Amlodipin-Teva

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Amlodipin-Teva

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 Amlodipin-Teva

Property Description
Active ingredient Amlodipine (as Amlodipine besilate)
Form Film-coated tablet
Pharmacological class Calcium Channel Blocker (CCB)
Common use Management of high blood pressure and angina
Origin Synthetic (Dihydropyridine derivative)

What is Amlodipine and What Type of Drug is It?

Amlodipin-Teva is a prescription-only medicine whose active ingredient is Amlodipine (supplied as Amlodipine besilate). It is a synthetic compound that belongs to the major drug class known as Calcium Channel Blockers (CCBs). More specifically, Amlodipine is classified as a Dihydropyridine calcium antagonist, known for its long duration of action. It functions as a long-acting calcium antagonist used for managing various cardiovascular conditions. This medicine provides sustained action over 24 hours, which is clinically recognized for its role in long-term blood pressure maintenance.

Composition and Physical Form of the Medicine

The medicine is a single-agent product intended for oral administration, typically provided as a solid, film-coated tablet. The formulation contains the active component, Amlodipine besilate, alongside standard pharmaceutical excipients that ensure the structural integrity of the dosage form. This defines Amlodipin-Teva as a monotherapy drug manufactured by Teva Pharmaceuticals, a distinction relevant for patients seeking products from recognized international pharmaceutical companies. This format supports a typical use scenario for adults requiring foundational therapy for blood pressure control.

What is the General Therapeutic Purpose of Amlodipine?

Amlodipine’s general therapeutic purpose is to reduce strain on the cardiovascular system, primarily serving as an antihypertensive agent and an antianginal agent. Its mechanism as a calcium antagonist promotes the relaxation of vascular smooth muscle, which effectively leads to the lowering of high blood pressure. The medicine is used in the treatment of both hypertension and stable angina. It is recognized as a core treatment for controlling elevated blood pressure and managing chest discomfort associated with reduced blood flow.

What side effects are possible with Amlodipin-Teva?

Possible Side Effects and Safety Information

The safety profile of Amlodipine is formally classified by regulatory authorities based on the frequency and the System-Organ Class (SOC) affected. The most frequently documented adverse reaction is oedema (swelling), which is categorized as Very Common and is typically noted as dose-related. Other side effects classified as Common include headache, dizziness, fatigue, and flushing. Headache and somnolence are reported as more likely to be observed at the beginning of treatment.


Adverse reactions are grouped into SOCs, covering systems such as Vascular disorders, Nervous System disorders, Cardiac disorders, and Gastrointestinal disorders. Uncommon side effects may include insomnia, mood changes, tremor, and various skin reactions.

Safety Considerations and Restrictions

The medicine is associated with a risk of serious adverse reactions, although these are classified as Very Rare. These serious, label-documented events include angioedema, pancreatitis, and hepatitis.

Safety limitations (contraindications) restrict the use of Amlodipine in certain severe pre-existing conditions, such as severe hypotension, cardiogenic shock, severe aortic stenosis, and haemodynamically unstable heart failure after acute myocardial infarction.

Special safety considerations are also noted for specific populations. Clearance of Amlodipine is reduced in older adults and in patients with hepatic impairment, which may necessitate caution in these groups. The official profile indicates the drug can have a minor or moderate influence on the ability to drive or operate machinery if effects such as dizziness or fatigue are experienced.

Overdose and Emergency Response

The official regulatory documents define Amlodipin-Teva overdose based on its profound effects on the cardiovascular system. Overexposure requires immediate medical attention and hospital monitoring due to the risk of severe, life-threatening outcomes.

