IBUPROFEN tablet, film coated

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

IBUPROFEN

রচনা:

IBUPROFEN 600 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS ). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted. IBU tablets are contraindicated in patients with known hypersensitivityto ibuprofen. IBU tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin orother NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthm

পণ্য সারাংশ:

IBU tablets are available in the following strengths, colors and sizes: 400 mg (white, oval, debossed 4I) Unit Dose Box of 100 NDC 0904-5853-61 Bottle of 100 Tablets NDC 0904-5853-60 Bottle of 500 Tablets NDC 0904-5853-40 600 mg (white, caplet, debossed 6I) Unit Dose Box of 100 NDC 0904-5854-61 Bottle of 100 Tablets NDC 0904-5854-60 Bottle of 500 Tablets NDC 0904-5854-40 800 mg (white, caplet, debossed 8I) Unit Dose Box of 100 NDC 0904-5855-61 Bottle of 100 Tablets NDC 0904-5855-60 Bottle of 500 Tablets NDC 0904-5855-40 Store at room temperature. Avoid excessive heat 40°C (104°F). Distributed by: Dr. Reddy’s Laboratories, Inc. Bridgewater, NJ 08807 USA Revised May, 2011 Distributed by: MAJOR® PHARMACEUTICALS Livonia, MI  48150 REFER TO PACKAGE LABEL FOR DISTRIBUTOR'S NDC NUMBER Store at room temperature. Avoid excessive heat 40°C (104°F). Manufactured by: Dr. Reddy’s Laboratories Louisiana, LLC Shreveport, LA 71106 USA Revised, October 2013

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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IBU TABLETS
BOXED WARNING
CARDIOVASCULAR RISK
1.
1.
GASTROINTESTINAL RISK
1.
DESCRIPTION
IBU tablets contain the active ingredient ibuprofen, which is (±) -2
- (_p_ - isobutylphenyl) propionic acid.
Ibuprofen is a white powde rwith 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:
IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400
mg, 600 mg, and 800 mg tablets
for oral administration.Inactive ingredients: carnauba wax, colloidal
silicon dioxide,croscarmellose
sodium, hypromellose, magnesium stearate, microcrystallinecellulose,
polydextrose, polyethylene
glycol, polysorbate,titanium dioxide.
CLINICAL PHARMACOLOGY
IBU tablets contain ibuprofen which possesses analgesic andantipyretic
activities. Its mode of action,
like that of other NSAIDs, isnot completely understood, but may be
related to prostaglandin
synthetaseinhibition.
In clinical studies in patients with rheumatoid arthritis
andosteoarthritis, Ibuprofen tablets have been
shown to be comparableto aspirin in controlling pain and inflammation
and to be associatedwith a
statistically significant reduction in the milder gastrointestinalside
effects (see ADVERSE
REACTIONS). Ibuprofen may be well toleratedin some patients who have
had gastrointestinal side
™
NSAIDs may cause an increased risk of serious cardiovascularthrombotic
events,
myocardial infarction, and stroke,which can be fatal. This risk may
increase with duration
ofuse. Patients with cardiovascular disease or risk factors
forcardiovascular disease may
be at greater risk (See WARNINGS).
IBU tablets are contraindicated for treatment of peri-operativepain in
the setting of coronary
artery bypass graft (CABG)surgery (See WARNINGS).
NSAIDS cause an increased risk of serious gastrointestinaladverse
events including
bleeding, ulceration, and perforationof