IBUPROFEN- ibuprofen suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

IBUPROFEN

Composition:

IBUPROFEN 100 mg in 5 mL

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 ). Ibuprofen is contraindicated in patients with known

Product summary:

Ibuprofen Oral Suspension USP, 100 mg/5 mL   Orange-colored, berry-flavored suspension - Bottles of 4 fl oz (118 mL) - NDC 0472-1270-94 - Bottles of ONE PINT (473 mL) - NDC 0472-1270-16 Shake well before using. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Dispense in a well-closed container as defined in the USP. Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA I602-1211 GW7043 Rev. 08/15

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

IBUPROFEN- IBUPROFEN SUSPENSION
Actavis Pharma, 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
•
older age
•
longer use of NSAIDs
•
poor health
•
smoking
•
advanced liver disease
•
drinking alcohol
•
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.
Before taking NSAIDs, tell your healthcare provider about all of your
medical conditions, including if
you:
•
have liver or kidney problems
•
have high blood pressure
•
have asthma
•
are pregnant or plan to become pregnant. Talk to your healthc

Summary of Product characteristics

IBUPROFEN- IBUPROFEN SUSPENSION
ACTAVIS PHARMA, INC.
----------
IBUPROFEN ORAL SUSPENSION, USP
100 MG/5 ML
REV. 08/15
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, orange-colored,
berry-flavored suspension
containing 100 mg of ibuprofen in 5 mL (20 mg/mL). Inactive
ingredients include: citric acid anhydrous,
glycerin, hypromellose, polysorbate 80, purified water, sodium
benzoate, sucrose, xanthan gum, D&C
yellow #10 and FD&C red #40, and artificial flavor