Adult Dosing

Chronic gouty arthritis

• Start 0.5 mg/500 mg PO qd x 1 wk
• Increase to 0.5 mg/500 mg PO bid thereafter
• May increase by 0.5 mg/500 mg q4 wks [Max: 4 tablets per day]

Note:

• Treatment should not be started until an acute gouty attack has subsided, however if acute attack is precipitated during therapy, continue with therapy with same dosage and additional colchicine or other appropriate therapy should be given

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Chronic gouty arthritis complicated by frequent and recurrent acute attacks

• Hypersensitivity to any of the ingredients of the product
• Children under 2 yrs of age
• Known blood dyscrasias or uric acid kidney stones
• Therapy should not be started until an acute gouty attack has subsided

• N/A

Renal Dose Adjustment

• Renal impairment: Increase dose by 1 tab q4 wks [Max: 4 tablets per day]

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised. Dose adjustments not defined

• A reducing substance may appear in the urine of patients; suspected glycosuria should be confirmed by glucose test
• Additional colchicine or other appropriate therapy is advisable if symptoms of gout exacerbate following therapy with probenecid and colchicine
• Methotrexate dose should be reduced when administered with probenecid and colchicine as probenecid increases plasma concentrations of methotrexate resulting in methotrexate toxicity
• Use of salicylates is contraindicated in patients on probenecid and colchicine therapy as it antagonizes the uricosuric action of probenecid. Use of acetaminophen would be preferred instead of salicylates
• Severe allergic reactions and anaphylaxis can occur with probenecid and colchicine, discontinue the therapy if any sign of allergic reaction appears
• As per animal study colchicine adversely affects spermatogenesis
• Hematuria, renal colic, costovertebral pain, and formation of uric acid stones associated with the use of probenecid and colchicine therapy in gouty patients can be prevented by alkalization of the urine and a liberal fluid intake, monitor acid base balance in these patients
• Probenecid and colchicine therapy will not be effective in chronic renal insufficiency with glomerular filtration rate 30 mL/minute or less

Cautions: Use cautiously in

• Hepatic impairment
• Peptic ulcer

Pregnancy Category:C/B

Breastfeeding: Limited data indicates that low level of probenecid is secreted in milk following maternal doses of up to 2 grams daily and would not be expected to cause any adverse effects in breastfed infants, especially if the infant >2 months. The implications of enhanced excretion of drugs given with probenecid for nursing mothers and their infants has not been studied; however, only a few drugs are known to undergo active transport into breastmilk. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 7 Jan 2011).Limited data indicates long term prophylactic maternal doses of colchicine up to 1.5 mg daily produce results in infant receiving less than 10% of the maternal dosage. No adverse event in breastfed infants reported. The infant dose can be minimized by avoiding breastfeeding 6-8 hrs after a dose as highest milk levels occur at this time. No report available with higher maternal dosages. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 7 Jan 2011).

• CNS: Headache, dizziness, peripheral neuritis
• METABOLIC: Precipitation of acute gouty arthritis
• GI: Hepatic necrosis, vomiting, nausea, anorexia, sore gums, abdominal pain, diarrhea
• GU: Nephrotic syndrome, uric acid stones with or without hematuria, renal colic, costovertebral pain, urinary frequency
• HYPERSENSITIVITY: Anaphylaxis, fever, urticaria, pruritus
• HEMA: Aplastic anemia, leukopenia, hemolytic anemia, agranulocytosis
• DERM: Dermatitis, alopecia, flushing
• MUSC: Muscular weakness

Probenecid

• Uricosuric and renal tubular blocking agent; inhibits the tubular reabsorption of urate, thereby increasing the urinary excretion of uric acid and decreasing serum urate levels
• Metabolized extensively by liver
• Renally excreted (5-10% unchanged)
• Half-life: 6-12 hrs

Colchicine

• Gout Suppressant; interrupts the cycle of monosodium urate crystal deposition in joint tissues and the resultant inflammatory response
• Metabolized by liver; CYP 450: 3A4
• Renally excreted (40-65% unchanged), bile
• Half-life: 26.6-31.2 hrs

US Trade Name(s)

• Col-Probenecid

US Availability

colchicine/probenecid (generic)

• TABS: 0.5 mg/500 mg

Col-Probenecid (colchicine/probenecid)

• TABS: 0.5 mg/500 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Endocrine/Metabolic

Antigout Agents

Analgesics

Antigout Agents

Rheumatologic

Antigout Agents

Drug Name: Colchicine 0.5 MG / Probenecid 500 MG Oral Tablet

Ingredient(s): Colchicine mixture with Probenecid

Imprint: DAN;DAN;5325

Color(s): White

Shape: Oval

Size (mm): 18.00

Score: 2

Inactive Ingredient(s): colloidal silicon dioxide / magnesium stearate / cellulose, microcrystalline / sodium lauryl sulfate / sodium starch glycolate type a potato

Drug Label Author:
Watson Laboratories, Inc.

DEA Schedule:
Non-Scheduled