IBUPROFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotheca Inc.

INN (International Name):

IBUPROFEN

Composition:

IBUPROFEN 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 PR

Product summary:

IBU tablets are available in the following strengths, colors and sizes: 400 mg (white, oval, debossed 4I) NDC 12634-171-00 Bottles of 10 NDC 12634-171-01 Bottles of 100 NDC 12634-171-09 Bottles of 35 NDC 12634-171-40 Bottles of 40 NDC 12634-171-42 Bottles of 42 NDC 12634-171-50 Bottles of 50 NDC 12634-171-52 Blister Pack of 12 NDC 12634-171-54 Blister Pack of 14 NDC 12634-171-57 Blister Pack of 20 NDC 12634-171-59 Blister Pack of 30 NDC 12634-171-60 Bottles of 60 NDC 12634-171-61 Blister Pack of 10 NDC 12634-171-63 Blister Pack of 3 NDC 12634-171-66 Blister Pack of 6 NDC 12634-171-67 Blister Pack of 7 NDC 12634-171-69 Blister Pack of 9 NDC 12634-171-71 Bottles of 30 NDC 12634-171-74 Bottles of 24 NDC 12634-171-78 Bottles of 28 NDC 12634-171-79 Bottles of 25 NDC 12634-171-80 Bottles of 20 NDC 12634-171-81 Bottles of 21 NDC 12634-171-82 Bottles of 12 NDC 12634-171-85 Bottles of 15 NDC 12634-171-91 Blister Pack of 1 NDC 12634-171-94 Bottles of 4 NDC 12634-171-95 Bottles of 5 NDC 12634-171-96 Bottles of 6 600 mg (white, caplet, debossed 6I) NDC 12634-191-00 Bottles of 10 NDC 12634-191-01 Bottles of 100 NDC 12634-191-09 Bottles of 35 NDC 12634-191-40 Bottles of 40 NDC 12634-191-42 Bottles of 42 NDC 12634-191-50 Bottles of 50 NDC 12634-191-52 Blister Pack of 12 NDC 12634-191-54 Blister Pack of 14 NDC 12634-191-57 Blister Pack of 20 NDC 12634-191-59 Blister Pack of 30 NDC 12634-191-60 Bottles of 60 NDC 12634-191-61 Blister Pack of 10 NDC 12634-191-63 Blister Pack of 3 NDC 12634-191-66 Blister Pack of 6 NDC 12634-191-67 Blister Pack of 7 NDC 12634-191-69 Blister Pack of 9 NDC 12634-191-71 Bottles of 30 NDC 12634-191-74 Bottles of 24 NDC 12634-191-78 Bottles of 28 NDC 12634-191-79 Bottles of 25 NDC 12634-191-80 Bottles of 20 NDC 12634-191-81 Bottles of 21 NDC 12634-191-82 Bottles of 12 NDC 12634-191-85 Bottles of 15 NDC 12634-191-91 Blister Pack of 1 NDC 12634-191-94 Bottles of 4 NDC 12634-191-95 Bottles of 5 NDC 12634-191-96 Bottles of 6 800 mg (white, caplet, debossed 8I) NDC 12634-682-00 Bottles of 10 NDC 12634-682-01 Bottles of 100 NDC 12634-682-09 Bottles of 35 NDC 12634-682-40 Bottles of 40 NDC 12634-682-42 Bottles of 42 NDC 12634-682-50 Bottles of 50 NDC 12634-682-52 Blister Pack of 12 NDC 12634-682-54 Blister Pack of 14 NDC 12634-682-57 Blister Pack of 20 NDC 12634-682-59 Blister Pack of 30 NDC 12634-682-60 Bottles of 60 NDC 12634-682-61 Blister Pack of 10 NDC 12634-682-63 Blister Pack of 3 NDC 12634-682-66 Blister Pack of 6 NDC 12634-682-67 Blister Pack of 7 NDC 12634-682-69 Blister Pack of 9 NDC 12634-682-71 Bottles of 30 NDC 12634-682-74 Bottles of 24 NDC 12634-682-78 Bottles of 28 NDC 12634-682-79 Bottles of 25 NDC 12634-682-80 Bottles of 20 NDC 12634-682-81 Bottles of 21 NDC 12634-682-82 Bottles of 12 NDC 12634-682-85 Bottles of 15 NDC 12634-682-91 Blister Pack of 1 NDC 12634-682-94 Bottles of 4 NDC 12634-682-95 Bottles of 5 NDC 12634-682-96 Bottles of 6 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 Repackaged and Distributed by: Apotheca Inc. Phoenix, AZ 85006

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET
APOTHECA INC.
----------
IBUPROFEN TABLETS
BOXED WARNING
CARDIOVASCULAR RISK
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).
GASTROINTESTINAL RISK
NSAIDS cause an increased risk of serious gastrointestinaladverse
events including bleeding,
ulceration, and perforationof the stomach or intestines, which can be
fatal. These eventscan
occur at any time during use and without warning symptoms.Elderly
patients are at greater risk
for serious gastrointestinalevents. (See WARNINGS).
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 signific