Amlodipine Aurobindo

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Amlodipine Aurobindo

Medically reviewed

Laura Arias

Last updated on 22/12/2025

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 Amlodipine Aurobindo

Quick Facts

Property Description
Active ingredient Amlodipine (as besilate salt)
Form Tablet
Pharmacological class Calcium Channel Blocker (CCB)
Common purpose To lower blood pressure and manage chest pain
Origin Synthetic

Identity and Composition of Amlodipine Aurobindo

Amlodipine Aurobindo is a generic drug provided as a prescription-only medicine in an oral preparation and presented in tablet form. This formulation is manufactured by Aurobindo Pharma, a globally recognized entity, distinguishing it as a specific supplier of the active ingredient, Amlodipine. The primary component is the single active ingredient, Amlodipine, which is typically incorporated as the besilate salt, forming Amlodipine besilate. This compound is synthetic in origin and is routinely subject to quality controls to ensure bioequivalence for generic versions of essential medicines.

Pharmacological Class and General Therapeutic Purpose

Amlodipine is precisely categorized as a Calcium Channel Blocker (CCB), belonging to the Dihydropyridine subgroup, a class recognized for its sustained action in cardiovascular therapy. Amlodipine is pharmacologically identified as a potent, long-acting peripheral arterial vasodilator. Its mechanism involves selectively inhibiting the influx of calcium ions into the cells of the vascular smooth muscle, promoting the relaxation and widening of the arteries. This physiological action consistently reduces the overall peripheral vascular resistance, a fundamental concept in its pharmacological action. The general purpose of this effect is to reduce strain on the circulatory system and improve blood flow, supporting the drug's general function as an Anti-hypertensive agent and Anti-anginal agent.

Regulatory References

  1. Amlodipine: MedlinePlus Drug Information

What side effects are possible with Amlodipine Aurobindo?

Possible Side Effects and Safety Information

The adverse effects and safety characteristics of Amlodipine Aurobindo are officially documented in regulatory labeling (e.g., FDA and EMA prescribing information) and are categorized by frequency and the organ system affected.

Frequency-Classified Adverse Reactions

The most frequently documented side effects are typically related to the drug's vasodilatory action, classified as follows:

Classification Examples of Documented Adverse Reactions
Very Common (ge 1/10) Peripheral edema (swelling of the extremities).
Common (< 1/10 to ge 1/100) Headache, dizziness, fatigue, nausea, abdominal pain, flushing, and palpitations.
Uncommon Hypotension, insomnia, mood changes, muscle cramps, and pruritus.
Rare to Very Rare Gingival hyperplasia, hepatitis, jaundice, and angioedema.

Serious Adverse Reactions and Safety Constraints

The official labeling notes several clinically significant reactions, though these are reported as rare or very rare. These include serious events affecting the Hepatobiliary system (e.g., Hepatitis) and the Cardiovascular system (e.g., Myocardial infarction, Arrhythmia, Angioedema).

The medicine is formally contraindicated and should not be used in individuals with severe hypotension, shock (including cardiogenic shock), or obstruction of the outflow tract of the left ventricle (e.g., severe aortic stenosis).

Population-Specific Notes

The regulatory safety profile includes specific cautions for certain populations. The half-life of Amlodipine is prolonged in patients with hepatic impairment, necessitating caution. For elderly patients, reduced clearance may increase systemic exposure. The documented adverse event profile for pediatric patients (ages 6–17) is generally consistent with that of adults.

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes the officially documented risks and required emergency actions for an Amlodipine overdose, as defined by authoritative regulatory sources.

Documented Overdose Presentations

The primary concern in an overdose is profound hemodynamic instability resulting from the drug's effects. Clinical manifestations documented in regulatory labels include:

  • Marked and potentially prolonged systemic hypotension (severely low blood pressure).
  • Massive peripheral vasodilation.
  • Reflex tachycardia (rapid heart rate).
  • Severe cases can progress to shock and have the potential to be fatal.

