FENOPROFEN CALCIUM- fenoprofen calcium tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Mylan Pharmaceuticals Inc.

INN (International Name):

FENOPROFEN CALCIUM

Sammensætning:

FENOPROFEN 600 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Carefully consider the potential benefits and risks of fenoprofen calcium tablets, USP and other treatment options before deciding to use fenoprofen calcium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Fenoprofen calcium tablets are indicated: Fenoprofen calcium tablets are contraindicated in patients who have shown hypersensitivity to fenoprofen calcium. Fenoprofen should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions, and PRECAUTIONS: Preexisting Asthma). Fenoprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). Fenoprofen is contraindicated in patients with a history of significantly impaired renal function (see WARNINGS: Advanced Renal Disease).

Produkt oversigt:

Fenoprofen Calcium Tablets, USP are available containing fenoprofen calcium, USP equivalent to 600 mg fenoprofen. The 600 mg tablet is an orange film-coated, capsule-shaped tablet debossed with M471 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0471-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

Mylan Pharmaceuticals Inc.
----------
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 about all of your
medic

Produktets egenskaber

FENOPROFEN CALCIUM- FENOPROFEN CALCIUM TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Fenoprofen calcium is a nonsteroidal, anti-inflammatory, antiarthritic
drug. Chemically, fenoprofen
calcium is an arylacetic acid derivative. The structural formula is as
follows:
BENZENEACETIC ACID, Α-METHYL-3-PHENOXY-, CALCIUM SALT (2:1)-(±)-,
DIHYDRATE
Fenoprofen calcium, USP is a white crystalline powder, soluble in
alcohol (95%) to the extent of
approximately 15 mg/mL at 25°C, slightly soluble in water and
insoluble in benzene.
The pKa of fenoprofen calcium is 4.5 at 25°C.
Film-coated fenoprofen calcium tablets for oral administration are
available containing fenoprofen
calcium as the dihydrate equivalent to 600 mg of fenoprofen and the
following inactive ingredients:
colloidal silicon dioxide, croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline
cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,
sodium lauryl sulfate, titanium
dioxide and FD&C Yellow No. 6 Aluminum Lake.
CLINICAL PHARMACOLOGY
Fenoprofen calcium is a nonsteroidal, anti-inflammatory, antiarthritic
drug that also possesses analgesic
and antipyretic activities. Its exact mode of action is unknown, but
it is thought that prostaglandin
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 (see
WARNINGS and PRECAUTIONS).
Fenoprofen calcium tablets are contraindicated in the setting of
coronary artery bypass graft
(CABG) surgery (see CONTRAINDICATIONS and WARNINGS).
NSAIDs cause an increased risk of serious gastrointestinal 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 are
at great