such as ethinyl estradiol and the nonsteroidal estrogens, are degraded very slowly in the liver and other tissues, which results in their high intrinsic potency. Estrogen drug products administered by non-oral routes are not subject to first-pass metabolism, but also undergo significant hepatic uptake, metabolism, and enterohepatic recycling. Excretion Estradiol, estrone, and estriol are excreted in the urine along with glucuronide and sulfate conjugates. Drug Interactions In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John's Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects. Clinical Studies Women's Health Initiative Studies The Women's Health Initiative (WHI) enrolled a total of 27,000 predominantly healthy postmenopausal women to assess the risks and benefits of either the use of oral 0.625 mg conjugated estrogens (CE) per day alone or the use of oral 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate (MPA) per day compared to placebo in the prevention of certain chronic diseases. The primary endpoint was the incidence of coronary heart disease (CHD) (nonfatal myocardial infarction and CHD death), with invasive breast cancer as the primary adverse outcome studied. A "global index" included the earliest occurrence of CHD, invasive breast cancer, stroke, pulmonary embolism (PE), endometrial cancer, colorectal cancer, hip fracture, or death due to other cause. The study did not evaluate the effects of CE or CE/MPA on menopausal symptoms. The CE/MPA substudy was stopped early because, according to the predefined stopping rule, the increased risk of breast cancer and cardiovascular events exceeded the specified benefits included in the "global index." Results of the CE/MPA substudy, which included 16,608 women (average age of 63 years, range 50 to 79; 83.9% White, 6.5% Black, 5.5% Hispanic), after an average follow-up of 5.2 years are presented in Table 1 below: Table 1. RELATIVE AND ABSOLUTE RISK SEEN IN THE CE/MPA SUBSTUDY OF WHI * Event Relative Risk CE/MPA vs placebo at 5.2 Years (95% CI ) Placebo n = 8102 CE/MPA n = 8506 Absolute Risk per 10,000 Person-years * adapted from JAMA, 2002; 288:321-333 a subset of the events was combined in a "global index", defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, or death due to other causes nominal confidence intervals unadjusted for multiple looks and multiple comparisons includes metastatic and non-metastatic breast cancer with the exception of in situ breast cancer not included in Global Index CHD events 1.29 (1.02-1.63) 30 37 Non-fatal MI 1.32 (1.02-1.72) 23 30 CHD death 1.18 (0.70-1.97) 6 7 Invasive breast cancer 1.26 (1.00-1.59) 30 38 Stroke 1.41 (1.07-1.85) 21 29 Pulmonary embolism 2.13 (1.39-3.25) 8 16 Colorectal cancer 0.63 (0.43-0.92) 16 10 Endometrial cancer 0.83 (0.47-1.47) 6 5 Hip fracture 0.66 (0.45-0.98) 15 10 Death due to causes other than the events above 0.92 (0.74-1.14) 40 37 Global Index 1.15 (1.03-1.28) 151 170 Deep vein thrombosis 2.07 (1.49-2.87) 13 26 Vertebral fractures 0.66 (0.44-0.98) 15 9 Other osteoporotic fractures 0.77 (0.69-0.86) 170 131 For those outcomes included in the "global index," the absolute excess risks per 10,000 women-years in the group treated with CE/MPA were 7 more CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers, while absolute risk reductions per 10,000 women-years were 6 fewer colorectal cancers and 5 fewer hip fractures. The absolute excess risk of events included in the "global index" was 19 per 10,000 women-years. There was no difference between the groups in terms of all-cause mortality. (See BOXED WARNING , WARNINGS , and PRECAUTIONS ). Women's Health Initiative Memory Study The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, enrolled 4,532 predominantly healthy postmenopausal women 65 years of age and older (47% were age 65 to 69 years, 35% were 70 to 74 years, and 18% were 75 years of age and older) to evaluate the effects of CE/MPA (0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate) on the incidence of probable dementia (primary outcome) compared with placebo. After an average follow-up of 4 years, 40 women in the estrogen/progestin group (45 per 10,000 women-years) and 21 in the placebo group (22 per 10,000 women-years) were diagnosed with probable dementia. The relative risk of probable dementia in the hormone therapy group was 2.05 (95% CI, 1.21 to 3.48) compared to placebo. Differences between groups became apparent in the first year of treatment. It is unknown whether these findings apply to younger postmenopausal women. (See BOXED WARNING and WARNINGS, Dementia ). Indications and Usage for Delestrogen Delestrogen (estradiol valerate injection, USP) is indicated in the: 1.Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3.Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4.Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Contraindications Delestrogen should not be used in women with any of the following conditions: 1.Undiagnosed abnormal genital bleeding. 2.Known, suspected, or history of cancer of the breast. 3.Known or suspected estrogen-dependent neoplasia. 4.Active deep vein thrombosis, pulmonary embolism or a history of these conditions. 5.Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6.Liver dysfunction or disease. 7.Delestrogen should not be used in patients with known hypersensitivity to its ingredients. 8.Known or suspected pregnancy. There is no indication for Delestrogen in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (See PRECAUTIONS ). Warnings See BOXED WARNINGS. The use of unopposed estrogens in women who have a uterus is associated with an increased risk of endometrial cancer. 1. Cardiovascular disorders Estrogen and estrogen/progestin therapy has been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism (venous thromboembolism or VTE). Should any of these occur or be suspected, estrogens should be discontinued immediately. Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. a. Coronary heart disease and stroke In the Women's Health Initiative (WHI) study, an increase in the number of myocardial infarctions and strokes has been observed in women receiving CE compared to placebo. These observations are preliminary. (See CLINICAL PHARMACOLOGY, Clinical Studies ). In the CE/MPA substudy of WHI, an increased risk of coronary heart disease (CHD) events (defined as non-fatal myocardial infarction and CHD death) was observed in women receiving CE/MPA compared to women receiving placebo (37 vs. 30 per 10,000 women-years). The increase in risk was observed in year one and persisted. In the same substudy of WHI, an increased risk of stroke was observed in women receiving CE/MPA compared to women receiving placebo (29 vs. 21 per 10,000 women-years). The increase in risk was observed after the first year and persisted. In postmenopausal women with documented heart disease (n=2,763, average age 66.7 years) a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement Study; HERS) treatment with CE/MPA (0.625mg/2.5mg per day) demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE/MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the CE/MPA-treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand three hundred and twenty one women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates of CHD events were comparable among women in the CE/MPA group and the placebo group in HERS, HERS II, and overall. Large doses of estrogen (5 mg conjugated estrogens per day), comparable to those used to treat cancer of the prostate and breast, have been shown in a large prospective clinical trial in men to increase the risks of nonfatal myocardial infarction, pulmonary embolism, and thrombophlebitis. b. Venous thromboembolism (VTE) In the Women's Health Initiative (WHI) study, an increase in VTE has been observed in women receiving CE compared to placebo. These observations are preliminary. (See CLINICAL PHARMACOLOGY, Clinical Studies .) In the CE/MPA substudy of WHI, a 2-fold greater rate of VTE, including deep venous thrombosis and pulmonary embolism, was observed in women receiving CE/MPA compared to women receiving placebo. The rate of VTE was 34 per 10,000 women-years in the CE/MPA group compared to 16 per 10,000 women-years in the placebo group. The increase in VTE risk was observed during the first year and persisted. If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. 2. Malignant neoplasms a. Endometrial cancer The use of unopposed estrogens in women with intact uteri has been associated with an increased risk of endometrial cancer. The reported endometrial cancer risk among unopposed estrogen users is about 2- to 12-fold greater than in non-users, and appears dependent on duration of treatment and on estrogen dose. Most studies show no significant increased risk associated with use of estrogens for less than one year. The greatest risk appears associated with prolonged use, with increased risks of 15- to 24-fold for five to ten years or more and this risk has been shown to persist for at least 8 to 15 years after estrogen therapy is discontinued. Clinical surveillance of all women taking estrogen/progestin combinations is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. b. Breast cancer The use of estrogens and progestins by postmenopausal women has been reported to increase the risk of breast cancer. The most important randomized clinical trial providing information about this issue is the Women's Health Initiative (WHI) substudy of CE/MPA (see CLINICAL PHARMACOLOGY, Clinical Studies ). The results from