IBUPROFEN tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Rebel Distributors Corp

INN (Internationale Bezeichnung):

IBUPROFEN

Zusammensetzung:

IBUPROFEN 400 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Ibuprofen tablets are available in the following strengths, colors and sizes: 200 mg: (white, oval, biconvex film coated tablets embossed '21'). NDC 21695-065-06         Bottles of 06 NDC 21695-065-14         Bottles of 14 NDC 21695-065-30         Bottles of 30 NDC 21695-065-60         Bottles of 60 400 mg: (white, oval, biconvex film coated tablets embossed '41'). NDC 21695-066-20         Bottles of 20 NDC 21695-066-30         Bottles of 30 NDC 21695-066-40         Bottles of 40 NDC 21695-066-90         Bottles of 90 600 mg: (white, oval, biconvex film coated tablets embossed '61'). NDC 21695-067-20         Bottles of 20 NDC 21695-067-21         Bottles of 21 NDC 21695-067-30         Bottles of 30 NDC 21695-067-40         Bottles of 40 NDC 21695-067-42         Bottles of 42 NDC 21695-067-60         Bottles of 60 NDC 21695-067-90         Bottles of 90 NDC 21695-067-72         Bottles of 120 800 mg: (white, oval, biconvex film coated tablets embossed '81'). NDC 21695-068-20         Bottles of 20 NDC 21695-068-21         Bottles of 21 NDC 21695-068-28         Bottles of 28 NDC 21695-068-30         Bottles of 30 NDC 21695-068-40         Bottles of 40 NDC 21695-068-42         Bottles of 42 NDC 21695-068-45         Bottles of 45 NDC 21695-068-60         Bottles of 60 NDC 21695-068-90         Bottles of 90 NDC 21695-068-00         Bottles of 100 NDC 21695-068-72         Bottles of 120 Store at controlled room temperature 20° to 25°C (68° to 77° F) [see USP]. Manufactured by: Dr. Reddy's Laboratories Louisiana. LLC Shreveport, LA 71106 Repackaged by: Rebel Distributors Corp, DBA Physician Partner Thousand Oaks, CA 91320 Rev: 11/09

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

IBUPROFEN - IBUPROFEN TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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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 tablets, a nonsteroidal anti-inflammatory drug (NSAID), is
available in 400 mg, 600 mg, and
800 mg tablets for oral administration. Inactive ingredients:
microcrystalline cellulose, copovidone
(plasdone-S630), sodium starch glycolate, colloidal silicon dioxide,
magnesium stearate, opadry white
(OY-LS-58900), polysorbate 80.
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 inflammation