1. Clinical & Scientific Overview
Hydroxychloroquine Sulfate (HCQ) (TIP-MED-000124, Reference Code [7.22]) is classified under
Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07) as a 4-Aminoquinoline Immunomodulator & Disease-Modifying Antirheumatic Drug — DMARD (Schedule H1 / H | NLEM 2022).
Within the Indian regulatory and compendial framework, it is governed under Schedule H Prescription Drug (To be sold by retail on the prescription of a Registered Medical Practitioner only — Drugs Rules 1945).
Representative Indian Market Examples (Edition 2.7 Ch 07 [7.22], p. 89): HCQS (Ipca), Zyq (Zydus), Oxiklorin (Wallace), Plaquenil — Strengths & Dosage Forms: Film-Coated Tablets: 200 mg, 300 mg, 400 mg
Film-Coated Tablets: 200 mg, 300 mg, 400 mg
3. Mechanism of Action & Pharmacodynamics
4-Aminoquinoline Immunomodulator & Disease-Modifying Antirheumatic Drug — DMARD (Schedule H1 / H | NLEM 2022) acting on target receptor/enzyme pathways in Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07): clinical efficacy is mediated via 4-Aminoquinoline Immunomodulator & Disease-Modifying Antirheumatic Drug — DMARD (Schedule H1 / H | NLEM 2022) for Rheumatoid arthritis (mild-to-moderate or in triple DMARD combination with Methotrexate + Sulfasalazine), Systemic Lupus Erythematosus (SLE — reduces flares, thrombosis, and mortality; safe & continued throughout pregnancy in SLE!), Sjogren's syndrome; also approved in India as 3rd/4th-line add-on in Type 2 DM.
4. Therapeutic Indications & Evidence-Supported Uses
- Rheumatoid arthritis (mild-to-moderate or in triple DMARD combination with Methotrexate + Sulfasalazine), Systemic Lupus Erythematosus (SLE — reduces flares, thrombosis, and mortality
- safe & continued throughout pregnancy in SLE!), Sjogren's syndrome
- also approved in India as 3rd/4th-line add-on in Type 2 DM
🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: 200–400 mg PO daily (MUST NOT EXCEED 5.0 mg/kg/day of actual body weight — e.g., max 200–300 mg/day if weight is 50–60 kg — to prevent bull's-eye retinal maculopathy!)
Administration & Meal Timing: Take WITH a meal or a glass of milk to minimise nausea and epigastric discomfort | Once Daily with Dinner (or 200 mg BD with Breakfast & Dinner)
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal: 50% renally cleared — reduce dose in CKD Stage 3–5 (eGFR <60 mL/min is a major risk factor for retinal toxicity!). Hepatic: Caution in hepatic disease
Renal: 50% renally cleared — reduce dose in CKD Stage 3–5 (eGFR <60 mL/min is a major risk factor for retinal toxicity!). Hepatic: Caution in hepatic disease
Renal: 50% renally cleared — reduce dose in CKD Stage 3–5 (eGFR <60 mL/min is a major risk factor for retinal toxicity!). Hepatic: Caution in hepatic disease
7. Contraindications, Precautions & High-Risk Warnings
- Contraindicated in pre-existing retinal maculopathy/visual field defects, 4-aminoquinoline hypersensitivity, and children <6 years (200 mg tablet not suitable for <31 kg). Caution in G6PD deficiency, psoriasis, and QTc prolongation
Key Clinical Precautions: Renal: 50% renally cleared — reduce dose in CKD Stage 3–5 (eGFR <60 mL/min is a major risk factor for retinal toxicity!). Hepatic: Caution in hepatic disease
8. Adverse Effects Profile
- Nausea, abdominal cramps, diarrhoea, anorexia, headache, skin hyperpigmentation, pruritus
- Irreversible Bull's-Eye Retinal Maculopathy (risk increases after >5 years of use, dose >5 mg/kg/day, CKD, or concurrent Tamoxifen!), QTc prolongation / Torsades de Pointes, rare cardiomyopathy, hypoglycaemia (even in non-diabetics!), haemolysis in G6PD deficiency
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Additive QTc prolongation with Azithromycin, Clarithromycin, Fluoroquinolones, Ondansetron, Domperidone, Amiodarone, and Escitalopram; increases Digoxin levels (P-gp inhibition); potentiates Insulin/Sulfonylurea hypoglycaemia; Antacids reduce absorption (space by >=4h); Tamoxifen increases retinopathy risk 5-fold
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Monitor clinical response, baseline renal/hepatic parameters, and relevant serum biomarkers.
Pharmacist Patient Counselling Points:
- Patient Counselling Checklist: Take with food or milk; takes 2–3 months to relieve joint pain fully; calculate dose by body weight (<=5 mg/kg/d) and get an eye specialist retinal check-up; safe and essential to continue during pregnancy if you have Lupus (SLE); report any reading difficulty or central blurry vision immediately
- Meal & Clock Timing Instruction: Take WITH a meal or a glass of milk to minimise nausea and epigastric discomfort (Once Daily with Dinner (or 200 mg BD with Breakfast & Dinner))
- Missed Dose Protocol: Take with next meal if remembered; do not double dose
- Geriatric Dispensing Pearl: Calculate mg/kg dose carefully in low-body-weight elderly Indian women (e.g., 45 kg -> max 200 mg/day!) and check eGFR
Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Film-Coated Tablets: 200 mg, 300 mg, 400 mg
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 07 [7.22] (p. 89)
Official Verification Portals: Indian Pharmacopoeia Commission (IPC) & National Formulary of India (NFI) • Central Drugs Standard Control Organization (CDSCO) • Ministry of Health & Family Welfare — NLEM 2022 • NCBI Bookshelf / StatPearls Pharmacology Reference • DailyMed (US FDA Official Prescribing Reference)
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: HANDBOOK_SOURCE_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.
13. Related Reference Monographs, Educational Guides & Visual Concept
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