NABUMETONE tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Advanced Rx Pharmacy of Tennessee, LLC

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of nabumetone tablets, USP 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, USP 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 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 contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Prehľad produktov:

Nabumetone Tablets USP: 500 mg–White film-coated, oval-shaped biconvex tablets debossed with IG on one side and 257 on the other are supplied in Bottles of 60 Tablets NDC: 80425-0053-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Rev: 03/2021

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

NABUMETONE- NABUMETONE TABLET, FILM COATED
Advanced Rx Pharmacy of Tennessee, LLC
----------
MEDICATION GUIDE SECTION
MEDICATION GUIDE FORNON-STEROIDAL 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 mayhappen 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
longer use of NSAIDs
smoking
drinking alcohol
older age
poor health
advanced liver disease
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 before or after heart bypass surgery.
Before taking NSAIDS, tell your healthcare provider about all of your
medic

Súhrn charakteristických

NABUMETONE- NABUMETONE TABLET, FILM COATED
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
NABUMETONE 500MG TABLETS
BOXED WARNING
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
NSAIDs1 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).
SPL UNCLASSIFIED SECTION
1Throughout 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.
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 tablet, for oral administration contains either 500 mg or 750 mg
of nabumetone. In
addition, each tablet contains the following inactive ingredients:
microcrystalline cellulose,
sodium starch glycolate, hydroxy propyl methyl cellulose, sodium
lauryl sulphate,
colloidal silicon dioxide and magnesium stearate. The 500 mg tablets
also contain opadry
white (Titanium dioxide, Hypromellose 3cP, Hypromellose 6cP, Macrogol
and Polysorbate
80) and the 750 mg tablets contain opadry beige (Hypromellose 6cP,
titanium dioxide,
iron oxide yellow, iron oxide red and Macrogol).
CLINICAL PHARMACOLOGY
Nabumeton