Tervalon

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Tervalon

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Tervalon

What is Tervalon? (Amlodipine Besilate)

Property Description
Active ingredient Amlodipine (as besilate salt)
Form Tablet
Pharmacological class Calcium Channel Blocker (Dihydropyridine)
General purpose Lowering blood pressure and improving heart blood flow
Origin Synthetic

Tervalon is a synthetic, single-ingredient pharmaceutical medication classified as a prescription-only medicine intended for adult cardiovascular management. Its identity is defined by the active compound, Amlodipine, which is typically administered as the stable salt, Amlodipine besilate.

What Type of Medicine is Tervalon?

Tervalon belongs to the Calcium Channel Blocker (CCB) pharmacological class, specifically falling within the dihydropyridine subset. This classification establishes the drug's role as both an antihypertensive agent and an antianginal agent. Amlodipine has an established role in the treatment of high blood pressure and chest pain caused by restricted blood flow. This application is a standard choice for long-term conditions where the circulatory system requires consistent assistance to function optimally. As a dihydropyridine, its action is primarily concentrated on relaxing the smooth muscle of the blood vessels, differentiating its profile within the broader CCB class.

Tervalon's Composition and Delivery Form

The therapeutic effect of Tervalon is derived from the Amlodipine besilate it contains, making it a monotherapy product. The active component is a synthetic chemical compound formulated with inert excipients to create a stable tablet suitable for oral administration. Amlodipine acts on the vascular smooth muscle cells, providing the mechanism for its therapeutic effect. The formulation focuses on delivering the active ingredient, Amlodipine, which is utilized as a primary agent for managing vascular resistance.

General Principle of Tervalon's Action

The fundamental principle of Tervalon's action is selective vasodilation, which is the widening and relaxation of arteries throughout the body. By inhibiting the influx of calcium ions into the vascular smooth muscle cells, Amlodipine causes a direct reduction of peripheral vascular resistance. This physiological action serves the general purpose of decreasing overall blood pressure and reducing the resistance against which the heart must pump, acting as a component of cardiovascular management.

Regulatory References

  1. MedlinePlus Drug Information

What side effects are possible with Tervalon?

Possible side effects and safety information

The safety profile of Tervalon (Amlodipine Besilate) is defined by officially documented adverse reactions classified by frequency and body system, strictly based on government regulatory data.

Frequency and System Classification

The most frequently reported adverse reactions, categorized as Common in clinical trials, include effects primarily related to the drug’s vasodilatory action. These reactions include peripheral edema (swelling), headache, fatigue, nausea, abdominal pain, and dizziness. Peripheral edema, in particular, is the most common adverse reaction and its incidence is confirmed to be dose-related in regulatory documents. Less common reactions have been observed across various System-Organ Classes, including the Nervous System (e.g., hypoesthesia, paresthesia), Cardiovascular System (e.g., arrhythmia, palpitation), and Gastrointestinal System (e.g., dyspepsia, gingival hyperplasia).

Serious Adverse Reactions and Safety Restrictions

Official regulatory documents include high-level safety warnings regarding the potential for symptomatic hypotension, a concern particularly relevant in patients with severe aortic stenosis. Furthermore, a risk for worsening angina or acute myocardial infarction is documented as a safety concern that may develop upon the initiation of therapy or following a dosage increase.

Safety notes mandate particular caution for certain patient populations. Individuals with hepatic impairment and elderly patients require cautious management due to documented decreased drug clearance, which increases systemic exposure. Use is generally restricted or avoided in conditions such as cardiogenic shock and acute unstable angina.

Overdose and Emergency Response

Tervalon overdosage is defined by the severe cardiovascular effects documented in regulatory labeling. The primary manifestation is marked and prolonged systemic hypotension, resulting from excessive peripheral vasodilation. Other documented presentations include reflex tachycardia, bradycardia, and syncope (fainting). In gross overdosage, the official literature states that shock may occur, up to and including a fatal outcome. Rarely, non-cardiogenic pulmonary oedema has been reported, sometimes with a delayed onset.

In the event of overdosage, immediate medical attention is required; patients must seek help or contact a Poison Control Center right away. The management outlined in official documents is strictly symptomatic and supportive, as no specific antidote is known to reverse the effects of Tervalon.

