SULINDAC tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Actavis Pharma, Inc.

INN (Међународно име):

SULINDAC

Састав:

SULINDAC 150 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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, USP are indicated for acute or 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 **The safety and effectiveness of sulindac have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair; little or no self-care). Sulindac tablets are co

Резиме производа:

Sulindac tablets, USP 150 mg are round, yellow tablets imprinted DAN and 5661 supplied in bottles of 100 (NDC 0591-5661-01) and 500 (NDC 0591-5661-05). Sulindac tablets, USP 200 mg are scored, yellow, round tablets imprinted DAN DAN and 5660 supplied in bottles of 100 (NDC 0591-5660-01) and 500 (NDC 0591-5660-05). Dispense in a well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. D 9/2021

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

Actavis Pharma, Inc.
----------
Dispense with Medication Guide available at: www.tevausa.com/medguides
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 NSAID

Карактеристике производа

SULINDAC- SULINDAC TABLET
ACTAVIS PHARMA, INC.
----------
SULINDAC 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).
SULINDAC 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).
DESCRIPTION
Sulindac, USP 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, USP 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, USP and its metabolites are:
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS_
Sulindac is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-
inflammatory, analgesic and