PROFENO fenoprofen calcium tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Wraser LLC

INN (International Name):

FENOPROFEN CALCIUM

Composition:

FENOPROFEN 600 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROFENO- FENOPROFEN CALCIUM TABLET, FILM COATED
WRASER LLC
----------
PROFENO
PROFENO™
(FENOPROFEN CALCIUM TABLET) FILM COATED, 600 MGWRASER PHARMACEUTICALS
CARDIOVASCULAR THROMBOTIC EVENTS
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
cardiovascular thrombotic events, including myocardial infarction and
stroke, which can be
fatal. This risk may occur early in treatment and may increase with
duration of use (see
WARNINGS and PRECAUTIONS).
ProFeno tablets are contraindicated in the setting of coronary artery
bypass graft (CABG)
surgery (see CONTRAINDICATIONS and 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
ProFeno is a nonsteroidal, anti-inflammatory, antiarthritic drug.
Chemically, fenoprofen calcium is an
arylacetic acid derivative. The structural formula is as follows: BENZENEACETIC ACID, Α-METHYL-3-PHENOXY-, CALCIUM SALT (2:1)-(±)-,
DIHYDRATE
Fenoprofen calcium, USP is a white crystalline powder, soluble in
alcohol (95%) to the extent of
approximately 15 mg/mL at 25°C, slightly soluble in water and
insoluble in benzene.
The pKa of fenoprofen calcium is 4.5 at 25°C.
Film-coated fenoprofen calcium tablets for oral administration are
available containing fenoprofen
calcium as the dihydrate equivalent to 600 mg of fenoprofen and the
following inactive ingredients:
colloidal silicon dioxide, croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline
cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,
sodium lauryl sulfate, titanium
dioxide and FD&C Yellow No. 6 Aluminum Lake.
CLINICAL PHARMACOLOGY
ProFeno is a nonsteroidal, anti-inflammatory, antiarthritic drug that
also possesses analgesic and
antipyretic activitie