Drug Catalog - Product Detail
SUMATRIPTAN SUCCINATE 50MG TB 9CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-5631-59 | MYLAN | 9 | 50MG | TABLET |
PACKAGE FILES
Generic Name
SUMATRIPTAN SUCCINATE
Substance Name
SUMATRIPTAN SUCCINATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA077744
Description
11 DESCRIPTION Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT 1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(Dimethylamino)ethyl]- N -methylindole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C 14 H 21 N 3 O 2 S•C 4 H 6 O 4 , representing a molecular weight of 413.5. Sumatriptan succinate, USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate, USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. Meets USP Dissolution Test 2. Sumatriptan Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan Tablets, USP are available containing 35 mg, 70 mg or 140 mg of sumatriptan succinate, USP equivalent to 25 mg, 50 mg or 100 mg of sumatriptan, respectively. The 25 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and S4 on the other side. They are available as follows: NDC 0378-5630-59 bottles of 9 tablets The 50 mg tablets are white, film-coated, round, unscored tablets debossed with M over S7 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5631-59 bottles of 9 tablets The 100 mg tablets are white, film-coated, round, unscored tablets debossed with M over S12 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5632-59 bottles of 9 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient.
Indications & Usage
1 INDICATIONS AND USAGE Sumatriptan tablets are 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 tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. • Sumatriptan tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. Sumatriptan tablets are 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 • Single dose of 25-mg, 50-mg, or 100-mg tablet. ( 2.1 ) • A second dose should only be considered if some response to the first dose was observed. Separate doses by at least 2 hours. ( 2.1 ) • Maximum dose in a 24-hour period: 200 mg. ( 2.1 ) • Maximum single dose should not exceed 50 mg in patients with mild to moderate hepatic impairment. ( 2.2 ) 2.1 Dosing Information The recommended dose of sumatriptan tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25-mg dose, but doses of 100 mg may not provide a greater effect than the 50-mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies (14) ] . If the migraine has not resolved by 2 hours after taking sumatriptan tablets, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 200 mg in a 24-hour period. Use After Sumatriptan Injection If the migraine returns following an initial treatment with sumatriptan injection, additional single sumatriptan tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses. The safety of treating an average of more than 4 headaches in a 30-day period has not been established. 2.2 Dosing in Patients with Hepatic Impairment If treatment is deemed advisable in the presence of mild to moderate hepatic impairment, the maximum single dose should not exceed 50 mg [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] .