SUMATRIPTAN SUCCINATE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Lake Erie Medical DBA Quality Care Products LLC

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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 Bottles of 30 (Child Resistant Cap)………………………..… . NDC 62756-520-83 Bottles of 100 (Child Resistant Cap) ……………………….… NDC 62756-520-88 Bottles of 100 (Non Child Resistant Cap) …………….…….....NDC 62756-520-08 Bottles of 1000 (Non Child Resistant Cap)………..…..……… NDC 62756-520-18 Unit dose blister pack of 9 (1x9) tablets……………….……… NDC 62756-520-69 Unit dose blister pack of 9 (3x3) tablets……………….……… NDC 62756-520-93 Sumatriptan succinate tablets, 50 mg are white, triangular-shaped, film-coated tablets debossed with “S” on one side and “50” on the other Bottles of 30 (Child Resistant Cap)………………….…….…. NDC 62756-521-83 Bottles of 100 (Child Resistant Cap) …………….……..…..…NDC 62756-521-88 Bottles of 100 (Non Child Resistant Cap) …………….……....NDC 62756-521-08 Bottles of 1000 (Non Child Resistant Cap) ………..…..…….. NDC 62756-521-18 Unit dose blister pack of 9 (1x9) tablets ……………….…….. NDC 62756-521-69 Unit dose blister pack of 9 (3x3) tablets……………..….…….NDC 62756-521-93 Sumatriptan succinate tablets, 100 mg are pink, triangular-shaped, film-coated tablets debossed with “S” on one side and “100” on the other. Bottles of 30 (Child Resistant Cap) …………………..……..NDC 62756-522-83 Bottles of 100 (Child Resistant Cap) ………………..………NDC 62756-522-88 Bottles of 100 (Non Child Resistant Cap)…………..…..….. NDC 62756-522-08 Bottles of 1000 (Non Child Resistant Cap) ………..…..……NDC 62756-522-18 Unit dose blister pack of 9 (1x9) tablets……..........................NDC 62756-522-69 Unit dose blister pack of 9 (3x3) tablets..................................NDC 62756-522-93 Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) (See USP controlled Room Temperature.)

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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