Sumatriptan Succinate (Imitrex)

Trade Name : IMITREX

GlaxoSmithKline LLC

TABLET, FILM COATED

Strength 25 mg/1

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 (Imitrex) which is also known as IMITREX and Manufactured by GlaxoSmithKline LLC. It is available in strength of 25 mg/1 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

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No data

IMITREX tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
IMITREX is a serotonin (5-HT) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. ()
Limitations of Use:

No data

25-mg Tablets:
50-mg Tablets:
100-mg Tablets:
Tablets: 25 mg, 50 mg, and 100 mg ()

IMITREX Tablets are contraindicated in patients with:

No data

The following adverse reactions are discussed in more detail in other sections of the prescribing information:
Most common adverse reactions (u22652% and >placebo) were paresthesia, warm/cold sensation, chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, other sensations of pain/pressure/tightness/heaviness, vertigo, and malaise/fatigue. ()
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or n

No data

Pregnancy: Based on animal data, may cause fetal harm. ()

Patients in clinical trials (Nu00a0=u00a0670) received single oral doses of 140 to 300u00a0mg without significant adverse reactions. Volunteers (Nu00a0=u00a0174) received single oral doses of 140 to 400u00a0mg without serious adverse reactions.
Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.
The elimination half-life of sumatriptan is approximately 2.5u00a0hours , and therefore monitoring of patients after overdose with IMITREX tablets should continue for at least 12u00a0hours or while symptoms or signs persist.
It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.

IMITREX tablets contain sumatriptan succinate, a selective 5u2011HT 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 offu2011white powder that is readily soluble in water and in saline.
Each IMITREX tablet for oral administration contains 35, 70, or 140u00a0mg of sumatriptan succinate equivalent to 25, 50, or 100u00a0mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium bicarbonate. Each 100-mg tablet also contains hypromellose, iron oxide, titanium dioxide, and triacetin.

No data

No data

The efficacy of IMITREX tablets in the acute treatment of migraine headaches was demonstrated in 3, randomized, double-blind, placebo-controlled trials. Patients enrolled in these 3 trials were predominately female (87%) and Caucasian (97%), with a mean age of 40u00a0years (range: u00a018 to 65 years). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 4u00a0hours after dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24u00a0hours postdose. A second dose of IMITREX tablets or other medication was allowed 4 to 24u00a0hours after the initial treatment for recurrent headache. Acetaminophen was offered to patients in Trials 2 and 3 beginning at 2u00a0hours after initial treatment if the migraine pain had not improved or had worsened. Additional medications were allowed 4 to 24u00a0hours after the initial treatment for recurrent headache or as rescue in all 3 trials. The frequency and time to use of these additional treatments were also determined. In all trials, doses of 25, 50, and 100u00a0mg were compared with placebo in the treatment of migraine attacks. In 1 trial, doses of 25, 50, and 100u00a0mg were also compared with each other.
In all 3 trials, the percentage of patients achieving headache response 2 and 4u00a0hours after treatment was significantly greater among patients receiving IMITREX tablets at all doses compared with those who received placebo. In 1 of the 3 trials, there was a statistically significant greater percentage of patients with headache response at 2 and 4u00a0hours in the 50-mg or 100-mg group when compared with the 25-mg dose groups. There were no statistically significant differences between the 50-mg and 100-mg dose groups in any trial. The results from the 3 controlled clinical trials are summarized in Tableu00a02.
Table 2. Percentage of Patients with Headache Response (Mild or No Headache) 2 and 4 Hours following Treatment
The estimated probability of achieving an initial headache response over the 4u00a0hours following treatment in pooled Trials 1, 2, and 3 is depicted in Figure 1.
Figure 1. Estimated Probability of Achieving Initial Headache Response within 4 Hours of Treatment in Pooled Trials 1, 2, and 3n
For patients with migraine-associated nausea, photophobia, and/or phonophobia at baseline, there was a lower incidence of these symptoms at 2u00a0hours (Trial 1) and at 4u00a0hours (Trials 1, 2, and 3) following administration of IMITREX tablets compared with placebo.
As early as 2u00a0hours in Trials 2 and 3, or as early as 4u00a0hours in Trial 1, through 24u00a0hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24u00a0hours following the initial dose of study treatment is summarized in Figureu00a02.
Figure 2. The Estimated Probability of Patients Taking a Second Dose of IMITREX Tablets or Other Medication to Treat Migraine over the 24 Hours following the Initial Dose of Study Treatment in Pooled Trials 1, 2, and 3n
There is evidence that doses above 50u00a0mg do not provide a greater effect than 50u00a0mg. There was no evidence to suggest that treatment with IMITREX tablets was associated with an increase in the severity of recurrent headaches. The efficacy of IMITREX tablets was unaffected by presence of aura; duration of headache prior to treatment; gender, age, or weight of the subject; relationship to menses; or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants). There were insufficient data to assess the impact of race on efficacy.

