Colchicine Schedule (India)

Schedule H

Colchicine Routes

Oral

Colchicine Formulations

Tablets: 0.5 mg

Colchicine Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Acute Gout Flare

Step Dose Clinical Notes

Starting dose 1 mg orally at first sign of flare Most effective when given within 12–24 hours of symptom onset

Followed by 0.5 mg one hour later Total Day 1 dose: 1.5 mg maximum

Subsequent days 0.5 mg twice daily Continue until flare resolves (usually 3–5 days)

Maximum dose 1.5 mg on Day 1; thereafter 1 mg/day Do not repeat full loading within 3 days

Key points:

Efficacy diminishes significantly if started >36 hours after flare onset

Diarrhoea often signals approaching toxicity — reduce dose if occurs

Not an analgesic — does not provide immediate pain relief

Gout Prophylaxis (During Urate-Lowering Therapy Initiation)

Step Dose Clinical Notes

Starting dose 0.5 mg once daily Begin when starting allopurinol or febuxostat

Usual maintenance dose 0.5 mg once or twice daily Adjust based on tolerability

Maximum dose 1 mg/day Higher doses do not improve prophylaxis

Duration 3–6 months after target serum uric acid achieved May extend if recurrent flares occur

Familial Mediterranean Fever (FMF) — Specialist Only

Step Dose Clinical Notes

Starting dose 0.5–1 mg once daily Single or divided doses

Titration Increase by 0.5 mg increments based on response Titrate every 2–4 weeks

Usual maintenance dose 1–1.5 mg/day Most patients controlled at this range

Maximum dose 2 mg/day in divided doses Higher doses rarely needed

Key points:

FMF is rare in Indian population — confirm diagnosis before long-term therapy

Lifelong treatment usually required

Monitor CBC, renal and hepatic function every 3–6 months

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Acute/Recurrent Pericarditis 0.5 mg twice daily (or 0.5 mg once daily if <70 kg) Acute: 3 months; Recurrent: 6 months or longer OFF-LABEL; Specialist only; Evidence: COPE, ICAP, CORP trials; used in Indian cardiology centres

Behçet's Disease (mucocutaneous/articular manifestations) 0.5–1.5 mg/day in 1–2 divided doses Long-term; individualised OFF-LABEL; Specialist only; Evidence: Small cohort studies; Indian rheumatology practice

Colchicine Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Familial Mediterranean Fever (FMF)

Age Group	Dose (mcg/kg/day)	Typical Total Daily Dose	Clinical Notes

1–4 years 0.25–0.5 mg once daily 1 mg/day

5–10 years 0.5 mg once or twice daily 1.5 mg/day

10 years 0.5–1 mg once or twice daily 2 mg/day

Safety notes:

Adjust dose based on clinical response and GI tolerability

Monitor CBC, renal function, and hepatic function every 3–6 months

Observe for myopathy (muscle weakness, elevated CPK)

Secondary Indications — Paediatrics (Off-label)

Indication Dose Duration Notes

Recurrent Pericarditis 0.5 mg once or twice daily (based on weight) 6 months or longer OFF-LABEL; Paediatric cardiology specialist only; Evidence: Extrapolated from adult CORP/CORP-2 trials; limited Indian paediatric data

Minimum age: Avoid below 1 year of age except under specialist supervision with confirmed diagnosis

Colchicine Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation

50 No adjustment required

30–50 Use with caution; maximum 0.5 mg once daily

10–29 Maximum 0.5 mg every other day; close monitoring essential

<10 or dialysis Avoid if possible; if essential, 0.5 mg every 2–3 days under specialist supervision; not removed by dialysis

Note: Risk of accumulation and toxicity markedly increased in renal impairment — monitor closely for neuromuscular and haematological toxicity

Colchicine Hepatic adjustment

Severity	Recommendation
Mild impairment (Child-Pugh A)	No dose adjustment required; monitor LFTs
Moderate impairment (Child-Pugh B)	Use with caution; consider 50% dose reduction; regular LFT monitoring
Severe impairment (Child-Pugh C)	Avoid use or use only under strict specialist supervision at reduced dose

Note: Hepatic metabolism is significant — accumulation risk in hepatic dysfunction

Colchicine Contraindications

Known hypersensitivity to colchicine

Combined severe renal AND hepatic impairment

Concurrent use of strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole) or P-glycoprotein inhibitors in patients with renal or hepatic impairment — risk of fatal toxicity

Blood dyscrasias or pre-existing bone marrow suppression

Active serious gastrointestinal disease (e.g., active peptic ulcer disease, inflammatory bowel disease with bleeding)

Colchicine Cautions

Renal impairment — risk of accumulation and dose-dependent toxicity; adjust dose

Hepatic impairment — reduced clearance; monitor closely

Elderly patients — increased sensitivity to adverse effects

Concurrent statin or fibrate therapy — additive myopathy risk

Gastrointestinal disorders — may exacerbate diarrhoea, nausea

Cardiac disease — may unmask or worsen arrhythmias in toxicity

Avoid repeating acute gout loading dose within 3 days

Colchicine Pregnancy

Parameter Recommendation

Safety category Limited data; animal studies suggest teratogenic potential at high doses

Preferred alternatives NSAIDs (second trimester only with caution); low-dose corticosteroids for acute gout flare

When it may be used FMF — may continue if essential for disease control; benefit usually outweighs risk; obstetric and rheumatology input required

Monitoring Fetal growth surveillance; maternal GI tolerance; consider first-trimester detailed anomaly scan

Colchicine Lactation

Parameter Recommendation

Compatibility Generally compatible; low levels excreted in breast milk

Drug levels in milk Low (infant receives <10% of maternal weight-adjusted dose)

