Drug Catalog - Product Detail
SUMATRIPTAN SUCCINATE NASAL SPRAY LIQ 5MG 6
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00527-1818-43 | LANNETT | 1 | 5MG/ACT | NA |
PACKAGE FILES
Generic Name
SUMATRIPTAN
Substance Name
SUMATRIPTAN
Product Type
HUMAN PRESCRIPTION DRUG
Route
NASAL
Application Number
ANDA204841
Description
11 DESCRIPTION Sumatriptan nasal spray, USP contains sumatriptan, a selective 5-HT 1B/1D 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 C 14 H 21 N 3 O 2 S, 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, USP contains 5 or 20 mg of sumatriptan in a 100-microL unit dose aqueous buffered solution containing purified water USP, sulfuric acid NF, sodium hydroxide NF, monobasic potassium phosphate NF, and anhydrous dibasic sodium phosphate 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, USP, respectively. suumatriptan-molec-struc
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan nasal spray, USP 5 mg (NDC 0527-1818-43) and 20 mg (NDC 0527-1859-43) 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.
Indications & Usage
1 INDICATIONS AND USAGE Sumatriptan nasal spray, USP is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks. Sumatriptan is not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan nasal spray, USP have not been established for cluster headache. Sumatriptan is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. ( 1 ) Not indicated for the prophylactic therapy of migraine attacks. ( 1 ) Not indicated for the treatment of cluster headache. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended adult dose of sumatriptan nasal spray, USP 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 [see Clinical Studies ( 14 )] . 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, USP, 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. Single dose of 5 mg, 10 mg, or 20 mg of nasal spray. ( 2 ) A second dose should only be considered if some response to the first dose was observed. Separate doses by at least 2 hours. ( 2 ) Maximum dose in a 24-hour period: 40 mg. ( 2 )