MIGRAINE PACK- sumatriptan succinate, mentholum, belladonna, iris versicolor, sanguinaria canadensis kit

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

TMIG Inc

INN (mednarodno ime):

SUMATRIPTAN SUCCINATE

Sestava:

SUMATRIPTAN 50 mg

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Sumatriptan Tablets USP, 25 mg, 50 mg, and 100 mg of sumatriptan (base) as the succinate. Sumatriptan Tablets USP, 25 mg are white to off-white, round, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘32’ on other side. Unit-dose package of 9 Tablets NDC 65862-146-36 Sumatriptan Tablets USP, 50 mg are white to off-white, capsule shaped, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘33’ on other side. Unit-dose package of 9 Tablets NDC 65862-147-36 Sumatriptan Tablets USP, 100 mg are white to off-white, capsule shaped, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘34’ on other side. Unit-dose package of 9 Tablets NDC 65862-148-36 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

MIGRAINE PACK- SUMATRIPTAN SUCCINATE, MENTHOLUM, BELLADONNA, IRIS
VERSICOLOR, SANGUINARIA
CANADENSIS
TMIG INC
----------
MIGRAINE PACK
SUMATRIPTAN TABLETS USP AND TOPICAL MIGRAINE PAIN RELIEVING GEL
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
cr