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MEDICINE MONOGRAPH CODE: [3.26] ID: TIP-MED-000026

Cilnidipine

Active Ingredient / Scientific Identity: Cilnidipine • Class: Dual L-Type & N-Type Dihydropyridine Calcium-Channel Blocker (Schedule H)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Cilnidipine ([3.26] | ID: TIP-MED-000026) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/3-26-cilnidipine/
Generic / Entity NameCilnidipine ([3.26])
Verified Indian Brands / RefRosuvas (Sun Pharma), Rozavel (Sun Pharma), Crestor (AstraZeneca), Novastat (Lupin)
Pharmacological ClassDual L-Type & N-Type Dihydropyridine Calcium-Channel Blocker (Schedule H)
Available Dosage FormsTablets: 5 mg, 10 mg, 20 mg; FDCs with Telmisartan (40/10 mg) or Metoprolol XL (25/50 + 10 mg)
Regulatory ClassificationSchedule H Prescription Drug (To be sold by retail on the prescription of a Registere
Key Warning & Review DateRenal: No dose adjustment needed in CKD (reduces intraglomerular pressure). Hepatic: Halve starting dose (5 mg OD) in moderat
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H Prescription Drug (To be sold by retail o✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Cilnidipine (TIP-MED-000026, Reference Code [3.26]) is classified under Cardiovascular & Antithrombotic Medicines (Ch 03) as a Dual L-Type & N-Type Dihydropyridine Calcium-Channel Blocker (Schedule H). 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).

Verified Indian Market Examples / Compendial Status:
Rosuvas (Sun Pharma), Rozavel (Sun Pharma), Crestor (AstraZeneca), Novastat (Lupin)
Representative Indian Market Examples (Edition 2.7 Ch 03 [3.26], p. 33): Cilacar (JB Chemicals), Cinod (Zuventus), Cilaheart (Mankind), Dilnip (Lupin) — Strengths & Dosage Forms: Tablets: 5 mg, 10 mg, 20 mg; FDCs with Telmisartan (40/10 mg) or Metoprolol XL (25/50 + 10 mg)
Dosage Forms & Available Strengths:
Tablets: 5 mg, 10 mg, 20 mg; FDCs with Telmisartan (40/10 mg) or Metoprolol XL (25/50 + 10 mg)
Routes: Oral / Parenteral / Topical as specified by formulation

3. Mechanism of Action & Pharmacodynamics

Dual L-Type & N-Type Dihydropyridine Calcium-Channel Blocker (Schedule H) acting on target receptor/enzyme pathways in Cardiovascular & Antithrombotic Medicines (Ch 03): clinical efficacy is mediated via Dual L-Type & N-Type Dihydropyridine Calcium-Channel Blocker (Schedule H) for Essential hypertension, especially in patients developing pedal oedema on Amlodipine or with sympathetic hyperactivity / proteinuric CKD.

4. Therapeutic Indications & Evidence-Supported Uses

  • Essential hypertension, especially in patients developing pedal oedema on Amlodipine or with sympathetic hyperactivity / proteinuric CKD

🇮🇳 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: Start 5–10 mg PO OD; titrate to max 20 mg OD (or 10 mg BD in resistant HTN)

Administration & Meal Timing: Take with or immediately after breakfast; swallow whole with water | Morning (OD) or Morning & Evening (if 10 mg BD)

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Metabolism & Biotransformation:
Renal: No dose adjustment needed in CKD (reduces intraglomerular pressure). Hepatic: Halve starting dose (5 mg OD) in moderate cirrhosis
Elimination & Renal Adjustment:
Renal: No dose adjustment needed in CKD (reduces intraglomerular pressure). Hepatic: Halve starting dose (5 mg OD) in moderate cirrhosis
Hepatic Impairment Considerations:
Renal: No dose adjustment needed in CKD (reduces intraglomerular pressure). Hepatic: Halve starting dose (5 mg OD) in moderate cirrhosis

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • Contraindicated in cardiogenic shock, severe aortic stenosis, unstable angina, and pregnancy

Key Clinical Precautions: Renal: No dose adjustment needed in CKD (reduces intraglomerular pressure). Hepatic: Halve starting dose (5 mg OD) in moderate cirrhosis

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Mild headache, flushing, dizziness; significantly lower incidence of ankle oedema than Amlodipine due to N-type sympathetic venular dilation
  • Symptomatic hypotension, reflex tachycardia (rare), gingival hyperplasia on long-term use
Serious / Dose-Limiting Adverse Effects:
  • Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.

