WARNINGS
Colchicine arrests cell division in
animals and plants. It has adversely affected spermatogenesis
in humans and in some animal species under certain conditions.
PRECAUTIONS
General
Colchicine should be administered with caution to aged
or debilitated patients, and to those with early manifestations
of gastrointestinal, renal, hepatic, cardiac, or hematological
disorders. (see CONTRAINDICATIONS).
If nausea, vomiting, or diarrhea occurs, the drug should
be discontinued,
Laboratory Tests
In patients receiving longterm therapy, periodic blood
counts should be done.
Drug Interactions
Colchicine is inhibited by acidifying agents. The action
of colchicine is potentiated by alkalinizing agents.
Colchicine may increase sensitivity to the CNS depressants.
Response to sympathomimetic agentsmay be enhanced by
colchicine.
Laboratory Test Interactions
Colchicine therapy may cause elevated alkaline phosphatase
and SGOT values.
Decreased thrombocyte values may be obtained during colchicine
therapy.
Colchicine may cause false positive results when testing
urine for RBC or hemoglobin.
Carcinogenesis
Data in the literature does not indicate colchicine as
a carcinogenic agent.
Fertility
See
WARNINGS
section for information on impairment of fertility.
Pregnancy
Pregnancy Category C. Colchicine has
been shown to be teratogenic in mice when given doses
of 1.25 and 1.5 mg/kg and in hamsters when given 10 mg/kg.
There are no adequate and well-controlled studies in pregnant
women. Colchicine should be used during pregnancy only
if the potential benefit justifies the potential risk
to the fetus.
Nursing Mothers
It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, caution
should be exercised when colchicine is administered to
a nursing woman.
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