Colchicine
Generic: COLCHICINE
Basic Information
Manufacturer
Hikma Pharmaceuticals USA Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
ee1583ac-c308-4beb-b602-9ecac4977026
Indications & Usage
1 INDICATIONS AND USAGE Colchicine capsules are indicated for prophylaxis of gout flares in adults.
Limitations of Use : The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied.
Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.
Colchicine capsules are an alkaloid indicated for prophylaxis of gout flares in adults ( 1 ).
Limitations of Use : • The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied.
• Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.
Limitations of Use : The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied.
Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.
Colchicine capsules are an alkaloid indicated for prophylaxis of gout flares in adults ( 1 ).
Limitations of Use : • The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied.
• Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.
Adverse Reactions
6 ADVERSE REACTIONS Gastrointestinal disorders are the most common adverse reactions with colchicine.
They are often the first signs of toxicity and may indicate that the colchicine dosage needs to be reduced or therapy stopped.
These include diarrhea, nausea, vomiting, and abdominal pain.
Colchicine has been reported to cause neuromuscular toxicity, which may present as muscle pain or weakness [see Warnings and Precautions (5.4) ].
Toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation, and injury to cells in the renal, hepatic, circulatory, and central nervous system.
These most often occur with excessive accumulation or overdosage [see Overdosage (10) ].
The following reactions have been reported with colchicine.
These have been generally reversible by interrupting treatment or lowering the dose of colchicine: Digestive : abdominal cramping, abdominal pain, diarrhea, lactose intolerance, nausea, vomiting Neurological : sensory motor neuropathy Dermatological : alopecia, maculopapular rash, purpura, rash Hematological : leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia Hepatobiliary : elevated AST, elevated ALT Musculoskeletal : myopathy, elevated CPK, myotonia, muscle weakness, muscle pain, rhabdomyolysis Reproductive : azoospermia, oligospermia The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc.
at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
They are often the first signs of toxicity and may indicate that the colchicine dosage needs to be reduced or therapy stopped.
These include diarrhea, nausea, vomiting, and abdominal pain.
Colchicine has been reported to cause neuromuscular toxicity, which may present as muscle pain or weakness [see Warnings and Precautions (5.4) ].
Toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation, and injury to cells in the renal, hepatic, circulatory, and central nervous system.
These most often occur with excessive accumulation or overdosage [see Overdosage (10) ].
The following reactions have been reported with colchicine.
These have been generally reversible by interrupting treatment or lowering the dose of colchicine: Digestive : abdominal cramping, abdominal pain, diarrhea, lactose intolerance, nausea, vomiting Neurological : sensory motor neuropathy Dermatological : alopecia, maculopapular rash, purpura, rash Hematological : leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia Hepatobiliary : elevated AST, elevated ALT Musculoskeletal : myopathy, elevated CPK, myotonia, muscle weakness, muscle pain, rhabdomyolysis Reproductive : azoospermia, oligospermia The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc.
at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.