INDICATIONS
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.
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the hormone is withdrawn.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.
HOW SUPPLIED
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 ).
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