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:

Physicians Total Care, Inc.

INN (International Name):

SUMATRIPTAN SUCCINATE

Composition:

SUMATRIPTAN SUCCINATE 50 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.

Product summary:

Sumatriptan Succinate Tablets, 25, 50, and 100 mg of sumatriptan (base) as the succinate. Sumatriptan Succinate Tablets, 50 mg are white, triangular-shaped, film-coated tablets debossed with “S ” on one side and “50” on the other in blister packs of 9 tablets (NDC 54868-6023-0 ). Sumatriptan Succinate Tablets, 100 mg, are white, triangular-shaped, film-coated tablets debossed with “S ” on one side and “100” on the other in blister packs of 9 tablets (NDC 54868-5978-0 ). Store between 36 ° and 86 °F (2 ° and 30 °C).

Authorization status:

New Drug Application

Summary of Product characteristics

SUMATRIPTAN SUCCINATE - SUMATRIPTAN SUCCINATE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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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 empirical 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
equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each
tablet also contains the inactive
ingredients croscarmellose sodium, dibasic calcium phosphate,
magnesium stearate, microcrystalline
cellulose, and sodium bicarbonate.
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 alpha -, alpha -, or beta-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 sumatriptan also activates 5-
HT receptors on peripheral terminals of the trigeminal nerve
innervating cranial blood vessels. Such
an action may also contribute to the antimigrainous effect of
sumatriptan in humans.
In the anesthetized d