observational studies are generally consistent with those of the WHI clinical trial and report no significant variation in the risk of breast cancer among different estrogens or progestins, doses, or routes of administration. The CE/MPA substudy of WHI reported an increased risk of breast cancer in women who took CE/MPA for a mean follow-up of 5.6 years. Observational studies have also reported an increased risk for estrogen/progestin combination hormone therapy, and a smaller increased risk for estrogen alone therapy, after several years of use. In the WHI trial and from observational studies, the excess risk increased with duration of use. From observational studies, the risk appeared to return to baseline in about five years after stopping treatment. In addition, observational studies suggest that the risk of breast cancer was greater, and became apparent earlier, with estrogen/progestin combination therapy as compared to estrogen alone therapy. In the CE/MPA substudy, 26% of the women reported prior use of estrogen alone and/or estrogen/progestin combination therapy. After a mean follow-up of 5.6 years during the clinical trial, the overall relative risk of invasive breast cancer was 1.24 (95% confidence interval 1.01-1.54), and the overall absolute risk was 41 vs. 33 cases per 10,000 women-years, for CE/MPA compared with placebo. Among women who reported prior use of hormone therapy, the relative risk of invasive breast cancer was 1.86, and the absolute risk was 46 vs. 25 cases per 10,000 women-years, for CE/MPA compared with placebo. Among women who reported no prior use of hormone therapy, the relative risk of invasive breast cancer was 1.09, and the absolute risk was 40 vs. 36 cases per 10,000 women-years for CE/MPA compared with placebo. In the same substudy, invasive breast cancers were larger and diagnosed at a more advanced stage in the CE/MPA group compared with the placebo group. Metastatic disease was rare with no apparent difference between the two groups. Other prognostic factors such as histologic subtype, grade and hormone receptor status did not differ between the groups. The use of estrogen plus progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation. All women should receive yearly breast examinations by a healthcare provider and perform monthly breast self-examinations. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results. c. Ovarian cancer The CE/MPA substudy of WHI reported that estrogen plus progestin increased the risk of ovarian cancer. After an average follow-up of 5.6 years, the relative risk for ovarian cancer for CE/MPA versus placebo was 1.58 (95% confidence interval 0.77 3.24) but was not statistically significant. The absolute risk for CE/MPA versus placebo was 4.2 versus 2.7 cases per 10,000 women-years. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The primary analysis, using case-control comparisons, included 12,110 cancer cases from the 17 prospective studies. The relative risks associated with current use of hormonal therapy was 1.41 (95% confidence interval [CI] 1.32 to 1.50); there was no difference in the risk estimates by duration of the exposure (less than 5 years [median of 3 years] vs. greater than 5 years [median of 10 years] of use before the cancer diagnosis). The relative risk associated with combined current and recent use (discontinued use within 5 years before cancer diagnosis) was 1.37 (95% CI 1.27-1.48), and the elevated risk was significant for both estrogen-alone and estrogen plus progestin products. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown. 3. Dementia In the Women's Health Initiative Memory Study (WHIMS), 4,532 generally healthy postmenopausal women 65 years of age and older were studied, of whom 35% were 70 to 74 years of age and 18% were 75 or older. After an average follow-up of 4 years, 40 women being treated with CE/MPA (1.8%, n = 2,229) and 21 women in the placebo group (0.9%, n = 2,303) received diagnoses of probable dementia. The relative risk for CE/MPA versus placebo was 2.05 (95% confidence interval 1.21 3.48), and was similar for women with and without histories of menopausal hormone use before WHIMS. The absolute risk of probable dementia for CE/MPA versus placebo was 45 versus 22 cases per 10,000 women-years, and the absolute excess risk for CE/MPA was 23 cases per 10,000 women-years. It is unknown whether these findings apply to younger postmenopausal women. (See CLINICAL PHARMACOLOGY, Clinical Studies and PRECAUTIONS, Geriatric Use ). It is unknown whether these findings apply to estrogen alone therapy. 4. Gallbladder disease A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported. 5. Hypercalcemia Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level. 