LODOCO .5 mg/1
Colchicine Tablets 0.5 mg · TABLET · AGEPHA Pharma USA, LLC
LODOCO is a tablet containing colchicine tablets 0.5 mg at .5 mg/1, taken oral. Manufactured by AGEPHA Pharma USA, LLC.
Key Facts
- Brand Name
- LODOCO
- Generic Name
- Colchicine Tablets 0.5 mg
- NDC Code (Product)
82867-001- Manufacturer
- AGEPHA Pharma USA, LLC
- Strength
- .5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA215727
- Drug Class
- Alkaloid [EPC]
- Marketing Start
- 06/16/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & Administration
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 ).
Contraindications
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 ).
Drug 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)] . 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 grapef…
Adverse Reactions
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. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure. These most often occur with excessive accumulation or overdosage [see Overdosage (10)] . Neuromuscular : myotoxicity, weakness, numbness, paresthesia, rhabdomyolysis. Gastrointestinal : diarrhea, vomiting, abdominal cramping, abdominal pain. Renal : acute renal impairment Dermatology : rashes and alopecia Hematological : thrombocytopenia, …
Frequently Asked Questions
What is LODOCO used for?
LODOCO contains Colchicine Tablets 0.5 mg. It is a tablet taken oral. Consult your doctor for specific uses.
Is LODOCO a controlled substance?
LODOCO is not classified as a controlled substance by the DEA.
What is the generic name for LODOCO?
The generic name for LODOCO is Colchicine Tablets 0.5 mg. There are no other listed brand versions of Colchicine Tablets 0.5 mg.
What is the NDC code for LODOCO .5 mg/1?
The NDC (National Drug Code) for LODOCO .5 mg/1 is 82867-001, listed by AGEPHA Pharma USA, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)