KETOPROFEN capsule

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Teva Pharmaceuticals USA, Inc.

INN:

KETOPROFEN

composition:

KETOPROFEN 50 mg

prescription_type:

PRESCRIPTION DRUG

authorization_status:

Abbreviated New Drug Application

SPC

KETOPROFEN- KETOPROFEN CAPSULE
TEVA PHARMACEUTICALS USA, INC.
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KETOPROFEN CAPSULES USP
3193
3195
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
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•
GASTROINTESTINAL RISK
•
DESCRIPTION
Ketoprofen capsules USP are a non-steroidal anti-inflammatory drug.
The chemical name for
ketoprofen, USP is 2-(3-benzoylphenyl)-propionic acid with the
following structural formula:
C
H O M.W. 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 practically white, crystalline 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.
Ketoprofen capsules USP contain 50 mg or 75 mg of ketoprofen, USP for
oral administration.
INACTIVE INGREDIENTS
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
WARNINGSand PRECAUTIONS).
Ketoprofen 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
Drug Product
Lactose, magnesium stearate, and sodium starch glycolate.
Capsule Shell Constituents
Gelatin, printing ink, sodium lauryl sulfate, titanium dioxide, D&C
Red #28, and FD&C Blue #1.
CLINICAL PHARMACOLOGY
Ketoprofen is a non-steroidal anti-inflammatory drug with analgesic
and antipyretic properties.
The anti-inflammatory, analgesic and antipyretic properties of
ketoprofen have been demonstrated