IBUPROFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Northwind Pharmaceuticals, LLC

INN (International Name):

IBUPROFEN

Composition:

IBUPROFEN 800 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 ). 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 hypersensitivityto ibuprofen. Ibuprofen 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 Asthma ). Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery(see WARNINGS ).

Product summary:

Ibuprofen tablets are available in the following strengths, colors and sizes: 800 mg : Caplet shaped, white, film-coated tablet debossed "8I" on one side. Bottles of 20 NDC 51655-851-20 Bottles of 40 NDC 51655-851-51 Store at room temperature. Avoid excessive heat 40°C (104°F). Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in India Revised: April 2022

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

IBUPROFEN- IBUPROFEN TABLET
Northwind Pharmaceuticals, LLC
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MEDICATION GUIDE
Medication Guide forNon-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Non-Steroidal 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 ofgetting 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 use 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 NSAIDs?
Do not take NSAIDs:
• if you had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAIDs
• right before or after heart bypass surgery
Before taking NSAIDs, tell your healthcare provider about all your
medical cond

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET
NORTHWIND PHARMACEUTICALS, LLC
----------
IBUPROFENTABLETS
BOXED WARNING
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. (See WARNINGSand PRECAUTIONS).
Ibuprofen tablets are contraindicated in the setting of coronary
artery bypass
graft (CABG) surgery (See CONTRAINDICATIONSand 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
Ibuprofen 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:
Ibuprofen, 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
Ibuprofen 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 associa