1. Amlodipine (as Amlodipine Besylate)

7. Pharmacokinetics (Absorption, Distribution, Metabolism, Excretion): Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.

16a. Renal Considerations: No dose adjustment required in renal impairment (including CKD Stages 3–5); Amlodipine is not dialysable.

16b. Hepatic Considerations: Extensively metabolised by hepatic CYP3A4; initiate at 2.5 mg once daily and titrate slowly in severe hepatic insufficiency (Child-Pugh C).

• Dose-dependent bilateral ankle/pedal oedema (due to pre-capillary arteriolar dilation without matching post-capillary venular dilation — responds to ACEi/ARB addition rather than loop diuretics)
• Facial flushing, headache, dizziness, palpitations
• Gingival hyperplasia (with long-term use; advise oral hygiene)

• Simvastatin: Co-administration with Amlodipine increases simvastatin systemic exposure; cap simvastatin dose at 20 mg/day to prevent myopathy/rhabdomyolysis.
• Strong CYP3A4 Inhibitors (Clarithromycin, Itraconazole, Ketoconazole): Increase plasma Amlodipine levels by up to 60%; monitor for hypotension and pedal oedema.
• CYP3A4 Inducers (Rifampicin, Phenytoin, Carbamazepine): Reduce Amlodipine plasma concentrations; monitor blood pressure control.

15. Use in Special Populations (Pregnancy, Lactation, Paediatrics, Geriatrics): Evaluate maternal-foetal benefit-risk ratio, paediatric mg/kg ceiling, and geriatric renal function prior to prescribing.

17. Clinical & Laboratory Monitoring: Monitor clinical response, baseline renal/hepatic parameters, and relevant serum biomarkers.

• Take once daily at the same time each day, with or without food.
• Report persistent ankle or foot swelling; do not abruptly discontinue antihypertensive therapy without medical guidance.
• Rise slowly from sitting or lying positions during the first week to minimise postural dizziness.

Storage & Dispensing Notes: Store below 30°C protected from light and moisture. Verify strength carefully (2.5 mg vs 5 mg vs 10 mg) and check whether prescribed as plain Amlodipine or an FDC (e.g., Amlodipine + Telmisartan or Amlodipine + Atenolol).