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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

FLURBIPROFEN

Composition:

FLURBIPROFEN 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to flurbiprofen or any components of the drug product [ see Warnings and Precautions (5.7, 5.9) ] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to nonsteroidal anti-inflammatory drugs have been reported in such patients [ see Warnings and Precautions (5.7, 5.8) ]. - In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions (5.1) ]. Use of NSAIDs, including flurbiprofen tablets, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including flurbiprofen tablets, in pregnant women starting at

Product summary:

Flurbiprofen Tablets, USP are available containing 100 mg of flurbiprofen, USP. The 100 mg tablets are beige, film-coated, 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: bottles of 10, 15, 30 and 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PD-Rx Pharmaceuticals, Inc.
----------
MEDICATION GUIDE FOR NONSTEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft
(CABG)”.
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You
may have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from
the mouth to the stomach), stomach and intestines:
•
anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs” or “SNRIs”
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
NSAIDs 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 NSAIDs?
Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthcare provider about all of your
med

Summary of Product characteristics

FLURBIPROFEN- FLURBIPROFEN TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLURBIPROFEN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLURBIPROFEN
TABLETS.
FLURBIPROFEN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1988
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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 ( 5.1)
FLURBIPROFEN TABLETS ARE CONTRAINDICATED IN THE SETTING OF CORONARY
ARTERY BYPASS GRAFT (CABG)
SURGERY ( 4, 5.1)
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
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 AND
PATIENTS WITH A PRIOR HISTORY
OF PEPTIC ULCER DISEASE AND/OR GI BLEEDING ARE AT GREATER RISK FOR
SERIOUS GI EVENTS ( 5.2)
RECENT MAJOR CHANGES
Boxed Warning 5/2016
Warnings and Precautions, Cardiovascular Thrombotic Events ( 5.1)
5/2016
Warnings and Precautions, Heart Failure and Edema ( 5.5) 5/2016
INDICATIONS AND USAGE
1. Flurbiprofen tablets are a nonsteroidal anti-inflammatory drug
indicated for
2. Relief of the signs and symptoms of rheumatoid arthritis
3. Relief of the signs and symptoms of osteoarthritis
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals ( 2)
The recommended starting dose of flurbiprofen tablets are 200 mg per
day to 300 mg per day, divided for
administration two, three, or four times a day. The largest
recommended single dose in a multiple-dose daily regimen is
100 mg ( 2)
DOSAGE FORMS AND STRE