SUMATRIPTAN SUCCINATE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Direct_Rx

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Sumatriptan succinate 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 succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks. Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache. Sumatriptan succinate tablets are contraindicated in patients with: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina [see Warnings and Precautions (5.1)] Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduc

Povzetek izdelek:

Sumatriptan succinate tablets, 25 mg, 50 mg, and 100 mg of sumatriptan (base) as the succinate. Sumatriptan succinate tablets, 25 mg are white, triangular-shaped, film-coated tablets debossed with "S" on one side and "I" on the other side. Bottles of 30 (Child Resistant Cap).........................................NDC 62756-520-83 Bottles of 100 (Child Resistant Cap).........................................NDC 62756-520-88 Bottles of 100 ..................................................................................NDC 62756-520-08 Bottles of 1000 ..................................................................................NDC 62756-520-18 Unit-of-use blister pack of 9 (1x9) tablets...................................NDC 72189-432-09 Unit-of-use blister pack of 9 (3x3) tablets....................................NDC 62756-520-93 Unit-of-use blister pack of 27 (3x9) tablets……………….…..NDC 62756-520-01 Sumatriptan succinate tablets, 50 mg are white, triangular-shaped, film-coated tablets debossed with "S" on one side and "50" on the other side. Bottles of 30 (Child Resistant Cap)......................................... NDC 62756-521-83 Bottles of 100 (Child Resistant Cap).........................................NDC 62756-521-88 Bottles of 100 .................................................................................NDC 62756-521-08 Bottles of 1000 ..................................................................................NDC 62756-521-18 Unit-of-use blister pack of 9 (1x9) tablets.........................................NDC 62756-521-69 Unit-of-use blister pack of 9 (3x3) tablets.........................................NDC 62756-521-93 Unit-of-use blister pack of 27 (3x9) tablets……………….…...NDC 62756-521-01 Sumatriptan succinate tablets, 100 mg are pink, triangular-shaped, film-coated tablets debossed with "S" on one side and "100" on the other side. Bottles of 30 (Child Resistant Cap) .........................................NDC 62756-522-83 Bottles of 100 (Child Resistant Cap).........................................NDC 62756-522-88 Bottles of 100 ..................................................................................NDC 62756-522-08 Bottles of 1000 .................................................................................. NDC 62756-522-18 Unit-of-use blister pack of 9 (1x9) tablets........................NDC 62756-522-69 Unit-of-use blister pack of 9 (3x3) tablets...............................NDC 62756-522-93 Unit-of-use blister pack of 27 (3x9) tablets..............................NDC 62756-522-01 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.)

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET, FILM COATED
DIRECT_RX
----------
SUMATRIPTAN SUCCINATE
Sumatriptan succinate 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
succinate tablets,
reconsider the diagnosis of migraine before sumatriptan succinate
tablets are
administered to treat any subsequent attacks.
Sumatriptan succinate tablets are not indicated for the prevention of
migraine attacks.
Safety and effectiveness of sumatriptan succinate tablets have not
been established for
cluster headache.
2.1 Dosing Information
The recommended dose of sumatriptan succinate 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
succinate 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 succinate 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)].
Sumatriptan succinate tablets, 25 mg are white, triangular-shaped,
film-coated tablets
debossed with "S