IBUPROFEN suspension

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Strides Pharma Science Limited

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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: - 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 or

Огляд продуктів:

Ibuprofen Oral Suspension, USP 100 mg/5 mL Pale yellow to orange color suspension with mixed berry flavor -Carton containing bottle of 4 fl oz (118 mL) - NDC 64380-997-03  -Bottles of One Pint (473 mL) – NDC 64380-997-04 -Unit Dose Cups of 5 mL – NDC 64380-997-01 -Tray containing 10 unit dose cups of 5 mL – NDC 64380-997-02 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: Strides Pharma Science Limited Bengaluru – 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 09/2023 Medication Guide available at: www.strides.com/ibu-os-rx/

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Strides Pharma Science Limited
----------
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 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 your
medical conditions, includi

Характеристики продукта

IBUPROFEN - IBUPROFEN SUSPENSION
STRIDES PHARMA SCIENCE LIMITED
----------
IBUPROFEN ORAL SUSPENSION, USP 100 MG/5 ML
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
WARNINGSand PRECAUTIONS).
Ibuprofen oral suspension is contraindicated in the setting of
coronary artery bypass graft (CABG)
surgery (see CONTRAINDICATIONSand 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 75° to 78°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 100 mg/5 mL is a sucrose-sweetened,
pale yellow to orange color suspension
with mixed berry flavor, containing 100 mg of ibuprofen in 5 mL (20
mg/mL). Inactive ingredients include:
acesulfame potassium, anhydrous citric acid, D&C yellow #10, FD&C red
#40, glycerin, hypromellose, mix
berry flavor (natural and artificial