SULINDAC - sulindac tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Heritage Pharmaceuticals Inc.

INN (mednarodno ime):

SULINDAC

Sestava:

SULINDAC 150 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 - Rheumatoid arthritis* - Ankylosing spondylitis - Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) - 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 NSAIDs have been reported in such patients (see WARNINGS -Anaphylactic/Anaphylactoid Reactions, and PRECAUTIONS - Preexisting Asthma). Sulindac is contraindicated for the tr

Povzetek izdelek:

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. They are supplied as follows: Bottles of 60 with CRC NDC 23155-005-06 Bottles of 100 with CRC NDC 23155-005-01 Bottles of 500 NDC 23155-005-05 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 as follows: Bottles of 60 with CRC NDC 23155-006-06 Bottles of 100 with CRC NDC 23155-006-01 Bottles of 500 NDC 23155-006-05 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 Iss. 11/09 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: 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: The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used: _____________________________________________________________________________ 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: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?Do not take an NSAID medicine: Tell your healthcare provider: What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: 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) NSAID medicines that need a prescription This Medication Guide has been approved by the U.S. Food and Drug Administration. * Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

SULINDAC - SULINDAC TABLET
HERITAGE PHARMACEUTICALS INC.
----------
SULINDAC TABLETS, USP
BOXED WARNING
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