IBUPROFEN tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Amneal Pharmaceuticals of New York LLC

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 Tablets. 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 Reactions , and PRECAUTIONS, Preexisting Asthma ]. In the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS ].

Produktbesonderheiten:

Ibuprofen Tablets, USP are available in the following strength, color and sizes: 600 mg (oval-shaped, white, film-coated tablets, debossed with "IP 132" on one side, on other side debossed with "600"). They are available as follows: Bottles of 30: NDC 53746-132-30 Bottles of 50: NDC 53746-132-50 Bottles of 60: NDC 53746-132-60 Bottles of 90: NDC 53746-132-90 Bottles of 100: NDC 53746-132-01 Bottles of 500: NDC 53746-132-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F). Dispense in a tight, light-resistant container as defined in the USP. Rx Only Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ  08807 Rev. 05-2021-05

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

IBUPROFEN- IBUPROFEN TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
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, USP contain the active ingredient ibuprofen, which
is (±)-2-(_p_-
isobutylphenyl) propionic acid. Ibuprofen is a white powder with a
melting point of 74° to
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 600 mg tablets for oral administration. Inactive ingredients:
Colloidal Silicon Dioxide,
Corn Starch, Hydroxypropyl Cellulose, Hypromellose, Lactose Anhydrous,
Magnesium
Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone,
Sodium Lauryl Sulfate,
Sodium Starch Glycolate, 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