FENOPROFEN CALCIUM capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Misemer Pharmaceuticals, Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

FENOPROFEN CALCIUM 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 CALCIUM 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

Produkt oversigt:

Fenoprofen calcium® (fenoprofen calcium, USP) are available in capsule form for oral administration, and are supplied as following: ● The 200 mg capsule has an opaque orange cap with an opaque white body imprinted with "RX681" and is 23mm long. . Storage: Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers

Autorisation status:

New Drug Application

Indlægsseddel

FENOPROFEN CALCIUM- fenoprofen calcium capsule
Misemer Pharmaceuticals, Inc.
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Medication Guide
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 o 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
•
older age
•
longer use of NSAIDs
•
poor health
•
smoking
•
advanced liver disease
•
drinking alcohol
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed o 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
medical condition

Produktets egenskaber

FENOPROFEN CALCIUM- FENOPROFEN CALCIUM CAPSULE
MISEMER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOPROFEN CALCIUM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FENOPROFEN CALCIUM. FENOPROFEN
CALCIUM, CAPSULES, 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 CALCIUM 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
Boxed Warning
4/2016
Warnings and Precautions, Cardiovascular Thrombotic Events ( 5.1)
4/2016
Warnings and Precautions, Heart Failure and Edema ( 5.5)
4/2016
INDICATIONS AND USAGE
FENOPROFEN CALCIUM 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 signs and