IBUPROFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Landmark Supply 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 ). 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 WA

Product summary:

Ibuprofen tablets are available in the following strengths, colors and sizes: 600 mg (white, olive, debossed BI 6) Bottles of 100 NDC 71862-003-01 800 mg (white, caplet, debossed BI 8) Bottles of 100 NDC 71862-007-01 Store at room temperature. Avoid excessive heat 40°C (104°F). Manufactured for: Landmark Supply, Inc. Keansburg, NJ 07734 Manufactured by: Anshi Pharmaceutical (Zhongshan) Inc Zhongshan, Guangdong 528437 P.R. China Rev. 11/17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET
LANDMARK SUPPLY INC.
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IBUPROFEN TABLETS, USP
IBUPROFEN TABLETS, USP
CARDIOVASCULAR THROMBOTIC EVENTS
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of
serious cardiovascular thrombotic events, including myocardial
infarction
and stroke, which can be fatal. This risk may occur early in treatment
and
may increase with duration of use (See WARNINGS and PRECAUTIONS).
Ibuprofen tablets are contraindicated in the setting of coronary
artery
bypass graft (CABG) surgery (see CONTRAINDICATIONS and 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
In clinical studies in patients with rheumatoid arthritis and
osteoarthritis, Ibuprofe