Documented Overdose Manifestations

Clinical Signs Severe Outcome Required Action Trigger
Excessive peripheral vasodilatation Shock (including fatal outcome) Onset of marked and prolonged systemic hypotension
Marked systemic hypotension
Possible reflex tachycardia

Required Emergency and Supportive Actions

In cases of clinically significant hypotension, immediate medical attention and active cardiovascular support are required. Regulators specify mandatory management steps:

  • Continuous Monitoring: Frequent monitoring of heart and respiratory function, alongside attention to circulating fluid volume and urine output.
  • Procedural Interventions: Supportive measures may include the administration of a vasopressor to restore blood pressure and the use of intravenous calcium gluconate to reverse effects of calcium channel blockade. Gastric lavage and activated charcoal (administered within two hours of ingestion) are documented options to reduce absorption.
  • Elimination Note: Due to the high protein-binding nature of the drug, haemodialysis is not considered likely to be beneficial in overdose management.

This profile mandates immediate contact with emergency services whenever severe symptoms are suspected.

Therapeutic Uses of Amlodipin-Teva

Amlodipin-Teva is commonly used to help with conditions marked by increased physiological stress on the cardiovascular system. Its main therapeutic applications fall into two key areas: the management of chronic high blood pressure (hypertension) and the easing of symptoms associated with angina (chest pain).

Controlling Chronic Conditions

This medication supports the long-term management of symptoms related to systemic imbalance by helping maintain support for arterial pressure management in conditions characterized by periods of heightened symptoms (hypertension). The key benefit is that it contributes to easing the overall symptom load and supports general well-being during symptomatic phases.

Amlodipin-Teva is also applied in addressing symptoms related to physical discomfort, specifically the recurrent chest pressure or tightness associated with chronic stable angina and vasospastic angina. This use is relevant for easing symptoms in conditions involving episodic or fluctuating manifestations. It provides supportive relief that may assist with patients coping more steadily with these difficult episodes.


Quick Fact: Support for Symptoms Related to Physical Discomfort

Amlodipin-Teva is commonly used for managing symptoms that interfere with daily functioning due to chronic stable angina.

Regulatory References

  1. National Institutes of Health overview

Eligibility and Restrictions for Use

Amlodipin-Teva (amlodipine) eligibility is strictly defined by regulatory documents, which list populations who are prohibited, restricted, or permitted to use the medicine.

Category Official Eligibility Classification
Absolute Contraindications Prohibited in patients with hypersensitivity to amlodipine or other dihydropyridine derivatives, severe hypotension, shock (including cardiogenic shock), obstruction of the left ventricular outflow tract, and haemodynamically unstable heart failure after a heart attack.
Age-Related Rules Adults are eligible for both hypertension and angina. Use is established for hypertension only in children aged 6 to 17 years. Safety and efficacy have not been established for children under 6 years of age.
Restricted Use Patients with hepatic impairment or who are elderly require caution and should be started on a lower initial dose due to reduced drug clearance. Use in patients with congestive heart failure requires caution, as regulatory data suggests a possible increased cardiovascular risk.
Pregnancy/Lactation Safety during pregnancy is not established, and use should be highly selective. Lactation is discouraged, as amlodipine is excreted in human milk.

These official statements define the regulatory boundaries for prescription, categorizing patients into clear permitted, restricted, and prohibited groups.

What should I know about interactions with other medicines?

Amlodipin-Teva (amlodipine) may interact with a variety of other medicines and products. It is essential to inform your doctor or pharmacist of all medications, over-the-counter drugs, herbal remedies, and supplements you are taking, as dose adjustments or close monitoring may be required.

Increased Risk of Low Blood Pressure

Taking Amlodipin-Teva with other medicines that lower blood pressure can increase the risk of severe hypotension (low blood pressure), leading to dizziness or fainting. This includes:

  • Other antihypertensives: such as beta-blockers (e.g., metoprolol), ACE inhibitors (e.g., ramipril), or diuretics.
  • Erectile dysfunction medications: such as sildenafil.

Effect on Amlodipin-Teva Blood Levels

Some medicines affect how Amlodipin-Teva is processed by the body, potentially increasing or decreasing its concentration in the blood:

Interaction Type Examples of Medicine Potential Result
Increase Amlodipine levels Certain antifungals (e.g., ketoconazole, itraconazole), certain antibiotics (e.g., clarithromycin), HIV antivirals (e.g., ritonavir) Increased risk of amlodipine side effects (e.g., edema, dizziness).
Decrease Amlodipine levels Rifampicin, certain antiepileptic drugs (e.g., carbamazepine, phenobarbital), St John’s wort Amlodipin-Teva may become less effective.

