SUMATRIPTAN SUCCINATE- sumatriptan succinate tablet

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 tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan 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 tablets have not been established for cluster headache, which is present in an older, predominantly male population. Sumatriptan 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 sumatriptane tablets. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort, vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, stro

Product summary:

Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.   55700-235-09 Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.   Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.   Store at 20 to 25°C (68 – 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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SUMATRIPTAN SUCCINATE
DESCRIPTION
Sumatriptan tablets USP contain sumatriptan (as the succinate), a
selective 5-hydroxytryptamine
receptor subtype agonist. Sumatriptan succinate USP 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 USP is a white to off-white powder that is
readily soluble in water and in saline.
Each sumatriptan tablet USP 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 croscarmellose sodium, lactose anhydrous, lactose
monohydrate, magnesium stearate,
mannitol, microcrystalline cellulose, talc, titanium dioxide and
triacetin.
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 ant