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SULINDAC

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Overview

What is SULINDAC?

DESCRIPTION

Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1- [[-(methylsulfinyl)phenyl]methylene]-1-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:



What does SULINDAC look like?



What are the available doses of SULINDAC?

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What should I talk to my health care provider before I take SULINDAC?

How should I use SULINDAC?

DOSAGE AND ADMINISTRATION


What interacts with SULINDAC?

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What are the warnings of SULINDAC?

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What are the precautions of SULINDAC?

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What are the side effects of SULINDAC?

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What should I look out for while using SULINDAC?

CONTRAINDICATIONS

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/anaphylactoid reactions to NSAIDs have been reported in such patients (see , and ).

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

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What might happen if I take too much SULINDAC?

MANAGEMENT OF OVERDOSAGE


How should I store and handle SULINDAC?

StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]HOW SUPPLIEDSulindac Tablets USP 150 mg are 12/32", round, yellow tablets imprinted and supplied in bottles of 100 and 500.Sulindac Tablets USP 200 mg are 14/32", scored, yellow, round tablets imprinted and supplied in bottles of 100 and 500.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: Corona, CA 92880 USADistributed By: Corona, CA 92880 USARevised: July 20080708B173339Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)HOW SUPPLIEDSulindac Tablets USP 150 mg are 12/32", round, yellow tablets imprinted and supplied in bottles of 100 and 500.Sulindac Tablets USP 200 mg are 14/32", scored, yellow, round tablets imprinted and supplied in bottles of 100 and 500.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: Corona, CA 92880 USADistributed By: Corona, CA 92880 USARevised: July 20080708B173339Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)HOW SUPPLIEDSulindac Tablets USP 150 mg are 12/32", round, yellow tablets imprinted and supplied in bottles of 100 and 500.Sulindac Tablets USP 200 mg are 14/32", scored, yellow, round tablets imprinted and supplied in bottles of 100 and 500.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: Corona, CA 92880 USADistributed By: Corona, CA 92880 USARevised: July 20080708B173339Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)HOW SUPPLIEDSulindac Tablets USP 150 mg are 12/32", round, yellow tablets imprinted and supplied in bottles of 100 and 500.Sulindac Tablets USP 200 mg are 14/32", scored, yellow, round tablets imprinted and supplied in bottles of 100 and 500.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: Corona, CA 92880 USADistributed By: Corona, CA 92880 USARevised: July 20080708B173339Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)HOW SUPPLIEDSulindac Tablets USP 150 mg are 12/32", round, yellow tablets imprinted and supplied in bottles of 100 and 500.Sulindac Tablets USP 200 mg are 14/32", scored, yellow, round tablets imprinted and supplied in bottles of 100 and 500.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: Corona, CA 92880 USADistributed By: Corona, CA 92880 USARevised: July 20080708B173339Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)HOW SUPPLIEDSulindac Tablets USP 150 mg are 12/32", round, yellow tablets imprinted and supplied in bottles of 100 and 500.Sulindac Tablets USP 200 mg are 14/32", scored, yellow, round tablets imprinted and supplied in bottles of 100 and 500.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: Corona, CA 92880 USADistributed By: Corona, CA 92880 USARevised: July 20080708B173339Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)HOW SUPPLIEDSulindac Tablets USP 150 mg are 12/32", round, yellow tablets imprinted and supplied in bottles of 100 and 500.Sulindac Tablets USP 200 mg are 14/32", scored, yellow, round tablets imprinted and supplied in bottles of 100 and 500.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: Corona, CA 92880 USADistributed By: Corona, CA 92880 USARevised: July 20080708B173339Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)HOW SUPPLIEDSulindac Tablets USP 150 mg are 12/32", round, yellow tablets imprinted and supplied in bottles of 100 and 500.Sulindac Tablets USP 200 mg are 14/32", scored, yellow, round tablets imprinted and supplied in bottles of 100 and 500.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: Corona, CA 92880 USADistributed By: Corona, CA 92880 USARevised: July 20080708B173339Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)HOW SUPPLIEDSulindac Tablets USP 150 mg are 12/32", round, yellow tablets imprinted and supplied in bottles of 100 and 500.Sulindac Tablets USP 200 mg are 14/32", scored, yellow, round tablets imprinted and supplied in bottles of 100 and 500.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: Corona, CA 92880 USADistributed By: Corona, CA 92880 USARevised: July 20080708B173339Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)HOW SUPPLIEDSulindac Tablets USP 150 mg are 12/32", round, yellow tablets imprinted and supplied in bottles of 100 and 500.Sulindac Tablets USP 200 mg are 14/32", scored, yellow, round tablets imprinted and supplied in bottles of 100 and 500.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: Corona, CA 92880 USADistributed By: Corona, CA 92880 USARevised: July 20080708B173339Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)HOW SUPPLIEDSulindac Tablets USP 150 mg are 12/32", round, yellow tablets imprinted and supplied in bottles of 100 and 500.Sulindac Tablets USP 200 mg are 14/32", scored, yellow, round tablets imprinted and supplied in bottles of 100 and 500.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: Corona, CA 92880 USADistributed By: Corona, CA 92880 USARevised: July 20080708B173339Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)


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Clinical Information

Chemical Structure

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Clinical Pharmacology

CLINICAL PHARMACOLOGY

With the twice-a-day dosage regimen, plasma concentrations of sulindac and its two metabolites accumulate: mean concentration over a dosage interval at steady state relative to the first dose averages 1.5 and 2.5 times higher, respectively, for sulindac and its active sulfide metabolite.

The mean effective half-life (T) is 7.8 and 16.4 hours, respectively, for sulindac and its active sulfide metabolite.

Because sulindac is excreted in the urine primarily as biologically inactive forms, it may possibly affect renal function to a lesser extent than other non-steroidal anti-inflammatory drugs; however, renal adverse experiences have been reported with sulindac (see ).

Non-Clinical Toxicology
CONTRAINDICATIONS

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/anaphylactoid reactions to NSAIDs have been reported in such patients (see , and ).

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

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Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid cannot be recommended.

The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and allopurinol administered concurrently.

In common with other broad-spectrum antibiotics, amoxicillin/clavulanate may reduce the efficacy of oral contraceptives.

PRECAUTIONS

Sulindac cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

Anemia is sometimes seen in patients receiving NSAIDs, including sulindac. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including sulindac, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving sulindac who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirinsensitive patients, sulindac should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

Sulindac metabolites have been reported rarely as the major or a minor component in renal stones in association with other calculus components. Sulindac should be used with caution in patients with a history of renal lithiasis, and they should be kept well hydrated while receiving sulindac.

Pancreatitis

Pancreatitis has been reported in patients receiving sulindac (see ). Should pancreatitis be suspected, the drug should be discontinued and not restarted, supportive medical therapy instituted, and the patient monitored closely with appropriate laboratory studies (e.g., serum and urine amylase, amylase/creatinine clearance ratio, electrolytes, serum calcium, glucose, lipase, etc.). A search for other causes of pancreatitis as well as those conditions which mimic pancreatitis should be conducted.

Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.

ADVERSE REACTIONS Incidence Greater Than 1% Incidence between 3% and 9%. Those reactions occurring in 1% to 3% of patients are not marked with an asterisk. Incidence Less Than 1 in 100 Causal Relationship Unknown

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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