KETOPROFEN capsule, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K)

Tilgængelig fra:

Mylan Pharmaceuticals Inc.

INN (International Name):

KETOPROFEN

Sammensætning:

KETOPROFEN 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Carefully consider the potential benefits and risks of ketoprofen extended-release capsules before deciding to use ketoprofen extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen extended-release capsules are contraindicated in patients who have shown hypersensitivity to ketoprofen. Ketoprofen extended-release capsules 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 reactions to ketoprofen have been reported in such patients (see WARNINGS: Anaphylactoid Reactions and

Produkt oversigt:

Ketoprofen Extended-Release Capsules, USP are available containing 200 mg of ketoprofen, USP. The 200 mg capsules are hard-shell gelatin capsules with a blue green opaque cap and an iron gray opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 8200 in black ink on both the cap and body. They are available as follows: NDC 0378-8200-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from direct light and excessive heat and humidity. 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:
o
with increasing doses of NSAIDs
o
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:
o
anytime during use
o
without warning symptoms
o
that may cause death
The risk of getting an ulcer or bleeding increases with:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o
increasing doses of NSAIDs
o
longer use of NSAIDs
o
smoking
o
drinking alcohol
o
older age
o
poor health
o
advanced liver disease
o
bleeding problems
NSAIDs should only be used:
o
exactly as prescribed
o
at the lowest dose possible for your treatment
o
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 conditions, including if
you:
�

Produktets egenskaber

KETOPROFEN- KETOPROFEN CAPSULE, EXTENDED RELEASE
MYLAN PHARMACEUTICALS INC.
----------
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Ketoprofen is a nonsteroidal anti-inflammatory drug. The chemical name
for ketoprofen
is (±)-_m_-Benzoylhydratropic acid with the following structural
formula:
Its molecular formula is C
H
O , with a molecular weight of 254.29. It has a pKa of
5.94 in methanol:water (3:1) and an n-octanol:water partition
coefficient of 0.97 (buffer
pH 7.4).
Ketoprofen, USP is a white or off-white, odorless, nonhygroscopic,
fine to granular
powder, melting at about 95°C. It is freely soluble in ethanol,
chloroform, acetone, ether
and soluble in benzene and strong alkali, but practically insoluble in
water at 20°C.
Each ketoprofen extended-release capsule, USP for oral administration
contains 200 mg
of ketoprofen, USP. In addition, each capsule contains the following
inactive ingredients:
ammonium hydroxide, black iron oxide, colloidal anhydrous silica,
dibutyl sebacate,
ethylcellulose, FD&C Blue No. 2, gelatin, hypromellose, maltodextrin,
methacrylic acid
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).
Ketoprofen extended-release capsules 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 the stomach or
intestines,
which can be fatal. These events can occur at any time during use and
without
warning symptoms. Elderly patients are at greater risk for serious
gastrointestinal (GI) events (see WARNINGS).
16
14
3
copolymer type B, oleic acid, polyacrylate dispersion, silicon
dioxide, sodium lauryl
sulfate, sugar spheres, talc, titanium dioxide