IBUPROFEN tablet, coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Доступно од:

Biomes Pharmaceuticals LLC

INN (Међународно име):

IBUPROFEN

Састав:

IBUPROFEN 400 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. Safety and effectiveness of ibuprofen tablets in pediatric patients have not been established. As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

Резиме производа:

Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg (white, round shaped, film-coated tablets engraved “IBU” over “400” on one side). Bottles of 500 NDC 69150-400-50 600 mg (white, oval shaped, biconvex film-coated tablets engraved “IBU” over “600” on one side) Bottles of 500 NDC 69150-600-50 800 mg (white, capsule shaped, film-coated tablets engraved “IBU” over “800” on one side) Bottles of 500 NDC 69150-800-50 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

IBUPROFEN - IBUPROFEN TABLET, COATED
BIOMES PHARMACEUTICALS LLC
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IBUPROFEN TABLETS, USP BOXED WARNINGS
Cardiovascular Risk
•
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and
stroke, which can be fatal. This risk may increase with duration of
use. Patients with
cardiovascular disease
or risk factors for cardiovascular disease may be at greater risk (see
WARNINGS).
•
Ibuprofen tablets are contraindicated for treatment of perioperative
pain in the setting of coronary
artery
bypass graft (CABG) surgery (see 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
events (see
WARNINGS).
DESCRIPTION
Ibuprofen tablets contain the active ingredient ibuprofen, which is
(±) -2 -(p -isobutylphenyl) propionic
acid.
Ibuprofen is a white powder with a melting point of 74° to 77° C and
is very slightly soluble in water
(less than1 mg/mL) and readily soluble in organic solvents such as
ethanol and acetone.
The structural formula is represented below:
Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), is
available in 400 mg, 600 mg, and
800 mg tablets for oral administration. Inactive ingredients:
colloidal silicon dioxide, microcrystalline
cellulose, pregelatinized starch, sodium starch glycolate, talc,
magnesium stearate, Opadry II contains
hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate
and titanium dioxide.
CLINICAL PHARMACOLOGY
Ibuprofen tablets contain ibuprofen which possesses analgesic and
antipyretic activities. Its mode of
action, like that of other NSAIDs, is not completely understood, but
may be related to prostaglandin
synthetase inhibition.
In clinical studies in patients with rheumatoid arthritis and
osteoarthritis,