SULINDAC tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

State of Florida DOH Central Pharmacy

INN (Међународно име):

SULINDAC

Састав:

SULINDAC 200 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 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 is contraindicated in patients with known hypersensitivity to sulindac or the excipients (see DESCRIPTION ). Sulindac 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/anaphylactoid reactions to NS

Резиме производа:

Sulindac Tablets USP 150 mg are round, convex, bright yellow color tablets which may be slightly mottled, engraved with “HP” above bisect and “5” below bisect on one side and plain on the other side.  Sulindac Tablets 200 mg are round, convex, bright yellow color tablets which may be slightly mottled, engraved with “HP” above bisect and “6” below bisect and plain on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Storage Store at 20° to 25°C (68-77ºF); excursions permitted to 15° to 30°C (59-86ºF) [See USP]. Dispense in a tight, light resistant container Rx Only ________________________________________________________________________ *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). ** Incidence between 3% and 9%. Those reactions occurring in 1% to 3% of patients are not marked with an asterisk. Manufactured for: Heritage Pharmaceuticals Inc. Edison, NJ 08837 1.866.901.DRUGS(3784) Manufactured by: Amneal Pharmaceuticals, L.L.C. Paterson, NJ 07504 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) 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 medicines should not be used by pregnant women late in their pregnancy. if you are breastfeeding. Talk to your doctor. What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Get emergency help right away if you have any of the following symptoms: shortness of breath or trouble breathing chest pain weakness in one part or side of your body slurred speech swelling of the face or throat Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: nausea more tired or weaker than usual itching your skin or eyes look yellow stomach pain flu-like symptoms vomit blood there is blood in your bowel movement or it is black and sticky like tar unusual weight gain skin rash or blisters with fever swelling of the arms and legs, hands and feet These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines. Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days. NSAID medicines that need a prescription

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

SULINDAC - SULINDAC TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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SULINDAC TABLETS, USP
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-I-[(_p_-(methylsulfinyl)phenyl]methylene]-1H-indene-3-acetic
acid. It is not a salicylate,
pyrazolone or propionic acid derivative. Its empirical formula is C
H FO S, with a molecular weight
of 356.42.
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 and 200 mg tablets for oral
administration. Each tablet contains the
following inactive ingredients: microcrystalline cellulose,
pregelatinized starch, povidone, magnesium
stearate, and sodium laurel sulfate.
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:
20
17
3
CLINICAL PHARMACOLOGY
_Pharmac