Posology
Gout
Acute gout attack
500 micrograms (2 ml) two to four (2-4) times daily until symptoms are relieved.
The course of treatment should end when symptoms are relieved or when a total of 6,000 micrograms (24 ml) have been taken. No more than 6,000 micrograms (24 ml) should be taken as a course of treatment.
After completion of a course, another course should not be started for at least 3 days (72 hours).
If diarrhoea or vomiting occurs, Colchicine should be discontinued immediately as these may be the first signs of an intoxication.
Prophylaxis of gout attack
500 micrograms – 1,000 micrograms per day (2 – 4 ml/day) to be taken in the evening.
Paediatric population
Colchicine should not be used in children and adolescents.
Acute and Recurrent Pericarditis
Adults
The recommended dose is 500 micrograms/day (2 ml/day) for patients weighing ≤70 kg or in patients with intolerance to higher doses.
The recommended dose is 500 micrograms (2 ml) twice daily for patients with a body weight of >70 kg.
Treatment duration is 6 months in recurrent pericarditis and 3 months in acute pericarditis.
Paediatric population
Colchicine should not be used in children and adolescents.
Familial Mediterranean Fever
The dose may be given as a single dose or doses higher than 1,000 micrograms/day (4 ml/day) may be divided and given twice daily.
Colchicine dosage should be increased in a stepwise fashion up to a maximum of 3,000 micrograms/day (12 ml/day) to control disease in patients who do not clinically respond to the standard dosage. Any increase of the daily dose should be monitored closely for adverse effects. Careful monitoring is needed in the presence of impaired renal or liver function. For these patients, the starting dose should be reduced by 50% (e.g. ≤ 1,000 micrograms/day, 4 ml).
Adults
1,000 to 3,000 micrograms per day (4 to 12 ml per day).
Paediatric population
For paediatric use, colchicine should only be prescribed under the supervision of a medical specialist with the necessary knowledge and experience.
A starting dose should be administered orally based on age:
- 500 micrograms/day (2 ml/day) in children less than 5 years of age
- 1,000 micrograms/day (4 ml/day) in children from 5 to 10 years of age
- 1,500 micrograms/day (6 ml/day) in children over 10 years of age
In children with amyloid nephropathy, higher daily doses up to 2,000 micrograms/day (8 ml/day) might be needed.
Colchicine dosage should be increased in a stepwise fashion (e.g. 250 micrograms/step) up to a maximum of 2,000 micrograms/day to control disease in patients who do not clinically respond to the standard dosage. Any increase of the daily dose should be monitored closely for adverse effects.
Concomitant treatment with other medicinal products
Concomitant treatment of colchicine with several drugs, mostly inhibitors of cytochrome P450 3A4 (CYP3A4)/P-glycoprotein have been shown to increase the risk for colchicine toxicity. If a patient has received concomitant therapy with a moderate or potent CYP3A4 inhibitor or with a P-glycoprotein inhibitor, the maximum recommended dosage of oral colchicine should be reduced and should be carefully monitored for adverse effects of colchicine.
Patients with renal impairment
In patients with mild and moderate renal impairment, the dose is 500 micrograms (2 mL oral solution) per day in gout, acute and recurrent pericarditis and the starting dose should be reduced by 50% (e.g. ≤ 1,000 micrograms/day) in Familial Mediterranean Fever.
The dose should be carefully monitored for adverse effects of colchicine.
Patients with any degree of renal impairment should not be given colchicine in conjunction with strong P-glycoprotein inhibitors or strong CYP3A4 inhibitors (see section 4.4).
For severe renal impairment, see section 4.3 contraindications.
Patients with hepatic impairment
In patients with mild and moderate hepatic impairment, the dose is 500 micrograms (2 mL oral solution) per day in gout, acute and recurrent pericarditis and the starting dose should be reduced by 50% (e.g. ≤ 1,000 micrograms/day) in Familial Mediterranean Fever.
The dose should be carefully monitored for adverse effects of colchicine.
Patients with any degree of hepatic impairment should not be given colchicine in conjunction with strong P-glycoprotein inhibitors or strong CYP3A4 inhibitors (see section 4.4).
For severe hepatic impairment, see section 4.3 contraindications.
