Asomex (Levamlodipine)

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Asomex (Levamlodipine)

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Method of action: Antihypertensive

Treatment option:

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Overview of Asomex (Levamlodipine)

Property Description
Active ingredient Levamlodipine (S-amlodipine)
Form Oral Tablet
Pharmacological class Dihydropyridine Calcium Channel Blocker (CCB)
Common use (General) Management of High Blood Pressure and Angina
Origin Synthetic; Single-Isomer Derivative

What Type of Medicine is Asomex (Levamlodipine)?

Asomex is a trade name for the prescription drug containing the synthetic active ingredient Levamlodipine. It is typically administered as an oral tablet and functions as a primary cardiovascular agent. Pharmacologically, Levamlodipine is categorized within the dihydropyridine class of calcium channel blockers (CCBs), a group clinically recognized for their selective action on vascular smooth muscle. The substance is primarily used in adults and supported by pharmacological studies confirming its efficacy in managing systemic hypertension.


How Levamlodipine Compares to Standard Amlodipine

Levamlodipine is chemically defined as an enantiopure (single-isomer) form, which differentiates it from standard Amlodipine. Standard Amlodipine is a racemic mixture, meaning it contains both the S-enantiomer (Levamlodipine) and the R-enantiomer. Extensive research confirms that the S-enantiomer is the component responsible for the substantial majority of the drug's therapeutic effect. The development of Levamlodipine as a single-isomer derivative focuses the pharmacological action, which is a key differentiating feature in its composition.


The General Purpose of This Cardiovascular Agent

The central purpose of Levamlodipine is to help manage conditions associated with excessive arterial stiffness by inducing peripheral vasodilation. This mechanism, achieved by controlling calcium movement within vessel walls, relaxes and widens the blood vessels. The resulting reduction in systemic vascular resistance effectively addresses issues like chronic high blood pressure. As an antihypertensive and antianginal agent, the medication is designed to provide long-term, consistent control over vascular tone, which is an established method for mitigating the risk of serious cardiac and vascular complications.

Regulatory References

  1. S-amlodipine (Levamlodipine) therapeutic activity
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What side effects are possible with Asomex (Levamlodipine)?

Possible Side Effects and Safety Information

Levamlodipine's official safety profile is structured by government regulatory agencies into distinct domains, categorizing potential adverse reactions by frequency and physiological system.


Official Classification of Common Adverse Reactions

The most frequently reported adverse reaction, classified as Very Common (an incidence 1/10) in regulatory documents, is oedema (swelling), predominantly peripheral edema, which has been observed in a dose-related manner. Reactions categorized as Common (incidence 1/100 to <1/10) include effects on the Nervous System, such as headache, dizziness, and somnolence. Other Common reactions include palpitations, flushing, nausea, abdominal pain, fatigue, and asthenia.


Serious and Infrequent Safety Patterns

Official labeling documents less frequent but clinically significant adverse reactions. These include Very Rare (incidence <1/10,000) events such as hepatitis, jaundice, and severe hypersensitivity reactions including angioedema, erythema multiforme, and Stevens-Johnson syndrome. In patients with severe obstructive coronary artery disease, there is a documented risk of worsening angina or acute myocardial infarction associated with initiating or increasing the dose of the medication.


Safety Considerations in Specific Populations

Safety notes for specific patient groups are documented due to the drug's pharmacokinetics. Both geriatric patients and those with hepatic impairment may experience decreased clearance, which can lead to increased systemic exposure. The medication is contraindicated for individuals with documented hypersensitivity to levamlodipine, amlodipine, or any component of the formulation. Additionally, coadministration with moderate or strong CYP3A inhibitors is noted to increase systemic exposure to the drug.

