NABUMETONE- nabumentone tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Lake Erie Medical DBA Quality Care Products 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 tablets USP and other treatment options before deciding to use nabumetone tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Nabumetone tablets USP are indicated: * For relief of the signs and symptoms of rheumatoid arthritis. * For relief of the signs and symptoms of osteoarthritis. Nabumetone is 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, General, Preexisting Asthma ). Nabumetone is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS )

Produkt oppsummering:

Nabumetone Tablets USP for oral administration are available as: 500 mg: Oval-shaped, white film coated tablets, debossed “E 145" on one side, plain on the other side and supplied as: 750 mg: Oval-shaped, white film coated tablets, debossed “E 146" on one side, plain on the other side and supplied as: NDC: 35356-685-30  Bottles of 30 NDC: 35356-685-60  Bottles of 60 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

NABUMETONE- NABUMENTONE TABLET
Lake Erie Medical DBA Quality Care Products LLC
----------
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)?
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 a 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

Preparatomtale

NABUMETONE- NABUMENTONE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
NABUMETONE TABLETS USP
RX ONLY
CARDIOVASCULAR RISK
•NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction (MI), 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 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 (GI) events. (See WARNINGS .)
DESCRIPTION
Nabumetone is a naphthylalkanone designated chemically as
4-(6-methoxy-2-naphthalenyl)-2-butanone.
It has the following structure:
NABUMETONE
Nabumetone is a white to off-white crystalline substance with a
molecular weight of 228.3. 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.
TABLETS FOR ORAL ADMINISTRATION
Each oval-shaped, film-coated tablet contains 500 mg or 750 mg of
nabumetone. Inactive ingredients
consist of colloidal silicon dioxide, croscarmellose sodium,
hypromellose, magnesium stearate,
microcrystalline cellulose, titanium dioxide, polyethylene glycol 400,
polysorbate 80 and sodium
lauryl sulfate.
CLINICAL PHARMACOLOGY
Nabumetone is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic
and antipyretic properties in pharmacologic studies. As with other
nonsteroidal anti-inflammatory
agents, its mode of action is not known. However, the ability to
inhibit prostaglandin s