IBUPROFEN tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Blenheim Pharmacal, Inc.

INN (Kansainvälinen yleisnimi):

IBUPROFEN

Koostumus:

IBUPROFEN 800 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

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 30: NDC 53746-464-30 Bottles of 60: NDC 53746-464-60 Bottles of 90: NDC 53746-464-90 Bottles of 100: NDC 53746-464-01 Bottles of 500: NDC 53746-464-05 600 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 50: NDC 53746-465-50 Bottles of 60: NDC 53746-465-60 Bottles of 90: NDC 53746-465-90 Bottles of 100: NDC 53746-465-01 Bottles of 500: NDC 53746-465-05 800 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 50: NDC 53746-466-50 Bottles of 90: NDC 53746-466-90 Bottles of 100: NDC 53746-466-01 Bottles of 500: NDC 53746-466-05 Store at controlled room temperature 20° to 25°C (68° to 77°F)[see USP]. Rx only

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

IBUPROFEN- IBUPROFEN TABLET
BLENHEIM PHARMACAL, INC.
----------
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).
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
and to be associated with a
statistically significant reduction in the milder gastrointestinal
side effects (see ADVERSE
REACTIONS).
Ibuprofen tablets may be well tolerated in some patients who have had
gastrointestinal side effects with
aspirin, but these patients when treated with ibuprofen tablets should
be carefully followed for signs
and symptoms of gastrointestinal ulceration and bleeding. Although it
is not definitely known whether
ibuprofen tablets causes less peptic ulceration than aspirin, in one
study involving 885 patients with
rheumatoid arthritis treated for up to one year, there were no reports
of gastric ulceration with
ibuprofen tablets whereas frank ulceration was repor