SULINDAC tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SULINDAC (UNII: 184SNS8VUH) (SULINDAC - UNII:184SNS8VUH)

Available from:

Physicians Total Care, Inc.

INN (International Name):

SULINDAC

Composition:

SULINDAC 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac tablets are indicated for acute long-term use in the relief of signs and symptoms of the following: - Osteoarthritis Osteoarthritis - Rheumatoid arthritis* Rheumatoid arthritis* - Ankylosing spondylitis Ankylosing spondylitis - Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) - Acute gouty arthritis Acute gouty arthritis Sulindac tablets are contraindicated in patients with known hypersensitivity to sulindac or the excipients (see DESCRIPTION ). Sulindac 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/anaphylactoi

Product summary:

Sulindac Tablets USP 150 mg are 12/32", round, yellow tablets imprinted DAN and 5661 supplied in Sulindac Tablets USP 200 mg are 14/32", scored, yellow, round tablets imprinted DAN DAN and 5660 supplied in Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Manufactured By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Corona, CA 92880 USA Revised: June 2009                                                                                                                               190770                                                                                                                               0609B Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Physicians Total Care, Inc.
----------
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 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 medicine

Summary of Product characteristics

SULINDAC - SULINDAC TABLET
PHYSICIANS TOTAL CARE, INC.
----------
SULINDAC TABLETS USP
REVISED: JUNE 2009
RX ONLY 190770
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.)
Sulindac 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.)
DESCRIPTION
Sulindac is a non-steroidal, anti-inflammatory indene derivative
designated chemically as (Z)-5-fluoro-
2-methyl-1-
[[_p_-(methylsulfinyl)phenyl]methylene]-1_H_-indene-3-acetic acid. It
is not a salicylate,
pyrazolone or propionic acid derivative. Sulindac, a yellow
crystalline compound, is a weak organic
acid practically insoluble in water below pH 4.5, but very soluble as
the sodium salt or in buffers of pH
6 or higher.
Sulindac is available in 150 mg and 200 mg tablets for oral
administration. Each tablet contains the
following inactive ingredients: magnesium stearate, microcrystalline
cellulose, starch (corn) and stearic
acid.
Following absorption, sulindac undergoes two major
biotransformations—reversible reduction to the
sulfide metabolite, and irreversible oxidation to the sulfone
metabolite. Available evidence indicates
that the biological activity resides with the sulfide metabolite.
The structural formulas of sulindac and its metabolites are:
C
H FO S M.W. 356.42
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Sulindac is a non-steroidal anti-inflammatory dru