NABUMETONE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Actavis Pharma, Inc.

INN (International Name):

NABUMETONE

Sammensetning:

NABUMETONE 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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). • In the setting of coronary artery bypass graft (CABG) surgery [see Warnings ].

Produkt oppsummering:

Nabumetone tablets USP, 500 mg are white, oval-shaped, film-coated, biconvex tablets debossed with “3670 ” on one side of the tablet and plain on the other side. They are available in bottles of 100 and 500. NDC 0591-3670-01...............................bottles of 100 NDC 0591-3670-05...............................bottles of 500 Nabumetone tablets USP, 750 mg are pink, oval-shaped, film-coated, biconvex tablets debossed with “3671 ” on one side of the tablet and plain on the other side. They are available in bottles of 100 and 500. NDC 0591-3671-01...............................bottles of 100 NDC 0591-3671-05...............................bottles of 500 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In India By: Watson Pharma Private Ltd. Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. D 2/2022 

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

NABUMETONE- NABUMETONE TABLET, FILM COATED
Actavis Pharma, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
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”,
“SSRIs”, or “SNRIs”
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.
______________________________________________________________________________

Preparatomtale

NABUMETONE- NABUMETONE TABLET, FILM COATED
ACTAVIS PHARMA, INC.
----------
NABUMETONE TABLETS, USP
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 _WARNINGS AND_
_PRECAUTIONS_].
NABUMETONE TABLETS ARE 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). THROUGHOUT THIS PACKAGE INSERT, THE TERM NSAID REFERS TO A NON-
ASPIRIN NON-STEROIDAL ANTI-INFLAMMATORY DRUG.
DESCRIPTION
Nabumetone, USP is a naphthylalkanone designated chemically as
4-(6-methoxy-2-
naphthalenyl)-2-butanone. It has the following structure:
Nabumetone, USP 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,
USP. 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.
CLINICAL PHARMACOLOGY
Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-
inflammatory, analgesic, and antipyretic properties in pharmacologic
studies. As with
1
other