FENOPROFEN capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

FENOPROFEN CALCIUM (UNII: 0X2CW1QABJ) (FENOPROFEN - UNII:RA33EAC7KY)

Disponible desde:

Medsource Pharmaceuticals

Designación común internacional (DCI):

FENOPROFEN CALCIUM

Composición:

FENOPROFEN 400 mg

tipo de receta:

PRESCRIPTION DRUG

Estado de Autorización:

New Drug Application

Ficha técnica

FENOPROFEN- FENOPROFEN CAPSULE
MEDSOURCE PHARMACEUTICALS
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FENOPROFEN CALCIUM CAPSULES, USP
200 MG AND 400 MG
RX ONLY
CARDIOVASCULAR RISK
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 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).
Fenoprofen Calcium is contraindicated for the treatment of
peri-operative pain in the setting of
coronary artery bypass graft (CABG) surgery (see WARNINGS).
GASTROINTESTINAL RISK
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including bleeding,
ulceration, and perforation of 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).
DESCRIPTION
Fenoprofen Calcium capsules, USP is a nonsteroidal, anti-inflammatory,
antiarthritic drug. Fenoprofen
Calcium capsules contain fenoprofen calcium as the dihydrate in an
amount equivalent to 200 mg (0.826
mmol) or 400 mg (1.65 mmol) of fenoprofen. The 200 mg capsules contain
cellulose, gelatin, iron
oxides, silicone, titanium dioxide and other inactive ingredients. The
400 mg capsules contain
crospovidone, FD&C Blue 1, FD&C Red 40, gelatin, iron oxide yellow,
magnesium stearate, sodium
lauryl sulfate, talc, and titanium dioxide. Chemically, Fenoprofen
Calcium is an arylacetic acid
derivative.
The structural formula is as follows:
Benzeneacetic acid, α-methyl-3-phenoxy-,calcium salt dihydrate, (±)-
Fenoprofen Calcium is a white crystalline powder that has the
structural formula C
H
CaO
•2H
O
representing a molecular weight of 558.65. At 25°C, it dissolves to a
15 mg/mL solution in alcohol
(95%). It is slightly soluble in water and insoluble in benzene.
30
26
6
2
CLINICAL PHARMACOLOGY
Fenoprofen Calcium is a nonsteroidal