IBUPROFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT RX USA 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 ). 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. IBU tablets are contraindicated in patients with known hypersensitivity to ibuprofen. IBU 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

Product summary:

IBU tablets are available in the following strengths, colors and sizes: 400 mg (white, oval, debossed 4I)   Bottles of 30         NDC 16590-124-30   Bottles of 40         NDC 16590-124-40   Bottles of 60         NDC 16590-124-60   Bottles of 90         NDC 16590-124-90   600 mg (white, caplet, debossed 6I)   Bottles of 30         NDC 16590-126-30   Bottles of 56         NDC 16590-126-56   Bottles of 60         NDC 16590-126-60   Bottles of 84         NDC 16590-126-62   Bottles of 90         NDC 16590-126-90   Bottles of 100       NDC 16590-126-71   Bottles of 120       NDC 16590-126-72   Bptt;es pf 270       NDC 16590-126-86 800 mg (white, caplet, debossed 8I) Bottles of 30            NDC 16590-125-30 Bottles of 40            NDC 16590-125-40 Bottles of 50            NDC 16590-125-50 Bottles of 60            NDC 16590-125-60 Bottles of 90            NDC 16590-125-90 Bottles of 100          NDC 16590-125-71 Bottles of 120          NDC 16590-125-72 Store at room temperature. Avoid excessive heat 40°C (104°F). Distributed by: Dr. Reddy’s Laboratories, Inc. Bridgewater, NJ 08807 USA Issued February, 2010 Relabeling and Repackaging by : STAT Rx USA LLC Gainesville, GA  30501

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN - IBUPROFEN TABLET
STAT RX USA LLC
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BOXED WARNING
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).
IBU tablets are contraindicated for treatment of peri-operative 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. (SeeWARNINGS).
DESCRIPTION
IBU tablets 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(less
than 1 mg/mL) and readily soluble in organic solvents such as ethanol
and acetone. The structural
formula is represented below:
IBU, a nonsteroidal anti-inflammatory drug (NSAID), is available in
400 mg, 600 mg, and 800 mg
tablets for oral administration.Inactive ingredients: carnauba wax,
colloidal silicon
dioxide,croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, polyethylene glycol, polysorbate,titanium dioxide.
CLINICAL PHARMACOLOGY
IBU 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 prosta gland in 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
statisticall