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Sumatriptan Succinate (Sumatriptan)

Trade Name : Sumatriptan

Teva Pharmaceuticals USA Inc

INJECTION

Strength 4 mg/.5mL

SUMATRIPTAN SUCCINATE Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sumatriptan Succinate (Sumatriptan) which is also known as Sumatriptan and Manufactured by Teva Pharmaceuticals USA Inc. It is available in strength of 4 mg/.5mL per ml. Read more

Sumatriptan Succinate (Sumatriptan) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Sumatriptan Injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.
  • Limitations of Use:
  • Sumatriptan injection is a serotonin (5-HT) receptor agonist (triptan) indicated for:
  • Limitations of Use:
  • No data
  • For subcutaneous use only. ()
  • Acute treatment of migraine: single dose of 1 to 6 mg. ()
  • Acute treatment of cluster headache: single dose of 6 mg. ()
  • Maximum dose in a 24-hour period: 12 mg, separate doses by at least 1 hour. ()
  • Patients receiving doses other than 4 or 6 mg: Use the 6 mg single-dose vial. ()
  • Sumatriptan injection: 4 mg and 6 mg single-dose prefilled syringe autoinjectors.
  • Injection: 4 and 6 mg single-doseu00a0prefilled syringe with an autoinjector ()
  • Sumatriptan injection is contraindicated in patients with:
  • History of coronary artery disease or coronary artery vasospasm ()
  • Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ()
  • History of stroke, transient ischemic attack, or hemiplegic or basilar migraine ()
  • Peripheral vascular disease ()
  • Ischemic bowel disease ()
  • Uncontrolled hypertension ()
  • Recent (within 24 hours) use of another 5-HT agonist (e.g., another triptan) or of an ergotamine-containing medication ()
  • Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor ()
  • Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) ()
  • Severe hepatic impairment ()
  • No data
  • Myocardial ischemia/infarction and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. ()
  • Arrhythmias: Discontinueu00a0sumatriptan injection if occurs. ()
  • Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk. ()
  • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinueu00a0sumatriptan injection if occurs. ()
  • Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinueu00a0sumatriptan injection if occurs. ()
  • Medication overuse headache: Detoxification may be necessary. ()
  • Serotonin syndrome: Discontinueu00a0sumatriptan injection if occurs. ()
  • Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. ()
  • The following serious adverse reactions are described below and elsewhere in the labeling:n
  • Most common adverse reactions (u22655% and > placebo) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness ()
  • No data
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ()
  • Coronary vasospasm was observed after intravenous administration ofu00a0sumatriptan injection . Overdoses would be expected from animal data (dogs at 0.1 g/kg, rats at 2 g/kg) to possibly cause convulsions, tremor, inactivity, erythema of the extremities, reduced respiratory rate,u00a0cyanosis, ataxia, mydriasis, injection site reactions (desquamation, hair loss, and scab formation), and paralysis.
  • The elimination half-life of sumatriptan is about 2 hours ; therefore monitoring of patients after overdose withu00a0sumatriptan injection should continue for at least 10 hours or while symptoms or signs persist.
  • It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.
  • Sumatriptan injection contains sumatriptan succinate a selective 5-HT receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:
  • The empirical formula is CHNOSu2022CHO, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline.
  • Sumatriptan injection is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL ofu00a0sumatriptan injection 8 mg/mL solution contains 4 mg of sumatriptan (base) as the succinate salt and 3.8 mg of sodium chloride, USP in Water for Injection, USP. Each 0.5 mL ofu00a0sumatriptan injection 12 mg/mL solution contains 6 mg of sumatriptan (base) as the succinate salt and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of both solutions is approximately 4.2 to 5.3. The osmolality of both injections is 291 mOsmol.
  • No data
  • No data
  • No data
  • Sumatriptan injection contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows:
  • Prefilled Syringe Autoinjector
  • Store between 2u00b0 and 30u00b0C (36u00b0 and 86u00b0F). Protect from light.
  • Advise the patient to read the FDA-approved patient labeling ( and ).
  • Patient Information
  • SumatriptanInjection, USP(SOO-ma-TRIP-tan)
  • Read this Patient Information before you start taking sumatriptan and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
  • What is the most important information I should know about sumatriptan?
  • Sumatriptan can cause serious side effects, including:
  • Heart attack and other heart problems. Heart problems may lead to death.
