Colchicine

Dosage ; Initially one mg then 500mcg every two to three hours until

the pain is relieved or vomiting or diarrhoea occur or a

total dose of 10mg has been administered.

The treatment should not be repeated within 3 days.

Prevention of attacks during initial treatment with allopurinol or uricosuric drugs: 8-12 hourly.

Colchicine Brands
Brand Name Manufacturer Name Distributor Drug Strength Packaging Formulation Formulation Strength Price
Goutnil Inga Laboratory PVT Ltd Sai Pharmaceuticals Ltd. 0.5mg 20 Tablet per tablet KES 135.00
Kout Modern Pharma Ltd. Metro Pharmaceuticals Ltd. 0.5mg 100 Tablet per tablet KES 800

Colchicine More info

Drug Indication Treatment and prophylaxis of gout.
Precautions Periodic blood counts on long term therapy, peptic ulcer or spastic colon.
Contra-Indications Allergy against colchine, blood dyscrasia, cardiac disorders, hepatic and renal impairment.
Side Effects Bone marrow depression resulting in agranulocytosis and thrombocytopaenia, purpura, myopathy, neuritis, loss of hair, reversible azoospermia, vomiting, diarrhoea, allergic reactions.
Dosage Initially one mg then 500mcg every two to three hours until the pain is relieved or vomiting or diarrhoea occur or a total dose of 10mg has been administered. The treatment should not be repeated within 3 days. Prevention of attacks during initial treatment with allopurinol or uricosuric drugs: 8-12 hourly.
Pregnancy Category Category B2
Pregnancy Category Description Drugs which have been taken by only a small number of pregnant women and women of child-bearing age with no any established rise in the frequency of malformations or other direct or indirect detrimental effects on the foetus having been noted. Studies in animals are inadequate or lacking but available data show no evi-dence of an increased occurrence of foetal damage. Studies in animals are inadequate or lacking but available data show no evi-dence of an increased occurrence of foetal damage.
Drug Category DRUGS ACTING ON CNS
Drug Sub-Category Drugs for treatment of gout

Dosing: Adult

Familial Mediterranean fever (FMF): Oral: 1.2-2.4 mg/day in 1-2 divided doses; titration: Increase or decrease dose in 0.3 mg increments based on efficacy or adverse effects; maximum: 2.4 mg/day

Gout: Oral:

Flare treatment: Initial: 1.2 mg at the first sign of flare, followed in 1 hour with a single dose of 0.6 mg (maximum: 1.8 mg within 1 hour). Patients receiving prophylaxis therapy may receive treatment dosing; wait 12 hours before resuming prophylaxis dose. Note: Current FDA-approved dose for gout flare is substantially lower than what has been historically used clinically. Doses larger than the currently recommended dosage for gout flare have not been proven to be more effective.

Prophylaxis: 0.6 mg once or twice daily; maximum: 1.2 mg/day

Pericarditis (unlabeled use): Oral: 0.6 mg twice daily (Antman, 2004)

Primary biliary cirrhosis (unlabeled use): Oral: 0.6 mg twice daily (Kaplan, 2005); Note: Use reserved for patients refractory to ursodiol.

Dosage adjustment for concomitant therapy with CYP3A4 or P-glycoprotein (P-gp) inhibitors: Dosage adjustment also required in patients receiving CYP3A4 or P-gp inhibitors up to 14 days prior to initiation of colchicine. Note: Treatment of gout flare with colchicine is not recommended in patients receiving prophylactic colchicine and CYP3A4 inhibitors.

