Indapril

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Indapril

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 Indapril

Property Description
Active ingredient Indapamide, Perindopril
Form Fixed-Dose Combination (FDC) Tablet
Pharmacological class Combination Antihypertensive Agent
Common use Essential Hypertension (High Blood Pressure)
Origin Synthetic Compound

What Type of Medicine is Indapril?

Indapril is a prescription-only medicine (POM) classified as a combination antihypertensive agent, developed for the management of high blood pressure. This synthetic product is defined as a Fixed-Dose Combination (FDC) tablet, a form clinically recognized for promoting patient adherence by consolidating multiple medications into a single pill. Indapril integrates two distinct therapeutic strategies into one preparation for oral administration. Fixed-dose combination preparations containing an ACE inhibitor and a diuretic are recognized as standard tools in comprehensive blood pressure control.


Indapamide and Perindopril: What is the Composition?

The composition of Indapril features the two active ingredients (INN): Perindopril and Indapamide. Perindopril belongs to the Angiotensin-Converting Enzyme (ACE) inhibitor pharmacological class, whose primary function is to promote the relaxation of blood vessels. Indapamide is categorized as a thiazide-like diuretic, which manages the body’s fluid and salt balance, serving as a distinctive component due to its long-acting nature. Other recognized fixed-dose combinations with the same active ingredients include Co-Perindopril/Indapamide and Coversyl Plus, establishing this dual composition as a globally standard therapeutic choice. Research confirms that this specific combination is highly effective in providing sustained reductions in both systolic and diastolic blood pressure.


General Purpose in Antihypertensive Therapy

The general purpose of this medication is to achieve robust and sustained blood pressure reduction in patients diagnosed with essential hypertension. This goal is supported by pharmacological studies that demonstrate the synergistic effect of combining the two compounds, which target both vascular resistance and fluid volume simultaneously. A typical neutral use scenario involves adults needing consistent control of arterial pressure to reduce cardiovascular risk. By integrating these two complementary actions, the fixed-dose tablet provides a comprehensive and effective strategy for chronic antihypertensive therapy.

What side effects are possible with Indapril?

Possible Side Effects and Safety Information

The safety profile for this fixed-dose combination of perindopril and indapamide is defined by regulatory documents, which formally classify adverse reactions by frequency and affected physiological systems. The most Common official adverse reactions include headache, dizziness, cough, nausea, and hypotension (low blood pressure), frequently reported under Nervous System, Respiratory, and Vascular Disorders. Less frequently, reactions classified as Uncommon or Rare may occur.


Serious Adverse Reactions and Safety Constraints

Official labeling highlights the risk of Serious Adverse Reactions, most notably Angioedema (severe swelling of the face or throat), Hepatic Encephalopathy (in patients with pre-existing severe liver impairment), and rare blood disorders like agranulocytosis. The product is strictly contraindicated during the second and third trimesters of pregnancy due to documented fetal toxicity. Use is also restricted in patients with severe renal impairment or pre-existing severe hypokalemia (low potassium).

Certain effects, such as hypotension, are often noted as being more likely to occur at the initiation of treatment or during dose increases. The safety profile requires cautious assessment in older adults, and its use is not established in the pediatric population.

Overdose and Emergency Response

Overdose and when to seek help

Overdose with the fixed-dose combination of Perindopril and Indapamide may present primarily as severe hypotension, a marked drop in blood pressure. Regulatory documents state that this can rapidly progress to life-threatening outcomes, including circulatory shock and acute renal failure. The official profile notes other documented manifestations such as dizziness, confusion, sleepiness, and gastrointestinal distress including nausea and vomiting.

Laboratory findings would likely indicate severe electrolyte disturbances, specifically hyponatraemia (low sodium) and hypokalaemia (low potassium), along with signs of compromised renal function.

Immediate Action Required

  • Seek immediate medical attention for any suspected overdose.
  • The official requirement is to call emergency services if severe manifestations, such as passing out or signs of circulatory shock, are present.

Treatment described in regulatory sources is symptomatic and supportive. If severe hypotension occurs, intravenous infusion for volume replacement is necessary. No specific antidote is known. However, the active metabolite, Perindoprilat, is officially noted to be removable by dialysis. Close monitoring of blood pressure, electrolytes, and renal function is required during management.

Therapeutic Uses of Indapril

What Indapril Treats: Main Uses and Benefits

The fixed-dose combination of perindopril and indapamide is generally used for the long-term management of Essential Hypertension, which is the primary condition characterized by persistent arterial pressure elevation. This therapeutic strategy is considered relevant in clinical settings that involve sustained systemic imbalance where supportive management of blood pressure is needed. The combination is generally recognized for its role in managing high blood pressure, specifically across conditions presenting with episodic or fluctuating manifestations, and is applicable in situations involving recurrent or chronic essential hypertension.

