NABUMETONE tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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, 750 mg are pink, oval-shaped, film-coated, biconvex tablets debossed with “3671” on one side of the tablet and plain on the other side. They are available in bottles of 30, 60. NDC 70934-432-60...............................bottles of 60 NDC 70934-432-30...............................bottles of 30 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
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
----------
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 shoul

Vara einkenni

NABUMETONE- NABUMETONE TABLET, FILM COATED
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
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-inflammatory,
analgesic, and antipyretic properties in pharmacologic studies. As
with o