SUMATRIPTAN- sumatriptan succinate tablet tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)

Prieinama:

DIRECT RX

INN (Tarptautinis Pavadinimas):

SUMATRIPTAN SUCCINATE

Sudėtis:

SUMATRIPTAN 100 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

- Sumatriptan tablets, USP 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, USP, reconsider the diagnosis of migraine before sumatriptan tablets, USP are administered to treat any subsequent attacks. Sumatriptan tablets, USP are not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan tablets, USP have not been established for cluster headache.  Sumatriptan tablets, USP 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, USP, reconsider the diagnosis of migraine before sumatriptan tablets, USP are administered to treat any subsequent a

Produkto santrauka:

Sumatriptan Tablets USP, 25 mg, 50 mg, and 100 mg of sumatriptan (base) as the succinate. Sumatriptan Tablets USP, 25 mg are white to off-white, round, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘32’ on other side.             Unit-dose package of 9 Tablets                      NDC 65862-146-36 Sumatriptan Tablets USP, 50 mg are white to off-white, capsule shaped, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘33’ on other side.             Unit-dose package of 9 Tablets                      NDC 65862-147-36 Sumatriptan Tablets USP, 100 mg are white to off-white, capsule shaped, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘34’ on other side.             Unit-dose package of 9 Tablets                      NDC 65862-148-36 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

SUMATRIPTAN- SUMATRIPTAN SUCCINATE TABLET TABLET
DIRECT RX
----------
SUMATRIPTAN - SUMATRIPTAN SUCCINATE TABLET
INDICATIONS AND USAGE
Sumatriptan tablets, USP 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, USP, reconsider the
diagnosis of migraine before sumatriptan tablets, USP are administered
to treat any subsequent
attacks.
Sumatriptan tablets, USP are not indicated for the prevention of
migraine attacks.
Safety and effectiveness of sumatriptan tablets, USP have not been
established for cluster
headache.
DOSAGE AND ADMINISTRATION
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) and Clinical
Pharmacology (12.3)].
DOSAGE FORMS AND STRENGTHS
25 mg Tablets: White to off-white, round, biconvex uncoated tablets,
debos