Hydroxychloroquine Schedule (India)

Schedule H

Hydroxychloroquine Routes

Oral

Hydroxychloroquine Formulations

Tablets: 200 mg, 300 mg, 400 mg (as hydroxychloroquine sulfate)

Hydroxychloroquine Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Rheumatoid Arthritis

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:

Clinical response may take 3–6 months

Baseline and periodic ophthalmologic monitoring mandatory

Often used in combination with other DMARDs (methotrexate, sulfasalazine)

Systemic Lupus Erythematosus (SLE)

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:

Continued long-term; reduces flare frequency and severity

Associated with reduced thrombotic events and improved survival

Consider continuation during pregnancy for SLE patients

Malaria

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:

For P. vivax and P. ovale: Follow with primaquine (after G6PD screening) for radical cure

Not recommended for chloroquine-resistant P. falciparum areas

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:

Begin 1–2 weeks before travel to endemic area

Continue for 4 weeks after leaving endemic area

Not effective for prophylaxis in chloroquine-resistant regions

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.

Hydroxychloroquine Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Juvenile Idiopathic Arthritis (JIA)

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:

Administer in 1–2 divided doses

Baseline ophthalmologic examination mandatory

Commercial tablets may require splitting; compounded suspension if needed

Paediatric Systemic Lupus Erythematosus

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:

Long-term therapy; critical for disease control

Annual ophthalmologic monitoring after baseline

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.

Hydroxychloroquine Renal Adjustments

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

Hydroxychloroquine Hepatic adjustment

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

Hydroxychloroquine Contraindications

Known hypersensitivity to hydroxychloroquine, chloroquine, or other 4-aminoquinolines

Pre-existing retinopathy or maculopathy

Pre-existing QT prolongation or history of torsades de pointes

Concurrent use with other QT-prolonging drugs known to cause torsades (especially in combination)

Known visual field defects attributable to 4-aminoquinoline compounds

Hydroxychloroquine Cautions

G6PD deficiency (risk of haemolysis; screen before use, especially for malaria treatment)

Long-term use (>5 years): Increased risk of retinal toxicity — regular ophthalmologic monitoring essential

Psoriasis (may exacerbate skin disease)

Epilepsy or history of seizures (may lower seizure threshold)

Porphyria (may exacerbate)

Pre-existing cardiac disease or arrhythmias

Myasthenia gravis (may worsen weakness)

Renal or hepatic impairment

Concurrent use of hepatotoxic drugs

Hypoglycaemia risk (even in non-diabetics)

Hydroxychloroquine Pregnancy

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

Hydroxychloroquine Lactation

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

Hydroxychloroquine Elderly

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

Hydroxychloroquine Major drug interactions

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

Hydroxychloroquine Moderate drug interactions

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

Hydroxychloroquine Common Adverse effects

Nausea, vomiting, diarrhoea

Abdominal cramps, anorexia

Headache, dizziness

Skin rash, pruritus

Blurred vision, difficulty in focusing (reversible)

Photosensitivity

Mood changes, irritability

Hydroxychloroquine Serious Adverse effects

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

Hydroxychloroquine Monitoring requirements

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.

Hydroxychloroquine Brands in India

HCQS® (Ipca Laboratories)

Plaquenil® (Sanofi)

HCQ® (Zydus)

Aqchlor® (Macleods)

Oxcq® (Mankind)

Hydroquin® (Walter Bushnell)

Multiple generics available

Hydroxychloroquine Price range (INR)

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:

Included in NLEM 2022

NPPA ceiling price applicable

Government supply available at subsidised rates

Hydroxychloroquine Clinical pearls

Dosing by body weight: Calculate dose using actual body weight (not ideal body weight as previously recommended); maximum 5 mg/kg/day reduces long-term retinal toxicity risk.

Retinal screening timing: Begin annual comprehensive eye screening after 5 years of use, or earlier if risk factors present (renal impairment, high dose, tamoxifen use).

Continue in pregnancy: HCQ is one of the safest DMARDs in pregnancy; discontinuation in SLE patients increases flare risk and adverse pregnancy outcomes.

COVID-19 use abandoned: Do not prescribe for COVID-19 prevention or treatment; ICMR recommendations have been withdrawn; no proven efficacy.

Hypoglycaemia awareness: Inform patients (especially diabetics on sulfonylureas/insulin) about hypoglycaemia risk; HCQ enhances insulin sensitivity.

Long-term SLE benefit: Continuous HCQ use in SLE reduces mortality, flares, organ damage accrual, and thrombotic events — strongly encouraged as lifelong therapy.

Hydroxychloroquine Tags

DMARD; antimalarial; SLE; rheumatoid-arthritis; retinal-toxicity; pregnancy-safe; NLEM-India; 4-aminoquinoline; ophthalmologic-monitoring; QT-prolongation-risk; Hydroxychloroquine

Hydroxychloroquine Version

RxIndia v1.1 — 07 Apr 2025

Hydroxychloroquine Reference

CDSCO approved product labelling

Indian Pharmacopoeia / National Formulary of India

NLEM 2022

API Textbook of Medicine (11th edition)

AIIMS Rheumatology Treatment Protocols

Indian Rheumatology Association Recommendations

ICMR COVID-19 Advisories (archived — for historical context only)

NCDC Malaria Treatment Guidelines

AAO (American Academy of Ophthalmology) Retinal Screening Guidelines 2016 (supportive reference for monitoring recommendations)

RxIndia

The Drug Registry

Hydroxychloroquine