Levamlodipine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Hypertension Monotherapy or in combination with other antihypertensive agents: As levamlodipine maleate/besylate: Initial: 2.5 mg once daily. Angina pectoris As levamlodipine besylate: 2.5 mg once daily. All doses may be increased as necessary according to patient response. Max: 5 mg once daily.
Dosage Details
Oral
Hypertension
Adult: As monotherapy or in combination with other antihypertensive agents: As levamlodipine maleate/besylate: Initially, 2.5 mg once daily, may increase dose (or titrate every 1-2 weeks for maleate) as necessary according to patient response. Max: 5 mg once daily.
Child: 6-17 years As levamlodipine maleate: 1.25-2.5 mg once daily.
Elderly: As levamlodipine maleate: Initially, 1.25 mg once daily, may titrate every 1-2 weeks as necessary according to patient response.

Oral
Angina pectoris
Adult: As levamlodipine besylate: 2.5 mg once daily, may be increased up to 5 mg once daily if necessary.
Hepatic Impairment
Hypertension: As levamlodipine maleate: Initially, 1.25 mg once daily, may be titrated slowly for severe impairment.
Special Precautions
Patient with severe aortic stenosis; severe obstructive coronary artery disease, heart failure with reduced ejection fraction, hypertrophic cardiomyopathy and outflow tract obstruction. Hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Worsening angina, acute MI, reflex tachycardia, symptomatic hypotension.
Cardiac disorders: Dyspnoea, palpitation.
Gastrointestinal disorders: Nausea, abdominal pain.
General disorders and administration site conditions: Fatigue, asthenia.
Hepatobiliary disorders: Jaundice.
Investigations: Increased liver enzymes.
Metabolism and nutrition disorders: Peripheral oedema.
Musculoskeletal and connective tissue disorders: Muscle cramps.
Nervous system disorders: Dizziness, extrapyramidal disorder.
Psychiatric disorders: Somnolence, insomnia.
Reproductive system and breast disorders: Sexual dysfunction, gynaecomastia.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Vascular disorders: Flushing.
MonitoringParameters
Monitor heart rate and blood pressure.
Overdosage
Symptoms: May be related to racemic amlodipine including excessive peripheral vasodilation, marked hypotension, reflex tachycardia. Management: In case of large overdose, monitor cardiac and respiratory function and perform gastric lavage. Monitor blood pressure. For hypotension, initiate CV support including elevation of extremities and administration of fluids. Consider administration of vasopressors (e.g. phenylephrine) in case hypotension remains unresponsive.
Drug Interactions
May increase serum concentrations with moderate and strong CYP3A4 inhibitors. May increase the serum levels of simvastatin, lovastatin, immunosuppressants (e.g. ciclosporin, tacrolimus).
Lab Interference
May result to false-negative aldosterone/renin ratio (ARR).
Action
Description: Levamlodipine, a dihydropyridine Ca channel blocker, is the pharmacologically active antihypertensive isomer of amlodipine. It reduces peripheral vascular resistance and blood pressure by directly inhibiting Ca ion transmembrane influx into vascular smooth muscles and to a lesser extent into cardiac muscle cells.
Synonym: (S)-amlodipine.
Onset: Gradual.
Duration: ≥24 hours.
Pharmacokinetics:
Absorption: Bioavailability: 64-90%. Time to peak plasma concentration: 6-12 hours.
Distribution: Plasma protein binding: Approx 93%.
Metabolism: Extensively metabolised in the liver (approx 90%) to form inactive metabolites.
Excretion: Via urine (10% as unchanged drug, 60% as metabolites). Elimination half-life: Approx 14.62-68.88 hours.
Chemical Structure

Chemical Structure Image
Levamlodipine

Source: National Center for Biotechnology Information. PubChem Database. Levamlodipine, CID=9822750, https://pubchem.ncbi.nlm.nih.gov/compound/Levamlodipine (accessed on May 26, 2020)

Storage
Store between 15-30°C.
MIMS Class
References
Dalal J, Mohan JC, Iyengar SS et al. S-Amlodipine: An Isomer with Difference - Time to Shift from Racemic Amlodipine. International Journal of Hypertension. 2018 May;2018. doi: 10.1155/2018/8681792. Accessed 15/05/2020. PMID: 29887996

Amlobes Tablet (Farma Iberica Corporation). MIMS Philippines. http://www.mims.com/philippines. Accessed 15/05/2020.

Anon. Levamlodipine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 18/03/2020.

Buckingham R (ed). Amlodipine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 18/03/2020.

Conjupri Tablets (CSPC Ouyi Pharmaceutical Co., Ltd.). U.S. FDA. https://www.fda.gov/. Accessed 18/03/2020.

Levamlodipine. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com/. Accessed 15/05/2020.

S-Ambes Tablet (The Government Pharmaceutical Organization [GPO]). MIMS Thailand. http://www.mims.com/thailand. Accessed 18/03/2020.

Disclaimer: This information is independently developed by MIMS based on Levamlodipine 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
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