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:

Sterling Knight Pharmaceuticals

INN (International Name):

FENOPROFEN CALCIUM

Composition:

FENOPROFEN 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 CALCIUM, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including FENOPROFEN CALCIUM, in pregnant w

Product summary:

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 yellow No. 97 cap and an opaque white body, imprinted with "RX681" on the cap and body. NDC 54288-0131-10 Bottles of 100. ● The 400 mg capsule has an opaque green cap and an opaque blue body, imprinted with "NALFON 400 mg" on the cap and "EP 123" on the body. NDC 54288-0132-09 Bottles of 90. 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

Authorization status:

New Drug Application

Patient Information leaflet

FENOPROFEN CALCIUM- FENOPROFEN CALCIUM CAPSULE
Sterling Knight Pharmaceuticals
----------
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

Summary of Product characteristics

FENOPROFEN CALCIUM- FENOPROFEN CALCIUM CAPSULE
STERLING KNIGHT PHARMACEUTICALS
----------
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, USP CAPSULES,
FOR ORAL USEINITIAL 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
sym