Required Emergency Actions

Immediate medical attention is necessary for any suspected overdose due to the risk of severe complications. The official guidance from regulatory bodies includes:

Action Instruction
Seeking Help Call emergency services immediately (e.g., 911 or equivalent) or a certified poison control center.
Immediate Monitoring Continuous and intensive monitoring of cardiac status and blood pressure is required.
Treatment Focus Management involves measures to reduce absorption (e.g., activated charcoal) and aggressive supportive care to restore cardiovascular stability, including the use of intravenous fluids, vasopressors, and potentially intravenous calcium to counter the calcium channel blockade effect.

Because Amlodipine has a long elimination half-life, extended observation in a medical facility is often required to monitor the patient's condition.

Therapeutic Uses of Amlodipine Aurobindo

What Amlodipine Aurobindo Treats: Main Uses and Benefits

Amlodipine is commonly used to support management for chronic cardiovascular conditions, primarily focusing on managing systemic imbalance and controlling symptoms related to physical discomfort. Amlodipine is used to help manage symptomatic relief for patients who experience symptoms related to heightened physiological activity in the circulatory system.

Amlodipine is applied across domains where additional symptomatic support is needed, being relevant for conditions such as Systemic Hypertension (high blood pressure) and various forms of Angina Pectoris (chest discomfort), including Chronic Stable Angina and Vasospastic Angina. It is generally used for managing symptoms that create noticeable physiological strain in adults and certain pediatric patients.

This therapy is considered relevant when supportive symptom management is appropriate, particularly during phases when symptoms become more noticeable. It supports the patient during difficult episodes by easing distress and is commonly used for managing conditions marked by increased physiological stress.

In patients with angiographically documented Coronary Artery Disease (CAD), Amlodipine is relevant in clinical settings that involve episodic or fluctuating manifestations. It contributes to easing the overall symptom load and helps maintain a sense of stability when symptoms are more noticeable.


Quick Fact: Relief for Vascular Symptoms

Category Therapeutic Focus
Primary Indication Sustained management of Systemic Hypertension
Symptom Focus Recurring chest discomfort (Angina)
Patient Benefit Supports maintenance of functional stability
Usage Context Chronic, long-term cardiovascular support

Eligibility and Restrictions for Use

Amlodipine is primarily prescribed to treat high blood pressure (hypertension) and certain types of chest pain (angina). Most adults may be eligible for treatment with Amlodipine Aurobindo, often after other first-line therapies have been considered or if they are unable to take them.


General Eligibility for Use

Patient Group Indication
Adults Treatment of hypertension; chronic stable angina; vasospastic angina (Prinzmetal's angina).

Contraindications (Who Cannot Use)

Amlodipine Aurobindo is generally contraindicated (should not be used) in patients with specific pre-existing conditions. It's essential to disclose your full medical history to your healthcare provider, especially if any of the following apply:

  • Allergy or Hypersensitivity: If you have a known allergy to amlodipine, other dihydropyridine derivatives, or any inactive ingredient in the tablet.
  • Cardiogenic Shock: A severe condition where the heart cannot pump enough blood.
  • Significant Aortic Stenosis: Severe narrowing of the heart's aortic valve.
  • Unstable Angina: Except for Prinzmetal's or vasospastic angina.
  • Severe Low Blood Pressure (Hypotension): Blood pressure that is pathologically low.

Use in children, adolescents, and older adults should be guided by specific clinical evaluation.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Amlodipine Aurobindo's interaction profile is officially structured around pharmacokinetic changes and additive effects, as documented in government regulatory labeling.

Metabolic and Exposure Alterations

Co-administration with strong and moderate CYP3A4 inhibitors, such as the antifungals Itraconazole and Ketoconazole, or the antibiotic Clarithromycin, may significantly increase the plasma concentration (exposure) of Amlodipine. Conversely, co-administration with CYP3A4 inducers, such as the herbal product St. John's wort, may reduce Amlodipine exposure.

The use of Amlodipine may increase the systemic exposure of several other medicines. Specifically, the dose of the cholesterol-lowering medicine Simvastatin must be limited to 20 mg daily when taken with Amlodipine. Additionally, frequent blood level monitoring is required when Amlodipine is co-administered with immunosuppressants like Tacrolimus or Ciclosporin, due to the risk of increased exposure to these agents.

Pharmacodynamic and Substance Interactions

Combining Amlodipine with other antihypertensive agents (e.g., beta-blockers, diuretics) or the PDE5 inhibitor Sildenafil can result in an additive blood pressure lowering effect. Furthermore, the regulatory label notes that Grapefruit juice may increase Amlodipine blood levels, and alcohol may potentiate the overall hypotensive effect. No mandatory timing separation rules are documented.

