LODOCO
Generic: COLCHICINE TABLETS 0.5 MG
Basic Information
Manufacturer
AGEPHA Pharma USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
ff06d68f-d65f-d097-e053-6294a90a7e5f
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 ).
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 ).
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, leukopenia, pancytopenia The common side-effects reported in published clinical studies and literature with the use of colchicine are gastrointestinal symptoms (diarrhea; vomiting; abdominal cramping) and myalgia ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact AGEPHA Pharma FZ LLC at 1 (800) 963-0353 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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, leukopenia, pancytopenia The common side-effects reported in published clinical studies and literature with the use of colchicine are gastrointestinal symptoms (diarrhea; vomiting; abdominal cramping) and myalgia ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact AGEPHA Pharma FZ LLC at 1 (800) 963-0353 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.