A key therapeutic benefit is commonly used in addressing the reduction of symptoms that create noticeable physiological strain on the cardiovascular system. By generally helping to lower pressure, this treatment assists with mitigating the risks associated with chronic high blood pressure, thereby supports general well-being during symptomatic phases. This is considered relevant as the medication is commonly used across conditions marked by increased physiological stress, such as in older adults or those with hypertensive diabetic conditions.

“This treatment provides support that helps ease the overall symptom burden associated with chronic hypertension, assisting with maintaining functional stability during symptomatic phases.”


Summary of Therapeutic Focus

Focus Description
Primary Condition Essential Hypertension
Target Domain Symptoms related to heightened physiological activity (persistent pressure)
Key Benefit Contributes to easing the overall symptom load

Regulatory References

  1. View the Health Canada Drug and Health Product Register

Eligibility and Restrictions for Use

The eligibility profile for Indapril (Perindopril/Indapamide) is strictly defined by official regulatory labeling, outlining specific populations that are permitted, restricted, or prohibited from using the medicine.

Eligibility Status Defined Population
Allowed (Established Use) Adults (Age ge 18 years) with essential hypertension.
Absolute Contraindication History of angioedema related to ACE inhibitors; Hypersensitivity to drug or related classes; Severe hepatic impairment; Severe renal impairment (CrCl < 30 mL/min); Pre-existing hypokalemia; Second and third trimesters of pregnancy.
Not Recommended/Restricted Children and adolescents (under 18 years, safety not established); Breastfeeding/Lactation; First trimester of pregnancy; Patients on Aliskiren (with diabetes/renal impairment); Patients on Sacubitril/Valsartan; Patients with moderate renal/hepatic impairment.

Age and Organ Function Rules The drug is approved only for adults. Use is not recommended for pediatric populations because safety and efficacy data have not been established by regulators. Severe organ impairment (kidney or liver) is an absolute exclusion criterion. Restrictions for specific concomitant therapies are also documented, including co-administration with Aliskiren in certain patients and initiation within 36 hours of taking Sacubitril/Valsartan.

What should I know about interactions with other medicines?

Indapril's official interaction profile is structured around combinations that pose risks to blood pressure, electrolyte balance, and the potential for severe reactions, as defined by regulatory agencies.

Contraindicated Combinations and Restrictions

Co-administration with Sacubitril/valsartan is formally prohibited due to the increased risk of angioedema, necessitating a mandatory 36-hour separation period between doses. The use of Aliskiren is contraindicated in patients with diabetes mellitus or those with impaired kidney function (GFR < 60 mL/min/1.73 m^2) due to the risk of dual RAAS blockade. Certain extracorporeal treatments, such as dialysis with high-flux membranes, are also prohibited procedures due to the risk of severe anaphylactoid reactions.

Pharmacodynamic and Exposure Risks

Indapril's label identifies interactions that affect physiological outcomes. Combination with Potassium-sparing drugs (e.g., Spironolactone) or Potassium supplements is generally not recommended due to the formal risk of hyperkalemia. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and high-dose Aspirin may reduce the antihypertensive effect and increase the risk of impaired renal function. Co-administration with Lithium is usually not recommended because Indapril is documented to increase the plasma concentration of Lithium, leading to potential toxicity. Additionally, the label advises that consumption of Alcohol (Ethanol) may result in an additive hypotensive effect.

Mechanism of Action

Calcium Channel Blockade: The Primary Target

Indapril acts as a calcium ion ( Ca^2+) channel blocker. Its core mechanism involves inhibiting the influx of Ca^2+ into both cardiac and vascular smooth muscle cells, which directly modulates cardiac conduction velocity and initiates the cascade leading to reduced peripheral vascular resistance.


Molecular Mechanism at the DHP Site

The drug specifically engages with the L-type Ca^2+ channel. Mechanistically, Indapril binds to the dihydropyridine ( DHP) binding site on the channel protein, reducing the overall conductance of Ca^2+ ions through the channel pore.


Downstream Systemic and Cardiac Effects

The resulting reduction in Ca^2+ entry in myocardial tissue decreases contractility and consequently lowers the oxygen demand of the cardiac tissue. In vascular smooth muscle, this action leads to vasodilation and a subsequent influence on systemic vascular smooth muscle tone and resistance.

Dosage and Administration Information

How to Use Indapril: Official Administration Guidelines

Indapril (Perindopril/Indapamide) is a fixed-dose combination medication. The following instructions detail the proper administration as directed by regulatory labeling.


Administration and Timing

Guideline Instruction
Route of Administration Oral (by mouth).
Frequency Once daily (qDay).
Time of Day Recommended to be taken in the morning.
Relation to Meals Should be taken before a meal (for optimal absorption of the perindopril component).

