Amlodipina Aurobindo

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Amlodipina Aurobindo

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 Amlodipina Aurobindo

Quick Facts

Property Description
Active ingredient Amlodipine (as besilate)
Form Oral Tablet
Pharmacological class Calcium Channel Blocker (Dihydropyridine)
General purpose Moderating cardiovascular resistance
Origin Synthetic compound

What is Amlodipina Aurobindo? Defining the Core Medicine

Amlodipina Aurobindo is a pharmaceutical product containing the active ingredient Amlodipine, which is formally classified as a Calcium Channel Blocker (CCB). This medicine is a synthetic, single-ingredient compound, specifically a dihydropyridine derivative, typically formulated as an oral tablet for systemic administration. The classification of Amlodipine places it within a core group of cardiovascular agents for its therapeutic profile.

Amlodipine's Role as a Selective Vasodilator

The primary pharmacological function of Amlodipine is its action as a powerful vasodilator, promoting the widening of blood vessels throughout the body. This effect is achieved through the selective inhibition of calcium ion influx into the muscle cells lining the arterial walls, a mechanism that prevents excessive constriction. This targeted action on the arteries involves the specific targeting of L-type calcium channels.

Amlodipine distinguishes itself by exhibiting high selectivity for vascular smooth muscle over cardiac tissue. This means its primary effect is focused on the arteries, resulting in a persistent reduction of peripheral vascular resistance (PVR). This specificity is a core element of its profile, making it a foundation in managing conditions where easing circulatory resistance is key.

The Therapeutic Benefit of Arterial Relaxation

Amlodipine’s mechanism of selectively relaxing the arterial walls serves the fundamental purpose of easing the cardiovascular workload. This reduction in systemic resistance translates to a direct benefit by making it easier for the heart to pump blood throughout the body.

Furthermore, by promoting vasodilation in the coronary arteries, the medicine supports enhanced oxygen delivery to the heart muscle itself. The overall function is to support cardiovascular health by consistently moderating the physical pressure and strain within the circulatory system, which is essential for the long-term management of chronic vascular conditions.

What side effects are possible with Amlodipina Aurobindo?

Possible side effects and safety information

The official safety profile of Amlodipine is classified by the frequency with which adverse reactions appeared in clinical trials and post-marketing data, primarily using categories such as Very Common, Common, and Uncommon.

Adverse reaction scope

Classification Examples of Officially Listed Effects
Very Common (ge 1/10) Oedema (fluid retention, typically ankle swelling).
Common (ge 1/100 to <1/10) Headache, Dizziness, Somnolence, Palpitations, Flushing, Nausea, Abdominal pain, Fatigue, Asthenia.
Uncommon Hypotension, Insomnia, Mood changes, Tremor, Syncope, Rash, Dry mouth.

These effects are grouped by System-Organ Classes, including Nervous System Disorders, Vascular Disorders, Gastrointestinal Disorders, and General Disorders.

Serious adverse reactions (label-documented)

Regulatory documentation highlights serious, though very rare, adverse reactions, including Acute Myocardial Infarction and Worsening Angina, particularly upon starting or increasing the dose, and severe hypersensitivity events like Angioedema and Stevens-Johnson syndrome. Very rare reports include Hepatitis and Pancreatitis.

Population-specific safety considerations

The label includes specific safety notes for certain populations. For Older Adults, lower initial dosing may be considered due to the greater likelihood of decreased physiological function. For patients with Hepatic Impairment, clearance is decreased, and caution is required. Use also requires caution in patients with Heart Failure due to an association with increased reports of pulmonary oedema.

Time- or exposure-related patterns

Headache, dizziness, and somnolence are specifically reported in regulatory sources as being observed especially at the beginning of the treatment. Worsening angina can develop after starting or increasing the dose.

Safety-related restrictions or limitations

The medicine is formally contraindicated in patients with severe hypotension, shock (including cardiogenic shock), or outflow tract obstruction (e.g., high grade aortic stenosis).

The official safety information structures the drug's risk profile by clearly delineating expected, common events from rare but serious adverse reactions, and highlights key physiological factors and time-related patterns that influence its use.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

This section outlines the officially documented overdose manifestations and mandated actions as described in government regulatory documents.

