SUMATRIPTAN SUCCINATE injection

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

JHP Pharmaceuticals LLC

INN (Alþjóðlegt nafn):

sumatriptan succinate

Samsetning:

sumatriptan 6 mg in 0.5 mL

Stjórnsýsluleið:

SUBCUTANEOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 t

Vörulýsing:

Sumatriptan succinate injection 6 mg (base)/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 42023-121-05. . . . . . . 6 mg (base)/0.5 mL single-dose vials in cartons of 5 vials. Store between 20° to 25°C (68° to 77°F). Protect from light.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE INJECTION
JHP PHARMACEUTICALS LLC
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SUMATRIPTAN SUCCINATE INJECTION
PRESCRIBING INFORMATION
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 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.
Sumatriptan succinate injection is a clear, colorless to pale yellow,
sterile, nonpyrogenic solution for
subcutaneous injection. Each 0.5 mL of sumatriptan succinate injection
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 the solution is approximately 4.2 to 5.3. The osmolality of
the injection is 291 mOsmol.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Sumatriptan has been demonstrated to be a selective agonist for a
vascular 5-hydroxytryptamine1
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
correlating with the relief of migraine and cluster headache. In the
anesthetized dog, sumatriptan
selectively reduces the carotid arterial blood flo