Colchicine

Registered South African indications:

• Acute attacks of gout

Contraindications

South African recommendations

• Hypersensitivity to colchicine or any of its excipients
• Patients undergoing haemodialysis
• Severe renal impairment (CrCl<10ml/min)
• Severe hepatic impairment
• Blood disorders
  - Myelosupression
  - Leucopenia
  - Granulocytopenia
  - Thrombocytopenia
  - Aplastic anaemia
• Coadministration with P-glycoprotein inhibitors such as ciclosporin, verapamil, or quinidine in patients with renal or hepatic impairment
• Coadministration with strong CYP3A4 inhibitors such as ritonavir, atazanavir, indinavir, clarithromycin, telithromycin, itraconazole, or ketoconazole in patients with renal or hepatic impairment
• Pregnancy
• Lactation
• Women of childbearing potential unless using effective contraceptive measures

Recommendations in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Patients with blood dyscrasias
• Pregnancy
• Breastfeeding
• Women of childbearing potential unless using effective contraceptive measures
• Patients with severe renal impairment
• Patients with severe hepatic impairment
• Use in patients undergoing haemodialysis
• Coadministration with P-glycoprotein inhibitors in patients with renal or hepatic impairment
• Coadministration with strong CYP3A4 inhibitors in patients with renal or hepatic impairment

Cautions

• Renal impairment (eGFR ≥10ml/min/1.73m²) (South African recommendations) 
• Mild to moderate renal impairment (Recommendations in other jurisdictions)
• Mild to moderate hepatic impairment
• Elderly
• Debilitated patients
• Cardiovascular disease
• Gastrointestinal disease
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption

Forms avail. in SA and covered in this monograph: tab

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Acute attacks of gout

• Oral (tab): Initial: 0.5-1mg immediately; Followed by 0.5mg every 2 hours until pain relief is obtained or until vomiting or diarrhoea occur; Max: 6mg; A minimum of 3 days, but preferably 7 days, should elapse between courses of gout treatment with colchicine to avoid cumulative toxicity

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Colchicine is not an analgesic medication and should not be used to treat pain from other causes

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Colchicine is potentially toxic, so it is important not to exceed the prescribed dose. Colchicine has a narrow therapeutic window, therefore the administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain, diarrhoea occur

No information available for children in South Africa

Pregnancy

South African recommendations & Recommendations in other jurisdictions

• Contraindicated
• Colchicine is genotoxic in vitro and in vivo and is teratogenic in animal studies. Colchicine is therefore contraindicated in pregnancy
• Women of childbearing potential have to use effective contraception during treatment

Breastfeeding

South African recommendations & Recommendations in other jurisdictions

• Contraindicated
• Colchicine is excreted in breast milk. Therefore, the use of colchicine is contraindicated in women who are breastfeeding

Fertility

South African recommendations & Recommendations in other jurisdictions

• Colchicine administration in animals induces significant reductions in fertility

Renal Impairment

South African recommendations

• eGFR ≥51ml/min/1.73m²: Caution; no dose adjustment recommended
• eGFR ≥10-50ml/min/1.73m²: Caution; dose adjustment recommended
  Administer 50% of normal dose
• CrCl<10ml/min: Contraindicated

Recommendations in other jurisdictions

• Mild: Caution; no dose adjustment recommended
• Moderate: Caution; dose adjustment recommended
  Reduce dose or increase interval between doses. Such patients should be carefully monitored for adverse effects of colchicine
• Severe: Contraindicated

Hepatic Impairment

South African recommendations

• Mild to moderate: Caution; no dose adjustment recommended
  Patients with liver impairment should be carefully monitored for adverse effects of colchicine
• Severe: Contraindicated

Recommendations in other jurisdictions

• Mild to moderate: Caution; no dose adjustment recommended
  Patients with liver impairment should be carefully monitored for adverse effects of colchicine
• Severe: Contraindicated

Elderly

• Caution; no dose adjustment recommended
  Reduce prophylactic daily dose by 50% in patients ≥70 years

Porphyria Information

• Probably not porphyrinogenic (PNP) 

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Peripheral neuritis
• Neuropathy

GastroIntestinal Disorders

• Abdominal pain
• Nausea and vomiting
• Diarrhoea
• Gastrointestinal haemorrhage

Hepatobiliary Disorders

• Hepatic impairment

Genitourinary Disorders

• Renal impairment
• Amenorrhoea
• Dysmenorrhoea
• Oligospermia
• Azoospermia

Musculoskeletal Disorders

• Myopathy
• Rhabdomyolysis

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Rash

Immune, Blood and Lymphatic System Disorders

• Bone marrow depression with agranulocytosis
• Aplastic anemia
• Thrombocytopenia

• Non-steroidal anti-inflammatory drugs
• Phenylbutazone
• CYP3A4 inhibitors
• Ritonavir
• Atazanavir
• Telithromycin
• Itraconazole
• Ketoconazole
• P-glycoprotein inhibitors  
• Verapamil
• Quinidine
• Cimetidine
• Tolbutamide
• Cyanocobalamin (Vit B12)
• Statins
• Fibrates
• Ciclosporin
• Digoxin
• Anticoagulants
• Agents that increase uric acid serum levels
• Erythromycin
• Clarithromycin
• CNS depressants
• Sympathomimetic agents

None routine. Specific cases may require

• Renal function
• Hepatic function
• Full blood count

Consult relevant treatment guidelines for gout management. Due to risk of accumulation and toxicity, colchicine is not always considered as first line treatment in acute gout.

Disrupts cytoskeletal functions by inhibiting beta-tubulin polymerization into microtubules, preventing activation, degranulation, and migration of neutrophils-mediated inflammatory responses induced by monosodium urate crystals in synovial fluid and tissues.

Tablet 0.5mg

• Aspen Colchicine (Pharmacare)
• Kolcrys (Forrester Pharma)
• Podagra OTC (Austell Pharmaceuticals)

Tablet 1mg  

• Aspen Colchicine DS (Pharmacare)
• Colchicine Houde (Cipla Medpro) originator