IBUPROFEN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals NY LLC

INN (International Name):

IBUPROFEN

Composition:

IBUPROFEN 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Ibuprofen tablets are contraindicated in patients with known hypersensitivity to Ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions , and PRECAUTIONS, Preexisting Asthma ). Ibuprofen tablets are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Product summary:

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 69238-1101-5 600 mg (white, oval shaped, biconvex film-coated tablets engraved “IBU” over “600” on one side) Bottles of 500                                     NDC 69238-1102-5 800 mg (white, capsule shaped, film-coated tablets engraved “IBU” over “800” on one side) Bottles of 500                                     NDC 69238-1103-5 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx only Made in India. Distributed by: Amneal Pharmaceuticals Glasgow, KY  42141 Rev. 12-2014-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
AMNEAL PHARMACEUTICALS NY LLC
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IBUPROFEN TABLETS, USP
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 (<1 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, ibuprofen
tablets have