Other Significant Interactions

  • Simvastatin: Amlodipin-Teva can increase the levels of simvastatin (a cholesterol-lowering drug), raising the risk of muscle-related side effects. The simvastatin dosage may need to be limited to a maximum of 20 mg per day.
  • Immunosuppressants: Amlodipin-Teva can increase blood levels of medicines like cyclosporine or tacrolimus, which are used to prevent organ rejection, requiring careful monitoring.
  • Grapefruit: Consuming grapefruit or grapefruit juice may increase amlodipine's effect, potentially worsening side effects.

Mechanism of Action

How Amlodipin-Teva Works

The action of Amlodipine involves targeted interference with the biological mechanisms that regulate the contraction and tension of blood vessels. It acts as an inhibitor molecule that disrupts the fundamental signaling pathway governing vascular muscle tone.


Molecular Blockade of L-Type Calcium Channels ( Ca v1)

The drug functions as an antagonist by binding to and blocking the voltage-dependent Ca v1 channels found on the membranes of arterial vascular smooth muscle cells. This inhibition prevents the necessary transmembrane influx of calcium ions ( Ca^2+) into the cell, which is the initial trigger for muscle contraction.


Modulation of Peripheral Vascular Tone and Resistance

The reduction of intracellular Ca^2+ limits the activation of the biochemical machinery required for muscle fibers to contract, leading directly to the sustained relaxation of the arterial wall—a process known as vasodilation. The systemic widening of peripheral arteries decreases the overall resistance to blood flow, which in turn reduces the physical force the heart must work against (afterload).


Kinetic Profile for Sustained Physiological Effect

The molecule is characterized by slow association and dissociation kinetics at the receptor site. This property means Amlodipine maintains its blockade for a prolonged period, contributing to a sustained physiological effect on vascular tone.

Dosage and Administration Information

How to Use Amlodipin-Teva

Amlodipin-Teva is a medication intended for oral administration as a tablet, consistent with its single-agent, long-acting profile. The official instructions for its use establish a standardized approach based on a once-daily schedule, which supports consistent long-term management.


Standard Labeled Administration

The medicine may be taken with or without food. Administration should occur at approximately the same time each day to maintain an even concentration of the active ingredient. Dosage adjustments, or titrations, are performed cautiously, typically requiring a period of 7 to 14 days between changes to properly evaluate the therapeutic response.


Official Dosing Rules

Population Initial Dose Maximum Daily Dose
Adults (Standard) 5 mg once daily 10 mg
Older Adults & Hepatic Impairment 2.5 mg once daily 10 mg
Pediatric (6–17 years) Hypertension 2.5 mg once daily 5 mg

For patients with hepatic impairment, a lower initial dose of 2.5 mg is advised, and titration must proceed slowly. No initial dosage adjustment is usually necessary for patients with renal impairment.


Procedural Instruction for Missed Doses

If a scheduled dose is missed, it should be taken as soon as it is remembered. However, if more than 12 hours have passed since the usual time, the missed dose must be skipped entirely, and the patient should resume the next scheduled dose. It is an explicit instruction not to take two doses to compensate for a single missed dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Amlodipin-Teva

This overview summarizes the structure of the official research that has been conducted on amlodipine, focusing on the types of research conducted and the aspects those studies examined. This information is descriptive and does not offer medical advice or treatment instructions.


Evidence for Use in Chronic High Blood Pressure (Hypertension)

Researchers utilized large-scale, randomized controlled trials (RCTs) and double-blind studies to evaluate the medicine. These studies often compare amlodipine to an inactive substance (placebo) or to other established blood pressure medicines. The principal outcomes monitored in this research were changes in systolic and diastolic blood pressure (BP), which reflects the main objective measurement of the research. Studies examined how blood pressure measurements evolved over time, including whether participants were able to reach specific, predefined blood pressure goals.

