"The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout f"...
DOSAGE AND ADMINISTRATION
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also be given in doses of at least 1 mg per day, and that the latter be continued for a few days after the hormone is withdrawn.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.
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 ).This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/4/2010
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