NABUMETONE tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Chartwell RX, LLC

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, 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) surg

Ringkasan produk:

Nabumetone Tablets, USP, for oral administration, are available as 500 mg White to off white, oval shaped, film-coated tablets, debossed with “ CE 39” on one side, plain on the other side and supplied as: NDC 62135-145-60 bottles of 60 750 mg White to off white, oval shaped, film-coated tablets, debossed with “ CE 40” on one side, plain on the other side and supplied as: NDC 62135-146-60 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. Dispense with Medication Guide available at www.chartwellpharma.com/medguides Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Made in USA Rev: 07/2022 L70977

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

NABUMETONE- NABUMETONE TABLET, FILM COATED
CHARTWELL RX, LLC
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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 (Gl) events (see WARNINGS).
*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:
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 2,400 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 hypromellose, microcrystalline
cellulose, polyethylene
glycol, polysorbate 80, sodium lauryl sulfate, croscarmellose sodium,
colloidal silicon
dioxide, magnesium stearate, and titanium dioxide.
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