IBUPROFEN suspension

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM)

Inapatikana kutoka:

Rebel Distributors Corp

INN (Jina la Kimataifa):

Ibuprofen

Tungo:

Ibuprofen 100 mg in 5 mL

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Carefully consider the potential benefits and risks of ibuprofen suspension and other treatment options before deciding to use ibuprofen suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). In Pediatric Patients , ibuprofen 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 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 suspension is contraindicated in patients with known

Bidhaa muhtasari:

Ibuprofen Suspension, 100 mg/5 mL is available as follows: Orange-colored, berry-flavored suspension Bottles of 120 mL - NDC 21695-420-12 Shake well before using. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

Rebel Distributors Corp
----------
MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSALDS)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery
bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called "corticosteroids" and "anticoagulants"
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant. NSAID medicines should not be

Tabia za bidhaa

IBUPROFEN- IBUPROFEN SUSPENSION
REBEL DISTRIBUTORS CORP
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IBUPROFEN SUSPENSION
100 MG/5 ML
_R ONLY_
Cardiovascular Risk
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk
(see WARNINGS).
Ibuprofen suspension is contraindicated for the treatment of
peri-operative pain in the setting
of coronary artery bypass graft (CABG) surgery (see 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 suspension 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 0 and it has the following structural formula:
Ibuprofen suspension is a sweetened, orange colored, berry flavored
suspension containing 100 mg of
ibuprofen in 5 mL (20 mg/mL). Inactive ingredients include:
butylparaben, citric acid, corn syrup, D&C
red #33, FD&C yellow #6, flavor, glycerin, hypromellose, polysorbate
80, propylene glycol, purified
water, sodium benzoate, sorbitol, xanthan gum.
CLINICAL PHARMACOLO