Table 1 – Colchicine dosage instructions
| Indication | Patient Group | Dose (µg) | Frequency | Special Notes |
| Acute Gout Attack | Adults | 500 micrograms (2 mL) | 2–4 times daily | Maximum dose: 6,000 micrograms
(24 mL) per course. Stop when symptoms resolve or max dose reached. Wait ≥72 hrs before the next course. Discontinue if diarrhoea or vomiting occurs. |
| Renal impairment | 500 micrograms (2 mL) | Once daily | Avoid with strong CYP3A4/P-gp inhibitors |
| Hepatic impairment | 500 micrograms (2 mL) | Once daily | Avoid with strong CYP3A4/P-gp inhibitors |
| Children | Not suitable for paediatric use |
| Prophylaxis of gout attack | Adults | 500–1,000 micrograms
(2–4 mL) | Once daily (evening) | — |
| Renal impairment | 500 micrograms (2 mL) | Once daily | Avoid with strong CYP3A4/P-gp inhibitors |
| Hepatic impairment | 500 micrograms (2 mL) | Once daily | Avoid with strong CYP3A4/P-gp inhibitors |
| Children | Not suitable for paediatric use |
| Acute Pericarditis | Adults ≤70 kg or intolerant to high doses | 500 micrograms (2 mL) | Once daily | Duration: 3 months |
| Adults >70 kg | 500 micrograms (2 mL) | Twice daily | Duration: 3 months |
| Renal impairment | 500 micrograms (2 mL) | Once daily | Avoid with strong CYP3A4/P-gp inhibitors |
| Hepatic impairment | 500 micrograms (2 mL) | Once daily | Avoid with strong CYP3A4/P-gp inhibitors |
| Children | Not suitable for paediatric use |
| Recurrent Pericarditis | Adults ≤70 kg or intolerant to high doses | 500 micrograms (2 mL) | Once daily | Duration: 6 months |
| Adults >70 kg | 500 micrograms (2 mL) | Twice daily | Duration: 6 months |
| Renal impairment | 500 micrograms (2 mL) | Once daily | Avoid with strong CYP3A4/P-gp inhibitors |
| Hepatic impairment | 500 micrograms (2 mL) | Once daily | Avoid with strong CYP3A4/P-gp inhibitors |
| Children | Not suitable for paediatric use |
| Familial Mediterranean Fever (FMF) | Adults | 1,000–3,000 micrograms
(4–12 mL) | Once daily or doses higher than 1,000 µg can be divided twice daily | Maximum dose: 3,000 micrograms /day (12 ml/day). Increase dose in stepwise fashion (e.g. 250 micrograms steps). Monitor for adverse effects. |
| Renal Impairment | Reduce FMF starting dose by 50% (e.g. ≤ 1,000 micrograms /day) | Once daily | Avoid with strong CYP3A4/P-gp inhibitors. |
| Hepatic Impairment | Reduce FMF starting dose by 50% (e.g. ≤ 1,000 micrograms /day). | Once daily | Avoid with strong CYP3A4/P-gp inhibitors. |
| Children <5 yrs | Starting does: 500 micrograms (2 mL) | Once daily | Specialist supervision required Maximum dose: Up to (8 mL). In children with amyloid nephropathy, higher daily doses up to 2,000 micrograms /day (8 ml/day) might be needed. Increase in stepwise fashion (e.g. 250 micrograms steps). |
| Children 5–10 yrs | Starting dose: 1,000 micrograms (4 mL) | Once daily |
| Children >10 yrs | Starting dose: 1,500 micrograms (6 mL) | Once daily |
Method of Administration
Colchicine is for oral use only. The oral solution should be considered especially for children younger than 1 year.
A 5 ml graduated oral syringe with intermediate graduations of 0.1 ml and a “Press-In” Bottle Adapter (PIBA) are provided with the product.
1. Open the bottle and at first use, insert the “Press-In” Bottle Adapter (PIBA).
2. Insert the syringe into the PIBA and draw out the required volume from the inverted bottle.
3. Remove the filled syringe from the bottle in the upright position
4. Discharge the syringe contents into the mouth.
5. Rinse the syringe and replace the cap on the bottle (PIBA remains in place).
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