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SUMATRIPTAN
Overview
What is SUMATRIPTAN?
Sumatriptan 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 Sumatriptan Nasal Spray contains 5 or 20 mg 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 742 mOsmol for the 5- and 20-mg Sumatriptan Nasal Spray, respectively.
What does SUMATRIPTAN look like?
What are the available doses of SUMATRIPTAN?
Nasal spray: 5 mg and 20 mg (, )
What should I talk to my health care provider before I take SUMATRIPTAN?
Pregnancy: Based on animal data, may cause fetal harm. ()
How should I use SUMATRIPTAN?
Sumatriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
The recommended adult dose of Sumatriptan 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 Sumatriptan 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 30‑day period has not been established.
What interacts with SUMATRIPTAN?
Sorry No Records found
What are the warnings of SUMATRIPTAN?
Sorry No Records found
What are the precautions of SUMATRIPTAN?
Sorry No Records found
What are the side effects of SUMATRIPTAN?
Sorry No records found
What should I look out for while using SUMATRIPTAN?
Sumatriptan Nasal Spray is contraindicated in patients with:
What might happen if I take too much SUMATRIPTAN?
In clinical trials, the highest single doses of Sumatriptan Nasal Spray administered without significant reactions were 40 mg to 12 volunteers and 40 mg to 85 subjects with migraine, which is twice the highest single recommended dose. In addition, 12 volunteers were administered a total daily dose of 60 mg (20 mg 3 times daily) for 3.5 days 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 half‑life of sumatriptan is approximately 2 hours , and therefore monitoring of patients after overdose with Sumatriptan 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.
How should I store and handle SUMATRIPTAN?
StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.Sumatriptan Nasal Spray 5 mg (NDC 0781-6524-86) and 20 mg (NDC 0781-6523-86) are each supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 5 mg and 20 mg, respectively, of sumatriptan.Store between 2°C and 30°C (36°F and 86°F). Protect from light.Sumatriptan Nasal Spray 5 mg (NDC 0781-6524-86) and 20 mg (NDC 0781-6523-86) are each supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 5 mg and 20 mg, respectively, of sumatriptan.Store between 2°C and 30°C (36°F and 86°F). Protect from light.
