IBUPROFEN suspension

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

PINNACLE PHARMA LLC

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

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 45802-952 -26) Bottle of 16 FL OZ (473 mL) (NDC 45802-952 -43) Shake well before using. Store at 20 - 25ºC (68 - 77ºF) [see USP Controlled Room Temperature]. Do not freeze. Preserve in well-closed containers. Manufactured and Distributed By Perrigo® Allegan, MI 49010 • www.perrigorx.com Rev 10-20 : 01900 RC J7

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

IBUPROFEN- IBUPROFEN SUSPENSION
PINNACLE PHARMA LLC
----------
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 provide

Tabia za bidhaa

IBUPROFEN- IBUPROFEN SUSPENSION
PINNACLE PHARMA LLC
----------
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, 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 74º to 77ºC.
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
13
18 2
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 glycol,
purifie