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Overdose and Emergency Response

Overdose Scope

Property Documented Regulatory Information
Documented overdose presentations Overdose is formally documented to result in excessive peripheral vasodilation, leading to profound and potentially prolonged systemic hypotension. Related clinical signs include variations in heart rhythm, such as bradycardia (slow heartbeat) or tachycardia (rapid heartbeat), along with dizziness and confusion.
Physiological systems affected Primarily the cardiovascular system, presenting as hypotension and shock; secondary effects on the central nervous system (confusion, drowsiness).
Dose-related or exposure-related factors The profile is associated with exposure to levels exceeding the recommended therapeutic dosage.
Population-specific overdose notes No unique management protocols or increased severity in specific patient populations are explicitly documented in the official overdose management sections.
Emergency-response statements Management requires the immediate initiation of active cardiac and respiratory monitoring and the provision of cardiovascular support. Supportive measures include elevation of the extremities and judicious administration of intravenous fluids.

Overdose Classifications (High-Level)

Classification Documented Regulatory Information
Severity classification Classified as potentially leading to shock due to profound and prolonged hypotension, indicating a severe and life-threatening scenario.
Overdose-context constraints No specific antidote is known. Hemodialysis is officially stated as not likely to be of benefit due to the high plasma protein binding of the drug.

Official Overdose Statements

Suspected overdose requires that immediate medical attention be sought. If hypotension is refractory, the administration of vasopressors (such as phenylephrine) may be considered to support blood pressure. Hospital monitoring is required for continued observation.

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Therapeutic Uses of Asomex (Levamlodipine)

What Asomex (Levamlodipine) Treats: Main Uses and Benefits

Levamlodipine (Asomex) is commonly used for managing the chronic condition of essential hypertension, which involves symptoms related to systemic imbalance of blood pressure. This application is considered relevant for patient groups, including adults and pediatric patients aged 6 years and older. The core therapeutic domains for its use include managing Systemic Hypertension and treating Angina Pectoris.

The medication contributes to easing the overall symptom burden associated with chronic hypertension. Levamlodipine is commonly used to address symptom patterns characteristic of Chronic Stable Angina and the sometimes unpredictable episodes of Vasospastic Angina. This medication supports patients during episodes of heightened discomfort and may assist with managing symptom intensity associated with angina attacks, which supports improved day-to-day comfort.


Quick Fact: Used for managing symptoms of Systemic Imbalance and Physical Discomfort

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Eligibility and Restrictions for Use

Population Eligibility for Levamlodipine (Asomex)

The eligibility for Levamlodipine (Asomex) use is strictly defined by regulatory documentation, based on population, age, and specific health status.

Absolute Contraindication: The medicine is contraindicated in patients with a known sensitivity or allergy to amlodipine. This is the primary prohibition established by regulatory authorities.

Age-Group Eligibility: Use is established for adults and for pediatric patients aged 6 years and older. However, safety and effectiveness have not been established for children younger than six years. Geriatric and small or fragile patients require conditional use and special consideration at the start of therapy.

Conditional and Restricted Use: Conditional use is required for patients with hepatic insufficiency (impaired liver function) and those diagnosed with severe aortic stenosis. While use is permitted in renal impairment, specific consideration must be given to patients during pregnancy and lactation, as the drug is known to pass into breast milk and safety data remain insufficient.

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What should I know about interactions with other medicines?

The interaction profile for Levamlodipine is primarily defined by its involvement in the CYP3A4 metabolic pathway and its potential for additive pharmacodynamic effects. Levamlodipine is a substrate of the CYP3A4 enzyme, meaning co-administration with strong and moderate CYP3A inhibitors (such as certain antifungals) increases its systemic exposure due to reduced clearance. Conversely, CYP3A inducers may potentially decrease its plasma concentration.


The drug also impacts the systemic exposure of co-administered medicines. The dose of Simvastatin must be formally limited to 20 mg daily when taken concurrently, as Levamlodipine increases Simvastatin's overall exposure. Levamlodipine may similarly increase the systemic exposure of Cyclosporine and Tacrolimus. Pharmacodynamic interactions occur with other antihypertensive agents, including nitrates and Sildenafil, which may result in an additive hypotensive effect.