Documented Overdose Presentations

Gross overdose of Amlodipina Aurobindo is primarily associated with pronounced effects on the cardiovascular system, which include:

  • Marked and Prolonged Systemic Hypotension: A severe and potentially extended drop in blood pressure.
  • Excessive Peripheral Vasodilation: Pronounced widening of blood vessels throughout the body.
  • Reflex Tachycardia (Possible): A compensatory increase in heart rate.

Serious Outcomes and Emergency Action

Severe outcomes officially associated with gross overdose include the risk of shock resulting from profound hypotension, which has been linked to a fatal outcome. Due to the life-threatening nature of these manifestations, immediate medical attention is required for any suspected overdose.

Action Mandated by Regulators Details
Urgent Medical Contact Individuals must seek immediate medical attention, such as contacting a hospital emergency department or Poison Control Centre.
Active Cardiovascular Support Clinically significant hypotension requires immediate and active cardiovascular support, including frequent monitoring of cardiac and respiratory function.

Officially Described Supportive Measures

No specific antidote is documented in the regulatory labeling. Management focuses on counteracting the cardiovascular collapse and removing unabsorbed drug, including:

  • Elevation of extremities.
  • Use of a vasoconstrictor (if hypotension persists after fluid replacement).
  • Gastric lavage may be considered in some cases.

Therapeutic Uses of Amlodipina Aurobindo

What Amlodipina Aurobindo Treats: Main Uses and Benefits

Amlodipina Aurobindo is primarily used for managing symptoms related to heightened physiological activity in the cardiovascular system. The medication is commonly used to help with high blood pressure, certain types of angina, and coronary artery disease. It assists with maintaining functional stability by easing symptoms related to systemic imbalance.

The medication is applied across therapeutic domains where additional symptomatic support is needed, specifically to address the symptom clusters of elevated pressure readings and recurrent chest discomfort. It is commonly used as supportive therapy in chronic disease management, often applied during phases when symptoms become more noticeable.

“This continuous support may help ease symptoms related to systemic imbalance and assists with managing conditions marked by increased physiological stress.”

Quick Fact Block

Quick Fact Description
Symptom Area of Focus Symptoms of systemic imbalance (high pressure) and recurrent chest discomfort.
Use Context Applied in settings requiring long-term, supportive symptom management for chronic conditions.
Main Benefit Supports stability during episodes and assists with maintaining functional stability.

Regulatory References

  1. NIH MedlinePlus overview on Amlodipine

Eligibility and Restrictions for Use

Who can and cannot use Amlodipina Aurobindo?

Eligibility for Amlodipina Aurobindo is formally determined by official regulatory bodies, setting clear guidelines for use and absolute exclusions.

Populations for Whom Use is Prohibited (Contraindications)

Contraindication Category Official Regulatory Statement
Hypersensitivity Patients with known allergy to amlodipine, dihydropyridine derivatives, or any tablet ingredients.
Circulatory Instability Patients with severe hypotension (very low blood pressure), circulatory shock (including cardiogenic shock), or haemodynamically unstable heart failure after a recent cardiac event.
Vascular Obstruction Patients with high grade aortic stenosis (obstruction of the left ventricular outflow tract).

Eligibility Based on Age and Physiological Status

  • Adults: The medicine is formally approved for use in adults for both hypertension and angina.
  • Pediatric Patients: Use is approved for children aged 6 to 17 years specifically for the treatment of hypertension. Use is not recommended in children under 6 years as safety and effectiveness have not been established.
  • Pregnancy and Lactation: Use during pregnancy is generally not recommended unless necessary, as safety has not been established. Due to excretion into human milk, breastfeeding is not advised during therapy.
  • Organ Function: Patients with impaired liver function require close monitoring and conditional use, typically starting at the lowest dose. Renal impairment does not necessitate dose adjustment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation outlines specific pharmacokinetic and pharmacodynamic interactions for Amlodipina (Amlodipine). This information is descriptive and relates only to documented changes in drug exposure or additive effects, based strictly on official prescribing information.