In patients with documented hepatic impairment, a decrease in Amlodipine clearance is observed, resulting in a documented increase in drug exposure.

Mechanism of Action

Cellular Mechanism: Blocking Calcium Entry

This drug acts as a calcium channel blocker by binding to specific protein structures called L-type calcium channels on the surface of vascular smooth muscle cells. This action inhibits the entry of calcium ions ( Ca^2+) from the extracellular space into the cytosol, which is the necessary molecular trigger for muscle contraction. This mechanism focuses on modulating activity within the vascular muscle tone system.

Physiological Result: Reducing Peripheral Resistance

The lack of calcium prevents the muscle cells in the arteries from contracting, leading them to relax and widen (vasodilation). This widening reduces the friction and opposition that blood encounters as it flows through the body, leading to a direct decrease in Total Peripheral Resistance (TPR). This key physiological change supports a shift in the circulatory pathways toward reduced mechanical load on the cardiovascular system.

Sustained Action and Selectivity

Amlodipine demonstrates a high affinity for the calcium channels in the arterial smooth muscle compared to those in the heart, making its primary effect the modulation of peripheral circulation. The molecule's slow and persistent binding at the channel contributes to a gradual onset and prolonged effect, initiating a long-lasting cascade that maintains reduced resistance to systemic blood flow.

Dosage and Administration Information

How to Use Amlodipine Aurobindo

The usage of Amlodipine Aurobindo, which contains the active ingredient amlodipine, follows standardized dosing and administration guidelines for the medicine.

Administration Route and Conditions

Amlodipine Aurobindo is administered orally (by mouth) as a tablet. The medicine is intended to be taken once daily, and it can be taken with or without food. For consistency, it is generally recommended to take the tablet at the same time each day.

Standard Labeled Dosing Regimens

Dosing is standardized for both hypertension and angina management. The table below outlines the general starting and maximum doses approved for adult use:

Indication Initial Starting Dose (Oral, Once Daily) Maximum Recommended Dose (Oral, Once Daily)
Hypertension/Angina 5 mg 10 mg

The typical adult maintenance dose range is 5 mg to 10 mg once daily. Dosage adjustments, or titration, are typically conducted at intervals of no less than 7 to 14 days to ensure the patient's full response to the current dose is assessed before increasing it.

Use in Specific Populations

General guidelines recommend modifications to the starting dose for certain patient groups:

  • Older Adults (Geriatric): A lower initial dose of 2.5 mg once daily may be considered.
  • Hepatic Impairment: Patients with liver problems may also begin therapy with a lower initial dose of 2.5 mg once daily, and the dose should be titrated slowly.
  • Pediatric Patients (6–17 years) for Hypertension: The recommended dose range is 2.5 mg to 5 mg once daily; doses exceeding 5 mg have not been formally studied in this age group.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research Evidence / Overview of Studies

Studies investigated the observed activity of Drug X on chemical messenger Z. The research focused on the effects of Drug X in relation to Condition A symptoms.


Clinical Trials on Condition A: Time to Outcome Evaluation

A randomized controlled trial (RCT) reported that patients receiving Drug X had a difference in symptom severity compared to those on placebo. Research has also explored the outcomes when Drug X was combined with behavioral therapy.


Long-Term Safety Profile: Extended Monitoring and Outcome Data

Long-term follow-up data was collected regarding the incidence of adverse events when Drug X was used for managing chronic symptoms. Information on discontinuation protocols was included in the study design.


Comparison with Other Treatments: Head-to-Head Studies

One meta-analysis evaluated the difference in outcomes between Drug X and Drug Y across five key measures. The analysis noted differences in reported outcomes between the treatments.

Key Studies & References

  1. NICE Guideline NG136: Hypertension in adults: diagnosis and management

Frequently Asked Questions (FAQ)

Common questions about Amlodipine Aurobindo (FAQ)

Q: Is Amlodipine Aurobindo the same as Amlodipine?

A: Amlodipine Aurobindo is the generic form of the medicine that contains the active ingredient, amlodipine. According to official guidance, generic medicines must meet the same strict quality and effectiveness standards as the original drug. Regulatory standards require generic and brand-name formulations to demonstrate bioequivalence.

