FENOPROFEN CALCIUM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FENOPROFEN CALCIUM (UNII: 0X2CW1QABJ) (FENOPROFEN - UNII:RA33EAC7KY)

Available from:

Bryant Ranch Prepack

INN (International Name):

FENOPROFEN CALCIUM

Composition:

FENOPROFEN 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fenoprofen is indicated for: - Relief of mild to moderate pain in adults. - Relief of the signs and symptoms of rheumatoid arthrites. - Relief of the signs and symptoms of osteoarthritis. Fenoprofen is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to fenoprofen 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 NSAIDs 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 fenoprofen, can cause prema

Product summary:

NDC: 71335-0307-1: 30 Capsules in a BOTTLE NDC: 71335-0307-2: 60 Capsules in a BOTTLE NDC: 71335-0307-3: 90 Capsules in a BOTTLE NDC: 71335-0307-4: 120 Capsules in a BOTTLE NDC: 71335-0307-5: 28 Capsules in a BOTTLE

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

FENOPROFEN CALCIUM- fenoprofen calcium capsule
Bryant Ranch Prepack
----------
Medication Guide for Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal
Antiinflammatory 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 health

Summary of Product characteristics

FENOPROFEN CALCIUM- FENOPROFEN CALCIUM CAPSULE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOPROFEN CALCIUM
CAPSULES, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR FENOPROFEN
CALCIUM CAPSULES, USP.
FENOPROFEN CALCIUM CAPSULES, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
NON-STEROIDAL 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)
FENOPROFEN IS 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 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
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms
(DRESS) ( 5.10)
04/2021
Warnings and Precautions, Fetal Toxicity ( 5.11)
04/2021
INDICATIONS AND USAGE
Fenoprofen is a nonsteroidal anti-inflammatory drug indicated for:
Relief of mild to moderate pain in adults. ( 1)
Relief of the signs and symptoms of rheumatoid arthritis. ( 1)
Relief of the signs and symptoms of osteoarthritis. ( 1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals
( 2.1)
Analgesia: For the treatment of mild to moderate pain, the recommended
dosage is 200 mg given
orally every 4 to 6 hours, as needed ( 2.1)
Rheumatoid Arthritis and Osteoarthritis: For the relief of