IMITREX- sumatriptan succinate injection

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Physicians Total Care, Inc.

INN (Међународно име):

SUMATRIPTAN SUCCINATE

Састав:

SUMATRIPTAN 6 mg in 0.5 mL

Пут администрације:

SUBCUTANEOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

IMITREX Injection is indicated for 1) the acute treatment of migraine attacks with or without aura and 2) the acute treatment of cluster headache episodes. IMITREX Injection is not for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). IMITREX Injection should not be given intravenously because of its potential to cause coronary vasospasm. IMITREX 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 IMITREX Injection. 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 limited to, strokes of any type as well as transient ischemic attacks. Peripheral v

Резиме производа:

IMITREX Injection contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: (NDC 54868-3180-0) IMITREX STATdose System, 6 mg, containing 2 prefilled single-dose syringe cartridges, 1 IMITREX STATdose Pen, 1 carrying case, and a patient information leaflet with instructions for use. Store between 2° and 30°C (36° and 86°F). Protect from light. IMITREX, IMITREX STATdose System, and IMITREX STATdose Pen are registered trademarks of GlaxoSmithKline. This product's prescribing information may have been updated. Please refer to ww.gsk.com for the most current version. GlaxoSmithKline Research Triangle Park, NC 27709 ©2010, GlaxoSmithKline. All rights reserved. February 2010 IMJ:3PI Additional barcode label applied by: Physicians Total Care, Inc. Tulsa, Oklahoma     74146

Статус ауторизације:

New Drug Application

Карактеристике производа

IMITREX - SUMATRIPTAN SUCCINATE INJECTION
PHYSICIANS TOTAL CARE, INC.
----------
IMITREX
(SUMATRIPTAN SUCCINATE)
INJECTION
FOR SUBCUTANEOUS USE ONLY.
DESCRIPTION
IMITREX (sumatriptan succinate) Injection is a selective
5-hydroxytryptamine 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 empirical 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.
IMITREX Injection is a clear, colorless to pale yellow, sterile,
nonpyrogenic solution for
subcutaneous injection. Each 0.5 mL of IMITREX Injection 8 mg/mL
solution contains 4 mg of
sumatriptan (base) as the succinate salt and 3.8 mg of sodium
chloride, USP in Water for Injection, USP.
Each 0.5 mL of IMITREX 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 both
solutions is approximately 4.2 to 5.3. The osmolality of both
injections is 291 mOsmol.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Sumatriptan is 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, is 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 clust