Drug: Colchicine

Colchicine is an alkaloid prepared from the dried corns and seeds of Colchicum autumnale, the autumn crocus or meadow saffron. It is a pale yellow powder soluble in water in 1:25 dilution. Colchicine Tablets, USP are oral anti-inflammatory agents supplied in two dosage strengths 0.5 mg (l/120 gr) and 0.6 mg (l/100 gr). The chemical name for colchicine is (S) N-(5,6,7,9-tetrahydro- 1,2,3, IO-tetramethoxy-9-oxobenzo [alpha] heptaien-7-yl) acetamide. Inactive Ingredients 0.5 mg tablet: Calcium carbonate, confectioner†s sugar (contains corn starch), D& C Yellow No. 10, dextrin, stearic acid, sucrose and talc. 0.6 mg tablet: Acacia, corn starch, D& C Yellow No. 10, lactose, stearic acid and talc.

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Adverse reactions in decreasing order of severity are: bone marrow depression, with aplastic anemia, with agranulocytosis or with thrombocytopenia may occur in patients receiving long-term therapy. Peripheral neuritis, purpura, myopathy, loss of hair, and reversible azoospermia have also been reported. Vomiting, diarrhea, and nausea may occur with colchicine therapy, especially when maximal doses are necessary for a therapeutic effect. To avoid more serious toxicity, the drug should be discontinued when these symptoms appear, regardless of whether or not joint pain has been relieved. Dermatoses have been reported. Hypersensitivity reactions may occur infrequently. Read the Colchicine (colchicine) Side Effects Center for a complete guide to possible side effectsLearn More »

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Colchicine is administered orally. For Acute Gouty Arthritis - The usual dose to relieve or abort an attack is 1 to 1.2 mg (two 0.5 mg granules or two 0.6 mg tablets). This dose may be followed by one unit of either preparation (granule or tablet) every hour, or two units every two hours, until pain is relieved or until diarrhea ensues. Each patient should learn the dose needed and should keep the drug at hand for use at the first sign of an attack. After the initial dose, it is sometimes sufficient to take 0.5 or 0.6 mg every two or three hours. The drug should be stopped if there is gastrointestinal discomfort or diarrhea. (Opiates may be needed to control diarrhea.) In subsequent attacks, the patient should be able to judge his medication requirement accurately enough to stop short of his "diarrheal dose." The total amount of colchicine needed to control pain and inflammation during an attack usually ranges from 4 to 8 mg. Articular pain and swelling typically abate within 12 hours and are usually gone in 24 to 48 hours, An interval of three days between colchicine courses is advised in order to minimize the possibility of cumulative toxicity. If corticotropin (ACTH) is administered for treatment of an attack of gouty arthritis, it is recommended that colchicine also be given in doses of at least 1 mg per day, and that the latter be continued for a few days after the hormone is withdrawn. For Prophlaxis During Intercritical Periods- To reduce the frequency of paroxysms and lessen their severity, colchicine may be administered continuously. In patients who have less than one attack per year, the usual dose is 0.5 or 0.6 mg per day, three or four days a week. For cases involving more than one attack per year, the usual dose is 0.5 or 0.6 mg daily; severe cases may require two or three 0.5 mg granules or 0.6 mg tablets daily. For Prophylaxis Against Attacks of Gout in Patients Undergoing Surgery - In patients with gout, an attack may be precipitated by even a minor surgical procedure. Colchicine, one 0.5 mg granule three times a day or one 0.6 mg tablet three times daily, should be administered for three days before and three days after surgery.

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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 agents' may be enhanced by colchicine. Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Colchicine is specifically indicated for treatment and relief of pain in attacks of acute gouty arthritis. It is also recommended for regular use between attacks as a prophylactic measure, and is often effective in aborting an attack when taken at the first sign of articular discomfort.

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Colchicine is contraindicated in patients with a known hypersensitivity to the drug, in those with serious gastrointestinal, renal, hepatic, or cardiac disorders, and in those with blood dyscrasias. Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

The onset of toxic effects is usually delayed for several hours or more after the ingestion of an acute overdose. Nausea, vomiting, abdominal pain, and diarrhea occur first. The diarrhea may be bloody due to hemorrhagic gastroenteritis. Burning sensations of the throat, stomach, and skin may be prominent symptoms. Extensive vascular damage may result in shock. Kidney damage, evidenced by hematuria and oliguria, may occur. Muscular weakness may be marked, and ascending paralysis of the central nervous system may develop; the patient usually remains conscious. Delirium and convulsions may occur. Death due to respiratory arrest may result. Although death from the ingestion of as little as 7 mg has been reported, much larger doses have been survived . Treatment of colchicine poisoning should begin with gastric lavage and measures to prevent shock. Recent studies appear to support the use of hemodialysis or peritoneal dialysis as proof of the treatment of acute overdosage in addition to gastric lavage. Symptomatic and supportive treatment may include atropine and morphine for the relief of abdominal pain, and artificial respiration with oxygen to combat respiratory distress. No specific antidote is known.

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Colchicine Tablets, USP are supplied as yellow sugar-coated granules each containing 0.5 mg (1/l20 gr), packaged in bottles of 100 (NDC 0074-0074-02); and as yellow tablets each containing 0.6 mg (l/100 gr), packaged in bottles of 100 (NDC 0074-3781-01). Dispense in a USP tight, light-resistant container. Recommended Storage: Store below 86° F (30° C ). Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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. Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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