Findings describe patterns observed in the studies related to how blood pressure measurements evolved in the observed populations. Longer-term observational data was also used in research examining outcomes related to cardiovascular events in participants over several years.


Evidence for Use in Chronic Stable Angina and Vasospastic Angina

Controlled clinical trials research examined the use of amlodipine in chronic stable angina, as well as vasospastic angina (sometimes called Prinzmetal's angina). This research involved trials designed to assess short-term or episodic symptom patterns in patients. Studies explored patient-reported outcomes describing perceived discomfort, specifically measuring changes in the frequency of anginal episodes and tracking the usage of supplementary medications like nitroglycerin.

Research describes patterns observed in the studies, including the tracking of outcomes related to daily functioning or activity level and symptom frequency. Trials primarily focused on adults with symptomatic angina and provided context for managing these conditions characterized by fluctuating or episodic manifestations.


Long-Term Studies and Follow-Up Data

Research has explored patterns observed in the sustained measurements of the medication. The initial efficacy trials were often short-term, covering defined time intervals of four to sixteen weeks. To understand the longer-term picture, researchers have relied on intermediate trials lasting up to one year and extensive observational data with follow-up durations extending to five years or more.

However, even with the presence of observational data, long-term data are not fully established across all measured outcomes or across all population groups. The initial controlled research provides limited information for long-term outcomes specific to every potential outcome.


What is Still Uncertain About the Research for Amlodipin-Teva

Evidence quality varies across studies, particularly in the case of older or smaller trials. The available research base still contains areas where data is limited or certainty remains low. For example, follow-up durations were often limited in the initial controlled trials, meaning long-term outcomes are not fully established by those specific trials.

Findings describe group patterns, not personal outcomes, and research does not determine whether an individual will respond similarly to the patterns observed in the studies. There is always uncertainty when attempting to generalize findings from one specific study population to the general population of potential users.

Frequently Asked Questions (FAQ)

Common questions about Amlodipin-Teva (FAQ)

Q: Is Amlodipin-Teva classified as a beta-blocker or a different type of heart medication?

According to official regulatory documents, Amlodipin-Teva belongs to the drug class known as Calcium Channel Blockers (CCBs). It is a specific type of calcium antagonist called a dihydropyridine. This medicine is not classified as a beta-blocker.

Q: Is Amlodipin-Teva considered a 'blood thinner' or an anticoagulant?

Amlodipin-Teva is officially classified as an antihypertensive (for high blood pressure) and an antianginal agent (for chest pain). It works by relaxing blood vessels. Official information confirms this medicine is not an anticoagulant and does not affect the blood clotting process.

Q: What happens if I miss taking Amlodipin-Teva for one day?

Regulatory documents describe that if a dose is missed, it can be taken as soon as it is remembered. However, if more than 12 hours have passed since the usual time, the official guidance is to skip the missed dose and resume the next scheduled dose. The labeling advises against taking two doses to compensate for the missed dose.

Q: Do headaches caused by Amlodipin-Teva usually go away after a few days?

Headaches are classified as a Common side effect in regulatory documents. Official information reports that headaches, along with somnolence (drowsiness), are described as being more likely to be observed at the beginning of treatment.

Q: Is it possible for Amlodipin-Teva to make my blood pressure too low?

Yes, official labeling notes that the medicine is associated with a risk of hypotension (low blood pressure). The drug is formally contraindicated (prohibited) in patients with severe hypotension. Excessive hypotension has been noted in clinical studies.

Q: Can Amlodipin-Teva affect sexual function in men or women?

Regulatory documents indicate that impotence (erectile dysfunction) has been reported as an adverse effect. This potential effect is generally listed among the uncommon or rare side effects associated with the medicine.

Q: What are the general guidelines for using Amlodipin-Teva during pregnancy or while breastfeeding?