Q: How quickly does Amlodipine Aurobindo start to lower blood pressure?

A: Official product information indicates that the medicine begins to decrease blood pressure gradually over a period of four to eight hours after taking a single dose. With continued daily use, the blood pressure lowering effect is sustained for at least 24 hours. The long duration of action supports its once-daily administration.

Q: Do I need to take Amlodipine Aurobindo at a specific time of day?

A: The medicine is prescribed to be taken once daily. Official guidance suggests taking the tablet at approximately the same time every day to help maintain consistent blood levels. The medicine may be taken in the morning or at night.

Q: Are there any food or drinks that should be avoided with Amlodipine Aurobindo?

A: Official regulatory labels note a specific interaction with grapefruit juice, which may increase the amount of medicine in the blood. Official guidance notes that alcohol may potentiate (strengthen) the hypotensive effects. The tablets themselves are approved to be taken with or without food.

Q: Can Amlodipine Aurobindo interact with herbal supplements?

A: The effects of amlodipine may be altered by certain compounds that affect a specific enzyme pathway in the body. One example cited in official documentation is the herbal product St. John's wort. Official documents recommend consulting with a healthcare professional regarding all supplements, including herbal ones, due to potential effects on medicine exposure.

Q: Does Amlodipine Aurobindo require regular blood tests?

A: For most patients, the medicine itself does not inherently require routine blood tests. However, frequent blood level monitoring is documented as necessary when the medicine is combined with specific immunosuppressants, such as Tacrolimus or Ciclosporin. The need for monitoring is due to the requirements of the other combined medicines.

Q: How long can Amlodipine Aurobindo be taken?

A: Official documents note that this medicine is indicated for the treatment of chronic (long-term) conditions such as high blood pressure and angina. Clinical study data and indications suggest the medicine is appropriate for extended use in managing these chronic health issues.

Q: What happens if I stop taking Amlodipine Aurobindo suddenly?

A: Abrupt changes to medicine regimens are generally discouraged. Official labeling has noted that worsening chest pain or the development of a heart attack can potentially occur, particularly in patients with severe heart disease, after starting or increasing the dose. Official guidance emphasizes consulting a healthcare provider before making changes to the treatment plan.

Q: Does Amlodipine Aurobindo affect heart rate?

A: In studies, chronic use of amlodipine is generally reported as not accompanied by a significant change in heart rate. However, official adverse event reporting includes palpitations, which is a sensation of heart fluttering, and more serious, though rare, reports of arrhythmia (irregular heartbeat), tachycardia (fast heart rate), and bradycardia (slow heart rate).

Q: Is Amlodipine Aurobindo suitable for people with diabetes?

A: Studies and official labeling have examined the use of amlodipine in patients with conditions such as Type 2 diabetes mellitus. The medicine is implied to be part of a regimen that may reduce the risk of cardiovascular events in this specific population. The determination of suitability is based on a full medical profile reviewed by a clinician.

Q: What is the difference between Amlodipine Aurobindo and Lisinopril?

A: The two medicines belong to different pharmacological classes. Amlodipine is classified as a Calcium Channel Blocker (CCB), which primarily works by relaxing blood vessels to improve blood flow. Lisinopril, in contrast, belongs to the class of ACE inhibitors, which affect a different bodily system to lower blood pressure.

Q: Does Amlodipine Aurobindo affect cholesterol levels?

A: Based on the established mechanism of action, amlodipine is not classified as a medicine that significantly alters cholesterol or lipid profiles. However, official documents note that it is often used as part of combination treatments alongside cholesterol-lowering agents (like statins).

Q: How is Amlodipine Aurobindo different from other calcium channel blockers?

A: Amlodipine is a specific type of medicine known as a dihydropyridine calcium channel blocker. Regulatory documents describe its action as having a selective and greater effect on the vascular smooth muscle (the arteries) than on the heart muscle cells.

Q: Does taking Amlodipine Aurobindo affect the kidneys?

A: Official guidance for Amlodipine monotherapy generally indicates that dose adjustments are not required for patients with most levels of renal (kidney) impairment. The medicine treats high blood pressure, a condition that can lead to severe health issues in the kidneys if left uncontrolled. Any determination of use requires clinical evaluation.

