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Anwendungsgebiete

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 ).

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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)] . LODOCO use is contraindicated in patients with renal failure (Creatinine clearance less than 15 mL/minute) and severe hepatic impairment.

LODOCO is contraindicated in patients with pre-existing blood dyscrasias and in patients hypersensitive to this drug or any inactive ingredient of LODOCO [see Description (11)] .

Concurrent use of strong CYP3A4 inhibitors or P-gp inhibitors with LODOCO is contraindicated, including in patients with hepatic or renal impairment ( 4 ).
LODOCO is contraindicated in patients with pre-existing blood dyscrasias, renal failure, and severe hepatic impairment ( 4 ).

Warnhinweise und Vorsichtsmaßnahmen

5. WARNINGS AND PRECAUTIONS

5.1Blood 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.

Anwendungsgebiete

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 ).

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LODOCO is contraindicated in patients with pre-existing blood dyscrasias and in patients hypersensitive to this drug or any inactive ingredient of LODOCO [see Description (11)] .

Concurrent use of strong CYP3A4 inhibitors or P-gp inhibitors with LODOCO is contraindicated, including in patients with hepatic or renal impairment ( 4 ).
LODOCO is contraindicated in patients with pre-existing blood dyscrasias, renal failure, and severe hepatic impairment ( 4 ).

Warnhinweise und Vorsichtsmaßnahmen

5. WARNINGS AND PRECAUTIONS

5.1Blood Dyscrasias

Wechselwirkungen

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)] . Moderate CYP3A4 Inhibitors amprenavir aprepitant diltiazem erythromycin fluconazole, fosamprenavir (prodrug of amprenavir) verapamil Significant increase in colchicine plasma concentration is anticipated. Monitor patients receiving moderate CYP3A4 inhibitors for signs of colchicine toxicity. Avoid use in patients with existing renal or hepatic impairment [see Warnings and Precautions (5)] .

Grapefruit grapefruit juice Grapefruit juice increases exposure to colchicine. Advise patients to avoid grapefruit or grapefruit juice when taking LODOCO. P- glycoprotein Inhibitors † cyclosporine ranolazine Significant increase in colchicine plasma levels is anticipated with P-gp inhibitors. Concomitant use of LODOCO with strong P-gp inhibitors is contraindicated [see Contraindications (4)] . HMG-Co A Reductase Inhibitors Pharmacokinetic and/or pharmacodynamic interaction: the addition of one drug to a stable long term regimen of the other has resulted in myopathy and rhabdomyolysis (including fatality).

Monitor patients for signs or symptoms of muscle pain toxicity. Other Lipid Lowering drugs fibrates gemfibrozil Digitalis Glycosides digoxin P-gp substrate; rhabdomyolysis has been reported. Oral contraceptives Ethinyl estradiol and norethindrone (Ortho-Novum 1/35) In healthy female volunteers given coadministered with 0.6 mg colchicine twice daily, hormone concentrations are not affected [see Clinical Pharmacology (12.3)] .

Colchicine can interact with oral contraceptives like norethindrone/ethinyl estradiol and can cause adverse events like diarrhea, nausea, upper abdominal pain, cold sweat etc. Females using oral contraceptives should be prescribed LODOCO with caution and observed for adverse events. † Patients with renal or hepatic impairment should not be given LODOCO in conjunction with strong CYP3A4 or P-gp inhibitors [see Contraindications (4)] .

Coadministration of P-gp and/or CYP3A4 inhibitors (e.g., cyclosporine or clarithromycin) have been demonstrated to alter the concentration of colchicine. The potential for drug-drug interactions must be considered prior to and during therapy. See FPI for a complete list of reported and potential interactions ( 7 ).

Lodoco

Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

5.1Blood Dyscrasias

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Lodoco

Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

5.1Blood Dyscrasias

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5.2Neuromuscular Toxicity

Wechselwirkungen

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6.2Postmarketing Experience

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