Official information states that safety during pregnancy is not established. Due to this uncertainty, official guidance describes that use should be highly selective. Use during lactation (breastfeeding) is discouraged because the active ingredient is known to be excreted in human milk.

Q: What is the purpose of the 'Teva' part of the name for this medicine?

Teva is the name of the manufacturer that produces this specific generic formulation of Amlodipine. The designation is consistent with the drug being manufactured by Teva Pharmaceuticals, while the active ingredient remains Amlodipine.

Q: Is Amlodipin-Teva used for any conditions other than high blood pressure and angina?

According to official regulatory documents, the medicine is formally indicated for the management of high blood pressure (hypertension) and specific forms of angina (chronic stable and vasospastic angina). Its use is defined by these official indications.

Q: Is it true that Amlodipin-Teva can cause weight gain?

Weight gain has been listed as an adverse event in clinical trial data for combination products that contain amlodipine. However, it is not consistently cited as a common adverse reaction in the labeling for the single-agent amlodipine product alone.

Q: Has Amlodipin-Teva been linked to hair loss?

Hair loss, medically known as alopecia, has been reported as a very uncommon adverse reaction. This type of reaction is seen in post-marketing experience (affecting up to 1 in 100 people).

Q: Does Amlodipin-Teva have known effects on sleep patterns?

Regulatory documents list sleep-related issues as adverse effects. Specifically, insomnia (difficulty sleeping) is reported as an uncommon reaction, while somnolence (sleepiness) is listed as a common reaction.

Q: Are muscle cramps a reported side effect of Amlodipin-Teva?

Muscle-related issues have been reported in clinical trials, including muscle spasms and myalgia (muscle pain). These reports indicate the presence of muscle-related discomfort in clinical data.

Q: Can Amlodipin-Teva cause mental or mood changes like depression or anxiety?

Official adverse reaction reports include mental changes, specifically citing mood changes and mental depression. These effects have been reported in association with the medication.

Q: Is there a risk of developing swollen or bleeding gums while taking Amlodipin-Teva?

Gingival hyperplasia, which is the swelling of the gums, has been reported as a side effect. This is documented in post-marketing experience for the medication.

Q: Can Amlodipin-Teva be taken safely with common pain relievers like ibuprofen?

Official drug interaction information indicates that common pain relievers classified as Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen, may potentially decrease the blood pressure-lowering effect of Amlodipin-Teva. Drug interaction data suggests that monitoring of blood pressure may be relevant.

Q: What are the known interactions between Amlodipin-Teva and herbal supplements?

The official interaction warnings specifically include the herbal supplement St John’s wort. This supplement may decrease Amlodipine levels in the body, potentially making the blood pressure medicine less effective.

Q: Is it necessary to avoid high-potassium foods like bananas while taking Amlodipin-Teva?

Amlodipin-Teva is generally not associated with high potassium levels. Unlike some other blood pressure medicines, no interaction with potassium supplements or high-potassium foods is typically cited in the main regulatory labeling.

Q: Does Amlodipin-Teva affect a person's ability to drive or operate machinery?

Official labeling describes that the medicine carries a potential minor or moderate influence on the ability to drive or operate machinery. This is particularly noted if side effects such as dizziness or fatigue are experienced.

Q: What are the inactive ingredients found in Amlodipin-Teva tablets?

The formulation contains the active component, Amlodipine besilate, alongside standard pharmaceutical excipients (inactive ingredients). These often include substances such as microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.

Q: Is Amlodipin-Teva known to cause low heart rate or palpitations?

The drug is associated with a possible reflex increase in heart rate (tachycardia) and palpitations, which are listed as adverse effects. Low heart rate, known as bradycardia, has also been reported, but less commonly.

Q: Is there an increased risk of gout or joint pain associated with Amlodipin-Teva?

Arthralgia (joint pain) is included in the adverse reaction listings from clinical trial data for amlodipine combination products. However, this is not consistently reported as a common reaction in the single-agent labeling.

Q: Does Amlodipin-Teva require any special dietary instructions besides avoiding grapefruit?

