NABUMETONE 500 MG- nabumetone tablet, film coated NABUMETONE 750 MG- nabumetone tablet, film coated NABUMETONE 1000 MG- nabume

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Nexgen Pharma, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 and PRECAUTIONS ). Nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Dettagli prodotto:

Nabumetone tablets USP, 500 mg are white, coated, modified capsule-shaped tablets, debossed with “HT” on one side and “500” on the other. They are available in bottles of: 100 tablets - NDC 0722-7076-01 500 tablets - NDC 0722-7076-05 Nabumetone tablets USP, 750 mg are white, coated, modified capsule-shaped tablets, debossed with “HT” on one side and “750” on the other. They are available in bottles of: 100 tablets - NDC 0722-7077-01 500 tablets - NDC 0722-7077-05 Nabumetone tablets USP, 1000 mg are white, coated, modified capsule-shaped tablets, deep bisect on one side and debossed logo “NB 1000” on the other. They are available in bottles of: 100 tablets - NDC 0722-7078-01 30 tablets – NDC 0722-7078-30 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). Manufactured by: Nexgen Pharma, Inc. Irvine, CA 92606 Rev 09/2019

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

NABUMETONE 750 MG- NABUMETONE TABLET, FILM COATED
NABUMETONE 1000 MG- NABUMETONE TABLET, FILM COATED
Nexgen Pharma, Inc.
----------
MEDICATION GUIDE
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:
▪
with increasing doses of NSAIDs
▪
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:
▪
anytime during use
▪
without warning symptoms
▪
that may cause death
The risk of getting an ulcer or bleeding increases with:
▪
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
▪
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
▪
increasing doses of NSAIDs
▪
older age
▪
longer use of NSAIDs
▪
poor health
▪
smoking
▪
advanced liver disease
▪
drinking alcohol
▪
bleeding problems
NSAIDs should only be used:
▪
exactly as prescribed
▪
at the lowest dose possible for your treatment
▪
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 bef

Scheda tecnica

NABUMETONE 500 MG- NABUMETONE TABLET, FILM COATED
NABUMETONE 750 MG- NABUMETONE TABLET, FILM COATED
NABUMETONE 1000 MG- NABUMETONE TABLET, FILM COATED
NEXGEN PHARMA, INC.
----------
NABUMETONE TABLETS USP
RX ONLY
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
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.
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 2,400 at pH 7.4.
Each tablet, for oral administration, contains either 500 mg, 750 mg,
or 1000 mg of nabumetone. In
addition, each tablet contains the following inactive ingredients:
povidone, croscarmellose, magnesium
stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The
coating contains hydroxypropyl
cellulose and hypromellose.
CLINICAL PHARMACOLOGY
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
WARNINGSand PRECAUTIONS].
Nabumetone is contraindicated in the setting of coronary artery bypass
graft (CABG)
surgery (see CONTRAINDICATIONS and WARNINGS).
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
15
16
2
Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory,
analgesic, and antipyretic properties in pharmacologic studies.