PHARMAPURERX IBU 600-EZS- ibuprofen

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PureTek Corporation

INN (International Name):

IBUPROFEN

Composition:

IBUPROFEN 600 mg

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 PRECAUTIONS, Preexisting Asthm

Product summary:

IBU tablets are available in the following strengths, colors and sizes: 400 mg (white, oval, debossed 4I) Bottles of 90 NDC 55111-682-09 Bottles of 100 NDC 55111-682-01 Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT) 600 mg (white, caplet, debossed 6I) Bottles of 30 NDC 55111-683-30 Bottles of 50 NDC 55111-683-50 Bottles of 90 NDC 55111-683-09 Bottles of 100 NDC 55111-683-01 Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT) 800 mg (white, caplet, debossed 8I) Bottles of 30 NDC 55111-684-30 Bottles of 50 NDC 55111-684-50 Bottles of 60 NDC 55111-684-60 Bottles of 90 NDC 55111-684-09 Bottles of 100 NDC 55111-684-01 Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT) Store at room temperature. Avoid excessive heat 40°C (104°F). Manufactured by: Dr. Reddy’s Laboratories Louisiana, LLC Shreveport, LA 71106 USA Revised, July 2016

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PHARMAPURERX IBU 600-EZS- IBUPROFEN
PureTek Corporation
----------
MEDICATION GUIDE
Medication Guide forNon-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What it 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 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 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 condi

Summary of Product characteristics

PHARMAPURERX IBU 600-EZS- IBUPROFEN
PURETEK CORPORATION
----------
PHARMAPURERX IBU 600-EZS™
(IBUPROFEN, PILL SWALLOWING SPRAY)
RX ONLY
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
WARNINGS and PRECAUTIONS).
IBU tablets are contraindicated in the setting of coronary artery
bypass graft (CABG) surgery
(See CONTRAINDICATIONS and 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 inf