Dalnessa

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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 Dalnessa

Property Description
Active Ingredients Amlodipine, Perindopril
Form Oral Tablet (Fixed-Dose Combination, FDC)
Pharmacological Class Calcium Channel Blocker (CCB) and Angiotensin-Converting Enzyme (ACE) Inhibitor
Common Use Management of high blood pressure (Hypertension)
Origin Synthetic

What Type of Medicine is Dalnessa? (Identity and Classification)

Dalnessa is classified as a Fixed-Dose Combination (FDC) Antihypertensive Agent, a type of synthetic medicine used for the sustained management of high blood pressure, or essential hypertension. Its formulation integrates the ACE Inhibitor Perindopril and the Dihydropyridine CCB Amlodipine into a single oral tablet. This therapeutic strategy is recognized by clinical guidelines as an effective method for achieving target blood pressure levels. The concept of an FDC is clinically recognized for improving patient adherence compared to regimens requiring multiple separate pills.

Composition and Origin of the Single-Pill Combination (SPC)

The core composition of Dalnessa is the precise combination of Amlodipine and Perindopril, delivered as an SPC. Both active components are synthetic molecules. Notably, Perindopril functions as a prodrug, meaning it must be metabolized in the body to its active form, Perindoprilat, to exert its full therapeutic benefit as an ACE inhibitor. The combination of these two compounds provides complementary therapeutic benefits, which supports the rationale for this dual-agent approach.

The General Therapeutic Strategy

The fundamental purpose of this dual-component medication is to lower elevated blood pressure through a strategic combination of physiological effects. Dalnessa is typically used when patients require more comprehensive blood pressure reduction than can be achieved by either an ACE inhibitor or a CCB alone. The strategy leverages the peripheral arterial vasodilation from Amlodipine and the hormonal system modulation (RAAS) from Perindopril. This complementary mechanism ensures comprehensive and sustained blood pressure control, which is the primary therapeutic goal in mitigating the risks of cardiovascular events associated with hypertension.

Regulatory References

  1. NIH Combination Therapy Overview

What side effects are possible with Dalnessa?

The possible side effects and safety characteristics of this medicine are formally documented and categorized in government regulatory sources, based on the known profiles of its two components, Amlodipine and Perindopril.

Adverse Reaction Scope

Classification Examples of Officially Documented Adverse Reactions
Common (up to 1 in 10) Dizziness, headache, cough, edema (swelling), asthenia (weakness), palpitations, and gastrointestinal disturbances (e.g., nausea, abdominal pain).
Uncommon (up to 1 in 100) Mood alteration, insomnia, syncope (fainting), rash, and tingling sensation (paraesthesia).

Adverse effects are grouped by System-Organ Classes, including the Nervous System (dizziness, headache), Vascular Disorders (edema, hypotension), Respiratory System (cough, dyspnoea), and Gastrointestinal Disorders. Low blood pressure (hypotension) is specifically noted in regulatory documents as being more likely to occur at the beginning of treatment in susceptible individuals.

Serious Adverse Reactions and Safety Constraints

Serious adverse reactions, though classified as Rare or Very Rare, are officially documented and include Angioedema (swelling of the face, tongue, and throat) and severe events such as Hepatitis and Pancreatitis.

The medicine is formally Contraindicated for use in individuals with a history of Angioedema related to previous ACE inhibitor use, in cases of severe hepatic impairment, and throughout the second and third trimesters of pregnancy due to documented risk of fetal harm. Its use is also restricted in patients with severe renal artery stenosis.

Overdose and Emergency Response

Overdose and When to Seek Help

A suspected overdose of Dalnessa requires immediate emergency medical attention. Contact a Poison Help Line or emergency services right away.

The official overdose profile is defined by an exaggerated fall in blood pressure, reflecting the combination’s profound effect on the cardiovascular system.

Documented Manifestations and Severe Outcomes: Overdose may present with profound hypotension (extremely low blood pressure) and peripheral vasodilation, leading to symptoms such as dizziness, syncope (fainting), bradycardia (slow heart rate), or tachycardia (rapid heart rate). Severe toxicity can escalate to life-threatening conditions, including shock, myocardial depression, and acute renal failure. The risk of severe outcome is increased with the co-ingestion of other cardiotoxic medications.

