Sumatriptan (Imitrex)

Trade Name : IMITREX

GlaxoSmithKline LLC

SPRAY

Strength 20 mg/1

SUMATRIPTAN 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 (Imitrex) which is also known as IMITREX and Manufactured by GlaxoSmithKline LLC. It is available in strength of 20 mg/1 per ml. Read more

Sumatriptan (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 nasal spray is 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:

The recommended adult dose of IMITREX nasal spray for the acute treatment of migraine is 5 mg, 10 mg, or 20 mg. The 20-mg dose may provide a greater effect than the 5-mg and 10-mg doses, but may have a greater risk of adverse reactions .
The 5-mg and 20-mg doses are given as a single spray in 1 nostril. The 10-mg dose may be achieved by the administration of a single 5-mg dose in each nostril.
If the migraine has not resolved by 2 hours after taking IMITREX nasal spray, or returns after a transient improvement, 1 additional dose may be administered at least 2 hours after the first dose. The maximum daily dose is 40 mg in a 24-hour period.
The safety of treating an average of more than 4 headaches in a 30u2011day period has not been established.

Unit dose nasal spray devices containing 5 mg or 20 mg sumatriptan.
Nasal spray: 5 mg and 20 mg (, )

IMITREX nasal spray is 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 (u22651% and >placebo) were burning sensation, disorder/discomfort of nasal cavity/sinuses, throat discomfort, nausea and/or vomiting, bad/unusual taste, and dizziness/vertigo. ()
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. ()

In clinical trials, the highest single doses of IMITREX nasal spray administered without significant reactions were 40u00a0mg to 12 volunteers and 40u00a0mg to 85 subjects with migraine, which is twice the highest single recommended dose. In addition, 12 volunteers were administered a total daily dose of 60u00a0mg (20u00a0mg 3 times daily) for 3.5u00a0days without significant 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 halfu2011life of sumatriptan is approximately 2u00a0hours , and therefore monitoring of patients after overdose with IMITREX nasal spray 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 nasal spray contains sumatriptan, a selective 5-HT receptor agonist. Sumatriptan is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide, and it has the following structure:
The empirical formula is CHNOS, representing a molecular weight of 295.4. Sumatriptan is a white to off-white powder that is readily soluble in water and in saline.
Each IMITREX nasal spray contains 5 or 20u00a0mg of sumatriptan in a 100-microL unit dose aqueous buffered solution containing monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, and purified water USP. The pH of the solution is approximately 5.5. The osmolality of the solution is 372 or 742u00a0mOsmol for the 5- and 20-mg IMITREX nasal spray, respectively.

No data

No data

The efficacy of IMITREX nasal spray in the acute treatment of migraine headaches was demonstrated in 8 randomized, double-blind, placebo-controlled trials, of which 5 used the recommended dosing regimen and used the marketed formulation. Patients enrolled in these 5 trials were predominately female (86%) and Caucasian (95%), with a mean age of 41 years (range: 18 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 2u00a0hours 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 nasal spray or other medication was allowed 2 to 24u00a0hours after the initial treatment for recurrent headache. The frequency and time to use of these additional treatments were also determined. In all trials, doses of 10 and 20u00a0mg were compared with placebo in the treatment of 1 to 3 migraine attacks. Patients received doses as a single spray into 1 nostril. In 2 trials, a 5-mg dose was also evaluated.
In all 5 trials utilizing the market formulation and recommended dosage regimen, the percentage of patients achieving headache response 2u00a0hours after treatment was significantly greater among patients receiving IMITREX nasal spray at all doses (with one exception) compared with those who received placebo. In 4 of the 5 trials, there was a statistically significant greater percentage of patients with headache response at 2u00a0hours in the 20-mg group when compared with the lower-dose groups (5 and 10u00a0mg). There were no statistically significant differences between the 5- and 10-mg dose groups in any trial. The results from the 5 controlled clinical trials are summarized in . Note that, in general, comparisons of results obtained in trials conducted under different conditions by different investigators with different samples of patients are ordinarily unreliable for purposes of quantitative comparison.
P
P
P
The estimated probability of achieving an initial headache response over the 2u00a0hours following treatment is depicted in Figureu00a01.
Figure 1. Estimated Probability of Achieving Initial Headache Response within 120u00a0Minutesn
For patients with migraine-associated nausea, photophobia, and phonophobia at baseline, there was a lower incidence of these symptoms at 2u00a0hours following administration of IMITREX nasal spray compared with placebo.
Two to 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 or Other Medication for Migraine over the 24 Hours following the Initial Dose of Study Treatmentn
There is evidence that doses above 20u00a0mg do not provide a greater effect than 20u00a0mg. There was no evidence to suggest that treatment with sumatriptan was associated with an increase in the severity of recurrent headaches. The efficacy of IMITREX nasal spray was unaffected by presence of aura; duration of headache prior to treatment; gender, age, or weight of the subject; 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 nasal spray 5u00a0mg (NDC 0173-0524-00) and 20u00a0mg (NDC 0173-0523-00) are each supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 5 mg and 20u00a0mg, respectively, of sumatriptan.
Store between 2u00b0C and 30u00b0C (36u00b0F 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 IMITREX nasal spray 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 nasal spray. 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 nasal spray 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 nasal spray 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 nasal spray may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of IMITREX nasal spray.
Local Irritation
Inform patients that they may experience local irritation of their nose and throat. The symptoms will generally resolve in less than 2u00a0hours.
How to Use IMITREX Nasal Spray
Provide patients instruction on the proper use of IMITREX nasal spray. Caution patients to avoid spraying the contents of the device in their eyes.
Trademarks are owned by or licensed to the GSK group of companies.
GlaxoSmithKlineResearch Triangle Park, NC 27709n
u00a92017 GSK group of companies or its licensor.
u00a0
IMN:5PI
u00a0

This Patient Information has been approved by the U.S. Food and Drug Administration. u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised December 2017
Instructions for Use
IMITREX (IM-i-trex)
(sumatriptan)
nasal spray
For use in the nose only. Do not spray in your eyes.
IMITREX and AMERGE are trademarks owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
GlaxoSmithKline
Research Triangle Park, NC 27709
u00a92017 GSK group of companies or its licensor.
December 2017
IMN:5PIL

PRINCIPAL DISPLAY PANEL
NDC 0173-0524-00
IMITREX
(SUMATRIPTAN)
NASAL SPRAY
5 mg
0.1 mL per unit
For Intranasal Use Only
Each unit dose nasal spray contains 5 mg of sumatriptan.
1 Spray per unit.
Do not test before use.
Rx only
6 Nasal Spray Units
Made in Spain
u00a92017 GSK group of companies or licensor.

PRINCIPAL DISPLAY PANEL
NDC 0173-0523-00
IMITREX
(SUMATRIPTAN)
NASAL SPRAY
20 mg
0.1 mL per unit
For Intranasal Use Only
Each unit dose nasal spray contains 20 mg of sumatriptan.
1 Spray per unit.
Do not test before use.
Rx only
6 Nasal Spray Units
u00a92017 GSK group of companies or licensor.

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Sumatriptan (Imitrex)

Trade Name : IMITREX

SPRAY

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 (Imitrex)

Trade Name : IMITREX

SPRAY

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

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US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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