Gloperba
Generic: COLCHICINE
Basic Information
Manufacturer
Scilex Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
467cd83f-d695-4040-9434-10e80b4271da
Indications & Usage
1 INDICATIONS AND USAGE GLOPERBA ® (colchicine) Oral Solution is indicated for prophylaxis of gout flares in adults.
GLOPERBA is indicated for prophylaxis of gout flares in adults ( 1 ).
Limitations of use: The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied.
GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes ( 1 ).
Limitations of use: The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied.
GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes.
GLOPERBA is indicated for prophylaxis of gout flares in adults ( 1 ).
Limitations of use: The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied.
GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes ( 1 ).
Limitations of use: The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied.
GLOPERBA is 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.
These disorders are often the first signs of toxicity and may indicate that the colchicine dose needs to be reduced or therapy stopped.
These disorders 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 systems.
These toxicities most often occur with excessive accumulation or overdosage [see Overdosage (10) ] .
The following adverse reactions have been reported with colchicine.
These adverse reactions have been generally reversible upon interrupting treatment or lowering the dose of colchicine.
Neurological: sensory motor neuropathy Dermatological: alopecia, maculopapular rash, purpura, rash Digestive: abdominal cramping, abdominal pain, diarrhea, lactose intolerance, nausea, vomiting 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 SCILEX Pharmaceuticals, Inc.
at 1-866-SCILEX3 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
These disorders are often the first signs of toxicity and may indicate that the colchicine dose needs to be reduced or therapy stopped.
These disorders 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 systems.
These toxicities most often occur with excessive accumulation or overdosage [see Overdosage (10) ] .
The following adverse reactions have been reported with colchicine.
These adverse reactions have been generally reversible upon interrupting treatment or lowering the dose of colchicine.
Neurological: sensory motor neuropathy Dermatological: alopecia, maculopapular rash, purpura, rash Digestive: abdominal cramping, abdominal pain, diarrhea, lactose intolerance, nausea, vomiting 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 SCILEX Pharmaceuticals, Inc.
at 1-866-SCILEX3 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).