Regarding non-medicinal substances, the ingestion of Grapefruit or Grapefruit Juice acts as a CYP3A inhibitor, increasing Levamlodipine levels. Acute consumption of alcohol is also documented to contribute to additive hypotension. The drug is restricted for use in patients with a known hypersensitivity to Amlodipine, and slower clearance in patients with severe hepatic impairment results in increased drug effects/exposure in that population.

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Mechanism of Action

How Asomex (Levamlodipine) Works

Selective Calcium Channel Blockade in Arterial Smooth Muscle

Levamlodipine exerts its primary effect by acting as a selective L-type voltage-gated calcium channel blocker. It targets these channels in the cell membranes of vascular smooth muscle, specifically inhibiting the influx of extracellular calcium ions (Ca^2+). This interaction interrupts the signaling pathway required for smooth muscle contraction, serving as the foundational mechanistic step.

Modulating Systemic Vascular Resistance

By inhibiting the calcium-dependent contraction of the arterial smooth muscle, Levamlodipine promotes arterial vasodilation (widening of the arteries). This relaxation reduces the peripheral vascular resistance (PVR), the total resistance encountered by blood flow in the systemic circulation, which represents a key factor in modulating systemic resistance.

Reducing Cardiac Afterload

The resulting widespread decrease in peripheral resistance results in a reduction of the force against which the heart must eject blood. This physiological adjustment effectively reduces the cardiac afterload. This reduction of afterload mechanically decreases the tension generated by the ventricular walls during systole.

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Dosage and Administration Information

The official administration of Asomex (Levamlodipine) is governed by specific instructions regarding dose, frequency, and patient populations. Levamlodipine is an oral tablet taken once daily, and the prescribed dose depends on the therapeutic requirements and individual patient response. The medication may be used alone or in combination with other antihypertensive agents.

The drug is supplied as 1.25 mg, 2.5 mg, and 5 mg tablets. The 2.5 mg and 5 mg tablets are functionally scored, a feature that is essential for achieving the required 1.25 mg dose for certain patient groups. Administration can occur with or without food.

Dosage adjustments, or titration, must proceed gradually, generally requiring a minimum period of 7 to 14 days between dose increase steps to allow for the stabilization of the therapeutic effect.

Population Initial Daily Oral Dose Maximum Daily Oral Dose
Adults (Standard) 2.5 mg 5 mg
Adults (Elderly/Fragile/Hepatic Insufficiency) 1.25 mg 5 mg
Pediatric (Ages 6–17) 1.25 mg 2.5 mg (Doses above this range have not been studied)

For patients identified with hepatic insufficiency, a lower initial dose of 1.25 mg is specified, and subsequent titration must be performed slowly. It is important to note that no specific dosage adjustment is required for patients with renal impairment.

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Recent Clinical Evidence

Research evidence / Overview of studies for Asomex (Levamlodipine)


Evidence for Use in Essential Hypertension (Systemic High Blood Pressure)

Levamlodipine was studied for its use in managing high blood pressure, a condition marked by functional limitations and physiological strain. The primary research approach involved Randomized Controlled Trials (RCTs) and comparative effectiveness studies. These studies examined outcomes related to systemic or functional imbalance by measuring change from baseline in systolic and diastolic blood pressure (SBP/DBP) and monitoring the attainment of target blood pressure levels in adult outpatients. Researchers were exploring how symptoms related to physiological strain change over a defined time interval.

The research so far describes patterns related to the comparative study of Levamlodipine and standard amlodipine. However, there is limited information for long-term outcomes specifically from dedicated Levamlodipine trials comparing it against other therapeutic classes. The long-term effects are not fully established and may be inferred from the extensive data available for the parent racemic compound.


Evidence for Use in Angina Pectoris

Levamlodipine was studied for use in patients experiencing angina pectoris, a condition characterized by fluctuating or episodic manifestations of outcomes related to physical discomfort. The evidence base includes clinical efficacy trials, often referencing the S-enantiomer within the original amlodipine research. These studies examined patient-reported outcomes describing perceived discomfort, and monitored the frequency of angina episodes and the need for relief medication.