Documented Exposure-Altering Interactions

The most significant interactions involve the CYP3A4 enzyme pathway, the primary route for Amlodipine metabolism:

  • Increased Amlodipine Exposure: Co-administration with strong or moderate CYP3A4 inhibitors (such as macrolide antibiotics or azole antifungals) may result in a significant increase in Amlodipine's systemic exposure.
  • Decreased Amlodipine Exposure: The use of CYP3A4 inducers (e.g., rifampicin, St. John's Wort) may lead to a reduction in Amlodipine plasma concentrations.
  • Simvastatin Restriction: Amlodipine increases the exposure of Simvastatin. Regulatory restrictions mandate that the daily dose of Simvastatin must not exceed 20 mg when co-administered.
  • Increased Immunosuppressant Levels: Amlodipine is documented to increase the blood levels of the immunosuppressants Cyclosporine and Tacrolimus.

Other Official Interaction Notes

Interaction Type Official Regulatory Statement
Pharmacodynamic Amlodipine's blood pressure-lowering effect is additive to that of other antihypertensive agents.
Contraindications No medicinal product combinations are formally classified as contraindicated combinations in the core regulatory labels.
Population Caution Clearance of Amlodipine is decreased in patients with impaired hepatic function, resulting in increased systemic exposure.

Mechanism of Action

Selective Blockade of Calcium Channels in Arteries

Amlodipine acts by selective inhibition of the L-type calcium channels (Cav1.2), which are ion gates on the membrane of arterial smooth muscle cells. This binding prevents the influx of extracellular calcium ions ( Ca^2+), the essential trigger required to initiate muscle contraction.

Disruption of the Contraction Signaling Cascade

The drug's blockade interrupts the internal cellular cascade: reduced Ca^2+ levels inhibit the activation of the Myosin Light-Chain Kinase (MLCK) enzyme. This interruption forces the vascular muscle cells to relax, which immediately promotes widespread arterial vasodilation (widening of the arteries).

Functional Modulation of Systemic Resistance

The resulting vasodilation causes a reduction in Peripheral Vascular Resistance (PVR), or resistance to blood flow, which in turn reduces the afterload placed on the heart. The mechanism also extends to the coronary arteries, causing their walls to relax and modulating the capacity for oxygen delivery to the heart muscle itself. This functional effect is sustained due to the molecule's slow release from the cell membrane.

Dosage and Administration Information

How to Use Amlodipina Aurobindo (Amlodipine) – Administration Guidelines

Administration Details

Amlodipina Aurobindo is approved for oral administration as a tablet. The tablet must be swallowed whole with water.

Condition Instruction
Timing Take once daily. It is recommended to take the medication at the same time each day.
Food and Drink May be taken with or without food.
Dose Titration Dosage adjustments (increases) should generally not occur more frequently than every 7 to 14 days to fully assess the patient's response.

Dosing Ranges

Patient Group Initial Recommended Daily Dose Maximum Daily Dose
Adults 5 mg once daily 10 mg once daily
Pediatrics (6–17 years) 2.5 mg once daily 5 mg once daily

Special Population Dosing

Specific considerations apply for certain patient groups:

  • Elderly Patients: A lower starting dose of 2.5 mg once daily should be considered.
  • Hepatic Impairment: A lower starting dose of 2.5 mg once daily is recommended, with a gradual and cautious titration schedule due to potential accumulation.

Missed Dose Instructions

If you miss a dose, take it as soon as you remember on that day. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not take a double dose to make up for a missed dose.

Recent Clinical Evidence

Amlodipina Aurobindo contains amlodipine, a dihydropyridine calcium channel blocker widely studied in the management of cardiovascular conditions.

Clinical Applications and Study Outcomes

Clinical trials have primarily evaluated amlodipine for two key indications:

  • Hypertension (High Blood Pressure): Studies, including large-scale trials, have demonstrated that amlodipine administration is associated with a reduction in both systolic and diastolic blood pressure. Its long duration of action supports once-daily dosing, and research suggests that this consistency in blood pressure lowering may contribute to reduced risk of major cardiovascular events, such as non-fatal myocardial infarction and stroke, when compared with placebo.
  • Chronic Stable Angina and Vasospastic Angina: Amlodipine has been assessed for its use in patients experiencing chest pain (angina). Clinical data indicates that administration may be associated with increased exercise tolerance, reduced frequency of angina attacks, and decreased need for nitroglycerin use compared to placebo. It is also utilized in the management of vasospastic angina (Prinzmetal's angina).

