FLURBIPROFEN tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLURBIPROFEN (UNII: 5GRO578KLP) (FLURBIPROFEN - UNII:5GRO578KLP)

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Name):

FLURBIPROFEN

Composition:

FLURBIPROFEN 100 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLURBIPROFEN- FLURBIPROFEN TABLET, FILM COATED
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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CARDIOVASCULAR RISK
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).
Flurbiprofen is contraindicated for the treatment of perioperative
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 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).
DESCRIPTION
Flurbiprofen is a member of the phenylalkanoic acid derivative group
of non-steroidal anti-inflammatory
drugs. Flurbiprofen tablets are beige, round, film-coated tablets for
oral administration. Flurbiprofen is
a racemic mixture of (+)S- and (-)R-enantiomers. Flurbiprofen, USP is
a white or slightly yellow
crystalline powder. It is slightly soluble in water at pH 7.0 and
readily soluble in most polar solvents.
The chemical name is [1,1’-biphenyl]-4-acetic acid,
2-fluoro-alpha-methyl-, (±)-. The molecular weight
is 244.26. Its molecular formula is C
H FO and it has the following structural formula:
Each tablet, for oral administration, contains 50 mg or 100 mg
flurbiprofen, USP. Inactive ingredients
are colloidal silicon dioxide, croscarmellose sodium, hypromellose,
lactose (anhydrous), magnesium
stearate, microcrystalline cellulose, polydextrose, polyethylene
glycol, sodium lauryl sulfate, titanium
dioxide, triacetin, yellow iron oxide and black iron oxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Flurbiprofen is a non-steroidal anti-inflammatory drug that exhibits
a