Official instructions state that the medicine can be taken with or without food. Beyond the specific caution regarding grapefruit, there are no other widely cited dietary restrictions or special instructions.

Q: Is there any evidence that Amlodipin-Teva can affect vision, such as causing double vision?

General visual disturbances are listed as reported adverse effects. Rare post-marketing reports have also documented temporary issues like dysgeusia (a decreased or altered sense of taste).

Q: Is Amlodipin-Teva recommended for people who have very low blood pressure?

The medicine is officially contraindicated (prohibited) in patients with severe hypotension (very low blood pressure). Calcium channel blockers are generally cautioned against in people who already have hypotension, often defined as a systolic pressure below 90 mm Hg.

Q: Can Amlodipin-Teva affect kidney function in healthy patients?

Regulatory information indicates that Amlodipin-Teva therapy has not been associated with clinically significant changes in routine laboratory tests of kidney function. Routine renal function monitoring is typically not required in patients with otherwise normal kidney function.

Q: Is it true that Amlodipin-Teva can be associated with increased sugar levels in the blood?

Clinical trial data states that no clinically relevant changes were noted in serum glucose or other metabolic parameters. Therefore, routine monitoring of blood sugar is not typically required for safety or efficacy.

Q: Can Amlodipin-Teva cause stomach issues like nausea, constipation, or diarrhea?

Gastrointestinal disturbances are listed as reported adverse effects. Specifically, regulatory documents mention that nausea, abdominal pain, and constipation have been reported in clinical trials.

Q: Is flushing (redness or warmth in the face) a sign that Amlodipin-Teva is working?

Flushing (redness or warmth in the face) is classified as a Common adverse reaction. This effect is a documented side effect related to the drug's action of vasodilation (widening of blood vessels), but it is not cited as an indicator of the medicine's overall efficacy.

Q: Is it common to feel more thirsty or have increased urination while taking Amlodipin-Teva?

Official adverse effect listings include increased micturition frequency (increased need to urinate) as a reported adverse effect. However, increased thirst is not generally reported as a common finding in the main regulatory labeling.

Q: How often is the effectiveness of Amlodipin-Teva typically monitored by a doctor?

Clinical monitoring of blood pressure is recommended to assess the medicine’s effectiveness. Official guidance on dosage adjustment suggests that initial blood pressure checks are often performed within 2–4 weeks of starting therapy or after a dose change.

Q: Are there specific warnings about discontinuing Amlodipin-Teva suddenly?

Official warnings state that sudden discontinuation of the medicine might be associated with an exacerbation of angina (worsening of chest pain) in some patients. Official warnings state that a patient should not stop taking the medicine without professional guidance.

Q: Is Amlodipin-Teva a suitable treatment for people with certain heart valve conditions?

The medicine is contraindicated (prohibited) in patients who have severe aortic stenosis (a type of heart valve problem). It should also be used with caution in other specified heart conditions.

Q: Can Amlodipin-Teva be linked to a decrease in one's sense of taste?

Rare post-marketing reports have documented dysgeusia, which is defined as a decreased or altered sense of taste, in association with the use of amlodipine.

How should Amlodipin-Teva be stored and disposed of?

How to Store and Dispose of Amlodipin-Teva

Amlodipin-Teva (amlodipine besilate tablets) must be stored and disposed of according to official regulatory guidelines to maintain stability and ensure environmental safety.


Storage Requirements

The tablets require storage at Controlled Room Temperature, specifically 20°C to 25°C (68°F to 77°F), with permitted brief excursions up to 30°C. The medication must be protected from light and moisture; therefore, it should be kept in the original, tightly closed container and not stored in the bathroom. As with all medicines, Amlodipin-Teva must be stored out of the sight and reach of children.


Disposal Instructions

Unused or expired Amlodipin-Teva must be disposed of according to local regulations for pharmaceutical waste. Disposal instructions prohibit releasing the product into the environment, which means the tablets should not be flushed down the toilet or thrown into wastewater.

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

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