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:

STAT RX USA 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 tablets or the excipients (see DESCRIPTION). Flurbiprofen 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: General: Preexisting Asthma). Flurbiprofen is contraindicated for the treatment

Product summary:

Flurbiprofen tablets, USP are available containing 50 mg or 100 mg of flurbiprofen, USP. The 50 mg tablets are film-coated beige, round, unscored tablets debossed with M over 76 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0076-01 bottles of 100 tablets The 100 mg tablets are film-coated beige, round, unscored, tablets debossed with M over 93 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0093-01 bottles of 100 tablets NDC 0378-0093-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED SEPTEMBER 2007 FRB:R8mc

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLURBIPROFEN - FLURBIPROFEN TABLET, FILM COATED
STAT RX USA LLC
----------
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(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 pharmacist.
•
if you a

Summary of Product characteristics

FLURBIPROFEN - FLURBIPROFEN TABLET, FILM COATED
STAT RX USA LLC
----------
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
FLURBIPROFEN 100MG STRUCTURE IMAGE
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 PHARMACOLOGYPharmacodynamics
Flurbiprofen is a non-steroidal anti-inflammatory drug that exhibits
anti-inflammatory, analgesic, and
antipyretic activities in animal models. The mechanism of action of
flurbiprofen, like that of other non-
steroidal anti-inflammatory drugs, is not completely understood but
may be related to prostaglandin
synthetase inhibition.
PharmacokineticsAbsorption
The mean oral bioavailability of flurbiprofen 100 mg tablets is 96%
relative to an oral solution.
Flurbiprofen is rapidly and non-stereoselectively absorbed with peak
plasma concentrations occurring
at about 2 hours (see Table 1). Administration of flurbiprofen with
either food or antacids may alter the
rate but not the extent of flurbiprofen absorption. Ranitidine has
been shown to have no effect on either
the rate or extent of flurbiprofen absorption.
Distribution
The apparent volume of distribution (Vz/F) of both R- and
S-flurbiprofen is approximat