SUMATRIPTAN SUCCINATE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

NuCare Pharmaceuticals,Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with RDY on one side and 292 on the other side. NDC 68071-4562-9 BOX OF 9 Store at 20 to 25°C (68 – 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).

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET
NUCARE 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 effect o