KETOPROFEN capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

PD-Rx Pharmaceuticals, Inc.

ИНН (Международная Имя):

KETOPROFEN

состав:

KETOPROFEN 75 mg

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

KETOPROFEN- KETOPROFEN CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
KETOPROFEN CAPSULES USP
3195
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
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).
GASTROINTESTINAL RISK
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).
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
CLINICAL PHARMACOLOGY
16
14
3
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 in
classical animal and _in vitro_ test systems. In anti-inflammatory
models ketoprofen has been shown to have
inhibitory effects on prostaglandin and leukotriene synthesis, to have
antibrad