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Sumatriptan (Sumatriptan)

Trade Name : SUMATRIPTAN

West-Ward Pharmaceuticals Corp

INJECTION

Strength 6 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 (Sumatriptan) which is also known as SUMATRIPTAN and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 6 mg/.5mL per ml. Read more

Sumatriptan (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, USP 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 succinateu00a0is a serotonin (5-HT) receptor agonist (triptan) indicated for:
  • Limitations of Use:
  • No data
  • For subcutaneous use only. ()n
  • Acute treatment of migraine: Single dose of 1 mg to 6 mg. ()n
  • Acute treatment of cluster headache: Single dose ofu00a06 mg. ()n
  • Maximum dose in a 24-hour period: 12 mg, Separate doses by at least 1u00a0hour. ()n
  • Patients receiving doses other than 4 or 6 mg: Use the 6 mg single-dose vial. ()
  • No data
  • Injection: 6 mg single-dose vial ()
  • Sumatriptan injection is contraindicated in patients with:
  • History of coronary artery disease or coronary artery vasospasm () n
  • Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders () n
  • History of stroke, transient ischemic attack, or hemiplegic or basilar migraine () n
  • Peripheral vascular disease () n
  • Ischemic bowel disease () n
  • Uncontrolled hypertension () n
  • Recent (within 24 hours) use of another 5-HT agonist (e.g., another triptan) or of an ergotamine-containing medication () n
  • Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor () n
  • Hypersensitivity to sumatriptan (angioedema andu00a0anaphylaxis seen)u00a0() n
  • Severe hepatic impairment ()
  • No data
  • Myocardial ischemia/infarction and Prinzmetalu2019s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. ()n
  • Arrhythmias: Discontinueu00a0sumatriptan if occurs. ()n
  • 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. ()n
  • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinueu00a0sumatriptan if occurs. ()n
  • Gastrointestinal ischemic reactions andu00a0peripheral vasospastic reactions: Discontinueu00a0sumatriptan if occurs. ()n
  • Medication overuse headache: Detoxification may be necessary. ()n
  • Serotonin syndrome: Discontinueu00a0sumatriptan if occurs. ()n
  • Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. ()
  • The following serious adverse reactions are described below and elsewhere in theu00a0labeling:
  • 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. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877u2011233-2001 oru00a0FDA at 1-800-FDA-1088 or .
  • No data
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ()n
  • Coronary vasospasm was observed after intravenous administration of sumatriptan 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, cyanosis, 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 with sumatriptan 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, USP 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 empiricalu00a0formula 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, USP is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of sumatriptan injection 12 mg/mL solution contains 6 mg of sumatriptan as the succinate salt and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range is approximately 4.2 to 5.3. The osmolality is 291 mOsmol.
  • No data
  • No data
  • No data
  • Sumatriptan Injection, USP contains sumatriptan (base)u00a0as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows:
  • Single-Dose Vial
  • Store between 2u00b0 and 30u00b0C (36u00b0 and 86u00b0F). Protect from light.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Risk of Myocardial Ischemia and/or Infarction, Prinzmetalu2019s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events
  • Inform patients that sumatriptan injection may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice if any indicative sign or symptoms are observed. Apprise patients of the importance of this follow-up .
  • Anaphylactic/Anaphylactoid Reactions
  • Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan injection. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens .
  • Concomitant Use with Other Triptans or Ergot Medications
  • Inform patients that use of sumatriptan injection within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated .
  • Serotonin Syndrome
  • Caution patients about the risk of serotonin syndrome with the use of sumatriptan injection or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors .
  • Medication Overuse Headache
  • Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) .
  • Pregnancy
  • Inform patients that sumatriptan injection should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus .
  • Nursing Mothers
  • Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed .
  • Ability to Perform Complex Tasks
  • Treatment with sumatriptan injection may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of sumatriptan injection.
  • How to Use Sumatriptan Injection
  • Provide patients instruction on the proper use of sumatriptan injection if they are able to self-administer sumatriptan injection in medically unsupervised situations.
  • Inform patients that the injection is intended to be given subcutaneously and intramuscular or intravascular delivery should be avoided. Instruct patients to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle.
  • Manufactured by:n
  • Distributed by:n
  • Revised: October 2015PIN311-WES/3
  • Patient Information
  • Sumatriptan Injection, USP
  • Read this Patient Information before you start taking sumatriptanu00a0and 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? n n- Sumatriptanu00a0can cause serious side effects, including:n n- Heart attack and other heart problems. Heart problems may lead to death. n n- Stop taking sumatriptanu00a0and get emergency medical help right away if you have any of the following symptoms of a heart attack:
  • Sumatriptanu00a0is 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? n
  • Who should not take sumatriptan? n n- Do not take sumatriptanu00a0if you have:
  • u00a0Ask your healthcare provider if you are not sure if your medicine is listed above.
  • What should I tell my healthcare provider before taking sumatriptan?n
  • Tell your healthcare provider about all the medicines you take,
  • 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?
  • What should I avoid while taking sumatriptan? n
  • What are the possible side effects of sumatriptan?n n- Sumatriptanu00a0may cause serious side effects.
  • u00a0u00a0 Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
  • The most common side effects of sumatriptan injectionu00a0include:
  • 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. 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-u00ad800-FDA-1088.
  • How should I store sumatriptan injection?
  • Keep sumatriptanu00a0and all medicines out of the reach of children.
  • General information about the safe and effective use of sumatriptann
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877u2011233-2001 oru00a0FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • What are the ingredients in sumatriptan injection? n
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • The brands listed are trademarks of their respective owners. The makers of these brands are not affiliated with and do not endorse this product.
  • Manufactured by:n
  • Distributed by:n
  • October 2015
  • PRINCIPAL DISPLAY PANEL
  • NDC 0143-9638-01n INJECTION, USP6 mg/0.5 mLFOR SUBCUTANEOUSINJECTION ONLYRx ONLY0.5 mL Single Dose VialStore between 2u00ba and 30u00baC (36u00ba to 86u00baF).n n
  • Arrayn- Array
  • u00a0n
  • NDC 0143-9638-055 x 0.5 mL Single Dose Vialsn n INJECTION, USP6 mg/0.5 mLFOR SUBCUTANEOUSINJECTION ONLYRx ONLY
  • PRINCIPAL DISPLAY PANEL
  • 25 X 0.5 mL Single Dose VialsNDC 0143-9638-25n n INJECTION, USP6 mg/0.5 mLFOR SUBCUTANEOUS INJECTION ONLYRx ONLY
  • No data

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