IBUPROFEN tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

St Marys Medical Park Pharmacy

INN (Nome Internazionale):

IBUPROFEN

Composizione:

IBUPROFEN 400 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

IBUPROFEN - IBUPROFEN TABLET
ST MARYS MEDICAL PARK PHARMACY
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IBUPROFEN TABLETS, USP
RX ONLY
CARDIOVASCULAR RISK
GASTROINTESTINAL RISK
DESCRIPTION
Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which
is (±) – 2 – (p – isobutylphenyl)
propionic acid. Ibuprofen is a white powder with 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:
Ibuprofen Tablets, USP, 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,
croscarmellose sodium, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polyvinyl
alcohol, pregelatinized starch, talc, stearic acid, 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, ibuprofen tablets have been
shown to be comparable to aspirin in controlling pain and inflammation
and to be associated with a
statistically significant reduction in the milder gastrointestinal
side effects (see ADVERSE
REACTIONS).
Ibuprofen tablets may be well tolerated in some patients who have had
gastrointestinal side effects with
• 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
peri-operative pain in the setting of
coronary artery bypass graft (CABG) surgery (see WARNINGS).
• NSAIDs cause an increased risk of serious