Official Supportive Measures

  • Interventions officially described to manage overdosage may include gastrointestinal decontamination (such as gastric lavage or administering activated charcoal).
  • Procedures for cardiovascular support include interventions to restore vascular tone and circulating fluid volume, such as volume expansion and the use of vasoconstrictors.
  • Continuous cardiac and respiratory monitoring is required, often necessitating extended clinical observation due to the drug's long elimination half-life.

Regulatory documents note that the half-life is prolonged and effects may be more severe or prolonged in patients with impaired liver function.

Therapeutic Uses of Tervalon

Quick Facts: Tervalon's Therapeutic Domain

  • Targeted Conditions: Management of hypertriglyceridemia (elevated triglyceride levels in the blood), primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), and homozygous familial hypercholesterolemia (HoFH).
  • Therapeutic Goal: To reduce elevated levels of LDL-C (low-density lipoprotein cholesterol), total-C (total cholesterol), and ApoB (apolipoprotein B) in the bloodstream.

Main Uses and Benefits of Tervalon

Tervalon is a prescription agent used to manage specific types of lipid disorders in adult patients. Its primary use is in the treatment of hypertriglyceridemia, a condition characterized by high levels of a type of fat called triglycerides in the blood.

Additionally, Tervalon is indicated for the management of primary dysbetalipoproteinemia (also known as Type III Hyperlipoproteinemia), a rare genetic disorder that affects the body's ability to clear specific fats from the blood. The medicine is also utilized in patients diagnosed with homozygous familial hypercholesterolemia (HoFH). This is a severe, inherited form of high cholesterol.

The therapeutic benefits of Tervalon are centered on its ability to reduce elevated levels of several key lipids and lipoproteins. Specifically, treatment aims to lower LDL-C, total-C, and ApoB in the circulation. The overall benefit is the comprehensive management of these lipid parameters to promote health outcomes.

Eligibility and Restrictions for Use

Absolute Contraindications

Tervalon is contraindicated and must not be used by patients with a known hypersensitivity to amlodipine, other dihydropyridines, or any component of the formulation. It is also contraindicated in specific clinical states: patients experiencing severe hypotension, individuals in shock (including cardiogenic shock), those with obstruction of the left ventricular outflow tract (e.g., high-grade aortic stenosis), and patients with haemodynamically unstable heart failure following acute myocardial infarction.

Age and Organ Restrictions

The medicine is approved for adults for all labeled uses and for pediatric patients aged 6 to 17 years for the treatment of hypertension only. Safety and effectiveness have not been established for use in children younger than six years old. Use requires caution in older adults and in patients with severe hepatic impairment; the latter requires careful, slow initiation of therapy. Dosage adjustment is not routinely required for patients with renal impairment.

Pregnancy and Lactation

Official regulatory documents state that the medicine’s safety during pregnancy has not been established. Use is only advised when the benefit to the mother justifies the risk. Tervalon is excreted into human milk, and therefore, use during lactation is not recommended.

What should I know about interactions with other medicines?

Tervalon Interactions with other medicines and products

Tervalon's interaction profile is primarily defined by the pharmacokinetic and pharmacodynamic outcomes documented in official regulatory labeling. Pharmacokinetic interactions are significant when Tervalon is co-administered with substances that alter the activity of the CYP3A4 enzyme. Strong and moderate CYP3A4 inhibitors, such as Ketoconazole and Itraconazole, officially result in a significant increase in the systemic exposure of Tervalon. Conversely, CYP3A4 inducers like Rifampicin or St. John’s Wort may cause a reduction in Tervalon's plasma concentration.

The drug's official labeling also documents interactions where Tervalon affects other medicines. Co-administration with Simvastatin leads to an increase in Simvastatin's systemic exposure; due to this finding, regulatory authorities restrict the maximum permitted Simvastatin dose to 20 mg daily. Similarly, official information states that Tervalon may increase the blood concentrations of Cyclosporine and Tacrolimus.

Pharmacodynamic interactions occur when Tervalon is combined with other antihypertensive agents or PDE5 inhibitors, resulting in an officially noted additive blood pressure lowering effect. The consumption of alcohol may also potentiate this hypotensive effect. Furthermore, interactions that increase systemic exposure are officially acknowledged to be more pronounced in patients with hepatic impairment and in the elderly due to underlying reduced drug clearance.

