IBUPROFEN tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Contract Pharmacy Services-PA

Designación común internacional (DCI):

IBUPROFEN

Composición:

IBUPROFEN 400 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 Reac

Resumen del producto:

400 mg (white, oval, debossed 4I) Blister of 30   NDC: 67046-309-30 600 mg (white, caplet, debossed 6I) Blister of 21   NDC: 67046-310-21 Blister of 30   NDC: 67046-310-30 Blister of 60   NDC: 67046-310-60 800 mg (white, caplet, debossed 8I) Blister of 30   NDC: 67046-311-30 Manufactured for:                                                PAR PHARMACEUTICAL COMPANIES, INC.                                               Spring Valley, NY 10977 Manufactured by:                                                Dr. Reddy's Laboratories Louisiana, LLC                                               Shreveport, LA 71106 Repackaged by: CONTRACT PHARMACY SERVICES-PA 125 TITUS AVE SUITE 200 WARRINGTON, PA 18976 USA

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

IBUPROFEN - IBUPROFEN TABLET
CONTRACT PHARMACY SERVICES-PA
----------
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 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. (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 74-77° 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, 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
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 inflammat