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Authoritative Clinical Reference
Schedule H
Oral
Formulation Strengths Available
Capsule 500 mg
Tablet 500 mg, 1000 mg
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
✦ Chronic Myeloid Leukaemia (CML) — Palliative or Cytoreductive
Parameter Details
Starting dose 20–30 mg/kg/day orally as single dose or in two divided doses
Titration Adjust weekly based on WBC response and tolerance
Usual maintenance dose 20–25 mg/kg/day
Maximum dose 35 mg/kg/day (short-term use only)
Clinical Notes:
✦ Polycythaemia Vera
Parameter Details
Starting dose 15–20 mg/kg/day orally
Titration Adjust every 1–2 weeks based on haematocrit and WBC response
Usual maintenance dose 500–1000 mg/day
Maximum dose 2000 mg/day in divided doses
Clinical Notes:
✦ Sickle Cell Disease — Prevention of Vaso-Occlusive Crises
Parameter Details
Starting dose 15 mg/kg/day orally (10 mg/kg/day if baseline cytopenia present)
Titration Increase by 5 mg/kg every 8 weeks based on tolerance and haematological response
Usual maintenance dose 20–30 mg/kg/day
Maximum dose 35 mg/kg/day
Clinical Notes:
Secondary Indications — Adults (Off-label, if any)
Indication Dose Duration Notes
Essential Thrombocythaemia Starting: 500 mg/day; titrate to 500–1500 mg/day based on platelet response Long-term Specialist only; target platelet count <400,000/mm³; based on Indian haematology practice
Myelofibrosis (symptomatic) 500–1000 mg/day; titrate per counts Long-term OFF-LABEL — Specialist only; for leucocytosis/thrombocytosis control
Severe Psoriasis (HIV-associated, refractory) 500–1000 mg/day Short intermittent courses OFF-LABEL — Specialist only; limited evidence from case series
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
✦ Sickle Cell Disease (Age ≥2 years)
Parameter Details
Eligibility Children ≥2 years of age; use actual body weight
Starting dose 15–20 mg/kg/day orally as single dose
Titration Increase by 5 mg/kg every 8 weeks if tolerated and response inadequate
Usual maintenance dose 20–25 mg/kg/day
Maximum dose 35 mg/kg/day
Weight-based Dosing Reference (using 500 mg capsules/tablets):
Body Weight (kg) Starting Dose Maximum Dose
10–15 250 mg/day 500 mg/day
16–25 500 mg/day 750–1000 mg/day
26–35 500–750 mg/day 1000–1250 mg/day
36–50 750–1000 mg/day 1500–1750 mg/day
50 1000 mg/day 2000 mg/day
Monitoring Requirements:
Clinical Notes:
Secondary Indications — Paediatric Doses (Off-label, if any)
Age Restriction Statement:
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| ≥60 | mL/min No adjustment required |
| 30–59 | mL/min Reduce starting dose by 50%; monitor CBC closely |
| <30 | mL/min Start at 50% of standard dose; very close monitoring essential |
| Haemodialysis | Administer after dialysis session on dialysis days; supplemental dose not typically required |
| Peritoneal dialysis | Limited data; use reduced dose with frequent monitoring |
Note: Enhanced myelotoxicity risk in renal impairment; CBC monitoring should be more frequent (twice weekly initially)
| Severity | Recommendation |
|---|---|
| Mild impairment (Child-Pugh A) | Standard starting dose; monitor LFTs monthly |
| Moderate impairment (Child-Pugh B) | Consider 50% starting dose; titrate cautiously; close hepatic monitoring |
| Severe impairment (Child-Pugh C) | Avoid use unless benefit clearly outweighs risk; specialist supervision mandatory |
Parameter Details
Safety Category Contraindicated (Teratogenic in animal studies; limited human data suggest risk)
Preferred Alternatives Phlebotomy for polycythaemia vera; supportive care and transfusion for sickle cell disease
When May Be Used Only if life-threatening condition with no safer alternative; joint haematology-obstetric team decision required
Contraception Effective contraception mandatory during treatment and for 6 months after discontinuation (both sexes)
