NABUMETONE tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

NuCare Pharmaceuticals,Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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, Anaphylactoid Reactions and PRECAUTIONS, General, Preexisting Asthma ). • In the setting of coronary artery bypass graft (CABG) surgery [see Warnings ]

Vörulýsing:

Nabumetone tablets USP, 500 mg are white, oval-shaped, film-coated, biconvex tablets debossed with 3670 on one side of the tablet and plain on the other side. They are available in bottles of 100, 500 and 1000. NDC 68071-4844-6 BOTTLES OF 60 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: Watson Pharma Private Ltd. Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: May 2016

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

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

Vara einkenni

NABUMETONE- NABUMETONE TABLET, FILM COATED
NUCARE 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 _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). 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 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 or 750 mg
of nabumetone.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
corn starch, hypromellose, magnesium stearate, povidone, sodium lauryl
sulfate,
sodium starch glycolate, titanium dioxide and triacetin. The 500 mg
tablets also contain
talc and the 750 mg tablets also contain iron oxide red.
CLINICAL PHARMACOLOGY
Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-
1
inflammatory, analgesic, and antipyretic properties in pharmacologic
studies. As with
other non-ster