Tolerability Profile

Research consistently examines the overall safety and tolerability of amlodipine. Findings from clinical trials show that the most commonly reported adverse events include peripheral edema (swelling of the ankles or feet), headache, and flushing. These effects are generally dose-related and may improve with continued administration. Serious side effects are rare. The adverse event data collected in large cohorts informs risk-benefit discussions for individual patients.

Comparative Efficacy

Some trials have compared amlodipine with other classes of antihypertensive agents, such as angiotensin-converting enzyme (ACE) inhibitors or diuretics. These comparisons suggest that amlodipine offers an effective approach to blood pressure control, often exhibiting comparable outcomes concerning the reduction of cardiovascular complications. The selection of an agent or combination of agents remains a clinical decision based on the patient's coexisting conditions and needs.

Frequently Asked Questions (FAQ)

Common questions about Amlodipina Aurobindo (FAQ)


Q: How quickly can one expect Amlodipina Aurobindo to start working?

According to official product information, the initial rise in drug levels occurs relatively quickly, with the peak concentration in the blood typically reached between 6 and 12 hours after administration.

However, the full therapeutic benefit of the medicine, known as 'steady-state,' is generally achieved after 7 to 8 days of consistent daily use.


Q: How long does the effect of Amlodipina Aurobindo last after taking it?

The official product information describes the molecule as having a prolonged terminal elimination half-life, which is the time it takes for half of the drug to be cleared from the body. This half-life is typically between 30 and 50 hours.

This long duration of activity supports the drug being approved for once-daily administration.


Q: What should I know about taking Amlodipina Aurobindo with grapefruit or grapefruit juice?

Regulatory information indicates that grapefruit is known to inhibit the drug's metabolic pathway (CYP3A4), which may slightly increase the plasma concentration of amlodipine in the body.

Individuals may wish to consider this potential, as grapefruit is described in official documents as affecting the drug’s metabolism.


Q: What happens if a dose of Amlodipina Aurobindo is forgotten?

Regulatory instructions describe that if a dose is missed, it can be taken as soon as it is remembered on that day. If it is almost time for the next scheduled dose (e.g., typically after 12 hours), the missed dose should be skipped, and the regular schedule resumed.

The official guidance states that a double dose should not be taken to make up for the forgotten one.


Q: Does Amlodipina Aurobindo interact with herbal supplements?

The drug is metabolized by the CYP3A4 enzyme pathway. Regulatory documents describe that certain herbal products, such as St. John's Wort, may interact with this pathway.

The use of such products may require caution, as they could potentially reduce the concentration of the medicine in the body.


Q: Are there any restrictions on driving or operating machinery while using Amlodipina Aurobindo?

Official sources state that common side effects such as dizziness, headache, and fatigue may occur when using the medicine.

Individuals who experience these effects may have impaired ability and should consider avoiding driving or operating machinery until the symptoms pass.


Q: What information is available about the long-term effects of taking Amlodipina Aurobindo?

Studies and official information indicate that long-term, consistent use of amlodipine is associated with a reduction in the risk of major cardiovascular events, such as heart attack and stroke.

Common side effects are often reported to change in nature or frequency as the body adjusts to the medicine.


Q: Can Amlodipina Aurobindo cause fatigue or tiredness?

Yes, regulatory documents list both Fatigue and Asthenia (a condition of weakness or loss of strength) as common adverse events.


Q: Can Amlodipina Aurobindo affect dental health (like gum swelling)?

A rare side effect associated with the calcium channel blocker class of medicines is gingival enlargement, which is an overgrowth or swelling of the gums.

Maintaining good oral hygiene is often emphasized when discussing the use of this class of medication.


Q: Can Amlodipina Aurobindo be crushed or split?

The official administration instructions for the oral tablet describe that the tablet is intended to be swallowed whole with water.

Tablets are not generally intended to be broken, crushed, or chewed unless otherwise specified in official prescribing information.


Q: Is Amlodipina Aurobindo the same as amlodipine besylate?

Amlodipina Aurobindo contains the active ingredient Amlodipine.

This active ingredient is chemically formulated and approved in many medicines as the salt Amlodipine Besylate.


Q: Can Amlodipina Aurobindo interact with common pain relievers like ibuprofen?

Regulatory warnings indicate that common nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may reduce the blood pressure-lowering effect of amlodipine.

Close blood pressure monitoring may be necessary when these medicines are used together.