Dosage and Titration

The treatment typically begins with the lowest available combination strength, such as 2 mg / 0.625 mg perindopril/indapamide.

  • Tablet Integrity: The tablet must be swallowed whole with water. It should not be crushed or chewed especially if it contains extended-release properties.
  • Dose Increase: If blood pressure is not adequately controlled, the dose may be increased to a higher strength (e.g., 4 mg / 1.25 mg or 8 mg / 2.5 mg). Dose adjustments, or titrations, should only occur after a minimum treatment period (often 4 weeks) to allow the full effect of the previous dose to stabilize.

Population-Specific Dosing

Official labeling includes specific administration rules for certain patient groups:

  • Elderly Patients: A cautious, lower initial dose is generally recommended.
  • Renal Impairment: The drug is not recommended or contraindicated in patients with severe renal impairment (e.g., Creatinine Clearance <30 mL/min). Dosing in moderate impairment must begin with the lowest strength, with close monitoring.

Missed Dose

If a dose is missed, do not take a double dose to compensate. The correct procedure is to skip the missed dose entirely and take the next scheduled dose at the usual time in the morning.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Indapril


Evidence for Use in Essential Hypertension and High Cardiovascular Risk

Research has explored the combination's use in essential hypertension via large-scale, long-term Randomized Controlled Trials (RCTs). These studies compare treatment regimens against controls and are further evaluated in Systematic Reviews and Meta-Analyses. Researchers primarily monitored changes in Systolic and Diastolic Blood Pressure (BP). The long-term trials also tracked the incidence of major cardiovascular events (such as stroke and heart attack) and changes in heart health markers like Left Ventricular Mass. Research examined treatment regimens containing this combination in patients at medium to high background cardiovascular risk, and findings described patterns related to changes in the rate of major cardiovascular events compared to controls. The research contributes to the broader evidence landscape regarding hypertension.


Evidence for Use in Patients with Type 2 Diabetes Mellitus

The combination was evaluated in a dedicated, large-scale Randomized Controlled Trial designed specifically for adults who have essential hypertension alongside Type 2 Diabetes Mellitus (T2DM). This research examined outcomes in this patient population. Researchers tracked major vascular outcomes and microvascular events, including rates of new or worsening renal disease and changes in Albumin Excretion Rate (AER). The research explored patterns of cardiovascular death and death from any cause over the study period.


Long-Term Studies and Follow-Up Periods

The research base for Indapril includes trials with long-term follow-up durations, which is relevant for evaluating chronic conditions like high blood pressure. Most major outcomes trials observed responses over defined time intervals that ranged over several years (typically around four to five years). The evidence highlights what is known about these extended outcomes, but there is limited information for long-term evidence that extends far beyond the maximum observation period of the primary studies.


Evidence in Special Patient Populations

Clinical research was evaluated in patient groups, including older adults and those with conditions involving periods of heightened symptoms such as Type 2 Diabetes Mellitus and associated Chronic Kidney Disease. However, the combination was not evaluated in children or adolescents with high blood pressure, meaning data for certain groups remain insufficient.


Key Research Gaps and Uncertainty

The combination was not evaluated in pediatric and adolescent populations, meaning the current results apply only to the populations studied (adults). The long-term evidence is not fully established beyond the observation periods of the original core trials. Furthermore, the research trials have used composite endpoints (combining several serious events), which means that subgroup findings are uncertain regarding the impact on a single outcome. Research does not determine whether an individual will respond similarly to the patterns observed in the studies; findings describe group patterns, not personal outcomes.

Key Studies & References

  1. Health Canada Drug and Health Product Register: Perindopril Erbumine / Indapamide.

Frequently Asked Questions (FAQ)

Common questions about Indapril (FAQ)

Q: What are the most common side effects reported for Indapril?

Official regulatory documents define Common side effects as those that occurred in 1% to 10% of patients during clinical studies. These frequency definitions are used to categorize effects like headache, dizziness, and cough in the official product information. This framework helps establish a context for how often different reactions have been reported.

Q: Do the side effects of Indapril usually go away over time?

Official safety information indicates that certain effects, such as low blood pressure (hypotension), may be more likely to occur when treatment is first started or when the dose is increased. Safety information notes that effects like low blood pressure may be more likely when the medicine is initiated.

Q: Does Indapril affect cholesterol levels?

The official product information describes potential changes in certain laboratory values. These changes may include an increase in blood triglyceride levels, which are a type of fat in the blood. Official documents also mention possible increases in uric acid levels.

Q: Does Indapril affect a person's ability to drive or operate machinery?

Official regulatory documents include a caution that side effects such as dizziness, fatigue, or low blood pressure may affect the ability to drive or operate machinery. This risk may be higher when first starting the medicine or after a dose adjustment. Official caution advises being aware of how the medicine affects reaction time before engaging in these activities.

