IBUPROFEN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pharmaceutical Associates, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of ibuprofen oral suspension 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 ). In Pediatric Patients, Ibuprofen Oral Suspension is indicated: - For reduction of fever in patients aged 6 months up to 2 years of age. - For relief of mild to moderate pain in patients aged 6 months up to 2 years of age. - For relief of signs and symptoms of juvenile arthritis. In Adults, Ibuprofen Oral Suspension is indicated: - For treatment of primary dysmenorrhea. - For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended (see PRECAUTIONS-Drug Interactions ).

Product summary:

Ibuprofen Oral Suspension USP, 100 mg/5 mL White to off-white, berry-flavored suspension NDC 0121-0918-05: 5 mL unit dose cup, in a tray of ten cups. Shake well before using. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Dispense in a well-closed container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

IBUPROFEN- IBUPROFEN SUSPENSION
Pharmaceutical Associates, Inc.
----------
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.
Before taking NSAIDs, tell your healthcare provider about

Summary of Product characteristics

IBUPROFEN- IBUPROFEN SUSPENSION
PHARMACEUTICAL ASSOCIATES, INC.
----------
IBUPROFEN ORAL SUSPENSION USP, 100 MG/5 ML
RX ONLY
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).
Ibuprofen oral suspension 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
The active ingredient in ibuprofen oral suspension USP is ibuprofen,
which is a member
of the propionic acid group of nonsteroidal anti-inflammatory drugs
(NSAIDs). Ibuprofen
is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to
off-white crystalline
powder, with a melting point of 74° to 77°C. It is practically
insoluble in water (< 0.1
mg/mL), but readily soluble in organic solvents such as ethanol and
acetone. Ibuprofen
has a pKa of \4.43 ± 0.03 and an n-octanol/water partition
coefficient of 11.7 at pH 7.4.
The chemical name for ibuprofen is (±)-2-( _p_-Isobutylphenyl)
propionic acid. The
molecular weight of ibuprofen is 206.28. Its molecular formula is C
H
O
and it has
the following structural formula:
Ibuprofen oral suspension USP is a sucrose-sweetened, white to
off-white, berry-
flavored suspension containing 100 mg of ibuprofen in 5 mL (20 mg/mL).
Inactive
ingredients include: acesulfame potassium, berry flavor natural &
artificial, citric acid
13
18
2
anhydrous, glycerin, pregelatinized modified starch, polysorbate 80,
sodium benzoate,
puri