Registered Kenya · PPB

NORVASC

AMLODEPINE BESYLATE

11643 5MG

What it does

Amlodipine is a medication used to treat certain heart and blood vessel conditions.

Commonly used for: high blood pressure (hypertension), angina (chest pain)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
11643
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
AMLODEPINE BESYLATE
Dosage form
5MG
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Mylan Laboratories
Applicant / LTR
-
Country of origin
FOREIGN
Manufacturer location
Plot No 564, A/22, Road No. 92, MLA Colony, Jubilee Hills, Hyderabad, Telangana 500034, India

Source: Pharmacy and Poisons Board · fetched 2026-01-28 21:46:31 · updated 2026-03-23 04:31:36

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Amlodipine is a medication used to treat certain heart and blood vessel conditions.

What it treats

  • high blood pressure (hypertension)
  • angina (chest pain)

How it works

Amlodipine helps relax and widen blood vessels, making it easier for the heart to pump blood.

Who it's for

It is prescribed for adults who have high blood pressure or chest pain caused by angina.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: amlodepine

Amlodipine is a long-acting dihydropyridine calcium channel blocker primarily used for the treatment of hypertension and angina pectoris. It works by relaxing blood vessels, thereby reducing blood pressure and decreasing the workload on the heart. Amlodipine is well-absorbed from the gastrointestinal tract, with a long half-life that allows for once-daily dosing.

Indications

  • Hypertension
  • Angina pectoris
  • Chronic stable angina
  • Vasospastic angina

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing guidelines.

Adults: Refer to the BNF for specific adult dosing guidelines.

Mechanism of action

Amlodipine inhibits the influx of calcium ions into vascular smooth muscle and cardiac muscle by blocking L-type calcium channels. This results in vasodilation, decreased peripheral vascular resistance, and reduced myocardial oxygen demand, which helps in managing conditions like hypertension and angina.

Pharmacodynamics

The pharmacodynamic effects of amlodipine include a decrease in systemic vascular resistance and arterial pressure. It leads to significant reductions in both systolic and diastolic blood pressure without causing reflex tachycardia. Amlodipine also improves exercise tolerance in patients with chronic stable angina.

Pharmacokinetics

Amlodipine has a bioavailability of approximately 64-90% and reaches peak plasma concentrations within 6-12 hours after oral administration. It is extensively metabolized in the liver, primarily by cytochrome P450 3A4, and has a half-life of about 30-50 hours, allowing for once-daily dosing. The drug is excreted mainly in the urine as metabolites, with less than 10% excreted unchanged.

Contra-indications

  • Severe hypotension
  • Aortic stenosis
  • Cardiogenic shock
  • Severe hepatic impairment
  • Hypersensitivity to amlodipine or any of its components

Adverse effects

  • Peripheral edema
  • Dizziness
  • Fatigue
  • Palpitations
  • Nausea
  • Flushing
  • Abdominal pain
  • Headache

Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) may increase amlodipine levels
  • CYP3A4 inducers (e.g., rifampicin, St. John's Wort) may decrease amlodipine levels
  • Other antihypertensives may have additive effects when used concomitantly with amlodipine

Precautions

  • Caution in patients with severe aortic stenosis
  • Caution in patients with heart failure
  • Monitor blood pressure regularly
  • Use with caution in patients with hepatic impairment

Pregnancy

Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution is advised.

Breast-feeding

Amlodipine is excreted in human breast milk. Caution is recommended when administered to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Tablets (2.5 mg, 5 mg, 10 mg)
  • Oral suspension (not widely available)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.