SUMATRIPTAN SUCCINATE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

MedVantx, Inc.

INN (Kansainvälinen yleisnimi):

SUMATRIPTAN SUCCINATE

Koostumus:

SUMATRIPTAN 50 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

Sumatriptan succinate tablets, 25, 50, or 100 mg of sumatriptan (base) as the succinate, are available as follows: 25 mg – white to off-white, film-coated, capsule-shaped tablets. One side of the tablet is debossed with the number "93". The other side of the tablet is debossed with the number "222". They are available in cartons of 9 tablets (3 x 3). 50 mg – white to off-white, film-coated, capsule-shaped tablets. One side of the tablet is debossed with the number "93". The other side of the tablet is debossed with the number "223". They are available in cartons of 9 tablets (3 x 3). 100 mg – light-pink, film-coated, capsule-shaped tablets. One side of the tablet is debossed with the number "93". The other side of the tablet is debossed with the number "224". They are available in cartons of 9 tablets (3 x 3). Store at 20° to 25°C (68° to 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).

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET, FILM COATED
MEDVANTX, INC.
----------
SUMATRIPTAN SUCCINATE TABLETS
0222
0223
0224
RX ONLY
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:
C
H N O S•C H O M.W. 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, hypromellose, lactose anhydrous,
lactose monohydrate, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, and
titanium dioxide. Additionally, the 100 mg
tablets contain iron oxide red, iron oxide yellow, 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