SUMATRIPTAN SUCCINATE injection

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:

Wockhardt Limited

INN (Tên quốc tế):

SUMATRIPTAN SUCCINATE

Thành phần:

SUMATRIPTAN 6 mg in 0.5 mL

Tuyến hành chính:

SUBCUTANEOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Sumatriptan succinate injection is indicated for 1) the acute treatment of migraine attacks with or without aura and 2) the acute treatment of cluster headache episodes. Sumatriptan succinate injection is not for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Sumatriptan succinate injection should not be given intravenously because of its potential to cause coronary vasospasm. Sumatriptan succinate injection 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 injection. 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.Cerebrovascular syndromes include, but are not limited to,

Tóm tắt sản phẩm:

Sumatriptan succinate injection 6 mg / 0.5 mL containing sumatriptan 6 mg (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: NDC 64679-728-01 sumatriptan succinate injection single-dose vial (6 mg/0.5 mL) in cartons containing 5 vials. Store between 2° and 25°C (36° and 77°F). Protect from light.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE INJECTION
WOCKHARDT LIMITED
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PRESCRIBING INFORMATION
SUMATRIPTAN SUCCINATE INJECTION
FOR SUBCUTANEOUS USE ONLY.
RX ONLY
DESCRIPTION
Sumatriptan succinate injection is a selective 5-hydroxytryptamine1
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 molecular formula is C
H N O SC H O , representing a molecular weight of 413.5.
Sumatriptan succinate is a white or almost off-white powder that is
readily soluble in water and in
saline.
Sumatriptan succinate injection is a clear, colorless to pale yellow,
sterile, nonpyrogenic solution for
subcutaneous injection. Each 0.5 mL of sumatriptan succinate injection
12 mg/mL solution contains 6 mg
of sumatriptan (base) as the succinate salt and 3.5 mg of sodium
chloride, USP in Water for Injection,
USP.
The pH range of solution is approximately 4.2 to 5.3. The osmolality
of injection is in between 270 to
330 mOsmol.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Sumatriptan has been demonstrated to be a selective agonist for a
vascular 5-hydroxytryptamine
receptor subtype (probably a member of the 5-HT
family) with no significant affinity (as measured
using standard radioligand binding assays) or pharmacological activity
at 5-HT , 5-HT receptor
subtypes or at alpha -, alpha -, or beta-adrenergic; dopamine ;
dopamine ; muscarinic; or
benzodiazepine receptors.
The vascular 5-HT receptor subtype to which sumatriptan binds
selectively, and through which it
presumably exerts its antimigrainous effect, has been shown to be
present on cranial arteries in both dog
and primate, on the human basilar artery, and in the vasculature of
the isolated dura mater of humans. In
these tissues, sumatriptan activates this receptor to cause
vasoconstriction, an action in humans
14
21
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2
4
6
4
1
1D
2
3
1
2
1
2
1
correlating with the relief of migraine and cluster headache. In the
anesthetized dog, su