flurbiprofen- Flurbiprofen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Flurbiprofen (UNII: 5GRO578KLP) (flurbiprofen - UNII:5GRO578KLP)

Available from:

CARACO PHARMACEUTICAL LABORATORIES, LTD.

INN (International Name):

Flurbiprofen

Pharmaceutical form:

TABLET

Composition:

50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Flurbiprofen Tablets 50 mg     Rounded convex, beige, debossed “164” on one side.     Bottles of 100                                    NDC 57664-164-08     Bottles of 2000                                  NDC 57664-164-20 Flurbiprofen Tablets 100 mg     Rounded convex, beige, debossed “165” on one side.     Bottles of 100                                    NDC 57664-165-08     Bottles of 500                                    NDC 57664-165-13 Store at controlled room temperature 15° - 30°C (59° - 86°F) [see USP]. Dispense in tight, light-resistant container. CARACO PHARMACEUTICAL LABORATORIES, LTD. DETROIT, MI 48202 Stock No. 5104T03

Patient Information leaflet

CARACO PHARMACEUTICAL LABORATORIES, LTD.
----------
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 are pregnan

Summary of Product characteristics

FLURBIPROFEN- FLURBIPROFEN TABLET
CARACO PHARMACEUTICAL LABORATORIES, LTD.
----------
BOXED WARNING
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 tablet, USP is 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 tablet, USP contain flurbiprofen, which is a member of
the phenylalkanoic acid derivative
group of nonsteroidal anti-inflammatory drugs. Flurbiprofen tablet,
USP are white, oval, 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-alphamethyl-, (±)-. 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 of
Flurbiprofen. In addition, each tablet
contains the following inactive ingredients: colloidal silicon
dioxide, croscarmellose sodium, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, povidone,
titanium dioxide, polydextrose,
hydroxypropyl methylcellulose, polyethylene glycol, yellow iron oxide,
black iron oxide, glyceryl
triacetate.
CLINICAL PHARMACOLOGY
PHARMACODYNAMI