SUMATRIPTAN SUCCINATE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Prenos Lastnosti izdelka (SPC)
11-05-2018

Aktivna sestavina:

sumatriptan succinate (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)

Dostopno od:

Preferred Pharmaceuticals, Inc

INN (mednarodno ime):

sumatriptan succinate

Sestava:

SUMATRIPTAN 25 mg

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

                                SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET
PREFERRED PHARMACEUTICALS, INC
----------
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 antimigrainous effec
                                
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