Delapride

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Delapride

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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 Delapride

What is Delapride?

Delapride is a pharmaceutical combination product used primarily in the management of certain gastrointestinal and psychosomatic disorders. It is a fixed-dose medication that typically contains two active pharmacological agents: delapril and sulpiride. By combining these two substances, the medication targets both physical symptoms and the underlying neurological or psychological factors that may contribute to digestive distress.

Components and Mechanism

The efficacy of Delapride is derived from its dual-action formula:

  • Delapril: This component is an ACE (angiotensin-converting enzyme) inhibitor. While primarily known for its cardiovascular applications, in this context, it contributes to systemic stabilization.
  • Sulpiride: This is a substituted benzamide neuroleptic. In lower doses, it acts as an antagonist to dopamine receptors, providing anxiolytic (anti-anxiety) and antidepressant effects. It is often used to treat gastric conditions because of its ability to regulate the gut-brain axis and improve gastric motility.

Therapeutic Use

Delapride is generally prescribed for patients experiencing functional gastrointestinal disturbances where stress or psychological tension plays a significant role. This includes conditions such as:

  • Psychosomatic gastric or duodenal issues.
  • Functional dyspepsia.
  • Disturbances in the digestive tract linked to anxiety or emotional imbalance.

The medication is designed to address the "somatization" of stress, where emotional pressure manifests as physical pain or dysfunction in the digestive system. By addressing both the nervous system and the physiological state of the gastrointestinal tract, it aims to provide a comprehensive approach to symptom relief.

Regulatory References

  1. NIH: National Library of Medicine

What side effects are possible with Delapride?

Possible side effects and safety information

The official safety profile for the fixed-dose combination product containing Delapril (an ACE inhibitor) and Indapamide (a diuretic) is structured by formal frequency classifications and system-organ-class groupings, as defined in regulatory documents.

Frequency-Classified Adverse Reactions

The following are examples of adverse reactions listed in the prescribing information according to their regulatory frequency categories:

  • Common: Dizziness, Headache, Cough, Fatigue, and Hypokalaemia (low potassium levels).
  • Uncommon: Nausea, vomiting, rash, and Hypotension (low blood pressure).
  • Rare: Angioedema, Paresthesia, and Cholestatic jaundice.
  • Very Rare: Pancreatitis, Agranulocytosis, and Hepatic failure.

Serious Adverse Reactions and Safety Constraints

Regulatory documents emphasize specific serious adverse reactions. The most significant concern for the ACE inhibitor component is Angioedema (swelling of the face, limbs, or airways), a potentially life-threatening event classified as rare. The diuretic component is associated with the risk of severe Electrolyte Imbalance (e.g., severe Hypokalaemia) and Hepatic Encephalopathy in individuals with pre-existing liver insufficiency.

Safety notes specify that certain effects, such as Hypotension, may be more likely to occur at the beginning of treatment or during dose escalation. Furthermore, the official labeling explicitly states that the medicine is contraindicated during the second and third trimesters of pregnancy and in individuals with severe renal or hepatic impairment, defining clear boundaries for its use.

Overdose and Emergency Response

Overdose and when to seek help

Overdose with Delapride, a fixed-dose combination of Delapril and Indapamide, is associated with the combined toxicological profiles of both components, leading to a risk of severe or life-threatening manifestations. The official regulatory documentation classifies this as a serious event requiring immediate emergency response.


Documented Overdose Manifestations

Classification Manifestations and Outcomes (as stated in label)
Clinical Signs Profound Hypotension, Nausea, Vomiting, Dizziness, Weakness, Dry mouth, Thirst, and Confusion.
Severe Outcomes Severe Hypotension (requiring intervention), Respiratory Depression, and critical Fluid and Electrolyte Imbalances (Hypokalemia, Hyponatremia).

Required Emergency Action

Official labeling mandates that urgent medical attention must be sought immediately upon any suspicion of overdose. Patients must contact emergency services or the Poison Help Line, as hospitalization and close monitoring are required for severe symptoms. Treatment is strictly symptomatic and supportive, aiming to manage the resultant hemodynamic instability and metabolic deficits. No specific pharmacological antidote is known for this overdose. Due to the prolonged action of the Indapamide component, severe effects, particularly electrolyte disturbances, may persist for up to 72 hours, necessitating extended observation.

Therapeutic Uses of Delapride

Quick Facts

  • Main Use: Is indicated for the management of high blood pressure (hypertension).
  • Therapeutic Goal: May assist in achieving and sustaining blood pressure control.
  • Clinical Setting: Can be used to address long-term elevated blood pressure.

What Delapride Treats: Main Uses and Benefits

Delapride is a prescription medication provided to individuals with primary (essential) hypertension, or high blood pressure. The preparation is a fixed-dose combination product containing two different active compounds.

