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Colbenemid Indications, Dosage, Storage, Stability - Probenecid and Colchicine

Colbenemid Indications, Dosage, Storage, Stability - Probenecid and Colchicine

INDICATIONS

For the treatment of chronic gouty arthritis when complicated by frequent, recurrent acute attacks of gout.

DOSAGE AND ADMINISTRATION

Therapy with probenecid and colchicine should not be started until an acute gouty attack has subsided. However, if an acute attack is precipitated during therapy, probenecid and colchicine may be continued without changing the dosage, and additional colchicine or other appropriate therapy should be given to control the acute attack.

The recommended adult dosage is 1 tablet of probenecid and colchicine daily for one week, followed by 1 tablet twice a day thereafter.

Some degree of renal impairment may be present in patients with gout. A daily dosage of 2 tablets may be adequate. However, if necessary, the daily dosage may be increased by 1 tablet every four weeks within tolerance (and usually not above 4 tablets per day) if symptoms of gouty arthritis are not controlled or the 24 hour uric acid excretion is not above 700 mg. As noted, probenecid may not be effective in chronic renal insufficiency particularly when the glomerular filtration rate is 30 mL/minute or less.

Gastric intolerance may be indicative of overdosage, and may be corrected by decreasing the dosage.

As uric acid tends to crystallize out of an acid urine, a liberal fluid intake is recommended, as well as sufficient sodium bicarbonate (3 to 7.5 g daily) or potassium citrate (7.5 g daily) to maintain an alkaline urine (see PRECAUTIONS).

Alkalization of the urine is recommended until the serum urate level returns to normal limits and tophaceous deposits disappear, i.e., during the period when urinary excretion of uric acid is at a high level. Thereafter, alkalization of the urine and the usual restriction of purine-producing foods may be somewhat relaxed.

Probenecid and colchicine (or probenecid) should be continued at the dosage that will maintain normal serum urate levels. When acute attacks have been absent for six months or more and serum urate levels remain within normal limits, the daily dosage of probenecid and colchicine may be decreased by 1 tablet every six months. The maintenance dosage should not be reduced to the point where serum urate levels tend to rise.

HOW SUPPLIED

Probenecid and Colchicine Tablets, USP 500 mg-0.5 mg are bisected, white, capsule-shaped tablets imprinted “DAN DAN” and “5325” supplied in bottles of 100 and 1000.

Dispense in well-closed, light-resistant container with child-resistant closure.

Store at controlled room temperature 15-30° C (59-86° F).

Protect from light.

CAUTION: Federal law prohibits dispensing without prescription.

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