IBUPROFEN tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

DirectRX

INN (International Name):

Ibuprofen

구성:

Ibuprofen 600 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

- Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted. Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

IBUPROFEN- IBUPROFEN TABLET
DIRECTRX
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IBUPROFEN
BOXED WARNING SECTION
BOXED WARNING
Cardiovascular Risk
NSAIDs may cause an increased risk of serious cardiovascularthrombotic
events,
myocardial infarction, and stroke,which can be fatal. This risk may
increase with duration
ofuse. Patients with cardiovascular disease or risk factors
forcardiovascular disease may
be at greater risk (See WARNINGS).
IBU tablets are contraindicated for treatment of peri-operativepain in
the setting of
coronary artery bypass graft (CABG)surgery (See WARNINGS).
Gastrointestinal Risk
NSAIDS cause an increased risk of serious gastrointestinaladverse
events including
bleeding, ulceration, and perforationof the stomach or intestines,
which can be fatal. These
eventscan occur at any time during use and without warning
symptoms.Elderly patients are
at greater risk for serious gastrointestinalevents. (See WARNINGS).
DESCRIPTION SECTION
IBU tablets contain the active ingredient ibuprofen, which is (±) -2
- (p - isobutylphenyl) propionic acid.
Ibuprofen is a white powde rwith a melting point of 74-77° C and is
very slightly soluble in water(<1
mg/mL) and readily soluble in organic solvents such as ethanol and
acetone. The structural formula is
represented below:
strucuture
IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400
mg, 600 mg, and 800 mg tablets
for oral administration.Inactive ingredients: carnauba wax, colloidal
silicon dioxide,croscarmellose
sodium, hypromellose, magnesium stearate, microcrystallinecellulose,
polydextrose, polyethylene
glycol, polysorbate,titanium dioxide.
CLINICAL PHARMACOLOGY SECTION
IBU tablets contain ibuprofen which possesses analgesic andantipyretic
activities. Its mode of
action, like that of other NSAIDs, isnot completely understood, but
may be related to prostaglandin
synthetaseinhibition.
In clinical studies in patients with rheumatoid arthritis
andosteoarthritis, Ibuprofen tablets have been
shown to be comparableto aspirin in controlling pain and inflammation
and to be associ