SUMATRIPTAN SUCCINATE tablet film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Hikma Pharmaceutical

INN (Medzinárodný Name):

SUMATRIPTAN SUCCINATE

Zloženie:

SUMATRIPTAN SUCCINATE 25 mg

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET, FILM COATED
HIKMA PHARMACEUTICAL
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SUMATRIPTAN SUCCINATE TABLETS
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 colloidal silicon
dioxide, croscarmellose sodium,
magnesium stearate , microcrystalline cellulose, Povidone K-30, sodium
bicarbonate, talc.
Each 100 mg tablet also contains polyvinyl alcohol, titanium dioxide,
polyethylene glycol 3350, talc,
iron oxide red, and each 50 mg and 25 mg tablet contains: polyvinyl
alcohol, titanium dioxide,
polyethylene glycol 3350 and talc.
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 f