9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions

  • CYP3A4 inhibitors (Clarithromycin, Itraconazole) increase levels; additive BP lowering with ARBs/beta-blockers; NSAIDs blunt effect

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: Switch option when Amlodipine causes ankle swelling; rise slowly from sitting; maintain low-salt (<5 g/d) diet
  • Meal & Clock Timing Instruction: Take with or immediately after breakfast; swallow whole with water (Morning (OD) or Morning & Evening (if 10 mg BD))
  • Missed Dose Protocol: Take on same day if remembered; skip if next day; never double dose
  • Geriatric Dispensing Pearl: Start at 5 mg OD in frail elderly; well tolerated with low orthostatic or bradycardic risk

Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Tablets: 5 mg, 10 mg, 20 mg; FDCs with Telmisartan (40/10 mg) or Metoprolol XL (25/50 + 10 mg)

11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)

THE 12-STEP ORAL DRUG JOURNEY THROUGH THE HUMAN BODY (LADME) Note: IV bolus enters Step 6 directly (F = 100%); Sublingual & Transdermal routes bypass Step 4–5 Portal First-Pass Metabolism 1. Oral Administration • Tablet / Capsule swallowed • Gastric emptying to duodenum pH 1.5–3.5 (Stomach) 2. Disintegration & Dissolution • Tablet breaks into granules • API dissolves in GI fluid Noyes-Whitney Dissolution Rate 3. GI Epithelial Absorption • Crosses intestinal villi • Passive / Active / P-gp efflux Small Intestine (Large Surface Area) 4. Portal Circulation • Mesenteric veins → Portal vein • Delivers blood to liver sinusoids Pre-systemic Venous Conduit 5. First-Pass Metabolism • Gut & hepatic CYP450 extraction • High: GTN, Propranolol, Morphine Determines Bioavailability (F = f_a × (1-E_H)) 6. Systemic Circulation • Hepatic vein → IVC → Heart • Unbound vs Albumin-bound drug Only FREE drug is active 7–8. Tissue Distribution (Vd) • Capillary permeation to organs • Blood-Brain & Placental barriers Vd = Dose / C_0 (L or L/kg) 9. Target Site of Action • Receptors (GPCR, Ion channel) • Enzymes & Carrier Transporters Pharmacodynamic Effect (E_max, EC50) 10. Hepatic Biotransformation • Phase I (CYP450 Oxidation/Hydrolysis) • Phase II (Glucuronidation/Sulfation) Converts lipophilic drug → hydrophilic metabolite 11. Renal & Biliary Elimination • Nephron: Filtration + Secretion − Reabsorption • Biliary excretion & Enterohepatic recycling Total Clearance CL_tot = CL_renal + CL_hepatic 12. Excretion from the Body • Urine (Primary polar metabolite route) • Bile/Faeces, Expired Air, Sweat, Milk Elimination Half-Life t1/2 = (0.693 × Vd) / CL
svg-v339-01-adme-12-step-journey — 8.1 Complete 12-Step Journey of an Orally Administered Drug (ADME): Figure 8.1: The 12-step physiological journey of a typical orally administered solid dosage form through Liberation, Absorption, Distribution, Metabolism, and Excretion (LADME). Note: Parenteral (IV), sublingual, and inhalational routes bypass gastrointestinal absorption and/or hepatic first-pass metabolism.

12. Authoritative References, Regulatory Sources & Editorial Disclaimer

Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 03 [3.26] (p. 33)

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.

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Educational Reference Notice: This printout from THE INDIAN PHARMACIST (https://theindianpharmacist.com/medicine/3-26-cilnidipine/, Last Reviewed: 2026-11-10) is an educational reference sheet for students and healthcare learners. It is NOT an official prescribing guideline or patient-specific treatment order.