The primary therapeutic aim of this medication is the management of blood pressure levels that are above the desired range. By assisting in the control of blood pressure, the medication supports the overall management plan for the condition.

For many individuals with elevated blood pressure, management often requires a combination of pharmacological approaches. The combination in Delapride can be used as part of a regimen to help patients maintain blood pressure within a desired range, which is a key component of cardiovascular health management. Consult with a qualified healthcare provider for a comprehensive therapeutic overview, including its use in addressing mild-to-moderate hypertension.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Delapride — Official Regulatory Information

The use of this medicine is strictly defined by regulatory eligibility criteria, primarily based on the patient's existing physiological status and age.

Eligibility Scope Official Regulatory Statement
Populations Allowed Adults with primary hypertension.
Contraindicated Populations Patients with known hypersensitivity to Delapril, Indapamide, other ACE inhibitors, or sulfonamide-derived drugs. Use is contraindicated in anuria and the second or third trimester of pregnancy.
Age-Related Rules Not recommended for children and adolescents because safety and efficacy are not established. Older adults are eligible but require cautious assessment.
Condition-Specific Rules Contraindicated in severe impairment of kidney function (e.g., creatinine clearance le 30 mL/min) or liver function (hepatic encephalopathy).
Eligibility Restrictions Use requires caution and close monitoring in patients with moderate renal impairment, pre-existing electrolyte imbalances, gout/hyperuricemia, or Systemic Lupus Erythematosus. Not recommended for breastfeeding women.

Connection to the overall eligibility profile: Official documents define eligibility by establishing boundaries based on component class hypersensitivity, the patient's existing organ function integrity, and specific life stages. The medicine is primarily limited to the adult population whose organ function is sufficient and whose medical history does not include any specific, labeled absolute contraindications.

What should I know about interactions with other medicines?

The interaction profile of Delapride (Delapril/Indapamide) is based on the official regulatory documentation for its components, an ACE inhibitor and a thiazide-like diuretic. This profile outlines specific prohibitions and documented outcomes when co-administered with other medicinal products.

Co-administration with Neprilysin Inhibitors (e.g., Sacubitril/Valsartan) is formally contraindicated due to the ACE inhibitor component, requiring a mandatory 36-hour separation window when switching to or from these agents. The use of Aliskiren is also contraindicated specifically in patients with diabetes mellitus because of the documented increase in the risk of renal, hypotensive, and hyperkalemic events.

The diuretic component officially reduces the renal clearance of Lithium, carrying a high risk of Lithium toxicity. Combination with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) results in a documented additive risk of renal function impairment and may reduce the blood pressure-lowering effect. The use of Potassium Supplements or Potassium-Sparing Diuretics increases the risk of hyperkalemia.

The Indapamide component also interacts with agents that prolong the QTc interval, and its effect on potassium levels can increase the sensitivity to Cardiac Glycosides (e.g., Digoxin). Severe cases of electrolyte imbalance have been reported primarily in elderly female patients. The product’s efficacy is not affected by simultaneous food intake, but co-administration with alcohol may increase the risk of orthostatic effects.

Mechanism of Action

Delapride operates through a coordinated dual-mechanism approach that addresses the two primary physiological determinants of pressure in the circulatory system: the tightness of the blood vessels and the total fluid volume.


Modulating Vascular Tone via the RAAS

The Delapril component acts by inhibiting the Angiotensin-Converting Enzyme (ACE), a central regulator of the Renin-Angiotensin-Aldosterone System (RAAS). This molecular action prevents the formation of the vasoconstrictor, Angiotensin II, while simultaneously preserving Bradykinin, an endogenous vasodilator. This sequence shifts the systemic balance toward vessel widening, which reduces the Total Peripheral Resistance (TPR).


Regulating Circulatory Volume and Counter-Regulatory Feedback

The Indapamide component exerts its primary action by blocking the sodium-chloride cotransporter in the kidney, which leads to increased salt and water excretion, thereby decreasing the total plasma volume. Crucially, the ACE inhibition provided by Delapril suppresses the RAAS activation that is normally triggered by volume depletion. This synergistic coordination blocks the body’s natural attempt to raise pressure in response to volume loss, contributing to a more consistent physiological reduction in pressure.

Dosage and Administration Information

Official Administration Guidelines

Delapride is administered as an oral tablet for the long-term management of hypertension, following a precise, structured protocol. The usage guidelines below describe the conditions of its appropriate administration.


Administration Scope

Instruction Detail
Route of administration Oral use.
Dosing schedule Once-daily dose of a single tablet. A common fixed dose is Delapril 30 mg and Indapamide 2.5 mg.
Timing in relation to meals Must be administered in the morning, preferably before a meal.
Tablet handling The tablet must be swallowed whole with water and should not be crushed or chewed to maintain its intended formulation properties.
Missed-dose rule The missed dose should be skipped, and the patient must take the next dose at the regular scheduled time.