Preferred alternatives Short-term NSAID use if needed for acute flare

Infant monitoring Observe for GI symptoms (loose stools, vomiting), feeding difficulties

Colchicine Elderly

Recommended starting dose: 0.5 mg once daily

Titration: Slower titration; increase only if tolerated and necessary

Additional risks:

Increased susceptibility to neuromuscular toxicity (myopathy, neuropathy)

Age-related decline in renal function — adjust dose accordingly

Higher risk of bone marrow suppression

GI intolerance more common

Monitoring: Regular renal function, CBC, and clinical assessment for muscle weakness

Colchicine Major drug interactions

Drug Interaction Management

Clarithromycin / Erythromycin Strong CYP3A4 and P-gp inhibition → marked ↑ colchicine levels → fatal toxicity reported AVOID combination; if essential, reduce colchicine dose by 50–75% and limit duration

Ketoconazole / Itraconazole Strong CYP3A4 inhibition → ↑ colchicine toxicity AVOID in renal/hepatic impairment; significant dose reduction required if used

Cyclosporine P-gp inhibition + additive nephrotoxicity and myotoxicity Reduce colchicine dose; monitor renal function and CPK

Ritonavir-boosted antiretrovirals Potent CYP3A4 inhibition → severe colchicine toxicity AVOID combination if possible

Verapamil / Diltiazem CYP3A4 and P-gp inhibition → ↑ colchicine levels Reduce colchicine dose; monitor for toxicity

Colchicine Moderate drug interactions

Drug Interaction Management

Statins (atorvastatin, simvastatin) Additive risk of myopathy/rhabdomyolysis Monitor for muscle symptoms; check CPK if symptomatic

Fibrates (fenofibrate, gemfibrozil) Additive myopathy risk Use with caution; clinical monitoring

Digoxin P-gp substrate; possible increased digoxin levels Monitor digoxin levels and signs of toxicity

Fluconazole Moderate CYP3A4 inhibition May need minor colchicine dose adjustment

Warfarin Minor interaction; possible INR fluctuation Monitor INR when initiating or changing colchicine dose

NSAIDs Additive GI toxicity with chronic co-administration Short-term use acceptable; avoid prolonged combination

Colchicine Common Adverse effects

Diarrhoea (most common — often dose-limiting)

Nausea and vomiting

Abdominal pain/cramping

Loss of appetite

Fatigue

Headache

Colchicine Serious Adverse effects

Reaction Action Required

Bone marrow suppression (agranulocytosis, aplastic anaemia, pancytopenia) Discontinue immediately; haematology referral; supportive care

Myopathy / Rhabdomyolysis Discontinue; check CPK; hydration; nephrology input if renal impairment

Peripheral neuropathy (axonal) Discontinue; usually reversible over weeks to months

Severe hepatotoxicity Discontinue; monitor LFTs; hepatology referral

Multi-organ failure (in overdose) Emergency hospitalisation; supportive care; no specific antidote

Note: Toxicity has narrow therapeutic window — even modest overdose can be fatal

Colchicine Monitoring requirements

Timing	Parameters
Baseline	CBC, renal function (eGFR), LFTs; neuromuscular assessment if on statins

During acute treatment Clinical monitoring for GI symptoms (diarrhoea indicates approaching toxicity)

Chronic use (every 2–3 months initially) CBC, renal function, LFTs

Long-term (every 6–12 months) CBC, renal function, LFTs; periodic CPK if on concurrent statin/fibrate

Clinical note: Onset of diarrhoea often precedes serious toxicity — counsel to reduce dose or hold if significant GI upset develops

Colchicine Brands in India

Zycolchin (Zydus Cadila)

Colgout (Glenmark)

Colchicine (generic — multiple manufacturers)

Goutnil (Alkem)

Colchimax (Intas)

Colchicine Price range (INR)

Formulation	Approximate Price (per tablet)
Tablet 0.5 mg ₹3–₹8 per tablet

NLEM status: Colchicine 0.5 mg tablet is included in NLEM 2022 — ceiling price applicable under NPPA

Colchicine Clinical pearls

Timing is critical in acute gout: Colchicine works best within 12–24 hours of flare onset; efficacy drops significantly after 36 hours

Diarrhoea is a warning sign: GI symptoms often herald toxicity — instruct patients to reduce dose or stop if significant diarrhoea develops

Low-dose regimen is as effective as high-dose: Modern evidence (AGREE trial) shows 1.5 mg total on Day 1 is as effective as older high-dose regimens with far fewer side effects

Never repeat loading within 3 days: Risk of cumulative toxicity is high

Beware of drug interactions: CYP3A4/P-gp inhibitors (macrolides, azole antifungals, CCBs) can cause fatal toxicity — always check before prescribing

Statin combination requires vigilance: Monitor for myopathy symptoms; consider CPK if muscle complaints arise

Colchicine Tags

colchicine; gout; acute gout flare; gout prophylaxis; FMF; pericarditis; CYP3A4 interaction; P-glycoprotein; myopathy risk; renal-adjusted; NLEM India

Colchicine Version

RxIndia v1.1 — 14 Jun 2025

Colchicine Reference

CDSCO Approved Product Information

Indian Pharmacopoeia 2022

NLEM 2022 (National List of Essential Medicines)

API Textbook of Medicine (11th Edition)

AIIMS Rheumatology Clinical Protocols

Goodman & Gilman's The Pharmacological Basis of Therapeutics (13th Edition)

Harrison's Principles of Internal Medicine (21st Edition)

AGREE Trial (Arthritis Rheum 2010) — low-dose colchicine efficacy

COPE, ICAP, CORP Trials — pericarditis evidence (off-label indication)

RxIndia

The Drug Registry

Colchicine