IBUPROFEN suspension

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Proficient Rx LP

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 ). 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-Preexisting Asthma ). Ibuprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNIN

ملخص المنتج:

Ibuprofen Oral Suspension USP, 100 mg/5 mL Orange-colored, berry-flavored suspension - Bottles of 4 fl oz (118 mL) – NDC 71205-367-72 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. South Plainfield, NJ 07080 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Rev. A 3/2019

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

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 about all of y

خصائص المنتج

IBUPROFEN- IBUPROFEN SUSPENSION
PROFICIENT RX LP
----------
IBUPROFEN ORAL SUSPENSION, USP
100 mg/5 mL
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
•
• GASTROINTESTINAL RISK
•
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: acesulfame potassium,
citric acid anhydrous, D&C yellow #10, FD&C red #40, glycerin,
polysorbate 80, pregelatinized corn
starch, purified water, sodium benzoate, strawberry flavor, sucrose
and xanthan gum.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS - Ibuprofen is a racemic mixture of [-]R-and
[+]S-isomers.
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