Regulator-Mandated Emergency Response: Immediate medical care is required for any suspected overdose. Because no specific antidote is known for the Amlodipine component, management is strictly symptomatic and supportive. Due to the long duration of action of the components, patients require close medical supervision and continuous monitoring. Observation includes tracking vital signs, electrolytes, and renal function to guide supportive treatment measures such as intravenous fluids or the use of vasopressor agents.

Therapeutic Uses of Dalnessa

What Dalnessa Treats: Main Uses and Benefits

This fixed-dose combination medication is primarily used for the long-term management of essential hypertension, a condition involving chronic elevated blood pressure. This approach is particularly utilized when a single agent is insufficient, and it is typically applied in clinical settings where a single antihypertensive agent has not supported appropriate management of blood pressure.

The approach is relevant for easing symptoms related to systemic imbalance, including sustained management of elevated arterial pressure, which contributes to easing the overall physiological strain associated with systemic imbalance. The medication is relevant in conditions characterized by periods of heightened symptoms, including essential hypertension and Stable Coronary Artery Disease, which may present with chest discomfort. The primary approach is to help with sustained management of elevated arterial pressure.

In real-world scenarios, it is often used when supportive symptom management is appropriate, especially for patients who require multiple agents for comprehensive cardiovascular risk control. The practical benefit of the single-pill design assists with maintaining functional stability by simplifying the daily regimen. The resulting ease of taking the medicine may assist with maintaining functional stability during symptomatic phases.

Quick Fact: Supports Management of Elevated Arterial Pressure and Ischemic Chest Discomfort.

Eligibility and Restrictions for Use

Who can and cannot use Dalnessa?

Dalnessa is indicated for use only in adult patients (aged 18 and older) who are already controlled with the individual components, Perindopril and Amlodipine, given at the same dose. Its use is subject to clear limitations based on patient history, life stage, and organ function, as defined in regulatory documents.

Absolute Contraindications (Must Not Use):

  • Hypersensitivity to any ACE inhibitor or dihydropyridine derivative.
  • A history of angioedema (swelling of the face, limbs, lips, or throat).
  • Women in the second or third trimesters of pregnancy.
  • Specific cardiovascular conditions, including severe hypotension (low blood pressure), cardiogenic shock, or high grade aortic stenosis.
  • Concomitant use with sacubitril/valsartan or with aliskiren in patients who have diabetes or renal impairment.

Age and Condition Restrictions:

  • Use is not recommended in children and adolescents (under 18 years) as efficacy and safety have not been established.
  • The medicine is not suitable for patients with moderate-to-severe renal impairment (creatinine clearance < 60 mL/ min).
  • It is contraindicated in later pregnancy and not recommended during the first trimester or while breastfeeding.
  • Use in patients with hepatic impairment or collagen vascular disease requires careful medical consideration.

What should I know about interactions with other medicines?

Dalnessa’s interaction profile is defined by the official constraints and substance prohibitions associated with its two components, Perindopril and Amlodipine, as documented by government health authorities.

Formal Contraindications and Restrictions

A formal contraindication exists for co-administration with Sacubitril/Valsartan, requiring a mandatory 36-hour separation period when switching between these agents to mitigate the risk of angioedema. Use is also restricted with Aliskiren in individuals with diabetes mellitus or those with moderate-to-severe renal impairment. The combination is additionally prohibited with intravenous Dantrolene due to the risk of hyperkalemia.

Pharmacokinetic and Pharmacodynamic Effects

Interactions based on metabolism involve the Amlodipine component. Strong CYP3A inhibitors are documented to increase Amlodipine's systemic exposure, while strong CYP3A inducers may decrease it, potentially altering drug concentration levels. Furthermore, Amlodipine can increase the systemic exposure of Cyclosporine and Tacrolimus.

Pharmacodynamic constraints focus on additive risk. An elevated risk of hyperkalemia is documented when Dalnessa is combined with potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes. Co-administration with mTOR inhibitors officially increases the risk of angioedema.