IMITREX tablets, 25 mg, 50 mg, and 100u00a0mg of sumatriptan (base) as the succinate.
IMITREX tablets, 25u00a0mg, are white, triangularu2011shaped, filmu2011coated tablets debossed with u201cIu201d on one side and u201c25u201d on the other in blister packs of 9 tablets (NDC 0173-0735-00).
IMITREX tablets, 50u00a0mg, are white, triangularu2011shaped, filmu2011coated tablets debossed with u201cIMITREX 50u201d on one side and a chevron shape (^) on the other in blister packs of 9 tablets (NDC 0173-0736-01).
IMITREX tablets, 100u00a0mg, are pink, triangularu2011shaped, filmu2011coated tablets debossed with u201cIMITREX 100u201d on one side and a chevron shape (^) on the other in blister packs of 9u00a0tablets (NDC 0173-0737-01).
Store between 2u00b0C and 30u00b0C (36u00b0F and 86u00b0F).

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 IMITREX tablets 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 IMITREX tablets. 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 IMITREX tablets within 24u00a0hours 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 tablets or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors n
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 tablets may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of IMITREX tablets.
Trademark is owned by or licensed to the GSK group of companies.
GlaxoSmithKline
Research Triangle Park, NC 27709
u00a92017 GSK group of companies or its licensor.
IMT:5PI

This Patient Information has been approved by the U.S. Food and Drug Administration. u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised December 2017

PRINCIPAL DISPLAY PANEL
NDC 0173-0735-00
IMITREXn
(SUMATRIPTAN SUCCINATE)
TABLETS
25 mg
R only
Each tablet contains sumatriptan succinate equivalent to 25 mg of sumatriptan.
9 Tablets
Do not use if package is torn or broken or if you receive fewer tablets than your doctor prescribed.
Made in Canada
u00a92017 the GSK group of companies.

PRINCIPAL DISPLAY PANEL
NDC 0173-0736-01
IMITREXn
(SUMATRIPTAN SUCCINATE)
TABLETS
50 mg
R only
Each tablet contains sumatriptan succinate equivalent to 50 mg of sumatriptan.
9 Tablets
Do not use if package is torn or broken or if you receive fewer tablets than your doctor prescribed.
Made in Canada
u00a92017 the GSK group of companies.

PRINCIPAL DISPLAY PANEL
NDC 0173-0737-01
IMITREXn
(SUMATRIPTAN SUCCINATE)
TABLETS
100 mg
R only
Each tablet contains sumatriptan succinate equivalent to 100 mg of sumatriptan.
9 Tablets
Do not use if package is torn or broken or if you receive fewer tablets than your doctor prescribed.
Made in Canada
u00a92017 the GSK group of companies.

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Sumatriptan Succinate (Imitrex)

Trade Name : IMITREX

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Sumatriptan Succinate (Imitrex)

Trade Name : IMITREX

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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