IBUPROFEN ORAL SUSPENSION, USP 100 mg/5 mL Rx Only

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

VistaPharm, LLC

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 is contraindicated in patients with

Tóm tắt sản phẩm:

Ibuprofen Oral Suspension, USP, 100 mg/5 mL Orange-colored, berry-flavored suspension is available as follows: NDC 66689-339-50: Case contains 50 unit-dose cups of 5 mL (NDC 66689-339-01), packaged in 5 trays of 10 unit-dose cups each. Shake well before using. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Manufactured by: Largo, FL 33771 VP2272R2 05/2021

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

IBUPROFEN- ibuprofen suspension
VistaPharm, Inc.
----------
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

Đặc tính sản phẩm

IBUPROFEN- IBUPROFEN SUSPENSION
VISTAPHARM, INC.
----------
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 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,
USP 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, USP 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, USP 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 strach,
purified water, sodium
benzoate, strawberry