IBUPROFEN- ibuprofen suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM)

Available from:

Cardinal Health

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: In Adults, Ibuprofen Oral Suspension is indicated: 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 hypersensitivity to ibuprofen. Ibuprofen should not be given to patients who have experienced asthma, urticaria, 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 WARNINGS - Anaphylactoid Reactions , and PRECAUTIONS - Pree

Product summary:

Orange-colored, berry-flavored suspension is available as follows: Overbagged with 5 x 5mL cups per bag, NDC 55154-4060-5 Shake well before using. Store at controlled room temperature 20° to 25°C (68° to 77°F). Dispense in a well-closed container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

IBUPROFEN- IBUPROFEN SUSPENSION
Cardinal Health
----------
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 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" and "anticoagulants"
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
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.
•
if you are pregnant. NSAID

Summary of Product characteristics

IBUPROFEN- IBUPROFEN SUSPENSION
CARDINAL HEALTH
----------
IBUPROFEN ORAL SUSPENSION USP 100 MG/5 ML
RX ONLY
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
The active ingredient in Ibuprofen Oral Suspension USP is ibuprofen,
which is a member of the
propionic acid group of non steroidal 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: anhydrous citric acid,
glycerin, hypromellose, polysorbate 80, purified water, sodium
benzoate, sucrose, xanthan gum, D&C
yellow #10 and FD&C red #40, and artificial flavors
(strawberry/vanillin).
CLINICAL PHARMACOLOGY
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).
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 ri