Colchicine Tablets 0.5 Mg

Generic Name: colchicine tablets 0.5 mg

Alkaloid [EPC]Over-the-Counter (OTC)

Brand Names:

Lodoco

11. DESCRIPTION LODOCO contains colchicine, which is an alkaloid chemically described as (S)-N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[a]heptalen-7-yl)acetamide with a molecular formula of C 22 H 25 NO 6 and a molecular weight of 399.4 g/mol. The structural formula of colchicine is given below. Colchicine occurs as white to pale yellow powder, very soluble in water.

Overview

Uses

1. INDICATION AND USAGE LODOCO is indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease. LODOCO is an alkaloid indicated: • to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease ( 1 ).

Dosage

2. DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage The recommended dosage is 0.5 mg orally once daily. If a dose of LODOCO is missed, the missed dose should be taken as soon as possible, and the patient should then return to the normal dosing schedule. If a dose is skipped, the patient should not double the next dose. The recommended dosage is 0.5 mg orally once daily ( 2.1 ).

Side Effects

6. ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice. In the LoDoCo2 trial, myalgia was reported for 21.2% of individuals randomized to colchicine and 18.5% of individuals randomized to matching placebo (hazard ratio 1.15, 95%CI 1.01-1.31). 6.2 Postmarketing Experience The following adverse reactions have been identified with colchicine.

Interactions

7. DRUG INTERACTIONS Colchicine is a substrate for the efflux transporter P-glycoprotein (P-gp). CYP3A4 is the primary enzyme involved in the metabolism of colchicine. If LODOCO is administered with drugs that inhibit P-gp, most of which also inhibit CYP3A4, increased concentrations of colchicine are likely (Table 1). Table 1: Drug Interactions Drug class Outcome/effect Clinical comment Strong CYP3A4 Inhibitors † atazanavir clarithromycin darunavir/ritonavir indinavir itraconazole ketoconazole lopinavir/ritonavir nefazodone nelfinavir ritonavir saquinavir telithromycin tipranavir/ritonavir Significant increases in colchicine plasma levels [see Clinical Pharmacology (12.3)] . Concomitant use of LODOCO with strong CYP3A4 inhibitors is contraindicated [see Contraindications (4)] .

Warnings

5. WARNINGS AND PRECAUTIONS 5.1 Blood Dyscrasias LODOCO can cause myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia, which can be life-threatening or fatal [see Adverse Reactions (6)] . Gastrointestinal symptoms often are the first sign of colchicine toxicity, so new symptoms should prompt an evaluation for toxicity. Concomitant use of drugs that reduce the metabolism of colchicine or the presence of hepatic or renal impairment increases the risk of developing blood dyscrasias. 4. CONTRAINDICATIONS Concurrent use of strong CYP3A4 inhibitors or P-glycoprotein inhibitors with LODOCO is contraindicated, because life-threatening and fatal colchicine toxicity has been reported in these patients with colchicine taken in therapeutic doses [see Drug interactions (7)] .

Storage

16. HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied LODOCO (colchicine) tablets 0.5 mg are white to slightly yellow, round, and biconvex and debossed with ‘L1’ on one side and plain on the other side and they are available as a single Aluminum/PVC blister pack of 30 tablets, which is secondary packaged in a carton: NDC 82867-001-01.

Frequently Asked Questions

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.