Q: Can people with diabetes use Indapril?

Research has formally studied the use of this medicine in adults who have Type 2 Diabetes Mellitus. Official product information does include specific warnings related to potential changes in blood sugar control. There is also a specific restriction against using the medicine in combination with Aliskiren in patients with diabetes or kidney impairment.

Q: Does Indapril interact with herbal products or natural remedies?

The official label does not specifically list every herbal product, but it does warn against combining the medicine with certain Potassium supplements due to safety concerns. Since some natural remedies may contain high levels of potassium, it is described that all supplements and herbal products should be reviewed with a healthcare provider.

Q: What is the relationship between Indapril and certain salt levels in the body?

Because the medicine affects fluid management, the official safety information addresses potential changes in the blood levels of essential salts, such as potassium and sodium. Regulatory documents include warnings about both low potassium (hypokalemia) and high potassium (hyperkalemia).

Q: How long does Indapril stay in your system after taking it?

Regulatory information describes the pharmacokinetic properties of the medicine's two components. The active part of the medicine's effects is described in official documents as lasting for approximately 24 hours, which relates to why it is taken once daily.

Q: Can Indapril cause feelings of dizziness or lightheadedness?

Official safety information does list dizziness as a common adverse effect reported by patients. Additionally, low blood pressure (hypotension) is also common, and this condition can cause feelings of lightheadedness. These effects may be more noticeable when first starting treatment.

Q: Why is Indapril sometimes taken in combination with another medicine?

The official product information explains that this medicine combines two compounds, an ACE inhibitor and a diuretic. This combination is described as creating a synergistic effect, meaning the two components work together to achieve a more comprehensive and sustained reduction in high blood pressure than either medicine might achieve alone.

Q: What kind of research has been done on the long-term use of Indapril?

Research involves large-scale, long-term Randomized Controlled Trials that tracked patients over several years. These studies examined the long-term patterns related to serious cardiovascular events, such as a stroke or a heart attack. This evidence contributes to the understanding of the medicine’s use in chronic disease management.

Q: Is Indapril a medicine that needs to be taken indefinitely?

The medicine is formally indicated for the management of essential hypertension, which is a condition requiring chronic, long-term therapeutic control. Regulatory documents describe the product's use in this context. The duration of treatment is determined by the ongoing management plan for the condition.

Q: Are there any specific safety warnings related to sun exposure while on Indapril?

Official safety information lists photosensitivity reactions as a possible adverse effect. This means the skin may become more sensitive to sunlight or ultraviolet light while taking the medicine.

Q: How is Indapril typically described in official medical documents?

In official medical documents, the medicine is formally described as a Fixed-Dose Combination product. It is classified as an ACE inhibitor combined with a thiazide-like diuretic, and is indicated for the treatment of essential hypertension (high blood pressure).

Q: What percentage of people experience the less common side effects of Indapril?

Official regulatory documents categorize side effects by frequency. Uncommon effects are defined as those occurring in between 0.1% and 1% of patients in trials. Rare effects are those reported in less than 0.1% of patients.

Q: Are there any specific instructions for disposal of unused Indapril?

Official instructions state that unused medicine must not be disposed of via wastewater or ordinary household waste. Official instructions indicate consulting a pharmacist for guidance on medicine take-back programs or safe disposal procedures specific to their local area.

Q: Can Indapril affect sleep or cause insomnia?

Official safety information lists certain nervous system disorders, including sleep disturbances and insomnia, as a possible, less common adverse effect.

Q: What should be done if someone thinks they have a rare side effect from Indapril?

Official product information specifies that suspected or rare adverse reactions should be reported to the national drug regulatory authority. This allows the regulatory body to continue monitoring the safety profile of the medicine.

Q: Is Indapril safe for someone with a history of liver problems?

The medicine has a formal safety warning regarding use in patients with any degree of liver impairment. Severe hepatic impairment is an absolute restriction to using the medicine. Use in patients with other liver issues is described as requiring cautious assessment and close monitoring.

Q: Does Indapril cause changes in mood or personality?

Official safety information lists certain nervous system disorders, including mood changes, as a possible, less common adverse effect that may be reported.

How should Indapril be stored and disposed of?

Storage and Disposal Requirements

Indapril (Perindopril/Indapamide FDC) tablets must be stored according to regulatory requirements to preserve product stability.

Storage Conditions

Requirement Details
Temperature Must be stored below 30 C (86 F)
Protection Keep in a cool, dry place, protected from moisture
Packaging Store in the original package with the container tightly closed
Safety Keep strictly out of the sight and reach of children

Disposal Instructions

To dispose of expired or unused tablets, the medicine must not be thrown away via wastewater or ordinary household waste. Patients are officially instructed to consult a pharmacist for guidance on how to properly discard the medicine, ensuring compliance with local environmental procedures.

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

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