For this indication, the available research mainly examines short-term symptom patterns over short timeframes. Dedicated, large-scale randomized trials focusing solely on Levamlodipine for hard cardiac outcomes (such as heart attack or death) in the context of angina are not the primary basis of the regulatory record. The data for long-term maintenance of the anti-anginal effect remain insufficient and often relies on conclusions drawn from the parent drug's studies.


Evidence in Special Populations

Levamlodipine was evaluated in special populations. For pediatric patients aged 6 years and older, research primarily involved pharmacokinetic (PK) bridging studies. These studies research examined the drug's systemic levels and profile in children and adolescents. Sample sizes were modest in the short-term efficacy studies conducted in the pediatric population. For older adults, findings related to systemic imbalance are often derived from the inclusion of these patients within the broader adult randomized trials.

Because follow-up durations were limited in many of the studies focusing on children, the long-term effects are not fully established in this age group. Data for certain groups remain insufficient when considering long-term outcomes for pediatric use, and the evidence is heavily based on extrapolation from the established effectiveness of the racemic drug in this population.

Key Studies & References

  1. A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension (NCT01131546)
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Frequently Asked Questions (FAQ)

Common questions about Asomex (Levamlodipine) (FAQ)

Q: How long does it usually take to notice a difference after starting Asomex?

A: Regulatory documents indicate that when adjusting the dose, a minimum period of 7 to 14 days is generally required between dose changes to allow the full therapeutic effect to become stable. This timeframe indicates a gradual process for the therapeutic effect to stabilize.

Q: What are the most common physical feelings people report when first taking Asomex?

A: Official product information classifies certain effects as Common adverse reactions, meaning they occur in 1% to less than 10% of patients. The reactions classified as Common include effects such as headache, dizziness, somnolence (sleepiness), fatigue, and flushing.

Q: Are there any specific foods or drinks that should be avoided with Asomex?

A: Official drug labeling specifically notes that Grapefruit and Grapefruit Juice should be avoided. These substances are noted as CYP3A inhibitors, which can result in increased systemic exposure to the medicine.

Q: Is it normal to feel dizzy or lightheaded when starting Asomex?

A: Regulatory documents list dizziness as a Common side effect, which means it has been observed in a notable percentage of patients during clinical trials. Somnolence (sleepiness) is also listed as a Common nervous system effect.

Q: What is the general recommendation for taking Asomex with food?

A: Official administration instructions state that the medicine can be taken with or without food. This means that the administration schedule is flexible regarding food intake.

Q: Can Asomex affect the ability to drive or operate machinery?

A: Due to reported effects on the nervous system, such as dizziness and somnolence (drowsiness), official caution notes that patients should be aware of how the medicine affects them before engaging in activities like driving or operating machinery.

Q: Is Levamlodipine used to treat conditions other than high blood pressure?

A: According to the official product information, the medicine is described for use in managing both high blood pressure (hypertension) and a type of chest pain known as angina pectoris.

Q: Is it true that Asomex might cause ankle swelling?

A: Official safety information documents swelling, referred to as oedema or peripheral oedema, as a known effect. This swelling most frequently appears in the feet and ankles and is listed in regulatory documents as a Very Common adverse reaction.

Q: Do studies support using Asomex for chest pain (angina)?

A: Clinical efficacy trials have been conducted to examine the medicine's use in patients experiencing angina pectoris, and it is officially approved for this indication. These studies examined patient outcomes such as the frequency of angina episodes.

Q: Does Asomex interact with common pain relievers like ibuprofen or aspirin?

A: Official labeling contains warnings about potential interactions with Nonsteroidal Anti-inflammatory Drugs (NSAIDs), which include medicines like ibuprofen. These substances are noted to potentially reduce the blood pressure-lowering effect.

Q: Can a patient split or crush Asomex tablets?