Population and Procedural Constraints

Classification Constraint Detail
Renal Impairment Administration is contraindicated in severe renal impairment (creatinine clearance below 30 mL/min). Caution is necessary in moderate impairment.
Age-group rules Not indicated for use in pediatric patients. Use in older adults requires caution due to the likelihood of decreased organ function.
Procedural Monitoring The protocol requires monitoring of serum creatinine and potassium levels, especially upon initiation of therapy.

The official use protocol structures the medication as a continuous, once-daily regimen with clear expectations for intake conditions and necessary procedural oversight for patients with organ function constraints.

Recent Clinical Evidence

Research Evidence and Overview of Studies for Delapride

Evidence for Use in Primary (Essential) Hypertension

Delapride was evaluated in Randomized Controlled Trials (RCTs) and subsequent analyses, which was studied for this type of treatment. This research examined how blood pressure (BP) levels were observed during the use of Delapride in adults with primary (essential) hypertension, particularly those whose high blood pressure was not controlled by treatment with a single drug (monotherapy).

Studies explored outcomes primarily involving changes in systolic and diastolic blood pressure (BP). These trials observed responses over defined time intervals, often up to several months. Findings describe patterns observed in the studies, including the measured data related to BP levels. Research also reported the percentage of participants who achieved specific target BP goals set by the study parameters.

However, research provides insight into short-term changes in BP. Follow-up durations were limited in many of the core efficacy trials. While these findings contribute to the broader evidence landscape, the evidence is limited regarding the long-term patterns of BP control.

Studies on Markers of Cardiovascular Health

Beyond measuring blood pressure itself, research also examined patterns related to intermediate markers that was associated with chronic physiological strain. These studies explored outcomes monitoring physiological strain or stress and systemic or functional imbalance related to the heart and kidneys.

Specifically, research monitored measurements of Left Ventricular Mass Index (LVMI), which is a measured marker of cardiac structure. Studies also explored changes in markers related to renal function, such as GFR (Glomerular Filtration Rate) and albuminuria. Trials focusing on these structural outcomes typically required observation periods of six months or longer. Findings describe patterns observed in the studies related to these structural and functional measurements.

It is important to note that these measured changes are based on surrogate markers; they are not direct measurements of hard clinical events (like a heart attack or stroke). Research highlights changes measured during the study period, but the certainty remains low regarding what this implies for major health events over many years.

What Is Still Uncertain About Delapride Research

Research provides context, but evidence highlights what is known and what is still uncertain. Several limitations in the existing research structure should be noted:

  • Reliance on Surrogate Outcomes: Much of the evidence was studied for Delapride focuses on changes in surrogate outcomes like BP reduction and LVMI, rather than dedicated, long-term studies tracking major clinical events like heart attack or stroke.
  • Limited Long-Term Data: Long-term effects are not fully established for this specific combination, meaning there is less available data on the persistence of the observed patterns over extended periods.
  • Limited Subgroup Data: Comparative evidence is lacking for many specific comorbidities or very high-risk patient groups, meaning results apply only to the populations studied.

Frequently Asked Questions (FAQ)

Common questions about Delapride (FAQ)

Q: How long does the effect of a Delapride dose last?

According to the official administration guidelines, Delapride is administered as a once-daily oral tablet. The formulation's structure is consistent with the need to maintain therapeutic activity over a 24-hour period for sustained blood pressure management.

Q: Can Delapride be taken with common over-the-counter painkillers?

Regulatory documents advise caution regarding the co-administration of Delapride with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as common over-the-counter ibuprofen. This is because NSAIDs are associated with documented risks of renal function impairment and may lessen the blood pressure-lowering effect of Delapride. Interactions with non-NSAID painkillers are generally not cited in official warnings.

Q: Is it normal to feel a little dizzy when first starting Delapride?

Official safety profiles list dizziness as a common side effect. Furthermore, regulatory warnings note that hypotension (low blood pressure), which can manifest as dizziness, is documented to be more likely to occur upon the initiation of therapy or when a dosage is increased.

Q: What is the maximum duration someone can continuously use Delapride?

Delapride is officially indicated for the long-term management of hypertension, a chronic condition. Regulatory documents do not define a specific maximum duration of continuous use, but rather provide guidance for monitoring of certain health markers during chronic therapy.

Q: What is the risk of having a serious interaction with Delapride?

Official prescribing information lists several serious contraindications and high-risk interactions when Delapride is combined with specific other medicines, such as Neprilysin Inhibitors or Lithium. These warnings indicate that serious events, including issues related to kidney function, low blood pressure, or high potassium levels, are documented risks when certain agents are co-administered.

Q: Is Delapride considered a 'schedule drug' or a controlled substance?

