IBUPROFEN tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Cardinal Health

INN (nemzetközi neve):

IBUPROFEN

Összetétel:

IBUPROFEN 400 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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, Anaphylact

Termék összefoglaló:

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 Overbagged with 10 tablets per bag, NDC 55154-6835-0 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

IBUPROFEN- IBUPROFEN TABLET
CARDINAL HEALTH
----------
IBUPROFEN TABLETS, USP
(400 MG, 600 MG AND 800 MG)
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
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° 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 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.
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].
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 studies in patients with rheumatoid arthritis and
osteoarthritis, ibuprofen tablets have been
shown to be compara