NABUMETONE- nabumentone tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

PD-Rx Pharmaceuticals, Inc.

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 ). In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS )

제품 요약:

Nabumetone Tablets, USP, for oral administration, are available as 750 mg Oval-shaped, white film coated tablets, debossed “ E 146" on one side, plain on the other side and supplied as: NDC 55289-609-20 bottles of 20 NDC 55289-609-30 bottles of 30 NDC 55289-609-40 bottles of 40 NDC 55289-609-60 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. KEEP TIGHTLY CLOSED.

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

PD-Rx Pharmaceuticals, Inc.
----------
Medication Guide
for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Nabumetone Tablets, USP
(nah-BYOO-meh-tone)
What is the most important information I should know about medicines
called Non-Steroidal 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 before or after heart bypass surgery.
Before taking NSAIDs, tell

제품 특성 요약

NABUMETONE- NABUMENTONE TABLET
PD-RX PHARMACEUTICALS, 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 WARNINGSand 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 (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 synthesis may be involved in the
anti-inflammat