Q: What should I do if I forget to take my Amlodipine Aurobindo dose?

A: Official guidance on a missed dose advises taking it as soon as you remember. However, if the time is less than 12 hours before your next scheduled dose, the missed dose should be skipped entirely. Regulatory guidance states a double dose should not be taken to make up for a missed one.

Q: Does Amlodipine Aurobindo cause constipation?

A: Constipation has been reported as an adverse reaction in clinical trials and during postmarketing experience with this medicine. Official regulatory documents list this as a reported adverse reaction under gastrointestinal effects.

Q: Do official documents mention weight change as a possible effect of Amlodipine Aurobindo?

A: Official regulatory documents list both weight gain and weight decrease as general adverse reactions. These effects have been reported during clinical trials and postmarketing experience with the medicine.

Q: Are there any restrictions on driving or operating machinery while taking Amlodipine Aurobindo?

A: Official safety information includes reports of side effects such as dizziness, fatigue, and somnolence (drowsiness). Official safety information notes that caution may be warranted when driving or operating machinery, especially when first starting the treatment.

Q: Can Amlodipine Aurobindo be taken during pregnancy?

A: Official guidance states there is inadequate data regarding the use of this medicine in pregnant women. Regulatory documents generally advise that the medicine should be used during pregnancy only if the potential benefit justifies the potential risk. This assessment is based on available animal study data and clinical necessity.

Q: Is Amlodipine Aurobindo used to prevent heart attacks?

A: The primary purpose of the medicine is to lower high blood pressure, which is known to reduce the risk of cardiovascular events, including a myocardial infarction (heart attack). Official documents also state that the medicine is specifically indicated to reduce the risk of heart attack in adults who have certain risk factors for Coronary Heart Disease (CHD).

Q: Are there official warnings about combining Amlodipine Aurobindo with certain non-prescription medications?

A: Official warnings highlight non-prescription products that may affect the body’s metabolism of the medicine, such as the herbal product St. John's wort. Official guidance recommends consulting a healthcare professional regarding all non-prescription medicines and supplements due to the potential for interactions.

Q: Is Amlodipine Aurobindo a drug that is intended for lifelong use?

A: The medicine is officially indicated for the treatment of chronic (long-term) conditions, including high blood pressure and angina. This suggests it is often used as a long-term regimen to manage these ongoing health issues. The appropriate duration of use is a clinical decision.

Q: What does official guidance say about patients with kidney issues using Amlodipine Aurobindo?

A: Official guidance for Amlodipine monotherapy generally indicates that dose adjustment is not required for patients with most levels of renal (kidney) impairment. The medicine treats high blood pressure, a condition that can lead to severe health issues in the kidneys if left uncontrolled. Any determination of use requires clinical evaluation.

Q: Is Amlodipine Aurobindo a Schedule drug?

A: The medicine is designated by regulatory authorities as a prescription-only medicine (Rx only). This means it can only be dispensed after a valid prescription has been issued by a healthcare professional. It is not classified as a controlled substance under drug scheduling systems.

Q: Do studies suggest Amlodipine Aurobindo is generally well-tolerated?

A: In clinical trials and official adverse event reporting, the medicine was generally reported to be well-tolerated by most patients at common daily doses. Most documented adverse reactions were classified as mild or moderate in severity.

How should Amlodipine Aurobindo be stored and disposed of?

Official Storage and Disposal Requirements

Storage and handling instructions for Amlodipine Aurobindo are defined by official regulatory labeling, focusing on product stability and public safety.

Storage Conditions

Requirement Official Statement Basis
Temperature Store at room temperature, often specifying Do not store above 25°C (77°F).
Protection Keep the product in the original blister and outer carton to protect from light and moisture.
Handling Keep out of the sight and reach of children, and avoid exposure to excess heat.
Stability The shelf life for the unmixed tablet formulation is generally 3 years.

Disposal Rules

Unused or expired Amlodipine Aurobindo must be disposed of in accordance with local requirements. Official guidance advises against flushing the medication down a toilet or drain. Preferred methods include using a drug take-back program or mixing the product with an undesirable substance (e.g., used coffee grounds) and securing it in a sealed container before placing it in household trash.

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

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