SUMATRIPTAN SUCCINATE- sumatriptan succinate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

SUMATRIPTAN SUCCINATE

Composition:

SUMATRIPTAN 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sumatriptan succinate tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.  Sumatriptan succinate tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache, which is present in an older, predominantly male population. Sumatriptan succinate tablets should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive sumatriptan succinate tablets. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort and vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovasc

Product summary:

Sumatriptan succinate tablets, 25, 50, 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 55700-092-09 55700-092-30 Sumatriptan succinate tablets, 50 mg are white, triangular-shaped, film-coated tablets debossed with “S” on one side and “50” on the other Sumatriptan succinate tablets, 100 mg are pink, triangular-shaped, film-coated tablets debossed with “S” on one side and “100” on the other. Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) (See USP controlled Room Temperature.)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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DESCRIPTION
Sumatriptan succinate tablets contain sumatriptan (as the succinate),
a selective 5-hydroxytryptamine
receptor subtype agonist. Sumatriptan succinate is chemically
designated as 3-(2-(dimethylamino)ethyl]-
N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the
following structure:
The molecular formula is C
H N O S·C H O representing a molecular weight of 413.5.
Sumatriptan succinate is a white to off-white powder that is readily
soluble in water and in saline. Each
sumatriptan succinate 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,
D&C Red # 27 aluminum lake (100 mg only), dibasic calcium phosphate,
hypromellose, iron oxide red
(100 mg only), magnesium stearate, microcrystalline cellulose,
polyethylene glycol (25 & 50 mg only),
polysorbate 80 (25 & 50 mg only) propylene glycol (100 mg only), talc,
titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Sumatriptan is an agonist for a vascular 5-hydroxytryptamine receptor
subtype (probably a member of
the 5-HT
family) having only a weak affinity for 5-HT
, 5-HT
, and 5-HT receptors and no
significant affinity (as measured using standard radioligand binding
assays) or pharmacological activity
at 5-HT , 5-HT or 5-HT receptor subtypes or at α
, α -, or β-adrenergic; dopamine , dopamine
muscarinic: or benzodiazepine receptors.
The vascular 5-HT receptor subtype that sumatriptan activates is
present on cranial arteries in both dog
and primate, on the human basilar artery, and in the vasculature of
human dura mater and mediates
vasoconstriction. This action in humans correlates with the relief of
migraine headache. In addition to
causing vasoconstriction, experimental data from animal studies show
that sumatripta