IBUPROFEN tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Quality Care Products LLC

INN (Rahvusvaheline Nimetus):

IBUPROFEN

Koostis:

IBUPROFEN 600 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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, urticarial, 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 Rea

Toote kokkuvõte:

Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg (white to off-white, oval, 'I 6' debossing on one side and plain on the other side) 600 mg (white to off-white, caplet, 'I 7' debossing on one side and plain on the other side) 55700-445-20 55700-445-30 55700-445-40 55700-445-60 55700-445-90 55700-445-00 800 mg (white to off-white, caplet, 'I 10' debossing on one side and plain on the other side) 55700-446-20 55700-446-21 55700-446-30 55700-446-40 55700-446-60 55700-446-90 55700-446-00 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Avoid excessive heat above 40ºC (104ºF). Manufactured by: Granules India Limited Hyderabad-500 081, India MADE IN INDIA Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645 Toll Free No.: 1-877-272-7901 Issued: November 2015

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
QUALITY CARE PRODUCTS LLC
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IBUPROFEN TABLETS USP
BOXED WARNING
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, 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, hypromellose 2910, hydroxypropyl cellulose,
magnesium
stearate, microcrystalline cellulose, polyethylene glycol 400,
pregelatinized starch,
povidone k-90, sodium lauryl sulphate, 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 b