Mechanism of Action

Selective Blockade of Vascular Calcium Channels

Tervalon's action centers on the selective blockade of L-type Voltage-Dependent Calcium Channels ( L-VDCCs) found in the arterial smooth muscle. By preventing the entry of extracellular calcium ions ( Ca^2+) into the muscle cells, the drug inhibits the molecular cascade necessary for cellular contraction. This molecular action directly produces vasodilation (widening) of the peripheral and coronary arteries.


Modulation of Arteriolar Tone and Systemic Resistance

The resulting vasodilation in the arterioles results in a reduction of the Systemic Vascular Resistance (SVR), also known as the afterload. This physiological consequence reduces the mechanical load (afterload) imposed on the heart. The drug's slow binding kinetics also contribute to a sustained block, resulting in a sustained modulation of arterial tone without affecting cardiac conduction or contractility.

Dosage and Administration Information

How Tervalon Is Used: Official Administration Guidelines

Tervalon (Amlodipine Besilate) is administered exclusively through the oral route, typically in the form of a tablet, which may be taken with or without food. A foundational principle of its usage is the once-daily (QD) frequency, maintaining a consistent therapeutic effect over 24 hours. To ensure stable plasma levels, the medicine is consumed at the same time each day.


Standard Dosing Regimens

The standard initial dose for adult patients is 5 mg once daily. The maintenance dose range is typically between 5 mg and 10 mg once daily, with 10 mg representing the maximum recommended daily dose. Dosage adjustments, if required, are governed by a titration period and should not generally occur more frequently than every 7 to 14 days to accurately assess the body’s response to the new dose level.


Population and Procedural Rules

Specific procedural rules are defined for certain patient populations. For older adults and patients with hepatic impairment, standard protocols involve initiating therapy at a reduced dose of 2.5 mg once daily due to potential changes in drug clearance. For pediatric patients aged 6 to 17 receiving Tervalon for hypertension, the maximum approved daily dose is 5 mg.

If a dose is missed, the standard procedure involves taking the dose as soon as it is remembered. However, if it is determined that the dose is more than 12 hours late, the missed dose is skipped entirely, and the regular schedule resumed, avoiding the use of a doubled dose. The overall protocol is structured for long-term, continuous oral administration.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Tervalon

Evidence for use in Managing High Blood Pressure (Hypertension)

Research on Tervalon was studied in clinical contexts involving high blood pressure, a condition related to systemic or functional imbalance. Researchers conducted numerous Randomized Controlled Trials (RCTs) to evaluate this. These short-term studies monitored changes in Systolic and Diastolic Blood Pressure (BP). Studies reported measured changes in both BP types when compared to a non-active treatment.

Beyond immediate BP measurement, large, long-term studies explored how the compound was associated with outcomes related to major cardiovascular events. Reports from these long-term trials described observed patterns in the incidence of events, including stroke and Myocardial Infarction (MI), when compared to other approaches studied. Long-term outcomes for patients are not fully established when considering the full scope of other treatment approaches across specific high-risk cohorts.


Evidence for use in Managing Angina (Chest Pain)

Tervalon was studied for its effect on stable and vasospastic chest pain (angina). The research primarily utilized double-blind, placebo-controlled trials relevant in trials assessing short-term symptom patterns. Measured outcomes included tracking the patient’s exercise tolerance time and the frequency of angina attacks reported by the observed populations. Trials described observed measurements of changes in exercise duration before symptom onset when compared to placebo.

Evidence is limited when it comes to long-term outcomes for angina specifically. The research is largely focused on short-term symptom relief, and data are also still emerging regarding outcomes for patients with certain complex or rare angina subtypes.


Long-Term Studies and Evidence Gaps

Studies explored the compound’s association with the incidence of stroke, heart attack, and the need for procedures over a sustained period, with follow-up durations typically ranging from 1.5 to 5 years. Evidence concerning the compound was associated with mixed findings for patients with pre-existing severe chronic heart failure, and the certainty remains low in this area.

Data for certain groups remain insufficient. Research explored measured changes in BP in a limited population of children aged 6 to 17 years; however, data for children under age 6, or for use in managing angina in children, remain insufficient and are not currently established.

