IBUPROFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, 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, Anaphylactoid Reac

Product summary:

Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg (white, round, debossed BI 4) 600 mg (white, olive, debossed BI 6) 55700-634-20 55700-634-30 55700-634-40 55700-634-60 55700-634-90 800 mg (white, caplet, debossed BI 8) 55700-633-30 55700-633-60 55700-633-90 Store at room temperature. Avoid excessive heat 40°C (104°F). Manufactured for: Method Pharmaceuticals, LLC Fort Worth, TX 76118 Manufactured by: Anshi Pharmaceutical (Zhongshan) Inc Zhongshan, Guangdong 528437 P.R. China Rev. 04/2017

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Lake Erie Medical DBA Quality Care Products LLC
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Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal
Anti-inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen
early in treatment and may increase:
° with increasing doses of NSAIDs
° with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass
graft (CABG)."
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you
to. You may have an increased risk of another heart attack if you take
NSAIDs after a recent
heart attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube
leading from the mouth to the stomach), stomach and intestines:
° anytime during use
° without warning symptoms
° that may cause death
The risk of getting an ulcer or bleeding increases with:
° past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
° taking medicines called “corticosteroids”,
“anticoagulants”, “SSRIs”, or “SNRIs”
° increasing doses of NSAIDs
° longer use of NSAIDs
° smoking
° drinking alcohol
° older age
° poor health
° advanced liver disease
° bleeding problems
NSAIDs should only be used:
° exactly as prescribed
° at the lowest dose possible for your treatment
° for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical
conditions such as different types of arthritis, menstrual cramps, and
other types of short-
term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any
other NSAIDs.
•
right before or after heart bypass surgery.
How should I take NAPROSYN Suspension?
Use ONLY a calibrated measuring de

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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IBUPROFEN TABLETS
IBUPROFEN TABLETS, USP
Cardiovascular Thrombotic Events
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
(SeeWARNINGSand PRECAUTIONS).
Ibuprofen tablets are contraindicated in the setting of coronary
artery bypass graft (CABG)
surgery (seeCONTRAINDICATIONSandWARNINGS).
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: carnauba wax,
colloidal silicon dioxide,
croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose, polydextrose,
polyethylene glycol, polysorbate, 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 been
shown to be comparable to aspirin in controlling pai