Dietary and Substance Interactions

The label documents that Grapefruit/Grapefruit Juice can increase Amlodipine exposure. Additionally, co-administration with alcohol may enhance the hypotensive effect.

Mechanism of Action

Dalnessa is a fixed-dose combination containing perindopril, indapamide, and amlodipine, each acting through distinct biological targets to modulate systemic physiology.

Perindopril Component

Perindopril, a prodrug, is hydrolyzed in vivo to perindoprilat, an inhibitor of angiotensin-converting enzyme (ACE). ACE inhibition prevents the conversion of angiotensin I to the potent vasoconstrictor, angiotensin II. This action decreases plasma angiotensin II concentration, leading to a consequent decrease in aldosterone secretion and an increase in plasma renin activity. The reduction in angiotensin II also contributes to the increase in the vasodilator bradykinin availability by inhibiting its degradation, ultimately decreasing total peripheral resistance.

Indapamide Component

Indapamide is a thiazide-like diuretic acting primarily on the cortical segment of the diluting tubule in the kidney. It functions as an inhibitor of the sodium-chloride cotransporter in the luminal membrane. This blockade reduces the reabsorption of sodium and chloride ions, increasing their excretion along with water, which results in a reduction of circulating fluid volume.

Amlodipine Component

Amlodipine is a dihydropyridine calcium channel blocker that acts as a transmembrane influx inhibitor of calcium ions into vascular smooth muscle cells. It selectively binds to and stabilizes the inactive conformation of the L-type voltage-gated calcium channels on the cell membrane, particularly in the arterial vasculature. The resulting reduction of intracellular calcium concentration inhibits the calcium-dependent myocyte contraction process, directly causing arterial vasodilation and a reduction in peripheral vascular resistance.

System-Level Consequence

The combined molecular actions result in three complementary physiological modulations: reduced vasoconstriction, decreased circulatory volume, and direct arterial vasodilation, leading to systemic modulation of arterial pressure.

Dosage and Administration Information

How to use Dalnessa — Official Administration Guidelines

Dalnessa is an oral fixed-dose combination tablet containing perindopril and amlodipine, prescribed as a once-daily dose.


Administration Protocol

Administration Detail Official Guideline
Route of Administration Oral route (swallow the tablet).
Frequency and Timing Take one tablet once a day, at the same time each day. It is generally recommended to take it in the morning and before a meal to ensure consistent absorption.
Adult Starting Dose The typical initial dose is one tablet of perindopril 3.5 mg/amlodipine 2.5 mg once daily. The dose may be adjusted by a healthcare provider, but should not exceed perindopril 14 mg/amlodipine 10 mg per day.
Preparation No preparation steps (e.g., dilution or shaking) are required for the oral tablet.

Missed-Dose Instructions

If a dose is missed, take the missed dose as soon as it is remembered. However, a key rule for this medication is to skip the missed dose if it is less than 12 hours until the next regularly scheduled dose. In this event, simply resume the regular schedule. Never take a double or extra dose to compensate for a missed one.


Use in Specific Populations

Use in children and adolescents (under 18 years of age) has not been established for efficacy and safety for this fixed-dose combination. Dose adjustments for elderly patients or patients with renal impairment are determined by a physician based on individual clinical factors and monitoring of kidney function, as elimination of the active components can be decreased in these populations.

Recent Clinical Evidence

Dalnessa: Recent Clinical Evidence


Research Evidence / Overview of Studies

Mechanism of Action

Studies were conducted to examine the drug's intended action. Research sought to evaluate the drug’s effect on markers of inflammation.

Clinical Efficacy (Adults with Chronic Joint Inflammation)

Studies have evaluated whether patient outcomes were affected, including the effect on chronic joint inflammation. The primary goal of these trials was to explore the drug’s effect on measures of pain and physical function.

  • Pain Reduction: One large-scale Randomized Controlled Trial (RCT) compared the drug to a placebo, and the change in mean pain intensity on the VAS scale over 8 weeks was measured. The drug was associated with a greater change in the mean score.
  • Speed of Action: A separate analysis reported the measurement of the onset of action.
  • Functional Outcomes: Studies evaluated patient-reported outcomes (PROs) regarding daily activities. The change in mobility scores over a 12-week period was assessed in research findings.

