NABUMETONE tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Aidarex Pharmaceuticals LLC

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 ). Nabumetone tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Produktu pārskats:

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 60 and 90. NDC 33261-0077-60...............................bottles of 60 NDC 33261-0077-90...............................bottles of 90 Store at 20° - 25°C (68° - 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: Watson Pharma, Inc. Corona, CA 92880 USA Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Rev. date: 12/10                    195702

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE
For Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a “coronary artery
bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called “corticosteroids” and “anticoagulants”
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant. NSAID medic

Produkta apraksts

NABUMETONE- NABUMETONE TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
----------
NABUMETONE
TABLETS, USP
REVISED: DECEMBER 2010
RX ONLY
195702
NABUMETONE TABLETS USP
RX ONLY
CARDIOVASCULAR RISK
NSAIDS MAY CAUSE AN INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC
EVENTS,
MYOCARDIAL INFARCTION, AND STROKE, WHICH CAN BE FATAL. THIS RISK MAY
INCREASE WITH
DURATION OF USE. PATIENTS WITH CARDIOVASCULAR DISEASE OR RISK FACTORS
FOR CARDIOVASCULAR
DISEASE MAY BE AT GREATER RISK (SEE WARNINGS).
NABUMETONE TABLETS ARE CONTRAINDICATED FOR THE TREATMENT OF
PERI-OPERATIVE PAIN IN THE
SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY (SEE 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
1
1
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 a