1. Clinical & Scientific Overview
Cytarabine (Ara-C) (TIP-MED-000553, Reference Code [ONC-04]) is classified under
Oncology & Antineoplastic Medicines as a Antimetabolite (S-Phase Specific) • Pyrimidine Nucleoside Analogue Antimetabolite.
Within the Indian regulatory and compendial framework, it is governed under Schedule H (Prescription Only — Specialist Oncology Supervision).
Cytosar (Pfizer Ltd), Bioarac (Biochem), Arasid (Intas Pharmaceuticals)
Solution for Injection: 100 mg/mL, 500 mg vial, 1 g vial
Oncology Specialisation & Cytotoxic Safety Protocol
Antimetabolite (S-Phase Specific)
Antineoplastic Cytotoxic
Standard Regimen & Cycle Context: 7+3 AML Induction: 100–200 mg/m2/day continuous IV infusion for 7 days + Daunorubicin Days 1–3; HiDAC Consolidation: 1.5–3 g/m2 IV over 3 hours q12h on Days 1, 3, 5.
Signature Dose-Limiting Toxicities & Organ Monitoring: High-Dose Cytarabine (HiDAC) Syndrome: cerebellar neurotoxicity (ataxia, dysarthria, nystagmus — increased risk if age >60 or CrCl <60 mL/min), chemical haemorrhagic conjunctivitis (prevented by prophylactic prednisolone/dexamethasone eye drops q6h starting before first HiDAC dose), and Cytarabine Syndrome (fever, myalgia, bone pain, maculopapular rash 6–12 h post-infusion).
Extravasation, Premedication & Safe Cytotoxic Handling: Perform finger-to-nose and gait cerebellar exam before EVERY HiDAC dose (discontinue immediately if ataxia or nystagmus develops); instil corticosteroid eye drops q6h during HiDAC and for 48 hours after completion.
3. Mechanism of Action & Pharmacodynamics
Phosphorylated intracellularly by deoxycytidine kinase to Ara-CTP, which competitively inhibits DNA polymerase alpha/delta and incorporates into replicating DNA strands, terminating chain elongation during S-phase.
4. Therapeutic Indications & Evidence-Supported Uses
- Acute Myeloid Leukaemia (AML — 7+3 induction at 100–200 mg/m2/day and HiDAC consolidation at 1.5–3 g/m2 q12h)
- CNS leukaemic meningitis (intrathecal preservative-free formulation only)
🇮🇳 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: Educational Oncology Regimen Context (Specialist Reference Only): 7+3 AML Induction: 100–200 mg/m2/day continuous IV infusion for 7 days + Daunorubicin Days 1–3; HiDAC Consolidation: 1.5–3 g/m2 IV over 3 hours q12h on Days 1, 3, 5.
Administration & Meal Timing: 7+3 AML Induction: 100–200 mg/m2/day continuous IV infusion for 7 days + Daunorubicin Days 1–3; HiDAC Consolidation: 1.5–3 g/m2 IV over 3 hours q12h on Days 1, 3, 5.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Specialist oncology pharmacokinetic profile; dosing depends on Body Surface Area (BSA in m2), Calvert GFR formula, or flat targeted dosing with strict organ-function adjustments.
Hepatic enzymatic activation/inactivation or proteolytic degradation (for monoclonal antibodies); see specific polymorphism and interaction notes.
Verify serum creatinine and eGFR before every cycle; see drug-specific renal dosing and uroprotection rules.
Check total bilirubin, AST, and ALT prior to each cycle; taxanes, anthracyclines, and TKIs require strict hepatic dose modification.