Key Studies & References

  1. Impact of amlodipine on clinical outcomes for heart failure in patients with dilated cardiomyopathy: a Korean nationwide cohort study (supports heart failure, older adult, and mixed findings context)

Frequently Asked Questions (FAQ)

Common questions about Tervalon (FAQ)


Q: How quickly can a person expect Tervalon to start having an effect?

Official product information describes that the active ingredient's peak concentration in the bloodstream is typically reached between 6 and 12 hours after a single dose. To achieve steady-state levels, where the medicine's amount in the body is consistent, it usually takes about 7 to 8 days of continuous daily use.


Q: Does Tervalon cause weight gain?

Regulatory documents list both weight gain and weight decrease as adverse reactions reported during clinical trials. Additionally, a common side effect of this medicine is peripheral edema (swelling), which is a buildup of fluid that may be associated with changes in body weight.


Q: Can Tervalon be taken by people with high blood pressure?

Yes, regulatory authorities have formally indicated Tervalon for the treatment of high blood pressure (hypertension), as well as for managing certain types of angina (chest pain). It is classified as an antihypertensive agent.


Q: Are there any common foods or drinks that interact with Tervalon?

Official patient guidance notes that consuming grapefruit or grapefruit juice is documented as possibly increasing the systemic exposure of the medicine, which may intensify the occurrence of side effects. Additionally, regulatory labeling documents that consuming alcohol may enhance the drug’s blood pressure lowering effect.


Q: Can Tervalon be used long-term?

Official administration protocols specify that this medicine is structured for long-term, continuous oral administration for the chronic conditions it is approved to treat. Evidence has been reported from studies with follow-up durations up to 5 years.


Q: What happens if I accidentally miss a dose of Tervalon?

Official regulatory guidance describes a protocol where a remembered dose is taken as soon as possible. The guidance further states that if the dose is determined to be more than 12 hours late, the regulatory instruction is to skip the missed dose and continue with the original schedule, avoiding the use of a doubled amount.


Q: Does Tervalon affect sleep?

Official reports from clinical trials include psychiatric and nervous system effects. Adverse reactions such as insomnia (difficulty sleeping) and somnolence (drowsiness) have been reported in the less common frequency categories.


Q: Can I take Tervalon if I am taking an antidepressant?

Official labeling documents a risk of interaction with any medicine that significantly alters the CYP3A4 enzyme system, which processes Tervalon in the body. This risk applies to any co-administered medicine, including certain antidepressants, identified as a strong or moderate CYP3A4 inhibitor.


Q: Does Tervalon interact with alcohol?

Regulatory documentation notes that alcohol consumption may result in an additive blood pressure lowering effect when combined with this medicine. This is a pharmacodynamic interaction, meaning the two substances affect the body in similar ways.


Q: How long was Tervalon studied in clinical trials?

Large-scale, long-term studies exploring cardiovascular outcomes have followed patient populations for sustained periods. Official clinical study reports indicate follow-up durations typically ranged from 1.5 to 5 years.


Q: What is the main difference between Tervalon and a supplement?

Tervalon is a prescription-only medicine (POM) that is classified as a synthetic pharmaceutical compound. It is subject to full governmental regulatory approval for safety and efficacy, which differs from the regulatory classification and testing required for dietary supplements.


Q: Are there any known interactions between Tervalon and herbal products?

Regulatory documents explicitly mention that the herbal product St. John’s Wort can interact with Tervalon. This is due to its classification as a CYP3A4 inducer, which may cause a reduction in the amount of Tervalon in the bloodstream.


Q: Why is Tervalon only available by prescription?

The medicine is classified as prescription-only because its safe and effective use requires professional supervision. This oversight is necessary for monitoring the medicine’s effects on the circulatory system, managing the correct dosage, and overseeing potential drug interactions or existing health conditions.


Q: If I have a mild allergic reaction, should I immediately stop Tervalon?

Official information states that Tervalon is contraindicated (must not be used) in patients with a known hypersensitivity or allergy to the active ingredient. A known hypersensitivity represents a contraindication to the medicine's use, as defined by regulatory documents.


Q: Are there any limitations on driving or operating machinery while using Tervalon?

Official product information advises that the ability to drive or operate machinery may be impaired if the user experiences side effects such as dizziness, headache, or fatigue. This potential impairment is especially relevant when beginning treatment or after a dosage increase.


