1. Pharmacology

Amlodipine Besilate is a dihydropyridine calcium channel blocker.

  • It inhibits the influx of calcium ions into vascular smooth muscle and cardiac muscle.

  • This leads to vasodilation, reduced peripheral resistance, and lowered blood pressure.

  • It also reduces myocardial oxygen demand, making it effective for angina pectoris.

2. Dosage & Administration

Adults

  • Hypertension/Angina: Starting dose is usually 5 mg once daily, can be increased to 10 mg once daily depending on patient response.

Elderly or Hepatic Impairment

  • Start with 2.5 mg once daily.

Children (6–17 years)

  • 2.5 to 5 mg once daily (only for hypertension).

Route: Oral, with or without food.

3. Interaction

  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): may increase amlodipine levels.

  • CYP3A4 inducers (e.g., rifampicin, phenytoin): may reduce efficacy.

  • May enhance effects of other antihypertensives.

  • Simvastatin: dose should not exceed 20 mg daily when co-administered.

4. Contraindications

  • Hypersensitivity to amlodipine or any component of the formulation.

  • Cardiogenic shock.

  • Severe aortic stenosis.

  • Unstable angina (except when being treated with beta-blockers).

  • Severe hypotension (SBP < 90 mmHg).

5. Side Effects

Common:

  • Edema (especially peripheral)

  • Fatigue

  • Dizziness

  • Palpitations

  • Flushing

  • Nausea

Less common:

  • Abdominal pain

  • Sleep disturbances

  • Muscle cramps

  • Gynecomastia (rare)

6. Pregnancy & Lactation

Pregnancy Category C

  • No adequate studies in pregnant women; use only if potential benefit justifies risk.

Lactation:

  • Unknown if excreted in breast milk; caution is advised.

7. Precautions & Warnings

  • Use cautiously in patients with heart failure, hepatic impairment, or severe hypotension.

  • Monitor BP regularly.

  • Avoid abrupt withdrawal in angina or coronary artery disease.

  • Use lower doses in elderly.

8. Overdose Effects

  • Symptoms: Hypotension, dizziness, reflex tachycardia.

  • Treatment: Supportive care, monitoring. IV fluids, vasopressors (like dopamine), and calcium infusion may be used in severe cases.

9. Therapeutic Class

  • Calcium Channel Blockers (Dihydropyridine group)

  • Antihypertensive & Antianginal Agent

10. Storage Conditions

  • Store below 25°C.

  • Protect from light and moisture.

  • Keep out of reach of children.

11. Chemical Structure

IUPAC Name:
3-Ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

Molecular Formula:
C₂₀H₂₅ClN₂O₅

Molecular Weight:
408.88 g/mol

Structural Formula:

O
||
C6H5—C—OCH2CH2NH2 attached to a dihydropyridine ring

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