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Sumatriptan Succinate (Imitrex)

Trade Name : IMITREX

GlaxoSmithKline LLC

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]

Delivery Process

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 (Imitrex) which is also known as IMITREX and Manufactured by GlaxoSmithKline LLC. It is available in strength of 6 mg/.5mL per ml. Read more

Sumatriptan Succinate (Imitrex) 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

Validated Cold Chain Shipment

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
  • IMITREX 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:
  • IMITREX injection is a serotonin (5-HT) receptor agonist (triptan) indicated for:
  • Limitations of Use:
  • No data
  • No data
  • IMITREX injection is contraindicated in patients with:
  • No data
  • The following serious adverse reactions are 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 GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or .
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ()
  • Coronary vasospasm was observed after intravenous administration of IMITREX 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 IMITREX 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.
  • IMITREX 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.
  • IMITREX injection is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of IMITREX 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 of IMITREX 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
  • IMITREX 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 and/or Autoinjector Pen:
  • The needle shield of the prefilled syringe contains dry natural rubber (a latex derivative) that has the potential to cause allergic reactions in latex-sensitive individuals.
  • Each pack contains a Patient Information and Instructions for Use leaflet.
  • 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 and Instructions for Use).
  • Risk of Myocardial Ischemia and/or Infarction, Prinzmetalu2019s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events
  • Inform patients that IMITREX 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 .
  • Hypersensitivity Reactions
  • Inform patients that anaphylactic reactions have occurred in patients receiving IMITREX 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 . Inform latex-sensitive patients that the needle shield of the IMITREX prefilled syringe contains dry natural rubber (a derivative of latex) that may cause allergic reactions in individuals sensitive to latex.
  • Concomitant Use with Other Triptans or Ergot Medications
  • Inform patients that use of IMITREX 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 IMITREX 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
  • Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant .
  • Lactation
  • Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed .
  • Ability to Perform Complex Tasks
  • Treatment with IMITREX injection may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of IMITREX injection.
  • How to Use IMITREX injection
  • Instruct patients to read the Instructions for Use before starting therapy. Provide patients instruction on the proper use of IMITREX injection if they are able to self-administer IMITREX injection in medically unsupervised situations. Instruct patients on storage and disposal of the pen .
  • Inform patients that the needle in the IMITREX STATdose Pen penetrates approximately 1/4 of an inch (5 to 6u00a0mm). 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.
  • Trademarks are owned by or licensed to the GSK group of companies.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92018 GSK group of companies or its licensor.
  • IMJ:8PI
  • No data
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0739-02
  • IMITREXn
  • (SUMATRIPTAN SUCCINATE)
  • INJECTION
  • 4 mg
  • 0.5 mL
  • For subcutaneous injection only.
  • 2 Single-Dose Syringe Cartridges
  • R only
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0478-00
  • IMITREXn
  • (SUMATRIPTAN SUCCINATE)
  • INJECTION
  • 6 mg
  • 0.5 mL
  • For subcutaneous injection only.
  • R only
  • 2 Single-Dose Syringe Cartridges
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0449-02
  • IMITREXn
  • (SUMATRIPTAN SUCCINATE)
  • INJECTION
  • 6 mg
  • 0.5 mL
  • For subcutaneous injection only.
  • Single-dose vial. Discard unused portion.
  • R only
  • 5 Single-Dose Vials
  • Made in Spain
  • u00a92017 the GSK group of companies
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0479-00
  • IMITREX
  • STATdose SYSTEM
  • 6 mg
  • This carton contains:
  • (sumatriptan succinate)
  • Injection
  • 2 prefilled 0.5-mL syringe cartridges, each containing 6 mg of sumatriptan for subcutaneous injection only
  • This Product Contains Dry Natural Rubber
  • Ru00a0 only
  • Do not use if tamper-evident label is broken or missing.
  • Made in India
  • u00a92018 the GSK group of companies

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