Q: Is Tervalon effective for everyone who uses it?

Clinical trials reported measured changes in blood pressure and angina symptoms when compared to a non-active treatment. Official documents do not contain guarantees regarding the outcome or magnitude of effect for every individual patient, as individual responses may vary.


Q: Is Tervalon safe to use while breastfeeding?

Official information notes that the active ingredient is excreted into human milk. Supporting evidence from government health resources suggests that while the dose is typically low, official regulatory statements generally advise against its use during lactation due to the presence of the active ingredient in milk.


Q: Can older adults use Tervalon safely?

The medicine is approved for older adults, but regulatory notes advise that this population requires cautious management. This is due to documented decreased drug clearance, which often means a reduced initial dose is specifically recommended for assessment.


Q: Can Tervalon be used by people with kidney problems?

According to official information, kidney impairment does not significantly change how the medicine is processed in the body. Therefore, patients with kidney problems do not routinely require a dose adjustment.


Q: Does Tervalon change mood or anxiety levels?

Adverse reactions documented in clinical trials include effects on the psychiatric system. Mood changes (including anxiety and nervousness) and depression have been reported in the less common frequency categories.


Q: If I stop taking Tervalon, will the effects immediately disappear?

Official pharmacokinetic information notes that the active ingredient has a prolonged elimination half-life of 30 to 50 hours. This indicates the medicine is slowly eliminated from the body, and its effects decline gradually over a period of time, rather than disappearing immediately.


Q: What are the signs of a serious side effect from Tervalon?

Official safety warnings include the potential for symptomatic hypotension (severe drop in blood pressure) and the risk of worsening angina (chest pain). Serious signs mentioned in patient counseling guides include more frequent or more severe chest pain and sensations like fainting.


Q: Is there a generic version of Tervalon available?

Yes, Tervalon contains the active ingredient Amlodipine Besilate. This compound is officially available in generic versions that contain the same active ingredient and are approved by regulatory bodies.


Q: Is Tervalon known to cause blurry vision?

Adverse reactions reported in clinical trials include effects on vision. Abnormal vision, diplopia (double vision), and vision blurred have all been reported in the less common frequency categories.


Q: Are there any specific lifestyle changes recommended when taking Tervalon?

Official patient guidance often includes general lifestyle measures alongside the medication. These lifestyle measures often include references to maintaining a healthy weight, engaging in physical activity, and moderating the intake of sodium (salt) and alcohol.


Q: How long does it take for Tervalon's full potential benefit to be seen?

The time it takes to assess the full response to the medicine is defined by the dosing protocol. Dosage adjustments (titrations) are typically used to assess the body’s full response to a new dose level and should not generally occur more frequently than every 7 to 14 days.


Q: Is Tervalon known to cause any skin reactions or rashes?

Yes, adverse reactions documented include various skin effects. These include common reactions like rash and pruritus (itching), and in rare cases, severe conditions such as erythema multiforme have been reported in the official safety profile.

How should Tervalon be stored and disposed of?

Storage & Disposal Map: How to Store and Dispose of Tervalon — official regulatory information

Requirement Mandatory Regulatory Statement
Labeled storage temperature requirements Store below 25 C (Controlled Room Temperature) or as specified (e.g., refrigerated 2 C to 8 C).
Light/moisture protection requirements Protect from moisture and/or protect from light.
Handling requirements Do not freeze or do not store above the maximum listed temperature.
Packaging-related storage rules (if applicable) Keep the medicine in the original container and keep the container tightly closed.
Stability after opening/reconstitution (if applicable) Discard X days (or hours) after first opening.
Child-protection storage requirements (if stated) Keep this medicine out of the sight and reach of children.
Disposal instructions (as documented in government sources) Do not throw away any medicines via wastewater or household waste. Return unused or expired medicine to a pharmacy or authorized collection point.

Connection to the overall storage/disposal profile: Regulatory documents formally define how the product must be stored, handled, and disposed of to maintain quality and ensure safety. This includes explicitly stating the required temperature and protection from elements like light and moisture, and specifying that the product must not be disposed of in general waste streams. These mandatory constraints ensure the medicine remains stable until its labeled expiry date.

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

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