colchicine
Generic: COLCHICINE
Basic Information
Manufacturer
NuCare Pharmaceuticals,Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
d010a735-1a20-23fe-e053-2995a90abe0f
Indications & Usage
1 INDICATIONS & USAGE Colchicine tablets are an alkaloid indicated for: · Familial Mediterranean fever (FMF) in adults and children 4 years or older ( 1.2 ).
1.2 Familial Mediterranean Fever (FMF) Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).
1.2 Familial Mediterranean Fever (FMF) Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).
Adverse Reactions
6 ADVERSE REACTIONS FMF Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating colchicine tablets, usually presenting within 24 hours, and occurring in up to 20% of patients given therapeutic doses.
Typical symptoms include cramping, nausea, diarrhea, abdominal pain and vomiting.
These events should be viewed as dose-limiting if severe, as they can herald the onset of more significant toxicity.
FMF: Most common adverse reactions (up to 20%) are abdominal pain, diarrhea, nausea and vomiting.
These effects are usually mild, transient and reversible upon lowering the dose ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.2 Postmarketing Experience Serious toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation and injury to cells in the renal, hepatic, circulatory and central nervous systems.
These most often occur with excessive accumulation or overdosage [see Overdosage ( 10 )] .
The following adverse reactions have been identified with colchicine.
These have been generally reversible upon temporarily interrupting treatment or lowering the dose of colchicine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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
Typical symptoms include cramping, nausea, diarrhea, abdominal pain and vomiting.
These events should be viewed as dose-limiting if severe, as they can herald the onset of more significant toxicity.
FMF: Most common adverse reactions (up to 20%) are abdominal pain, diarrhea, nausea and vomiting.
These effects are usually mild, transient and reversible upon lowering the dose ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.2 Postmarketing Experience Serious toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation and injury to cells in the renal, hepatic, circulatory and central nervous systems.
These most often occur with excessive accumulation or overdosage [see Overdosage ( 10 )] .
The following adverse reactions have been identified with colchicine.
These have been generally reversible upon temporarily interrupting treatment or lowering the dose of colchicine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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