  • Stop taking sumatriptan and get emergency medical help right away if you have any of the following symptoms of a heart attack:
  • Sumatriptan is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:
  • What is sumatriptan?
  • Sumatriptan is a prescription medicine used to treat acute migraine headaches with or without aura and acute cluster headaches in adults who have been diagnosed with migraine or cluster headaches.
  • Sumatriptan is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.
  • Sumatriptan is not used to prevent or decrease the number of migraine or cluster headaches you have.
  • It is not known if sumatriptan is safe and effective in children under 18 years of age.
  • Who should not take sumatriptan injection?
  • Do not take sumatriptan injection if you have:
  • Ask your healthcare provider if you are not sure if your medicine is listed above.
  • What should I tell my healthcare provider before taking sumatriptan injection?
  • Before you take sumatriptan, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take,
  • Using sumatriptan with certain other medicines can affect each other, causing serious side effects.
  • Especially tell your healthcare provider if
  • Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
  • Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
  • How should I take Sumatriptan Injection?
  • What should I avoid while taking sumatriptan injection?
  • Sumatriptan can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.
  • What are the possible side effects of sumatriptan injection?
  • Sumatriptan may cause serious side effects.n- See u201cWhat is the most important information I should know about sumatriptan injection?u201d
  • These serious side effects include:
  • The most common side effects of sumatriptan injection include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of sumatriptan injection. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store sumatriptan injection?
  • Keep sumatriptan injection and all medicines out of the reach of children.
  • General information about the safe and effective use of sumatriptan injection
  • Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use sumatriptan injection for a condition for which it was not prescribed. Do not give sumatriptan injection to other people, even if they have the same symptoms you have. It may harm them.
  • This Patient Information leaflet summarizes the most important information about sumatriptan injection. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about sumatriptan injection that is written for healthcare professionals.
  • For more information, go to www.antarespharma.com or call 1-855-287-7476.
  • What are the ingredients in sumatriptan injection?
  • Active ingredient: sumatriptan succinate
  • Inactive ingredients: sodium chloride, water for injection
  • This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.
  • *The following are registered trademarks of their respective manufacturers: AXERTu00ae/ Janssen Pharmaceuticals, Inc; RELPAXu00ae/ Roerig, a Division of Pfizer Inc.; FROVAu00ae / Endo Pharmaceuticals Inc.; MAXALTu00ae, MAXALT-MLTu00ae/ Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.; CAFERGOTu00ae/ Sandoz, Inc.; ERGOMARu00ae/ Rosedale Therapeutics; MIGERGOTu00ae/ Crealta Pharmaceuticals LLC; D.H.E. 45u00ae and MIGRANALu00ae/ Valeant Pharmaceuticals North America LLC; and AMERGEu00ae, IMITREXu00ae, and TREXIMETu00ae/ GlaxoSmithKline. The brands listed are trademarks of their respective owners and are not trademarks of the Antares Pharma, Inc. The makers of these brands are not affiliated with and do not endorse Antares Pharma, Inc. or its products.
  • Manufactured In Israel For:Antares Pharma, Inc.Ewing, NJ 08628
  • Distributed by: TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454u00a92018, Antares Pharma, Inc. All rights reserved.
  • These instructions apply to both the 4 mg and 6 mg dose Sumatriptan Injection (autoinjector). Make sure that you have the dose that has been prescribed for you (the 4 mg autoinjector safety cap is yellow, the 6 mg autoinjector safety cap is blue).
  • Read this Patient Instructions for Use before you start to use your autoinjector. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about sumatriptan injection when you start taking it and at regular checkups.
  • Each autoinjector is a single dose, disposable device.
  • Important things that you need to know:
  • Getting ready for the injection:
  • STEP 1: INSPECT VIEWING WINDOW
  • STEP 2: REMOVE SAFETY CAP
  • STEP 3: INSERT THE NEEDLE
  • Figures F or G:
  • STEP 4: INJECT THE DRUG
  • STEP 5: CONFIRM SUCCESSFUL INJECTION
  • STEP 6: Dispose of Sumatriptan Injection (autoinjector)
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Israel For:Antares Pharma, Inc.Ewing, NJ 08628
  • Distributed by: TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454
  • 05/2018
  • LB-0065 V03
  • No data
  • No data
  • No data

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