IBUPROFEN- 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:

REMEDYREPACK INC.

INN (International Name):

IBUPROFEN

Composition:

IBUPROFEN 600 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, Preexisting

Product summary:

IBU tablets are available in the following strengths, colors and sizes: 400 mg (white, oval, debossed 4I) Unit Dose Box of 100 NDC 0904-5853-61 Bottle of 100 Tablets NDC 0904-5853-60 Bottle of 500 Tablets NDC 0904-5853-40 600 mg (white, caplet, debossed 6I) Unit Dose Box of 100 NDC 0904-5854-61 Bottle of 100 Tablets NDC 0904-5854-60 Bottle of 500 Tablets NDC 0904-5854-40 800 mg (white, caplet, debossed 8I) Unit Dose Box of 100 NDC 0904-5855-61 Bottle of 100 Tablets NDC 0904-5855-60 Bottle of 500 Tablets NDC 0904-5855-40 Store at room temperature. Avoid excessive heat 40°C (104°F). Distributed by: Dr. Reddy’s Laboratories, Inc. Bridgewater, NJ 08807 USA Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 Revised May, 2011 Refer to package label for Distributor's NDC Number. Store at room temperature. Avoid excessive heat 40°C (104°F). Manufactured by: Dr. Reddy’s Laboratories Louisiana, LLC Shreveport, LA 71106 USA Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 Revised, October 2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
REMEDYREPACK INC.
----------
IBU TABLETS
BOXED WARNING
CARDIOVASCULAR RISK
1. 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).
2. IBU tablets are contraindicated for treatment of peri-operative
pain in the setting of coronary
artery bypass graft (CABG)surgery (See WARNINGS).
GASTROINTESTINAL RISK
1. 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
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(<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 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