NALFON- fenoprofen calcium capsule

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Proficient Rx LP

INN (Jina la Kimataifa):

FENOPROFEN CALCIUM

Tungo:

FENOPROFEN 400 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

NALFON is indicated for: NALFON is contraindicated in the following patients: Risk Summary Use of NSAIDs, including NALFON, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including NALFON, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of NALFON in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss. In animal reproduction studies, embryo-fetal lethality and skeletal abnormalities were noted in offspring of pregnant rabbits following oral administration of fenoprofen during organogenesis at 0.6 times the maximum human daily dose of 3200 mg/day. How

Bidhaa muhtasari:

Nalfon ® (fenoprofen calcium, USP) are available in capsule form for oral administration, and are supplied as following: 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.

Idhini hali ya:

New Drug Application

Taarifa za kipeperushi

Proficient Rx LP
----------
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:
NSAIDs should only be used:
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 conditions, including if you:
•
have liver or kidney problems
•
have high blood pressure
•
have asthma
•
are pregnant or plan to become pregnant. Talk to your healthcare
provivder if you are considering
taking NSAIDs during pregnancy. You should not take NSAIDs after 29
weeks of pregnancy.
•
are breastfeeding or plan to breast feed.
Tell your healthcare provider about all of the medicines you take,
including prescription or over-the-counter
medicines, vitamins or h

Tabia za bidhaa

NALFON- FENOPROFEN CALCIUM CAPSULE
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NALFON SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NALFON.
NALFON (FENOPROFEN CALCIUM, USP) 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_
•
•
•
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
NALFON is a nonsteroidal anti-inflammatory drug indicated for:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
NALFON (fenoprofen calcium) capsules: 200 mg and 400 mg ( 3)
CONTRAINDICATIONS
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)
NALFON 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)
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)
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