FLURBIPROFEN tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

NuCare Pharmaceuticals,Inc.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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) ]. Risk Summary Use of NSAIDs, including flurbiprofen

Sommarju tal-prodott:

Flurbiprofen Tablets, USP, 100 mg are round, convex, blue, film-coated tablets debossed “93” and “711” . NDC 68071-2480-4 BOTTLES OF 14 NDC 68071-2480-3 BOTTLES OF 30 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).

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

NuCare Pharmaceuticals,Inc.
----------
MEDICATION GUIDE
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 ab

Karatteristiċi tal-prodott

FLURBIPROFEN- FLURBIPROFEN TABLET, FILM COATED
NUCARE 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)
INDICATIONS AND USAGE
Flurbiprofen tablets are a nonsteroidal anti-inflammatory drug
indicated for (1)
Relief of the signs and symptoms of rheumatoid arthritis
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 is 200 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 STRENGTHS
Flurbiprofen tablet USP, 100 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity to flurbiprofen or any components of the drug
product ( 5.7, 5.9)
History of asthma, urticaria, or other allergi