LODOCO Dosage & Rx Info | Uses, Side Effects

Lodoco Generic Name & Formulations

Legal Class

General Description

Colchicine 0.5mg; tabs.

Pharmacological Class

Antiinflammatory.

How Supplied

Tabs—30

Manufacturer

Agepha Pharma USA, LLC

Generic Availability

Mechanism of Action

Colchicine inhibits β-tubulin polymerization, disrupting cytoskeletal functions. This prevents the activation, degranulation, and migration of neutrophils. Colchicine may also interfere with the intracellular assembly of the inflammasome complex in neutrophils and monocytes that mediates activation of interleukin-1β. These anti-inflammatory effects are consistent with clinical data demonstrating that colchicine reduces high sensitivity C-reactive protein (hs-CRP).

Lodoco Indications

Indications

To reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular (CV) death in adults with established atherosclerotic disease or with multiple risk factors for CV disease.

Lodoco Dosage and Administration

Adult

0.5mg orally once daily.

Children

Not established.

Lodoco Contraindications

Contraindications

Concomitant strong P-glycoprotein (eg, cyclosporine, ranolazine) or strong CYP3A4 inhibitors (eg, atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir); life-threatening and fatal colchicine toxicity possible. Renal failure (CrCl <15mL/min). Severe hepatic impairment. Pre-existing blood dyscrasias.

Lodoco Boxed Warnings

Not Applicable

Lodoco Warnings/Precautions

Warnings/Precautions

Monitor for colchicine toxicity in those with any degree of renal or hepatic impairment. Discontinue and treat appropriately if signs of neuromuscular toxicity develop. Elderly. Pregnancy. Nursing mothers.

Lodoco Pharmacokinetics

Absorption

Mean absolute bioavailability: ~45%.

Distribution

Mean apparent volume of distribution: ~1300 L.

Metabolism

Hepatic (CYP3A4) by demethylation.

Elimination

Renal (unchanged), enterohepatic recirculation, and biliary excretion.

Lodoco Interactions

Interactions

See Contraindications. Potentiated by moderate CYP3A4 inhibitors (amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil): monitor for toxicity; avoid in those with renal or hepatic impairment. Avoid grapefruit or grapefruit juice. Concomitant statins, gemfibrozil, fibrates, digoxin may potentiate myopathy and rhabdomyolysis; monitor. Caution with oral contraceptives (eg, norethindrone/ethinyl estradiol).

Lodoco Adverse Reactions

Adverse Reactions

GI symptoms (eg, diarrhea, vomiting, abdominal cramping), myalgia; blood dyscrasias, neuromuscular toxicity, rhabdomyolysis.

Lodoco Clinical Trials

See Literature

Lodoco Note