IBUPROFEN tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

American Health Packaging

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in children have not been conducted. Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen tablets 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 ]. In the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS ].

Produkt oppsummering:

Ibuprofen Tablets, USP are available in the following strengths, colors and sizes: Ibuprofen Tablets USP, 400 mg are white, round, biconvex, aqueous film-coated tablets, debossed "IP 464" on obverse and plain on reverse. They are available as follows: Unit dose packages of 100 (10 x 10) NDC 60687-446-01 Ibuprofen Tablets USP, 600 mg are white, oval-shaped, biconvex, aqueous film-coated tablets, debossed "IP 465" on obverse and plain on reverse. They are available as follows: Unit dose packages of 100 (10 x 10) NDC 60687-457-01 Ibuprofen Tablets USP, 800 mg are white, capsule-shaped, biconvex, aqueous film-coated tablets, debossed "IP 466" on obverse and plain on reverse. They are available as follows: Unit dose packages of 100 (10 x 10) NDC 60687-468-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

IBUPROFEN- IBUPROFEN TABLET
American Health Packaging
----------
MEDICATION GUIDE
8444601/0223
Dispense with Medication Guide:
To order more Medication Guides call American Health Packaging at
1-800-707-4621.
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Ibuprofen (eye” bue proe’ fen) Tablets, USP
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 yo

Preparatomtale

IBUPROFEN- IBUPROFEN TABLET
AMERICAN HEALTH PACKAGING
----------
IBUPROFEN TABLETS, USP
8444601/0223
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 WARNINGSand PRECAUTIONS].
Ibuprofen Tablets are 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
Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which
is (±)-2-( _p_-
isobutylphenyl) propionic acid. Ibuprofen is a white powder with a
melting point of 74° to
77° C and is very slightly soluble in water (<1 mg/mL) and readily
soluble in organic
solvents such as ethanol and acetone.
The structural formula is represented below:
Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID),
is available in
400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive
ingredients:
colloidal silicon dioxide, croscarmellose sodium, magnesium stearate,
microcrystalline
cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized
starch, talc, stearic acid,
and titanium dioxide.
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
Ibuprofen tablets contain ibuprofen which possesses analgesic and
antipyretic activities.
Its mode of action, like that of other NSAIDs, is not completely
understood, but may be
related to prostaglandin synthetase inhibition.
In clinical studies in patients with rheumatoid arthritis and
osteoarthritis, ibuprofen
tablets have been shown to be co