IBUPROFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals 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, 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

Product summary:

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 10: NDC 33261-155-10 Bottles of 20: NDC 33261-155-20 Bottles of 30: NDC33261-155-30 Bottles of 60: NDC 33261-155-60 Bottles of 90: NDC 33261-155-90 Bottles of 120: NDC 33261-155-02 600 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 10: NDC 33261-061-10 Bottles of 20: NDC 33261-061-20 Bottles of 30: NDC 33261-061-30 Bottles of 40: NDC 33261-061-40 Bottles of 42: NDC 33261-061-42 Bottles of 60: NDC 33261-061-60 Bottles of 90: NDC33261-061-90 Bottles of 100: NDC 33261-061-00 Bottles of 120: NDC 33261-061-02 800 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 09: NDC 33261-062-09 Bottles of 10: NDC 33261-062-10 Bottles of 20: NDC 33261-062-20 Bottles of 21: NDC 33261-062-21 Bottles of 24: NDC 33261-062-24 Bottles of 30: NDC 33261-062-30 Bottles of 40: NDC 33261-062-40 Bottles of 42: NDC 33261-062-42 Bottles of 45: NDC 33261-062-45 Bottles of 60: NDC 33261-062-60 Bottles of 90: NDC 33261-062-90 Bottles of 100: NDC 33261-062-00 Bottles of 120: NDC 33261-062-02 Store at controlled room temperature 20° to 25°C (68° to 77°F)[see USP]. Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET
AIDAREX PHARMACEUTICALS LLC
----------
IBUPROFEN TABLETS, USP
RX ONLY
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, 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
shown to be co