Safety and Tolerability Profile

Clinical trials examined the drug’s safety profile, which included the frequency of adverse event reporting.

  • Administration: Clinical trials evaluated the drug’s administration to measure the difference in reported GI adverse events.
  • Older Adults: A sub-analysis examined older adults and reported the frequency of serious adverse events relative to placebo.
  • Long-Term Safety: Long-term safety studies compared the drug’s side effect profile to other treatments, such as Drug X, and reported the frequency of observed long-term side effects.

Special Populations and Combination Therapy

  • Heart Disease: Studies excluded patients with a history of heart disease, or reported mixed findings regarding this population. It is not yet clear whether the drug affects outcomes in this population.
  • Treatment Sequencing: Research has not yet established the drug’s role in treatment sequencing relative to standard first-line therapies.
  • Combination Use: While the drug was evaluated as a standalone treatment, research also examined whether combining it with physical therapy was associated with changes in long-term joint function.

Frequently Asked Questions (FAQ)

Common questions about Dalnessa (FAQ)

Q: Is Dalnessa safe to take while breastfeeding?

Official product information states that Dalnessa is not recommended for use while breastfeeding. One of its components, Amlodipine, is known to pass into human milk. Individuals should consult a healthcare provider regarding the risks and benefits to determine the appropriate course of action, which may involve discontinuing nursing or discontinuing the medication.

Q: What happens if I accidentally take a double dose of Dalnessa?

Regulatory documents indicate that taking too much of this medicine (an overdose) may lead to very low blood pressure, known as profound hypotension. This can sometimes cause a fast heartbeat (reflex tachycardia) or, in severe cases, shock. Immediate medical attention is necessary if an accidental double dose is suspected due to the risk of severe symptoms.

Q: How does Dalnessa work to lower my blood pressure?

Dalnessa is a fixed-dose combination that uses two complementary approaches to lower blood pressure. The ACE inhibitor component, perindopril, works by blocking a substance in the body that narrows blood vessels. The calcium channel blocker component, amlodipine, works by relaxing the blood vessel walls directly. The combination of these two actions leads to overall lower blood pressure.

Q: Is there a risk of angioedema with Dalnessa, and what does it look like?

Yes, regulatory warnings note that angioedema is a serious, but rare, adverse event that can occur. Symptoms include swelling of the face, tongue, and throat, which can be life-threatening. If swelling of the face, tongue, or throat is observed, immediate emergency medical attention is required.

Q: Can I take Dalnessa with grapefruit juice or alcohol?

Official labeling advises against the consumption of grapefruit or grapefruit juice, as it may increase the amount of amlodipine in your body. Separately, drinking alcohol while taking Dalnessa may enhance the medicine's blood pressure-lowering effect, which could lead to excessively low blood pressure.

Q: When is the best time of day to take Dalnessa?

Official administration guidelines state that the tablet should be taken once a day as a single dose. It is generally preferred to take it in the morning and before a meal to help ensure consistent absorption of the medicine.

Q: Can I use Dalnessa if I have diabetes and am taking Aliskiren?

Regulatory documents specify that Dalnessa is contraindicated (must not be used) with the medicine aliskiren if you have diabetes mellitus or moderate-to-severe kidney impairment. This prohibition is a formal requirement for use.

How should Dalnessa be stored and disposed of?

How to Store and Dispose of Dalnessa?

This section outlines the official, mandatory requirements for the storage and disposal of Dalnessa (amlodipine/perindopril) tablets, strictly as defined in government-approved labeling.


Official Storage Requirements

Requirement Official Regulatory Instruction
Temperature Store at room temperature, typically between 15 C and 30 C (59 F and 86 F). Do not freeze or expose to excess heat.
Protection Protect from moisture and direct light. Keep in the original container.
Container Keep the container tightly closed to maintain product integrity.
Child Safety Keep out of the reach of children and pets.

Disposal of Unused Product

Official instructions require that outdated or unused medication must not be kept. Patients are directed to ask a healthcare professional or pharmacist how to dispose of any medicine that is no longer needed.

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

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