NABUMETONE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

NABUMETONE (UNII: LW0TIW155Z) (NABUMETONE - UNII:LW0TIW155Z)

Tilgjengelig fra:

STAT RX USA LLC

INN (International Name):

NABUMETONE

Sammensetning:

NABUMETONE 750 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Carefully consider the potential benefits and risks of nabumetone and other treatment options before deciding to use nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone 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 ). Nabumetone tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Produkt oppsummering:

Nabumetone Tablets are available as light yellow, oval shaped, film coated, unscored tablets, debossed “P649” on one side and “500” on the other side containing 500 mg of nabumetone, packaged in bottles of 100 (NDC 49884-649-01) and 500 (NDC 49884-649-05) tablets. Nabumetone Tablets are available as dark yellow, oval shaped, film coated, unscored tablets, debossed “P650”on one side and “750” on the other side containing 750 mg of nabumetone, packaged in bottles of 100 (NDC 49884-650-01) and 500 (NDC 49884-650-05) tablets. PHARMACIST: Dispense in a well-closed, light-resistant container as defined in the USP. Use child-resistant closure (as required). Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser. Store at 25°C (77°F); excursions permitted to 15 – 30°C (59-86°F) in well-closed container; dispense in light resistant container

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

STAT RX USA LLC
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MEDICATION GUIDE FOR NON-
STEROIDAL ANTI-INFLAMMATORY
DRUGS (NSAIDS)
(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)?
NSAIDmedicines 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 (NSAIDs)?
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 of 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

Preparatomtale

NABUMETONE - NABUMETONE TABLET
STAT RX USA LLC
----------
NABUMETONE TABLETS USP
Rx 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).
• Nabumetone tablets are 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).
Throughout this package
insert, the term NSAID refers to a non-aspirin nonsteroidal
anti-inflammatory drug.
DESCRIPTION
Nabumetone is a naphthylalkanone designated chemically as
4-(6-methoxy-2-naphthalenyl)-2-butanone.
It has the following structure:
C
H O
M.W. 228.3
Nabumetone is a white to off-white crystalline substance. It is
nonacidic and practically insoluble in
water, but soluble in alcohol and most organic solvents. It has an
n-octanol:phosphate buffer partition
coefficient of 2400 at pH 7.4.
Each nabumetone tablet, for oral administration, contains 500 mg or
750 mg of nabumetone and has the
following inactive ingredients: colloidal silicon dioxide, D&C yellow
#10 aluminum lake,
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate 80,
sodium lauryl sulfate, sodium starch glycolate and titanium dioxide.
In addition, the 750 mg contains
FD&C yellow #6 aluminum lake.
1
1
15
16
2
CLINICAL PHARMACOLOGY
Nabumetone is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic
and antipyretic properties in pharmacologic stu