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Authoritative Clinical Reference
Schedule H
Oral
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
Parameter Recommendation
Starting dose 400 mg once daily OR 200 mg twice daily
Titration Assess response at 6–8 weeks; reduce to maintenance if adequate response or ADRs
Usual maintenance dose 200–400 mg/day
Maximum dose 5 mg/kg/day based on actual body weight (not exceeding 400 mg/day)
Clinical Notes:
Parameter Recommendation
Starting dose 200–400 mg once daily OR in 2 divided doses
Titration Not typically required unless adverse effects occur
Usual maintenance dose 200–400 mg/day (long-term)
Maximum dose 5 mg/kg/day based on actual body weight
Clinical Notes:
a) Treatment — Uncomplicated P. vivax, P. ovale, Chloroquine-sensitive P. falciparum
Day Dose
Day 1 800 mg stat, then 400 mg after 6 hours
Day 2 400 mg single dose
Day 3 400 mg single dose
Total 2000 mg over 3 days
Clinical Notes:
b) Prophylaxis — Chloroquine-sensitive areas only
Parameter Recommendation
Starting dose 400 mg once weekly
Titration Not applicable
Usual maintenance dose 400 mg once weekly
Maximum dose 400 mg/week
Clinical Notes:
Secondary Indications — Adults Only (Off-label, if any)
Indication Dose Duration Notes
Chronic Cutaneous Lupus Erythematosus (CCLE) — OFF-LABEL 200–400 mg/day Long-term; specialist discretion Specialist dermatology supervision; Indian dermatology practice
Sjögren's Syndrome — OFF-LABEL 200–400 mg/day Long-term Specialist only; used for arthralgias and fatigue; Indian rheumatology practice
Primary Antiphospholipid Syndrome (thromboprophylaxis adjunct) — OFF-LABEL 200–400 mg/day Long-term Specialist only; adjunct to anticoagulation; evidence from international RCTs
Note: Hydroxychloroquine is NOT recommended for COVID-19 prophylaxis or treatment. ICMR advisory for COVID-19 chemoprophylaxis (2020) has been withdrawn.
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
Parameter Recommendation
Starting dose 5–6.5 mg/kg/day based on ideal body weight
Titration Not typically required
Usual maintenance dose 5 mg/kg/day
Maximum dose 6.5 mg/kg/day OR 400 mg/day (whichever is lower)
Clinical Notes:
Parameter Recommendation
Starting dose 5–6.5 mg/kg/day based on ideal body weight
Titration Not applicable
Usual maintenance dose 5 mg/kg/day
Maximum dose 6.5 mg/kg/day OR 400 mg/day (whichever is lower)
Clinical Notes:
Secondary Indications — Paediatrics (Off-label, if any)
Indication Dose Duration Notes
Juvenile Dermatomyositis — OFF-LABEL 5–6.5 mg/kg/day (max 400 mg/day) Long-term; specialist discretion Paediatric rheumatology supervision; Indian specialist practice
Age Restriction: Not generally recommended in children <6 years due to challenges in reliable ophthalmologic monitoring; use only under specialist paediatric rheumatology supervision if essential below this age.