Coadministration of strong CYP3A4 inhibitor (eg, atazanavir, clarithromycin, darunavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir):

FMF: Maximum dose: 0.6 mg/day (0.3 mg twice daily)

Gout prophylaxis:

If original dose is 0.6 mg twice daily, adjust dose to 0.3 mg once daily

If original dose is 0.6 mg once daily, adjust dose to 0.3 mg every other day

Gout flare treatment: Initial: 0.6 mg, followed in 1 hour by a single dose of 0.3 mg; do not repeat for at least 3 days

Coadministration of moderate CYP3A4 inhibitor (eg, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil):

FMF: Maximum dose: 1.2 mg/day (0.6 mg twice daily)

Gout prophylaxis:

If original dose is 0.6 mg twice daily, adjust dose to 0.3 mg twice daily or 0.6 mg once daily

If original dose is 0.6 mg once daily, adjust dose to 0.3 mg once daily

Gout flare treatment: 1.2 mg as a single dose; do not repeat for at least 3 days

Coadministration of P-gp inhibitor (eg, cyclosporine, ranolazine):

FMF: Maximum dose: 0.6 mg/day (0.3 mg twice daily)

Gout prophylaxis:

If original dose is 0.6 mg twice daily, adjust dose to 0.3 mg once daily

If original dose is 0.6 mg once daily, adjust dose to 0.3 mg every other day

Gout flare treatment: Initial: 0.6 mg as a single dose; do not repeat for at least 3 days

Dosing: Pediatric

(For additional information see "Colchicine: Pediatric drug information")

Familial Mediterranean fever (FMF):Oral:

Children 4-6 years: 0.3-1.8 mg/day in 1-2 divided doses

Children 6-12 years: 0.9-1.8 mg/day in 1-2 divided doses

Children >12 years: Refer to adult dosing.

Gout prophylaxis/treatment: Oral: Children >16 years: Refer to adult dosing.

Dosing: Geriatric

Use caution; reduce prophylactic daily dose by 50% in individuals >70 years (Terkeltaub, 2009)

Dosing: Renal Impairment

Concurrent use of colchicine and P-gp or strong CYP3A4 inhibitors is contraindicated in renal impairment. Fatal toxicity has been reported. Treatment of gout flares is not recommended in patients with renal impairment receiving prophylactic colchicine.

FMF:

Clcr 30-80 mL/minute: Monitor closely for adverse effects; dose reduction may be necessary.

Clcr <30 mL/minute: Initial dose: 0.3 mg/day; use caution if dose titrated; monitor for adverse effects.

Dialysis: 0.3 mg as a single dose; use caution if dose titrated; dosing can be increased with close monitoring; monitor for adverse effects. Not removed by dialysis.

Gout prophylaxis:

Clcr 30-80 mL/minute: Dosage adjustment not required; monitor closely for adverse effects.

Clcr <30 mL/minute: Initial dose: 0.3 mg/day; use caution if dose titrated; monitor for adverse effects.

Dialysis: 0.3 mg twice weekly; monitor closely for adverse effects.

Gout flare treatment:

Clcr 30-80 mL/minute: Dosage adjustment not required; monitor closely for adverse effects.

Clcr <30 mL/minute: Dosage reduction not required but may be considered; treatment course should not be repeated more frequently than every 14 days.

Dialysis: 0.6 mg as a single dose; treatment course should not be repeated more frequently than every 14 days. Not removed by dialysis.

Hemodialysis: Avoid chronic use of colchicine.

Dosing: Hepatic Impairment

Concurrent use of colchicine and P-glycoprotein or strong CYP3A4 inhibitors is contraindicated in hepatic impairment. Fatal toxicity has been reported. Treatment of gout flare with colchicine is not recommended in patients with hepatic impairment receiving prophylactic colchicine.

FMF:

Mild-to-moderate impairment: Use caution; monitor closely for adverse effects.

Severe impairment: Consider dosage reduction.

Gout prophylaxis:

Mild-to-moderate impairment: Dosage adjustment not required; monitor closely for adverse effects.

Severe impairment: Dosage adjustment should be considered.

Gout flare treatment:

Mild-to-moderate impairment: Dosage adjustment not required; monitor closely for adverse effects.

Severe impairment: Dosage reduction not required but may be considered; treatment course should not be repeated more frequently than every 14 days