FLURBIPROFEN- 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

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of flurbiprofen tablets and other treatment options before deciding to use flurbiprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Flurbiprofen tablets are indicated: - For relief of the signs and symptoms of rheumatoid arthritis. - For relief of the signs and symptoms of osteoarthritis. Flurbiprofen tablets are contraindicated in patients with known hypersensitivity to flurbiprofen. Flurbiprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs. Severe, rarely fatal, anaphylactic-like reactions to non-steroidal anti-inflammatory drugs have been reported in such patients (see WARNINGS , Anaphylactoid Reactions and PRECAUTIONS , Preexisting Asthma ). Flurbiprofen tablets are contraindicated for the treatment of peri-operative pain in the setting o

Product summary:

Flurbiprofen tablets USP, 100 mg are round, blue, film-coated tablets debossed “93”-“711” available in bottles of 100 and 500. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. I 9/2010

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
----------
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Rx only
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a “coronary artery
bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called “corticosteroids” and “anticoagulants”
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat
(inflammation) from medical
conditions such as:
•
different types of arthritis
•
menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and ph

Summary of Product characteristics

FLURBIPROFEN- FLURBIPROFEN TABLET, FILM COATED
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
FLURBIPROFEN TABLETS USP, 100 MG
0711
RX ONLY
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 tablets are contraindicated for 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 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 USP are round, blue, film-coated tablets
for oral administration.
Flurbiprofen is a racemic mixture of (+)S- and (-)R- enantiomers.
Flurbiprofen 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-α-methyl-, (±)-. It has the
following structural formula:
C
H FO M.W. 244.26
Each tablet, for oral administration, contains 100 mg flurbiprofen. In
addition, each tablet contains the
following inactive ingredients: colloidal silicon dioxide,
croscarmellose sodium, hypromellose,
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate
80, titanium dioxide, and FD&C Blue #1 aluminum lake.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Flurbiprofen tablets contain flurbiprofen, a non-steroidal
anti-inflammatory drug