Amlodipine


Generic Medicine Info
Indications and Dosage
Oral
Hypertension
Adult: Initially, 5 mg once daily, may be increased to 10 mg once daily according to clinical response.
Elderly: Initiate at lower doses and titrate according to clinical response.
Child: 6-17 years Initially, 2.5 mg once daily, may be increased to 5 mg once daily after 4 weeks according to clinical response.

Oral
Chronic stable angina, Prinzmetal's angina
Adult: Initially, 5 mg once daily, may be increased to 10 mg once daily according to clinical response.
Elderly: Initiate at lower doses and titrate according to clinical response.
Hepatic Impairment
Initiate at lower doses and titrate according to clinical response.
Administration
May be taken with or without food.
Contraindications
Severe hypotension, shock (including cardiogenic shock), left ventricular outflow tract obstruction (e.g. high-grade aortic stenosis), haemodynamically unstable heart failure after acute MI.
Special Precautions
Patient with CHF. Hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Symptomatic hypotension, peripheral oedema.
Cardiac disorders: Palpitations.
Eye disorders: Visual disturbance.
Gastrointestinal disorders: Abdominal pain, nausea, dyspepsia, diarrhoea, constipation.
General disorders and administration site conditions: Oedema, fatigue, asthenia.
Musculoskeletal and connective tissue disorders: Ankle swelling, muscle cramps.
Nervous system disorders: Somnolence, dizziness, headache.
Respiratory, thoracic and mediastinal disorders: Dyspnoea.
Vascular disorders: Flushing.
Patient Counseling Information
This drug may cause dizziness, headache, fatigue or nausea, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor blood pressure and heart rate.
Overdosage
Symptoms: Excessive peripheral vasodilation, reflex tachycardia, hypotension, shock. Management: Initiate active cardiac and respiratory monitoring if massive overdose occurs. Frequent blood pressure measurements are essential. For clinically significant hypotension, provide CV support including elevation of the extremities and judicious administration of fluids. If hypotension remains unresponsive, consider administration of vasopressors (e.g. phenylephrine) with attention to circulating volume and urine output. IV Ca gluconate may help reverse the effects of Ca channel blockade. In healthy volunteers, the use of activated charcoal immediately after or up to 2 hours after ingestion has been shown to significantly reduce the absorption rate. Gastric lavage may be beneficial in some cases.
Drug Interactions
Increased exposure with strong or moderate CYP3A4 inhibitors (e.g. protease inhibitors, azole antifungals, macrolides, verapamil, diltiazem). Decreased plasma concentration with CYP3A4 inducers (e.g. rifampicin). Risk of hyperkalemia with dantrolene. Additive blood pressure-lowering effects with other antihypertensives. May increase the exposure of simvastatin, ciclosporin, and mTOR inhibitors (e.g. sirolimus, tacrolimus, temsirolimus, everolimus).
Food Interaction
Increased bioavailability with grapefruit or grapefruit juice. Decreased plasma concentration with St John's wort.
Lab Interference
May cause a false-negative aldosterone/renin ratio (ARR).
Action
Description:
Mechanism of Action: Amlodipine, a dihydropyridine Ca-channel blocker, reduces peripheral vascular resistance and blood pressure by relaxing the coronary vascular smooth muscle and coronary vasodilation through inhibition of Ca ion transmembrane influx into cardiac and vascular smooth muscles.
Onset: Antihypertensive effect: 24-48 hours.
Duration: Antihypertensive effect: ≥24 hours.
Pharmacokinetics:
Absorption: Well absorbed. Bioavailability: Approx 64-90%. Time to peak plasma concentration: 6-12 hours.
Distribution: Enters breast milk. Volume of distribution: Approx 21 L/kg. Plasma protein binding: Approx 97.5%.
Metabolism: Extensively metabolised in the liver to inactive metabolites.
Excretion: Via urine (60% as metabolites, 10% as unchanged drug). Terminal elimination half-life: Approx 35-50 hours.
Chemical Structure

Chemical Structure Image
Amlodipine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 2162, Amlodipine. https://pubchem.ncbi.nlm.nih.gov/compound/Amlodipine. Accessed Oct. 26, 2023.

Storage
Store between 15-30°C. Protect from light.
MIMS Class
Calcium Antagonists
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.
References
Amlodipine 1 mg/mL Oral Solution (Brillpharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 31/03/2023.

Amlodipine 1 mg/mL Oral Suspension (Rosemont Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk. Accessed 31/03/2023.

Amlodipine 10 mg Tablets (Torrent Pharma UK Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 10/02/2023.

Amlodipine Besylate Tablet (ACI Healthcare USA, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/02/2023.

Anon. Amlodipine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 10/02/2023.

Anon. Amlodipine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/02/2023.

Buckingham R (ed). Amlodipine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/02/2023.

Istin 10 mg Hard Capsules (Upjohn UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/02/2023.

Joint Formulary Committee. Amlodipine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/02/2023.

Katerzia Suspension (Azurity Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 31/03/2023.

Norliqva Solution (CMP Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 31/03/2023.

Norvasc Tablet (Pfizer Laboratories Div Pfizer Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/02/2023.

Norvasc Tablet (Pfizer Pharmaceuticals LLC). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/02/2023.

Rex Medical Limited. Vasorex Tablet data sheet 04 August 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 10/02/2023.

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 © 2024 MIMS. All rights reserved. Powered by MIMS.com
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