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Sumatriptan Succinate (Sumatriptan Succinate)

Trade Name : Sumatriptan Succinate

Proficient Rx LP

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 Succinate (Sumatriptan Succinate) which is also known as Sumatriptan Succinate and Manufactured by Proficient Rx LP. It is available in strength of 6 mg/.5mL per ml. Read more

Sumatriptan Succinate (Sumatriptan Succinate) 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

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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.

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 injection, USP is a serotonin (5-HT) receptor agonist (triptan) indicated for:
  • Limitations of Use
  • No data
  • No data
  • u2022
  • 3
  • Sumatriptan injection is contraindicated in patients with:
  • No data
  • The following serious adverse reactions areu00a0 described below and elsewhere in the labeling:
  • 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 Wockhardt USA LLC. at 1-800-346-6854 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.u00a0
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ()
  • 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 molecular formula is CHNOSu2022CHO, representing a molecular weight of 413.5. Sumatriptan succinate, USP is a white or almost 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.u00a0 Each 0.5 mL of sumatriptan injection, 12 mg/mL 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 solution is approximately 4.2 to 5.3. The osmolality of injection is in between 270 to 330 mOsmol.
  • No data
  • No data
  • No data
  • Sumatriptan injection, USP contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows:
  • Single-Dose Vial
  • NDC 71205-111-01 sumatriptan injection, USP single-dose vial (6 mg/0.5 mL) in cartons containing 1 vial.
  • Store between 2u00b0 and 25u00b0C (36u00b0 and 77u00b0F). Protect from light.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Risk of Myocardial Ischemia and/or Infarction, Prinzmetal's 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
  • Instruct patients to read the Instructions for Use before starting therapy. 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:
  • Wockhardt Limited
  • At:
  • Sy. No. 166, 171, 172, 177,
  • Phase - III, TSIIC, Pashamylaram (V),
  • Patancheru (M), Sangareddy Dist. - 502307,
  • Telangana State, India.
  • Distributed by:
  • Wockhardt USA LLC.
  • 20 Waterview Blvd.
  • Parsippany, NJ 07054
  • USA.
  • Iss.100417
  • Patient Information
  • Sumatriptan (SOO-ma-TRIP-tan) Injection, USP
  • Read this Patient Information before you start taking sumatriptan injection 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 Injection?
  • Sumatriptan injectionn- can cause serious side effects, including:
  • Heart attack and other heart problems. Heart problems may lead to death.
  • Stop taking sumatriptan injectionn- and get emergency medical help right away if you have any of the following symptoms of a heart attack:
  • Sumatriptan injection 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 injection?
  • Sumatriptan injection 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 injection 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 injection is not used to prevent or decrease the number of migraine or cluster headaches you have.
  • It is not known if sumatriptan injection 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:
  • u00a0u00a0u00a0u00a0 u25cfu00a0 almotriptan (AXERT)*
  • u00a0u00a0u00a0u00a0 u25cfu00a0 eletriptan (RELPAX)*
  • u00a0u00a0u00a0u00a0 u25cfu00a0 frovatriptan (FROVA)*
  • u00a0u00a0u00a0u00a0 u25cfu00a0 naratriptan (AMERGE)*
  • u00a0u00a0u00a0u00a0 u25cfu00a0 rizatriptan (MAXALT, MAXALT-MLT)*
  • u00a0u00a0u00a0u00a0 u25cfu00a0 sumatriptan and naproxen (TREXIMET)*
  • u00a0u00a0u00a0u00a0 u25cfu00a0 ergotamines (CAFERGOT, ERGOMAR, MIGERGOT)*
  • u00a0u00a0u00a0u00a0 u25cfu00a0 dihydroergotamine (D.H.E. 45, MIGRANAL)*
  • u00a0u00a0u00a0 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 injection, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take
  • Sumatriptan injection and 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 injection 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 injection may cause serious side effects.
  • These serious side effects include:
  • u00a0u00a0u00a0u00a0 u25cfu00a0 sudden or severe stomach pain
  • u00a0u00a0u00a0u00a0 u25cfu00a0 stomach pain after meals
  • u00a0u00a0u00a0u00a0 u25cfu00a0 weight loss
  • u00a0u00a0u00a0u00a0 u25cfu00a0 nausea or vomiting
  • u00a0u00a0u00a0u00a0 u25cfu00a0 constipation or diarrhea
  • u00a0u00a0u00a0u00a0 u25cfu00a0 bloody diarrhea
  • u00a0u00a0u00a0u00a0 u25cfu00a0 fever
  • u00a0u00a0u00a0u00a0 u25cfu00a0 cramping and pain in your legs or hips
  • u00a0u00a0u00a0u00a0 u25cfu00a0 feeling of heaviness or tightness in your leg muscles
  • u00a0u00a0u00a0u00a0 u25cfu00a0 burning or aching pain in your feet or toes while resting
  • u00a0u00a0u00a0u00a0 u25cfu00a0 numbness, tingling, or weakness in your legs
  • u00a0u00a0u00a0u00a0 u25cfu00a0 cold feeling or color changes in 1 or both legs or feet
  • Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
  • 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 injectionn- 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, call 1-800-346-6854.
  • What are the ingredients in sumatriptan injection?
  • Active ingredient: sumatriptan succinate, USP
  • Inactive ingredients: sodium chloride, water for injection
  • This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • AMERGE, TREXIMET are registered trademarks of the GSK group of companies.
  • *The other brands listed are trademarks of their respective owners and are not trademarks of Wockhardt. The makers of these brands are not affiliated with and do not endorse Wockhardt or its products.
  • Manufactured by:
  • Wockhardt Limited
  • At:
  • Sy. No. 166, 171, 172, 177,
  • Phase - III, TSIIC, Pashamylaram (V),
  • Patancheru (M), Sangareddy Dist. - 502307,
  • Telangana State, India.
  • Distributed by:
  • Wockhardt USA LLC.
  • 20 Waterview Blvd.
  • Parsippany, NJ 07054
  • USA.
  • Iss.100417
  • Relabeled By;
  • Proficient Rx LP
  • Thousand Oaks CA 91320
  • DRUG: Sumatriptan succinate
  • GENERIC: Sumatriptan succinate
  • DOSAGE: Injection
  • ADMINSTRATION: subcutaneous
  • NDC: 71205-111-01
  • STRENGTH: 6 mg (base)/0.5 mL
  • QTY: 0.5 mL Single-Dose Vial Label

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