IBUPROFEN tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Blenheim Pharmacal, Inc.

DCI (Denominação Comum Internacional):

IBUPROFEN

Composição:

IBUPROFEN 400 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP 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 patie

Resumo do produto:

Ibuprofen Tablets, USP are available in the following strengths, colors and sizes: 400 mg (white, round, biconvex, aqueous film-coated tablets, debossed “IP 464” on obverse and plain on reverse. They are available as follows: Bottles of 100: NDC 10544-030-30 600 mg (white, oval-shaped, biconvex, aqueous film-coated tablets, debossed “IP 465” on obverse and plain on reverse. They are available as follows: Bottles of 100: NDC 10544-015-30 800 mg (white, capsule-shaped, biconvex, aqueous film-coated tablets, debossed “IP 466” on obverse and plain on reverse. They are available as follows: Bottles of 100: NDC 10544-024-30 Store at controlled room temperature 20° to 25°C (68° to 77°F)[see USP]. Rx only Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Major Pharmaceuticals Livonia, MI 48150 Marketed/ Packaged by: Blenheim Pharmacal, Inc. North Blenheim, NY 12131, (USA) Rev. 09-2009

Status de autorização:

Abbreviated New Drug Application

Características técnicas

IBUPROFEN- IBUPROFEN TABLET
BLENHEIM PHARMACAL, INC.
----------
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
• 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 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 ).
In clinical st