TREXIMET sumatriptan and naproxen sodium tablet film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

GlaxoSmithKline LLC

INN (Միջազգային անվանումը):

SUMATRIPTAN SUCCINATE

Կազմը:

SUMATRIPTAN 85 mg

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

TREXIMET- SUMATRIPTAN AND NAPROXEN SODIUM TABLET, FILM COATED
GLAXOSMITHKLINE LLC
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TREXIMET
(SUMATRIPTAN AND NAPROXEN SODIUM)
TABLETS
WARNINGS
CARDIOVASCULAR RISK: TREXIMET MAY CAUSE AN INCREASED RISK OF SERIOUS
CARDIOVASCULAR
THROMBOTIC EVENTS, MYOCARDIAL INFARCTION, AND STROKE, WHICH CAN BE
FATAL. THIS RISK MAY
INCREASE WITH DURATION OF USE. PATIENTS WITH CARDIOVASCULAR DISEASE OR
RISK FACTORS FOR
CARDIOVASCULAR DISEASE MAY BE AT GREATER RISK (SEE WARNINGS:
CARDIOVASCULAR EFFECTS).
GASTROINTESTINAL RISK: TREXIMET CONTAINS A NONSTEROIDAL
ANTI-INFLAMMATORY DRUG
(NSAID). NSAID-CONTAINING PRODUCTS CAUSE AN INCREASED RISK OF SERIOUS
GASTROINTESTINAL
ADVERSE EVENTS INCLUDING BLEEDING, ULCERATION, AND PERFORATION OF THE
STOMACH OR INTESTINES,
WHICH CAN BE FATAL. THESE EVENTS CAN OCCUR AT ANY TIME DURING USE AND
WITHOUT WARNING
SYMPTOMS. ELDERLY PATIENTS ARE AT GREATER RISK FOR SERIOUS
GASTROINTESTINAL EVENTS (SEE
WARNINGS: RISK OF GASTROINTESTINAL ULCERATION, BLEEDING, AND
PERFORATION WITH
NONSTEROIDAL ANTI-INFLAMMATORY DRUG THERAPY).
DESCRIPTION
TREXIMET contains sumatriptan (as the succinate), a selective
5-hydroxytryptamine (5-HT ) receptor
subtype agonist, and naproxen sodium, a member of the arylacetic acid
group of nonsteroidal anti-
inflammatory drugs (NSAIDs).
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.
Naproxen sodium is chemically designated as
(S)-6-methoxy-α-methyl-2-naphthaleneacetic acid,
sodium salt, and it has the following structure:
®
1
1
14
21
3
2
4
6
4
The empirical formula is C
H NaO , representing a molecular weight of 252.23. Naproxen sodium is
a white-to-creamy white crystalline solid, freely soluble in water at
neutral pH.
Each TREXIMET Tablet for oral administration contains