Prescribing Guides
Hydroxychloroquine Prescribing Guide for Indian Clinical Practice
Hydroxychloroquine prescribing guide for Indian clinicians covering rheumatological use, retinal toxicity screening, lupus dosing and NEET PG pharmacology.
MedNext Editorial Team | 2026-08-01 | 9 min read
Hydroxychloroquine Prescribing Guide for Indian Clinical Practice
Hydroxychloroquine prescribing guide for Indian clinicians covering rheumatological use, retinal toxicity screening, lupus dosing and NEET PG pharmacology.
Hydroxychloroquine (HCQ) is a disease-modifying antirheumatic drug (DMARD) indispensable in Indian rheumatology and dermatology practice, particularly for systemic lupus erythematosus and rheumatoid arthritis. India is the world's largest manufacturer of HCQ.
Clinical Pharmacology Overview
Hydroxychloroquine is a 4-aminoquinoline with immunomodulatory and anti-inflammatory properties. Its mechanisms include: inhibition of lysosomal activity and autophagy, suppression of toll-like receptor (TLR 7 and 9) signalling, reduction of pro-inflammatory cytokine production (TNF-alpha, IL-1, IL-6), and inhibition of antigen processing and MHC class II presentation. It is NOT immunosuppressive in the traditional sense.
Pharmacokinetics: Well absorbed orally (bioavailability 67-74%). Extensive tissue distribution with a very large volume of distribution (approximately 44,000 L). Highly protein-bound. Half-life is extremely long -- 40-50 days. Metabolised by CYP2C8, CYP3A4, and CYP2D6. Renally excreted. Accumulates in melanin-containing tissues (retina, skin).
Indian Brand Names
- HCQS (IPCA Laboratories -- India's largest HCQ manufacturer)
- Plaquenil (Sanofi -- original brand)
- Zyq (Zydus Cadila)
- Hydroxychloroquine Sulphate IP (multiple generic manufacturers)
- Oxcq (Cipla)
Approved Indications in Indian Clinical Practice
- Systemic lupus erythematosus (SLE) -- recommended for ALL SLE patients unless contraindicated
- Rheumatoid arthritis (as monotherapy or combination DMARD therapy)
- Discoid lupus erythematosus
- Sjogren syndrome
- Antiphospholipid syndrome (as adjunctive therapy)
- Porphyria cutanea tarda (low-dose)
- Photosensitive skin disorders
- Malaria treatment and prophylaxis (less used now due to resistance)
Dosing in Adults
SLE and RA: 200-400 mg daily (usually 200 mg twice daily or 400 mg once daily). Maximum dose to minimise retinal toxicity: 5 mg/kg/day based on ACTUAL body weight.
Discoid lupus: 200-400 mg daily.
Malaria prophylaxis: 400 mg weekly, starting 2 weeks before travel.
Malaria treatment: 800 mg initially, 400 mg at 6-8 hours, then 400 mg daily for 2 days (total 2000 mg over 3 days) -- used only for sensitive P. vivax.
Loading dose is not used for rheumatological indications. Therapeutic effect takes 2-3 months to become apparent.
Important Drug Interactions
- Digoxin: HCQ increases digoxin levels
- Tamoxifen: increased risk of retinal toxicity
- Insulin, oral hypoglycaemics: HCQ has hypoglycaemic effects -- may need dose adjustment of diabetic medications
- QT-prolonging drugs (azithromycin, amiodarone, fluoroquinolones): additive QT prolongation
- Ciclosporin: HCQ may increase ciclosporin levels
- Antacids: may reduce HCQ absorption (separate by 4 hours)
- Mefloquine: increased seizure risk
Side Effects and Monitoring
Common: nausea, diarrhoea, abdominal cramps, headache, skin hyperpigmentation (blue-grey).
Serious: retinal toxicity (bull's-eye maculopathy -- irreversible), QT prolongation and cardiomyopathy (rare, usually with prolonged high-dose use), neuromyopathy, hypoglycaemia, bone marrow suppression (rare).
Retinal screening protocol (AAO/revised guidelines): baseline examination within first year of starting HCQ. Annual screening after 5 years of use (or sooner if risk factors present: dose above 5 mg/kg/day, renal impairment, tamoxifen use, pre-existing retinal disease). OCT (optical coherence tomography) and visual field testing are the primary screening tools.
Monitoring: ophthalmological screening as above. Baseline and periodic CBC. Blood glucose in diabetics. ECG if cardiac symptoms develop.
Special Populations
Pregnancy: Safe in pregnancy. Should NOT be discontinued in pregnant SLE patients -- discontinuation increases flare risk. Compatible with breastfeeding. One of very few DMARDs safe throughout pregnancy.
Renal impairment: Caution in significant renal impairment (reduces HCQ clearance, increases retinal toxicity risk). No specific dose reduction recommended but ophthalmological monitoring should start earlier.
Hepatic impairment: Use with caution. No specific guidelines.
Elderly: Higher risk of retinal toxicity. Use lowest effective dose and monitor closely.
G6PD deficiency: Generally safe at standard doses (unlike primaquine). HCQ has a very low risk of haemolysis in G6PD deficiency.
NEET PG High-Yield Points
- Disease-modifying (NOT immunosuppressive) -- safe in infections unlike methotrexate
- Recommended for ALL SLE patients (reduces flares, improves survival)
- Retinal toxicity: bull's-eye maculopathy -- irreversible, dose-dependent (>5 mg/kg/day)
- Very long half-life (40-50 days) -- accumulates in melanin-rich tissues
- Safe in pregnancy -- one of the few DMARDs safe throughout pregnancy
- Mechanism: inhibits TLR signalling, lysosomal pH elevation, antigen processing
- QT prolongation risk -- relevant when combined with azithromycin
- Has hypoglycaemic effect -- reduces insulin resistance
- No benefit in COVID-19 (RECOVERY trial)
- India is world's largest HCQ manufacturer
Indian Regulatory Status
Hydroxychloroquine is a Schedule H drug under the Drugs and Cosmetics Act. It is included in the NLEM of India. India manufactures approximately 70% of the world's HCQ supply, with IPCA Laboratories being the largest producer. During the COVID-19 pandemic, the Government of India temporarily restricted HCQ exports (later lifted). Price is controlled under DPCO. Available as 200 mg and 300 mg tablets.
Frequently Asked Questions
What is the retinal toxicity risk of hydroxychloroquine?
Hydroxychloroquine accumulates in the retinal pigment epithelium and can cause irreversible bull's-eye maculopathy. Risk increases significantly after 5 years of use and with doses exceeding 5 mg/kg/day (actual body weight). Baseline ophthalmological screening is recommended within the first year, then annually after 5 years of use (or sooner with risk factors).
Is hydroxychloroquine safe in pregnancy?
Yes. Hydroxychloroquine is safe in pregnancy and should NOT be discontinued in pregnant SLE patients. Discontinuation increases flare risk. It is one of the few DMARDs considered safe throughout pregnancy and breastfeeding.
What happened with hydroxychloroquine and COVID-19?
HCQ was widely promoted and stockpiled in India during the COVID-19 pandemic, but large RCTs (RECOVERY, SOLIDARITY) showed no benefit for treatment or prevention of COVID-19. The ICMR withdrew its recommendation. The episode caused temporary shortages for rheumatology and dermatology patients who genuinely needed it.
Why is hydroxychloroquine preferred over chloroquine?
HCQ is less toxic than chloroquine, with a better safety profile for retinal toxicity, cardiac toxicity, and GI tolerability. It can be used long-term at appropriate doses with monitoring, whereas chloroquine has a narrower therapeutic index.
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