IBUPROFEN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT Rx USA LLC

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 Oral Suspension. 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 Oral Suspension is co

Product summary:

Ibuprofen Oral Suspension USP, 100 mg/5 mL is available as follows: Orange-colored, berry-flavored suspension Bottle of 4 FL OZ (120 mL) NDC 16590-422-04 Shake well before using. Store at 20 - 25°C (68 - 77°F) [see USP Controlled Room Temperature]. Do not freeze.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

STAT Rx USA LLC
----------
MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSALDS)
(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 Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
● with longer use of NSAID medicines
● in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery
bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
● can happen without warning symptoms
● may cause death
The chance of a person getting an ulcer or bleeding increases with:
●taking medicines called "corticosteroids" ●drinking alcohol
and "anticoagulants" ●older age
●longer use ●having poor health
●smoking
NSAID medicines should only be used:
●exactly as prescribed ●for the shortest time needed
●at the lowest dose possible for your treatment
______________________________________________________________________
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
● if you had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAID medicine
● for pain right before or after heart bypass surgery
Tell your healthcare provider:
● about all your medical conditions.
● about all of the medicines you take. NSAIDs and some other
medicines can interact with each other and
cause serious side effects. Keep a list of your medicines to show to
your healthcare provider and
pharmacist.
�

Summary of Product characteristics

IBUPROFEN- IBUPROFEN SUSPENSION
STAT RX USA LLC
----------
IBUPROFEN ORAL SUSPENSION USP, 100 MG/5 ML
RX ONLY
CARDIOVASCULAR RISK
● NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk (see
WARNINGS).
● Ibuprofen Oral Suspension is contraindicated for the treatment of
peri-operative pain in the
setting of coronary artery bypass graft (CABG) surgery (see 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, 100 mg/5 mL 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 0 and it has the
following structural formula:
Ibuprofen Oral Suspension is a sweetened, orange colored, berry
flavored suspension containing 100
mg of ibuprofen in 5 mL (20 mg/mL). Inactive ingredients include:
anhydrous citric acid, artificial berry
flavor, butylparaben, D&C red #33, FD&C yellow #6, glycerin, high
fructose corn syrup,
hypromellose, polysorbate 80, propylene