Q: Is it okay for older adults (seniors) to use Amlodipina Aurobindo?

Use is approved for adults, including older adults. Official labeling recommends that a lower initial starting dose be considered for elderly patients.

This consideration is due to official notes regarding the potential for decreased physiological function in older adults.


Q: Is Amlodipina Aurobindo safe to use during pregnancy?

Official information states that use during pregnancy is generally not recommended unless deemed absolutely necessary, as safety has not been fully established.

Furthermore, due to the drug's excretion into human milk, breastfeeding is not advised during therapy.


Q: Are there any known interactions between Amlodipina Aurobindo and alcohol?

Alcohol consumption may potentially enhance the blood pressure-lowering effect of the drug.

This combination can sometimes lead to an increased risk of side effects such as dizziness, sleepiness, or headache.


Q: Is there a risk of withdrawal symptoms if Amlodipina Aurobindo is suddenly stopped?

Regulatory data on discontinuation indicate that stopping the medicine results in a slow return of blood pressure to baseline levels, usually over 7 to 10 days.

Official sources show no evidence of a 'rebound' effect, where blood pressure dramatically increases above pre-treatment levels, upon sudden stopping.


Q: Does Amlodipina Aurobindo affect sleep or cause insomnia?

Insomnia (difficulty sleeping) is officially listed in regulatory documents as an uncommon adverse reaction to the medication.


Q: Is Amlodipina Aurobindo a generic drug?

Yes, Amlodipina Aurobindo is a product containing the active ingredient Amlodipine.

This product is available as a widely approved generic medication.


Q: How is Amlodipina Aurobindo different from other blood pressure medicines?

Amlodipine is defined as a Calcium Channel Blocker (Dihydropyridine). This class of medicine acts by selectively relaxing the walls of the arteries through the inhibition of calcium ion influx.

This specific mechanism of action distinguishes it from other major blood pressure classes, such as diuretics or ACE inhibitors.


Q: Does Amlodipina Aurobindo affect kidney function?

Official documentation states that renal impairment typically does not necessitate a dose adjustment for amlodipine.

No specific dose restrictions are generally needed based on kidney function alone.


Q: What is the risk of overdose with Amlodipina Aurobindo?

Overdose is considered a serious event that can lead to excessive peripheral vasodilation (widening of blood vessels) and subsequent marked and possibly prolonged systemic hypotension (very low blood pressure).

Regulatory documents note that immediate medical attention is required in the case of a suspected overdose.


Q: What are the key ingredients in Amlodipina Aurobindo besides the active one?

In addition to the active ingredient, the tablets contain inactive ingredients, also known as excipients, which are used for forming the tablet.

These ingredients are fully listed in the official prescribing information and typically include compounds such as microcrystalline cellulose, dibasic calcium phosphate dihydrate, and magnesium stearate.


Q: How long does it take for Amlodipina Aurobindo to be cleared from the body?

The terminal elimination half-life, which describes the rate of clearance from the body, is typically between 30 and 50 hours.

This indicates that the medicine is cleared relatively slowly from the systemic circulation.


Q: Does Amlodipina Aurobindo cause changes in mood or depression?

Mood changes are officially listed in regulatory documents as an uncommon adverse reaction to the medication.


Q: What is the risk of a severe allergic reaction to Amlodipina Aurobindo?

Severe allergic reactions, known as hypersensitivity events, are officially listed as a very rare possibility with this medicine.

Signs of a severe reaction documented in official sources include angioedema (swelling of the face, lips, or tongue) and severe skin reactions.

How should Amlodipina Aurobindo be stored and disposed of?

Official Storage and Disposal Requirements

Storage and disposal instructions for Amlodipina Aurobindo are defined by official regulatory labeling to ensure product stability and environmental safety.

Requirement Area Regulatory Statement
Temperature The 7.5 mg strength must be stored below 30 C; other strengths often require no special storage conditions.
Child Protection The medicine must be kept out of the sight and reach of children at all times.
Stability Do not use the medicine after the expiry date (EXP) stated on the packaging.
Disposal Mandate Do not throw away this medicine via wastewater or household waste.
Procedure Consult a pharmacist for instructions on how to dispose of unused or expired medicine, as these measures help protect the environment.

Some official monographs also specify that the product requires protection from light during storage.

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

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