SUMATRIPTAN spray

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Physicians Total Care, Inc.

INN (इंटरनेशनल नाम):

SUMATRIPTAN

रचना:

SUMATRIPTAN 20 mg in 100 uL

प्रशासन का मार्ग:

NASAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Sumatriptan Nasal Spray is indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan Nasal Spray is 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 nasal spray have not been established for cluster headache, which is present in an older, predominantly male population. Sumatriptan Nasal Spray 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 Nasal Spray. 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

उत्पाद समीक्षा:

Sumatriptan Nasal Spray 20 mg (NDC 54868-6052-0) are each supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 20 mg, respectively, of sumatriptan. Store between 36° and 86°F (2 ° and 30 °C). Protect from light.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

SUMATRIPTAN - SUMATRIPTAN SPRAY
PHYSICIANS TOTAL CARE, INC.
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SUMATRIPTAN
NASAL SPRAY
DESCRIPTION
Sumatriptan Nasal Spray contains sumatriptan, a selective
5-hydroxytryptamine receptor subtype
agonist. Sumatriptan is chemically designated as
3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-
methanesulfonamide, and it has the following structure:
The empirical formula is C
H N O S, representing a molecular weight of 295.4. Sumatriptan is a
white to off-white powder that is readily soluble in water and in
saline. Each Sumatriptan Nasal Spray
contains 5 or 20 mg of sumatriptan in a 100-μL unit dose aqueous
buffered solution containing
monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate
USP, sulfuric acid NF,
sodium hydroxide NF, and purified water USP. The pH of the solution is
approximately 5.5. The
osmolality of the solution is 372 or 742 mOsmol for the 5- and 20-mg
Sumatriptan Nasal Spray,
respectively.
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 contribute to the antimigrainous effect of sumatriptan
in humans.
In the anesthetized dog, su