IBUPROFEN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

QPharma Inc

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, urticarial, 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 W

Product summary:

Ibuprofen tablets are available in the following strengths, colors and sizes: 600 mg (white to off-white, caplet, 'I 7' debossing on one side and plain on the other side) Bottles of 60; NDC 42708-006-60 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Avoid excessive heat above 40ºC (104ºF). Manufactured by: Granules India Limited Hyderabad-500 081, India MADE IN INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Toll-free: 1-877-272-7901 Issued: October 2016 For more information, please call to 1-877-770-3183. Rev: May/2019

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
QPharma Inc
----------
SPL MEDGUIDE
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
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 aft

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
QPHARMA INC
----------
IBUPROFEN TABLETS, USP 600MG
BOXED WARNING
CARDIOVASCULAR THROMBOTIC EVENTS
· Non-steroidal 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).
· Ibuprofen Tablets is contraindicated in the setting of coronary
artery bypass
graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS).
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:
colloidal silicon dioxide,
croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose,
magnesium
stearate, microcrystalline cellulose, polyethylene glycol 400,
pregelatinized starch,
povidone k-90, sodium lauryl sulphate, 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