| eGFR (ml/min/1.73m²) | Recommendation |
|---|
60 No dose adjustment required
30–59 Use with caution; no specific dose adjustment, but monitor for toxicity
<30 Consider dose reduction (e.g., 50% reduction); close monitoring required
Haemodialysis Not significantly dialysed; no supplementation needed post-dialysis
| Severity | Recommendation |
|---|---|
| Mild impairment (Child-Pugh A) | No dose adjustment required |
| Moderate impairment (Child-Pugh B) | Use with caution; consider dose reduction if prolonged use |
| Severe impairment (Child-Pugh C) | Avoid or use with extreme caution under specialist supervision |
Parameter Details
Risk category Considered safe in pregnancy; no evidence of teratogenicity at therapeutic doses
Preferred alternatives None — HCQ is often the preferred DMARD during pregnancy for SLE and RA
When to use Continue throughout pregnancy in SLE patients to prevent flares; benefit clearly outweighs risk
Monitoring Fetal growth monitoring; maternal blood glucose if at risk for hypoglycaemia
Parameter Details
Breastfeeding compatibility Compatible; considered safe during breastfeeding
Preferred alternatives Not necessary to switch
Drug levels in milk Low (infant receives <2% of maternal dose)
Infant monitoring Observe for rash, GI upset, feeding difficulties; generally well-tolerated
Parameter Recommendation
Starting dose Use lower end of dosing range (200 mg/day), especially if body weight <60 kg
Titration Slower titration if increasing dose; assess tolerance
Extra risks Increased risk of retinal toxicity (cumulative dose effect), cardiac conduction abnormalities, hypoglycaemia, reduced renal reserve
Monitoring More frequent ophthalmologic and cardiac monitoring
Drug/Class Interaction Management
QT-prolonging drugs (azithromycin, fluoroquinolones, amiodarone, haloperidol, ondansetron) Additive QT prolongation; risk of torsades de pointes Avoid combination; if essential, ECG monitoring mandatory
Digoxin HCQ increases digoxin plasma levels Monitor digoxin levels and ECG; consider dose reduction of digoxin
Tamoxifen Increased risk of retinal toxicity Avoid concurrent use if possible
Mefloquine Increased risk of seizures and cardiac effects Avoid combination
Drug/Class Interaction Management
Beta-blockers (metoprolol, propranolol) HCQ may inhibit CYP2D6 metabolism of beta-blockers Monitor for bradycardia and hypotension
Antidiabetic agents (insulin, sulfonylureas) Additive hypoglycaemic effect Monitor blood glucose more frequently
Rifampicin May reduce HCQ levels via enzyme induction Monitor clinical response; dose adjustment may be needed
Antacids (aluminium/magnesium-containing) Reduced HCQ bioavailability Separate administration by at least 4 hours
Ciclosporin HCQ may increase ciclosporin levels Monitor ciclosporin trough levels and renal function
Antiepileptics (phenytoin, carbamazepine) HCQ may lower seizure threshold Monitor seizure control
Adverse Effect Notes
Retinopathy / Maculopathy Irreversible if not detected early; risk increases with cumulative dose >1000 g or duration >5 years; discontinue immediately if detected
Cardiomyopathy May present as conduction defects, heart failure; consider if unexplained cardiac symptoms develop
QT prolongation / Torsades de pointes Risk increased with concurrent QT-prolonging drugs; ECG monitoring if risk factors
Severe hypoglycaemia Can occur even in non-diabetics; may be life-threatening
Bone marrow suppression (agranulocytosis, aplastic anaemia) Rare; discontinue and investigate if unexplained infection or bleeding
Stevens-Johnson Syndrome / TEN Very rare; discontinue immediately
Neuromyopathy Proximal muscle weakness with long-term use; may be irreversible
| Timing | Parameters |
|---|---|
| Baseline | Fundoscopy with visual acuity testing (mandatory); OCT and automated visual field testing if available; blood glucose; renal and hepatic function; ECG if cardiac risk factors |
During treatment (first 5 years) Annual visual acuity check; symptom enquiry for visual disturbances
Long-term (>5 years or high-risk) Annual comprehensive ophthalmologic examination including OCT, spectral domain imaging, and central visual field testing (10-2)
As needed ECG if concurrent QT-prolonging drugs or cardiac symptoms; blood glucose monitoring if hypoglycaemia symptoms; CBC if prolonged therapy
High-risk factors for retinal toxicity: Cumulative dose >1000 g, duration >5 years, renal impairment, concomitant tamoxifen use, pre-existing macular disease.
| Formulation | Approximate Price (per tablet) |
|---|---|
| Tablet 200 mg | ₹3–8 per tablet |
| Tablet 300 mg | ₹5–10 per tablet |
| Tablet 400 mg | ₹6–12 per tablet |
Notes:
DMARD; antimalarial; SLE; rheumatoid-arthritis; retinal-toxicity; pregnancy-safe; NLEM-India; 4-aminoquinoline; ophthalmologic-monitoring; QT-prolongation-risk; Hydroxychloroquine
RxIndia v1.1 — 07 Apr 2025
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