6. Visual abnormalities Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, estrogens should be permanently discontinued. Precautions A. GENERAL 1. Addition of a progestin when a woman has not had a hysterectomy Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include a possible increased risk of breast cancer. 2. Elevated blood pressure In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogen therapy on blood pressure was not seen. Blood pressure should be monitored at regular intervals with estrogen use. 3. Hypertriglyceridemia In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications. 4. Impaired liver function and past history of cholestatic jaundice Estrogens may be poorly metabolized in patients with impaired liver function. For patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised and in the case of recurrence, medication should be discontinued. 5. Hypothyroidism Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Patients with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T 4 and T 3 serum concentrations in the normal range. Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These patients should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range. 6. Fluid retention Because estrogens may cause some degree of fluid retention, patients with conditions that might be influenced by this factor, such as a cardiac or renal dysfunction, warrant careful observation when estrogens are prescribed. 7. Hypocalcemia Estrogens should be used with caution in individuals with severe hypocalcemia. 8. Exacerbation of endometriosis Endometriosis may be exacerbated with administration of estrogens. A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered. 9. Exacerbation of other conditions Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions. 10. Hypercoagulability Some studies have shown that women taking estrogen replacement therapy have hypercoagulability, primarily related to decreased antithrombin activity. This effect appears dose- and duration-dependent and is less pronounced than that associated with oral contraceptive use. Also, postmenopausal women tend to have increased coagulation parameters at baseline compared to premenopausal women. There is some suggestion that low dose postmenopausal mestranol may increase the risk of thromboembolism, although the majority of studies (of primarily conjugated estrogens users) report no such increase. 11. Uterine bleeding and mastodynia Certain patients may develop undesirable manifestations of estrogenic stimulation, such as abnormal uterine bleeding and mastodynia. B. Patient Information Physicians are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe Delestrogen. C. Laboratory Tests Estrogen administration should be initiated at the lowest dose approved for the indication and then guided by clinical response rather than by serum hormone levels (e.g., estradiol, FSH). D. Drug/Laboratory Test Interactions 1.Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of antifactor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity. 2.Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T 4 levels (by column or by radioimmunoassay) or T 3 levels by radioimmunoassay. T 3 resin uptake is decreased, reflecting the elevated TBG. Free T 4 and free T 3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone. 3.Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG)) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin). 4.Increased plasma HDL and HDL 2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels. 5.Impaired glucose tolerance. 6.Reduced response to metyrapone test. E. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term continuous administration of estrogen, with and without progestin, in women with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer. (See BOXED WARNINGS, WARNINGS and PRECAUTIONS ). Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver. F. Pregnancy Delestrogen should not be used during pregnancy. (See CONTRAINDICATIONS ). G. Nursing Mothers Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. without boundary lines


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came across Epipen Jr (Injection) Generic Name: epinephrine (Injection route) ep-i-NEF-rin Overview Side Effects Dosage Interactions Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Commonly used brand name(s) In the U.S. Adrenaclick Adrenalin Adrenalin Chloride Auvi-Q Epipen Epipen Jr Symjepi Twinject Available Dosage Forms: Injectable Solution Therapeutic Class: Anaphylaxis Agent Pharmacologic Class: Adrenergic Chemical Class: Alkylarylamine Slideshow Prednisone: 12 Things You Should Know Uses For Epipen Jr Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis caused by unknown substances or triggered by exercise. This medicine is available only with your doctor's prescription. Before Using Epipen Jr 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of epinephrine injection in children. Geriatric No information is available on the relationship of age to the effects of epinephrine injection in geriatric patients. However, elderly patients are more likely to have age-related heart disease which may require caution in patients receiving epinephrine injection. Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Interactions with Medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Dihydroergotamine Isocarboxazid Linezolid Phenelzine Tranylcypromine Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Amitriptyline Amoxapine Bucindolol Carteolol Carvedilol Clomipramine Desipramine Digoxin Dilevalol Dothiepin Doxepin Entacapone Halothane Imipramine Iobenguane I 123 Levalbuterol Levobunolol Lofepramine Metipranolol Nadolol Nortriptyline Opipramol Oxprenolol Penbutolol Pindolol Propranolol Protriptyline Rasagiline Sotalol Tertatolol Timolol Trimipramine 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. Labetalol 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: Angina pectoris (severe chest pain) or Asthma or Blood vessel problems or Depression, history of or Diabetes or Heart attack or Heart disease (eg, coronary artery disease, organic heart disease) or Heart rhythm problems (eg, arrhythmia) or Hypertension (high blood pressure) or Hyperthyroidism (overactive thyroid) or Parkinson's disease Use with caution. May make these conditions worse. Proper Use of epinephrine This section provides information on the proper use of a number of products that contain epinephrine. It may not be specific to Epipen Jr. Please read with care. Use this medicine 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. If you are using this medicine at home, make sure you or any of your family members understand exactly how to give them. Also, tell your doctor if you or your caregiver has severe arthritis of the hands. If you have any questions about this, check with your doctor. This medicine is injected into the muscle of your outer thigh only . Do not inject this medicine into a vein, into the muscle of your buttocks, or into your fingers, toes, hands, or feet. To do so, may increase the chance of having serious side effects. This medicine comes with patient information and instructions leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. This medicine comes in 2 forms: an autoinjector syringe and needle kit or a prefilled syringe . This contains the correct dose of medicine your doctor has prescribed. This medicine comes with an autoinjector trainer and a separate trainer instructions for use. Be sure to practice first with your autoinjector trainer before an allergy emergency happens to make sure you are ready to use the real Adrenaclick , EpiPen , or EpiPen Jr autoinjector in an actual emergency. The autoinjector trainer has a grey color (for EpiPen or EpiPen Jr ) or beige color (for Adrenaclick ) and does not contain any medicine or needle. Do not remove the blue safety release (EpiPen or EpiPen Jr ) or the gray end caps (Adrenaclick ) on the autoinjector until you are ready to use it. Do not put your thumb, fingers, or hand over the orange (EpiPen or EpiPen Jr ) or red (Adrenaclick ) tip of the autoinjector or over the needle of the Symjepi prefilled syringe . This is to avoid an accidental injection. If you use the Symjepi prefilled syringe : Do not remove the needle cap until you are ready to use it. Slowly inject the syringe into the thigh while sitting down. Push the plunger all the way down until you hear a "clicking" sound. Hold it for 2 seconds. Remove the syringe and massage the area for 10 seconds. Call your medical provider right away after injection. You may need to use more than one injection if your allergic reaction does not get better after the first shot. If more than 2 injections are needed for 1 reaction, however, those should be given only under medical supervision. If you are using the epinephrine injection in a child, make sure to hold his leg firmly in place and limit movement before and during an injection. Carry this medicine with you at all times for emergency use in case you have a severe allergic reaction. Check the injection kits regularly to make sure that the liquid has not changed its color. It should be clear and colorless. Do not use this medicine if the liquid has changed its color (pinkish or brown in color), has become cloudy, or if there are particles in it. Do not reuse the remaining portion of the medicine that is left in the autoinjector or prefilled syringe. Throw away the autoinjector or prefilled syringe after you have used it. 