NABUMETONE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

St. Mary's Medical Park Pharmacy

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Nabumetone tablets USP, 500 mg are white colored, oval shaped, biconvex, film coated tablets, debossed with ‘SG’ on one side ‘465’ on other side. NDCs 60760-368-15 BOTTLES OF 15 60760-368-60 BOTTLES OF 60 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] in well-closed container; dispense in light-resistant container. Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Revised: 07/19

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

St. Mary's Medical Park Pharmacy
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Medication Guide
for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal
Antiinflammatory 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
• 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
m

Karakteristik produk

NABUMETONE- NABUMETONE TABLET
ST. MARY'S MEDICAL PARK PHARMACY
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NABUMETONE TABLETS USP
BOXED WARNING
CARDIOVASCULAR RISK
• 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).
DESCRIPTION
Nabumetone is a naphthylalkanone designated chemically as
4-(6-methoxy-2- naphthalenyl)-2-butanone.
It has the following structure:
Nabumetone is a white or almost white crystalline substance with a
molecular weight of 228.3. It is
nonacidic, freely soluble in acetone, sparingly soluble in alcohol and
in methanol, practically insoluble
in water. It has an n-octanol:phosphate buffer partition coefficient
of 2400 at pH 7.4.
TABLETS FOR ORAL ADMINISTRATION: Each white coloured, oval shaped,
biconvex, film coated tablet
contains 500 mg or 750 mg of nabumetone. Inactive ingredients consists
of hypromellose,
microcrystalline cellulose, sodium lauryl sulfate, sodium starch
glycolate and opadry white OY 58900
[hypromellose, polyethylene glycol 400, and titanium dioxide].
CLINICAL PHARMACOLOGY
Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory,
analgesic, and antipyretic properties in pharmacologic studies. As
with other non-steroidal anti-
inflammatory agents, its mode of action is not known; however, the
ability to inhibit prostaglandin
synthesis may be i