Probenecid And Colchicine

Generic Name: probenecid and colchicine

Alkaloid [EPC]Over-the-Counter (OTC)

Brand Names:

Probenecid And Colchicine

DESCRIPTION Probenecid and colchicine contains probenecid, which is a uricosuric agent, and colchicine, which has antigout activity, the mechanism of which is unknown. Probenecid is the generic name for p-(Dipropylsulfamoyl)benzoic acid. The structural formula is represented below: C 13 H 19 NO 4 S M.W.285.36 Probenecid is a white or practically white, fine, crystalline powder.

Overview

DESCRIPTION Probenecid and colchicine contains probenecid, which is a uricosuric agent, and colchicine, which has antigout activity, the mechanism of which is unknown. Probenecid is the generic name for p-(Dipropylsulfamoyl)benzoic acid. The structural formula is represented below: C 13 H 19 NO 4 S M.W.285.36 Probenecid is a white or practically white, fine, crystalline powder.

Uses

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

Dosage

DOSAGE & 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.

Side Effects

ADVERSE REACTIONS The following adverse reactions have been observed and within each category are listed in order of decreasing severity. Probenecid Central Nervous System: headache, dizziness. Metabolic: precipitation of acute gouty arthritis. Gastrointestinal: hepatic necrosis, vomiting, nausea, anorexia, sore gums. Genitourinary: nephrotic syndrome, uric acid stones with or without hematuria, renal colic, costovertebral pain, urinary frequency. Hypersensitivity: anaphylaxis, fever, urticaria, pruritus. Hematologic: aplastic anemia, leukopenia, hemolytic anemia which in some patients could be related to genetic deficiency of glucose-6-phosphate dehydrogenase in red blood cells, anemia. Integumentary: dermatitis, alopecia, flushing.

Interactions

DRUG INTERACTIONS When probenecid is used to elevate plasma concentrations of penicillin, or other beta-lactams, or when such drugs are given to patients taking probenecid therapeutically, high plasma concentrations of the other drug may increase the incidence of adverse reactions associated with that drug. In the case of penicillin, or other beta-lactams, psychic disturbances have been reported. The use of salicylates antagonizes the uricosuric action of probenecid (see WARNINGS ). The uricosuric action of probenecid is also antagonized by pyrazinamide. Probenecid produces an insignificant increase in free sulfonamide plasma concentrations but a significant increase in total sulfonamide plasma levels.

Warnings

WARNINGS Exacerbation of gout following therapy with probenecid and colchicine may occur; in such cases additional colchicine or other appropriate therapy is advisable. Probenecid increases plasma concentrations of methotrexate in both animals and humans. In animal studies, increased methotrexate toxicity has been reported. If probenecid and colchicine is given with methotrexate, the dosage of methotrexate should be reduced and serum levels may need to be monitored. In patients on probenecid and colchicine the use of salicylates in either small or large doses is contraindicated because it antagonizes the uricosuric action of probenecid. The biphasic action of salicylates in the renal tubules accounts for the so-called “paradoxical effect” of uricosuric agents. CONTRAINDICATIONS Hypersensitivity to this product or to probenecid or colchicine. Probenecid and colchicine tablets are contraindicated in children under 2 years of age. Not recommended in persons with known blood dyscrasias or uric acid kidney stones. Therapy with probenecid and colchicine should not be started until an acute gouty attack has subsided.

Storage

HOW SUPPLIED Probenecid and Colchicine Tablets, USP 500 mg/0.5 mg are bisected, white to off-white capsule shaped, tablets debossed with “C81” on one side and break line on another side. They are supplied in bottles of 100 count: NDC 16571-832-01 Dispense in a well closed, light-resistant container with child-resistant closure.

Frequently Asked Questions

What is Probenecid And Colchicine used for?

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

What are the side effects of Probenecid And Colchicine?

ADVERSE REACTIONS The following adverse reactions have been observed and within each category are listed in order of decreasing severity. Probenecid Central Nervous System: headache, dizziness. Metabolic: precipitation of acute gouty arthritis. Gastrointestinal: hepatic necrosis, vomiting, nausea, anorexia, sore gums. Genitourinary: nephrotic syndrome, uric acid stones with or without hematuria, renal colic, costovertebral pain, urinary frequency. Hypersensitivity: anaphylaxis, fever, urticaria, pruritus. Hematologic: aplastic anemia, leukopenia, hemolytic anemia which in some patients could be related to genetic deficiency of glucose-6-phosphate dehydrogenase in red blood cells, anemia. Integumentary: dermatitis, alopecia, flushing.

What are the important warnings for Probenecid And Colchicine?

WARNINGS Exacerbation of gout following therapy with probenecid and colchicine may occur; in such cases additional colchicine or other appropriate therapy is advisable. Probenecid increases plasma concentrations of methotrexate in both animals and humans. In animal studies, increased methotrexate toxicity has been reported. If probenecid and colchicine is given with methotrexate, the dosage of methotrexate should be reduced and serum levels may need to be monitored. In patients on probenecid and colchicine the use of salicylates in either small or large doses is contraindicated because it antagonizes the uricosuric action of probenecid. The biphasic action of salicylates in the renal tubules accounts for the so-called “paradoxical effect” of uricosuric agents. CONTRAINDICATIONS Hypersensitivity to this product or to probenecid or colchicine. Probenecid and colchicine tablets are contraindicated in children under 2 years of age. Not recommended in persons with known blood dyscrasias or uric acid kidney stones. Therapy with probenecid and colchicine should not be started until an acute gouty attack has subsided.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.