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 injection dosage form: For allergic reactions: Adults and children weighing more than 30 kilograms (kg) 0.3 milligram (mg) injected under the skin or into the muscle of your thigh. Children weighing 15 to 30 kg 0.15 mg injected under the skin or into the muscle of your thigh. Children weighing less than 15 kg Use and dose must be determined by your doctor. Storage 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. Store the injection kits at room temperature, away from heat, moisture, and direct light. Do not store the medicine in the refrigerator or freezer, or into your vehicle's glove box. Keep the autoinjector or prefilled syringe in its carrier tube or case to protect from damage. However, this tube or case is not waterproof. If you accidentally drop it, check for damage or leakage. Precautions While Using Epipen Jr Anaphylaxis is a life-threatening reaction and requires immediate medical attention. Check with your doctor right away, or go to an emergency room as soon as possible, even if you feel better after using this medicine. Tell your doctor if you develop symptoms of an infection (such as redness that does not go away, swelling, warmth, or tenderness) at the injection site. This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor. Do not inject this medicine into your buttocks. Epinephrine may not work as well and may cause gas gangrene. Check with your doctor or go to the hospital emergency room right away to get additional treatment. Do not inject this medicine into your hands or feet. There is already less blood flow to the hands and feet, and epinephrine could make that worse and cause damage to these tissues. If you accidentally inject epinephrine into your hands or feet, check with your doctor or go to the hospital emergency room right away. This medicine may worsen the condition of patients with heart disease or heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain. You might also feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. 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. Epipen Jr 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: Incidence not known Abnormal or decreased touch sensation anxiety arm, back, or jaw pain bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site blurred vision chest pain or discomfort chest tightness or heaviness cold, pale, or bluish color of the skin of the fingers or toes dizziness fainting fast, slow, irregular, pounding, or racing heartbeat or pulse fear or nervousness headache nausea or vomiting numbness, tingling, or pain in the fingers paleness of the skin pounding in the ears restlessness shakiness in the legs, arms, hands, or feet stroke sweating trembling or shaking of the hands or feet troubled breathing unusual tiredness or weakness Get emergency help immediately if any of the following symptoms of overdose occur: Symptoms of overdose Agitation coldness of the skin coma confusion decreased awareness or responsiveness decreased urine output depression drowsiness hostility irritability lightheadedness, dizziness, fainting muscle twitching rapid weight gain rapid, deep breathing seizures severe sleepiness stomach cramps swelling of the face, ankles, or hands unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness 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 EpiPen Jr (epinephrine) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: adrenergic bronchodilators Consumer resources Other brands: Adrenalin , Auvi-Q , Adrenaclick , Adrenalin Chloride , ... +3 more Professional resources Epinephrine (AHFS Monograph) Epinephrine Injection (FDA) Other Formulations EpiPen EpiPen 2-Pak EpiPen JR 2-Pak Related treatment guides Allergic Reactions Anaphylaxis Oral Allergy Syndrome Pupillary Dilation} Generics for EpiPen: What Are Your Options? Learn more about Epipen costs, generics and alternatives for treatment of severe life-threatening allergies (anaphylaxis): Epipen Costs & Alternatives Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA WADA Class Anti-Doping Classification Manufacturer Mylan Pharmaceuticals Inc. Drug Class Adrenergic bronchodilators Catecholamines Vasopressors Related Drugs Anaphylaxis promethazine , EpiPen , Phenergan , epinephrine , EpiPen 2-Pak , Adrenalin , More... Allergic Reactions prednisone , promethazine , loratadine , triamcinolone , diphenhydramine , Benadryl , More... Oral Allergy Syndrome EpiPen , epinephrine , EpiPen 2-Pak , Adrenalin , Auvi-Q , More... Pupillary Dilation EpiPen , epinephrine , atropine ophthalmic , phenylephrine ophthalmic , scopolamine ophthalmic , EpiPen 2-Pak , More... EpiPen Jr Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Related Questions & Answers What guage needle is in epi pen jr? Read more questions} } really fizzling out


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