Delapride is classified by regulatory authorities as a prescription-only medicine. It is not classified as a federally controlled substance or a 'schedule drug' in the regulatory systems, as its components do not carry a risk profile associated with dependency.

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

Official prescribing information advises that side effects like dizziness and fatigue are common and may occur, particularly at the beginning of treatment. Patients should be aware that these effects have the potential to temporarily impair reaction time and attention, which may affect the ability to drive or operate machinery.

Q: What does the research say about the long-term safety profile of Delapride?

Research studies conducted for Delapride primarily focused on short-term changes in blood pressure. Official documents note that there is limited available data on the persistence of the observed effects over extended periods. The full list of observed adverse reactions, classified by frequency, is maintained in the official safety profile.

Q: What is the official definition of Delapride's main contraindication?

Official regulatory documents list several absolute prohibitions for the use of this medicine. One of the most significant stated contraindications is its use during the second and third trimesters of pregnancy, due to the documented risk of harm to the developing fetus.

Q: Are there different strengths of Delapride available, and why?

Delapride is available as an oral tablet in multiple fixed-dose strengths that contain varying amounts of the two active ingredients. The availability of these strengths is intended to offer options for the adjustment of treatment intensity within the regulated dosing range.

Q: What are the common signs of an allergic reaction to Delapride?

The official safety profile lists rash as an uncommon side effect, which may be a sign of hypersensitivity to the components. A more severe, rare allergic reaction involving swelling of the face, limbs, or airways (Angioedema) is also specifically noted as a documented risk in the regulatory warnings.

Q: Do men and women experience different side effects from Delapride?

The official safety notes highlight that severe cases of electrolyte imbalance (such as dangerously low potassium levels), a known risk with the diuretic component, have been reported primarily in elderly female patients using the medicine.

Q: Can Delapride be used by people who have diabetes?

Regulatory warnings indicate a specific contraindication for the use of Delapride in patients who have diabetes mellitus and are also taking the drug Aliskiren. The presence of diabetes, in the absence of the Aliskiren co-administration, is listed as a condition that requires caution and close monitoring.

Q: Are there any known issues with taking Delapride before surgery?

Official warnings indicate that the use of Delapride may cause severe hypotension (low blood pressure), particularly when combined with anesthetic agents during surgery. Therefore, official information emphasizes the need to ensure the prescribing healthcare provider is fully informed of Delapride use before any planned surgical procedure.

Q: Is Delapride the type of medicine you can stop taking right away?

Delapride is prescribed for the long-term management of a chronic condition. Regulatory standards do not provide instructions for abrupt discontinuation, and stopping the medication without guidance may lead to a rapid return of elevated blood pressure.

Q: Is it possible to become dependent on Delapride?

Delapride is not classified as a controlled substance in regulatory systems. Official documentation confirms the medicine is not known to produce physical or psychological dependence, and warnings about the potential for addiction are not included.

Q: What is the purpose of the 'Boxed Warning' on Delapride's official information?

Although the presence of a 'Boxed Warning' may vary by region, the ACE inhibitor component of Delapride is typically subject to a major regulatory caution regarding the potential for fetal toxicity. This specific warning applies when the medicine is used during the second and third trimesters of pregnancy.

Q: Why are people with certain heart conditions advised not to use Delapride?

The Indapamide component can cause severe electrolyte imbalances, such as dangerously low potassium levels (hypokalemia), which may increase the risk of serious irregular heart rhythms. Official documents recommend caution and close monitoring in patients with conditions that predispose them to electrolyte issues or who are taking drugs like Cardiac Glycosides.

Q: Is Delapride known to interact with birth control pills?

According to the official drug interaction profile, there is no common or known interaction cited that impacts the measured effectiveness of oral hormonal contraceptives (birth control pills).

Q: Are there any specific lifestyle changes that official documents suggest alongside Delapride?

Official documentation focuses primarily on the safe administration and side effects of the medication itself. The only specific lifestyle caution noted is that co-administration with alcohol may increase the risk of orthostatic effects (dizziness upon standing). Specific guidance on general recommendations regarding diet and exercise is generally considered outside the scope of the official drug label.

How should Delapride be stored and disposed of?

How to Store and Dispose of Delapride?

Delapride tablets must be stored according to official regulatory specifications to maintain product integrity.

Storage Conditions

The required storage condition is Controlled Room Temperature, which is defined as 20 C to 25 C (68 F to 77 F). It is mandatory to keep from freezing and to avoid excessive heat. The tablets must be protected from moisture and direct light.

Container and Safety

Delapride should be stored in a tightly closed, light-resistant container. The medicine must be placed out of the reach of children to prevent accidental exposure.

Disposal Requirements

Outdated or unused Delapride should not be kept. Patients must follow the specific disposal instructions provided on the medication's labeling or consult a healthcare professional for guidance on how to properly discard the remaining product.

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

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