IBUPROFEN tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

PD-Rx Pharmaceuticals, Inc.

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. 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, An

Produkt oppsummering:

800 mg (white, capsule shaped, film-coated tablets engraved "IBU" over "800" on one side) Bottles of 10 NDC 72789-200-10 Bottles of 12 NDC 72789-200-12 Bottles of 15 NDC 72789-200-15 Bottles of 20 NDC 72789-200-20 Bottles of 21 NDC 72789-200-21 Bottles of 30 NDC 72789-200-30 Bottles of 40 NDC 72789-200-40 Bottles of 60 NDC 72789-200-60 Bottles of 90 NDC 72789-200-90 Bottles of 180 NDC 72789-200-93 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx only

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

PD-Rx Pharmaceuticals, Inc.
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SPL MEDGUIDE
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:
o with increasing doses of NSAIDs
o 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:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with :
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
o taking medicines called "corticosteroids", "anticoagulants",
"SSRls", or "SNRls"
o increasing doses of NSAIDs
o longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o bleeding problems
NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o 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 NSAlDS , tell your healthcare provider about all of your
medical conditions , including if
you:
• have

Preparatomtale

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
IBUPROFEN TABLETS
BOXED WARNING
CARDIOVASCULAR THROMBOLIC 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 tablets 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
Ibuprofen tablets 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, 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, microcrystalline cellulose, pregelatinized starch, sodium
starch glycolate, talc,
magnesium stearate, Opadry II contains hypromellose, polyethylene
glycol, sodium
citrate, lactose monohydrate and titanium dioxide.
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