7. Contraindications, Precautions & High-Risk Warnings
- Severe hypersensitivity to Cytarabine or formulation vehicle
- Pregnancy and lactation (potent teratogen/embryotoxic class warning unless explicitly evaluated by oncology specialist)
- Severe unrecovered bone marrow aplasia or decompensated organ failure per protocol thresholds
Key Clinical Precautions: High-Dose Cytarabine (HiDAC) Syndrome: cerebellar neurotoxicity (ataxia, dysarthria, nystagmus — increased risk if age >60 or CrCl <60 mL/min), chemical haemorrhagic conjunctivitis (prevented by prophylactic prednisolone/dexamethasone eye drops q6h starting before first HiDAC dose), and Cytarabine Syndrome (fever, myalgia, bone pain, maculopapular rash 6–12 h post-infusion).
8. Adverse Effects Profile
- High-Dose Cytarabine (HiDAC) Syndrome: cerebellar neurotoxicity (ataxia, dysarthria, nystagmus — increased risk if age >60 or CrCl <60 mL/min), chemical haemorrhagic conjunctivitis (prevented by prophylactic prednisolone/dexamethasone eye drops q6h starting before first HiDAC dose), and Cytarabine Syndrome (fever, myalgia, bone pain, maculopapular rash 6–12 h post-infusion).
- High-Dose Cytarabine (HiDAC) Syndrome: cerebellar neurotoxicity (ataxia, dysarthria, nystagmus — increased risk if age >60 or CrCl <60 mL/min), chemical haemorrhagic conjunctivitis (prevented by prophylactic prednisolone/dexamethasone eye drops q6h starting before first HiDAC dose), and Cytarabine Syndrome (fever, myalgia, bone pain, maculopapular rash 6–12 h post-infusion).
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- High-Dose Cytarabine (HiDAC) Syndrome: cerebellar neurotoxicity (ataxia, dysarthria, nystagmus — increased risk if age >60 or CrCl <60 mL/min), chemical haemorrhagic conjunctivitis (prevented by prophylactic prednisolone/dexamethasone eye drops q6h starting before first HiDAC dose), and Cytarabine Syndrome (fever, myalgia, bone pain, maculopapular rash 6–12 h post-infusion).
- Avoid live-attenuated vaccines during immunosuppressive chemotherapy; verify CYP3A4, UGT1A1, DPD, and QTc interactions before each cycle.
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Perform finger-to-nose and gait cerebellar exam before EVERY HiDAC dose (discontinue immediately if ataxia or nystagmus develops); instil corticosteroid eye drops q6h during HiDAC and for 48 hours after completion.
Pharmacist Patient Counselling Points:
- Perform finger-to-nose and gait cerebellar exam before EVERY HiDAC dose (discontinue immediately if ataxia or nystagmus develops); instil corticosteroid eye drops q6h during HiDAC and for 48 hours after completion.
- Report fever >=38.0°C (100.4°F) immediately (medical emergency: possible febrile neutropenia).
- Follow strict reproductive contraception and safe cytotoxic oral handling instructions.
Storage, Stability & Dispensing Safeguards: Perform finger-to-nose and gait cerebellar exam before EVERY HiDAC dose (discontinue immediately if ataxia or nystagmus develops); instil corticosteroid eye drops q6h during HiDAC and for 48 hours after completion.
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: National Cancer Grid (NCG) India Consensus Guidelines; NLEM 2022 Antineoplastic Section; Indian Pharmacopoeia (IP) & CDSCO Approved Oncology Prescribing Information.
Official Verification Portals: National Cancer Grid (NCG) India — Evidence-Based Oncology Guidelines • CDSCO — Central Drugs Standard Control Organization Approved Drug Data • Indian Pharmacopoeia Commission (IPC)
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: VERIFIED_EDUCATIONAL_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
💊 Related Pharmacological / Category Profiles
- [ONC-03] Temozolomide — Alkylating / Methylating Agent • Imidazotetrazine Oral DNA Methyl
- [ONC-05] Gemcitabine Hydrochloride — Antimetabolite (Pyrimidine Analogue) • Deoxycytidine Fluorinated
- [ONC-06] Capecitabine — Antimetabolite (Fluoropyrimidine) • Oral Fluoropyrimidine Carbama
- [ONC-07] Pemetrexed Disodium — Antimetabolite (Folate Antagonist) • Multi-Targeted Antifolate An
