Levamlodipine: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

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.
Elderly: As levamlodipine maleate: Initially, 1.25 mg once daily, may titrate every 1-2 weeks as necessary according to patient response.
Child: 6-17 years As levamlodipine maleate: 1.25-2.5 mg once daily.

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.

Administration

May be taken with or without food.

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.

Monitoring Parameters

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:
Mechanism of Action: 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

Storage

Store between 15-30°C.

MIMS Class

Calcium Antagonists

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.

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