Monitoring If exposure occurs: detailed fetal anomaly scanning; genetic counselling
Parameter Details
Compatibility Not compatible with breastfeeding
Drug Levels in Milk Moderate (excreted in breast milk in significant amounts)
Preferred Alternative Formula feeding if mother requires hydroxyurea
Recommendation Avoid breastfeeding during therapy and for at least 1 week after final dose
Infant Monitoring Not applicable — breastfeeding contraindicated
Parameter Recommendation
Starting Dose Use lower end of dosing range (10–15 mg/kg/day)
Titration Slower titration; extend intervals between dose adjustments
Special Risks Increased myelosuppression risk; age-related renal decline affects clearance; fatigue and malaise more pronounced
Monitoring More frequent CBC (weekly initially); baseline and periodic renal function assessment
Interacting Drug Mechanism/Effect Recommendation
Zidovudine (AZT) Additive myelosuppression; severe neutropenia and anaemia Avoid combination; if essential, very close CBC monitoring
Didanosine + Stavudine Fatal hepatotoxicity and pancreatitis reported Contraindicated combination
Live vaccines Risk of disseminated vaccine infection due to immunosuppression Avoid during therapy and until immune recovery
Other myelosuppressive agents (cyclophosphamide, methotrexate) Profound bone marrow suppression Use with extreme caution; dose reduction and close monitoring required
Interacting Drug Mechanism/Effect Recommendation
Clozapine Additive neutropenia risk Avoid if possible; if used, monitor WBC/ANC weekly
Allopurinol May increase risk of skin reactions Monitor for cutaneous toxicity
Interferon alpha Enhanced myelosuppression Monitor CBC closely; may require dose adjustment of either drug
Antineoplastic agents (busulfan, cytarabine) Additive bone marrow toxicity Coordinate with oncology; stagger dosing if feasible
ACE inhibitors May potentiate leucopenia Clinical monitoring advised
Adverse Effect Clinical Notes
Severe myelosuppression Neutropenic sepsis possible; requires immediate drug discontinuation and supportive care
Secondary leukaemia Reported with long-term use; particularly in patients with prior exposure to other cytotoxic agents
Pancreatitis Especially with concurrent antiretroviral therapy; discontinue if suspected
Hepatotoxicity Monitor LFTs; discontinue if significant elevation
Pulmonary toxicity Interstitial pneumonitis/fibrosis reported; discontinue if respiratory symptoms develop
Severe cutaneous reactions (SJS/TEN) Rare; immediate discontinuation required
Vasculitic ulcers Particularly leg ulcers; may require drug withdrawal
Phase Parameters
Baseline CBC with differential and reticulocyte count; LFTs; RFTs; pregnancy test (females of childbearing potential)
During Titration CBC weekly for first 4–6 weeks, then every 2 weeks until stable
Maintenance (Stable) CBC every 4–8 weeks; LFTs and RFTs every 3 months
Sickle Cell Disease HbF levels every 3–6 months to assess therapeutic response
Long-term Annual dermatological examination (risk of skin malignancies); monitor for secondary malignancy signs
Thresholds for Dose Modification Hold if: ANC <2,000/mm³, platelets <80,000/mm³, Hb falls >2 g/dL below baseline, or reticulocytes <80,000/mm³ with Hb <9 g/dL
Brand Name Manufacturer
Hydrea Bristol-Myers Squibb
Myelostat Intas
Cytodrox Cipla
Hycibin Hetero
Novastat-HU Novartis
Oncoxyurea Neon Labs
Hydrox Sun Pharma
| Formulation | Approximate Price (per tablet) |
|---|---|
| Capsule/Tablet 500 mg | ₹5–20 per unit |
| Tablet 1000 mg | ₹40–60 per unit |
Notes:
hydroxyurea; sickle cell disease; CML; polycythaemia vera; cytoreduction; myelosuppression; HbF induction; teratogenic; renal-adjustment required; haematology; NLEM India
RxIndia v1.1 — 27-01-2026
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