Amlodipine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Hypertension; Chronic stable angina; Prinzmetal’s angina Initial: 5 mg once daily. Dosage is individualised and may be increased after at least 1-2 weeks. Max dose: 10 mg/day.
Dosage Details
Oral
Chronic stable angina, Hypertension, Prinzmetal's angina
Adult: Initially, 5 mg once daily. Dosage is individualised and may be increased after at least 1-2 weeks. Max: 10 mg once daily.
Child: 6-17 years Initially, 2.5 mg once daily, may increase to 5 mg once daily after 4 weeks intervals according to clinical response.
Elderly: Initially, 2.5 mg once daily.
Hepatic Impairment
Severe: Initially, 2.5 mg once daily, may be titrated according to clinical response.
Administration
May be taken with or without food.
Contraindications
Severe hypotension, cardiogenic shock, left ventricular outflow tract obstruction (e.g. high-grade aortic stenosis), heart failure after acute MI.
Special Precautions
Patients with aortic stenosis, congestive heart failure, hypertrophic cardiomyopathy, outflow tract obstruction, severe obstructive coronary disease. Hepatic impairment. Elderly and children. Pregnancy and lactation.
Adverse Reactions
Significant: Peripheral oedema, hypotension, angina/MI.
Blood and lymphatic system disorders: Leucopenia, thrombocytopenia.
Cardiac disorders: Bradycardia, ventricular tachycardia, chest pain, palpitation.
Ear and labyrinth disorders: Tinnitus.
Eye disorders: Visual disturbance, diplopia, conjunctivitis.
Gastrointestinal disorders: Nausea, dyspepsia, diarrhoea, constipation, abdominal pain.
General disorders and admin site conditions: Fatigue, asthenia.
Investigations: Weight gain, elevated hepatic enzymes.
Musculoskeletal and connective tissue disorders: Muscle cramps, arthralgia, back pain.
Nervous system disorders: Headache, somnolence, dizziness, extrapyramidal symptoms.
Psychiatric disorders: Insomnia, anxiety, depression.
Renal and urinary disorders: Micturition disorder, nocturia.
Reproductive system and breast disorders: Sexual dysfunction, gynaecomastia.
Respiratory, thoracic and mediastinal disorders: Pulmonary oedema, dyspnoea, cough, rhinitis.
Skin and subcutaneous tissue disorders: Rash, skin discolouration, pruritus.
Vascular disorders: Flushing.
Patient Counseling Information
This drug may cause dizziness, headache, fatigue or nausea, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor BP, heart rate, pulse, frequency and intensity of angina, weight, and peripheral oedema.
Overdosage
Symptoms: Bradycardia, dysrhythmia, marked hypotension, excessive peripheral vasodilation, reflex tachycardia, shock. Management: Perform gastric lavage and administration of charcoal up to 2 hours after ingestion. Initiate active cardiovascular support, monitor cardiac and respiratory function, elevation of extremities and attention of circulation fluid volume and urine output. For restoring vascular tone and blood pressure, may give a vasoconstrictor and IV Ca gluconate to reverse the effects of Ca channel blocker.
Drug Interactions
Increased systemic plasma concentration with immunosuppressants (e.g. ciclosporin, tacrolimus). Increased serum concentration of simvastatin. Increased exposure with CYP3A4 enzyme inhibitors (e.g. protease inhibitors, azole antifungals, erythromycin, diltiazem). Decreased plasma concentration with CYP3A4 inducers (e.g. rifampicin).
Food Interaction
Increased plasma concentration with grapefruit or grapefruit juice. Decreased plasma concentrations with St. John’s wort.
Lab Interference
May result to false-positive aldosterone/renin ratio (ARR).
Action
Description: Amlodipine, a dihydropyridine Ca-channel blocker, reduces peripheral vascular resistance and BP by relaxing coronary vascular smooth muscle and coronary vasodilation through inhibition of Ca ion transmembrane influx into cardiac and vascular smooth muscles.
Onset: 24-48 hours.
Duration: 24 hours.
Pharmacokinetics:
Absorption: Well absorbed from the gastrointestinal tract. Bioavailability: Approx 60-65%. Time to peak plasma concentration: 6-12 hours.
Distribution: Crosses placenta and enters breast milk. Volume of distribution: 21 L/kg. Plasma protein binding: Approx 98%.
Metabolism: Extensively metabolised in the liver to inactive metabolites.
Excretion: Via urine (60% as metabolites, 10% as unchanged drug). Terminal elimination half-life: 35-50 hours.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store between 15-30°C. Protect from light.
MIMS Class
ATC Classification
C08CA01 - amlodipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
Disclaimer: This information is independently developed by MIMS based on Amlodipine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Amcor
  • Amlibon
  • Amlodac
  • Amlodipine Winthrop
  • Amlong
  • Amlopres
  • Amvaz
  • Camlodin
  • Hovasc
  • Lotense 10 mg Capsule
  • Lotense 5 mg Capsule
  • Nordipine
  • Vamlo
  • Zynor
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in