A: Official documentation states that the 2.5 mg tablet is functionally scored. This feature enables the tablet to be split to obtain smaller doses for certain patient populations, as specified in administration instructions.

Q: Does Asomex have any known interactions with herbal supplements?

A: The medicine is metabolized through the CYP3A4 enzyme system in the body. Certain herbal products or supplements that are known to interfere with this enzyme may alter the amount of the drug in your system.

Q: What is the general duration of action for one dose of Asomex?

A: The drug is typically prescribed for once-daily dosing. This is based on its active ingredient having a long elimination half-life, which supports a consistent effect throughout a 24-hour period.

Q: What is the main concern about combining Asomex with alcohol?

A: The primary concern documented in regulatory sources is the possibility of additive hypotension. This effect means that acute alcohol consumption can contribute to a drop in blood pressure.

Q: Are there official warnings about using Asomex during pregnancy?

A: Official documents state that there are no controlled studies in human pregnancy. Regulatory documentation indicates that use during pregnancy should occur only if the potential benefit is considered to justify the potential risk.

Q: What are the symptoms of taking too much Asomex?

A: Taking too much of this medicine may result in a rapid drop in blood pressure, leading to severe hypotension (extremely low blood pressure) and a risk of a significantly slowed heart rate. In the event of an overdose, emergency medical assistance is required immediately.

Q: Does Asomex have any known severe allergic reactions?

A: Official safety information documents Very Rare but clinically significant severe reactions. These include angioedema (swelling of the face, lips, tongue, or throat), erythema multiforme, and Stevens-Johnson syndrome.

Q: Are there any known drug interactions between Asomex and statins?

A: The medicine is known to interact with certain statins. Official information describes a required dose limitation for the concurrent use of Simvastatin to manage increased exposure of the statin.

Q: How should Asomex be stored at home?

A: Official guidance indicates the tablets should be stored at controlled room temperature, typically between 20 C and 25 C (68 F and 77 F). They should be kept in a closed container, and protected from moisture, heat, and direct light.

Q: Is there any difference in how Asomex works compared to how Amlodipine works?

A: Levamlodipine is the single active isomer (S-enantiomer) of Amlodipine. Official research confirms that this S-enantiomer is the component responsible for the substantial majority of the drug's therapeutic action in the body.

Q: Are there warnings about combining Asomex with certain cough or cold medicines?

A: Warnings exist regarding certain over-the-counter medicines, such as those that may contain sympathomimetic agents (like phenylephrine). These agents can potentially counteract the blood pressure-lowering effect by increasing blood pressure and heart rate.

Q: How common is the side effect of headache with Asomex?

A: Headache is listed in regulatory documents as a Common adverse reaction. This classification means that the side effect was observed in a frequency range of approximately 1% to less than 10% of patients during clinical trials.

Q: Are there official warnings about using Asomex during lactation?

A: Official information notes that the medicine is excreted into human milk. Safety and effectiveness have not been established for infants while breastfeeding, and use requires conditional consideration.

Q: Is Asomex a medicine that needs to be taken long-term?

A: The medicine is designed for the management of chronic conditions, such as high blood pressure. Its general purpose is to provide long-term, consistent control over vascular tone, which suggests a sustained course of therapy.

Q: Does Asomex affect sleep patterns?

A: An effect on the nervous system is documented in official safety information. Somnolence (drowsiness or sleepiness) is listed as a Common side effect, indicating a potential effect on the sleep-wake cycle.

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How should Asomex (Levamlodipine) be stored and disposed of?

Storage and Disposal Requirements for Levamlodipine

Levamlodipine tablets must be stored at controlled room temperature, specifically between 20 C to 25 C (68 F to 77 F), with permitted excursions up to 30 C (86 F). The medication requires protection from environmental factors: it must be stored away from heat, moisture, and direct light, and should be kept from freezing.

For stability, the tablets must be maintained in a closed container and kept out of the reach of children. Do not retain outdated or unneeded medicine. Patients should consult a healthcare professional regarding the proper disposal method for any unused product.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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