Colchicine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of colchicine.
Drugs List
Therapeutic Indications
Uses
Gout (prophylaxis)
Gout - acute
Treatment of acute gout.
Prophylaxis of acute gout, during initial therapy with allopurinol and uricosuric drugs.
Unlicensed Uses
Familial Mediterranean fever : prophylaxis
Prophylaxis of familial Mediterranean fever (recurrent polyserositis).
Dosage
Adults
Treatment of acute gout
Initial dose 1mg, followed by 500micrograms two to three times a day until acute gout resolves. Discontinue treatment if no improvement occurs after 2 to 3 days.
Total dose should not exceed 6mg per course and the course should not be repeated within 3 days.
The following alternative dosing schedule may be suitable:
1mg initially, followed by 500micrograms after 1 hour. No further tablets should be taken for 12 hours.
After 12 hours, treatment can be resumed if necessary with a maximum dose of 500micrograms every 8 hours until symptoms are relieved.
Total dose should not exceed 6mg per course and the course should not be repeated within three days.
Prophylaxis during initial treatment with allopurinol or uricosuric drugs
500micrograms once daily to 500micrograms twice daily, or 1mg once daily.
Prophylaxis of familial Mediterranean fever (unlicensed)
500micrograms to 2mg once daily.
Patients with Renal Impairment
Glomerular filtration rate (GFR)
GFR 10 to 50ml/minute: Reduce dose or increase dosage interval by 50%.
GFR less than 10ml/minute: 500micrograms three to four times a day. Maximum total dose of 3mg.
Contraindications
Children under 18 years
Galactosaemia
Haematological disorder
Pregnancy
Severe hepatic impairment
Severe renal impairment
Precautions and Warnings
Debilitation
Elderly
Females of childbearing potential
Breastfeeding
Cardiac disorder
Gastrointestinal disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Monitor blood counts regularly
Advise patient to seek urgent medical advice if blood dyscrasias suspected
Discontinue if blood dyscrasia develops
Discontinue if severe nausea, vomiting or abdominal distress occurs
Discontinue therapy if marked diarrhoea occurs
Grapefruit juice should not be taken simultaneously
Female: Contraception required during and for 3 months after treatment
Male: Contraception required during and for 6 months after treatment
Advise patient how to recognise signs / symptoms of blood dyscrasias
Use with caution in elderly and debilitated patients as there is a greater risk of cumulative toxicity.
Perform blood counts if skin abnormalities occur.
Discontinue if toxic symptoms such as nausea, vomiting, abdominal pain or diarrhoea occur.
Pregnancy and Lactation
Pregnancy
Colchicine is contraindicated during pregnancy.
The manufacturer does not recommend the use of colchicine during pregnancy, and that women of childbearing age should use effective contraception during and for 3 months after treatment. If pregnancy occurs during this time genetic counselling should be offered.
Animal studies have shown teratogenic effects. There is limited published information regarding the use of colchicine during pregnancy, therefore potential risks cannot be excluded (Briggs, 2015).
Lactation
Use with caution during breastfeeding.
The manufacturer does not recommend the use of colchicine during breastfeeding.
Colchicine is excreted into breast milk.
The highest milk levels occur in the 2 to 4 hours after a dose, so avoiding breastfeeding during this time can minimise the infant dose. No adverse effects in breastfed infants have been reported (Lactmed, 2019).
Side Effects
Abdominal pain
Agranulocytosis
Alopecia
Amenorrhoea
Aplastic anaemia
Azoospermia
Blood disorders
Bone marrow depression
Diarrhoea
Dysmenorrhoea
Gastro-intestinal haemorrhage
Hepatic damage
Myopathy
Nausea
Neuropathy
Oligospermia
Peripheral neuritis
Pharyngolaryngeal pain
Rash
Renal damage
Rhabdomyolysis
Spermatogenesis suppression
Thrombocytopenia
Vitamin B12 deficiency
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2019
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
Summary of Product Characteristics: Colchicine 500 micrograms Tablets. Wockhardt UK Ltd. Revised June 2017.
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 03 April 2019.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Colchicine Last revised: 28 February 2019
Last accessed: 03 April 2019.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.