NABUMETONE tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Northwind Pharmaceuticals, LLC

ИНН (Международная Имя):

NABUMETONE

состав:

NABUMETONE 750 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Please see the FDA site for the manufacturer's complete drug information: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53656d70-6572-4669-6465-6c6973555341 Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. 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 product excipients. Nabumetone 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, General, Preexisting Asthma). Nabumetone tablets are co

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

NABUMETONE- NABUMETONE TABLET, FILM COATED
Northwind Pharmaceuticals, 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 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 not be used by pregnan

Характеристики продукта

NABUMETONE- NABUMETONE TABLET, FILM COATED
NORTHWIND PHARMACEUTICALS, LLC
----------
NABUMETONE
BOXED WARNING
Cardiovascular Risk
NSAIDs1 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).
1 Throughout this package insert, the term NSAID refers to a
non-aspirin non-steroidal anti-
inflammatory drug.
DESCRIPTION
Nabumetone is a naphthylalkanone designated chemically as
4-(6-methoxy-2-naphthalenyl)-2-butanone.
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 2,400 at pH 7.4.
Each tablet, for oral administration, contains either 500 mg or 750 mg
of nabumetone. In addition, each
tablet contains the following inactive ingredients: colloidal silicon
dioxide, corn starch, hypromellose,
magnesium stearate, povidone, sodium lauryl sulfate, sodium starch
glycolate, titanium dioxide and
triacetin. The 500 mg tablets also contain talc and the 750 mg tablets
also contain iron oxide red.
PLEASE SEE THE FDA SITE FOR THE MANUFACTURER'S COMPLETE DRUG
INFORMATION:
HTTP://DAILYMED.NLM.NIH.GOV/DAILYMED/DRUGINFO.CFM?S
ETID=53656D70-6572-4669-6465-
6C6973555341
CLINICAL PHARMACOLOGY
Nabumetone is a non-steroidal anti-inf