IBUPROFEN suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Proficient Rx LP

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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: 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 Oral Suspension is contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen Oral Suspension 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

Produkt oppsummering:

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 71205-716 -72) Shake well before using. Store at 20 - 25ºC (68 - 77ºF) [see USP Controlled Room Temperature]. Do not freeze. Preserve in well-closed containers. Manufactured By Perrigo® Minneapolis, MN • www.perrigorx.com Relabeled By Proficient Rx LP Thousand Oaks, CA 91320 2204263 Rev 11-20 A 16K00 RC J1

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

IBUPROFEN- IBUPROFEN SUSPENSION
Proficient Rx LP
----------
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 ab

Preparatomtale

IBUPROFEN- IBUPROFEN SUSPENSION
PROFICIENT RX LP
----------
IBUPROFEN ORAL SUSPENSION USP, 100 MG/5 ML
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
Ibuprofen Oral Suspension is contraindicated in the setting of
coronary artery
bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS).
GASTROINTESTINAL RISK
•
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:
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).
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).
13
18 2
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, artif