Digoxine Nativelle

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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 Digoxine Nativelle

Property Description
Active ingredient Digoxin
Form Tablet, oral solution (elixir), injectable solution
Pharmacological class Cardiac Glycoside
General purpose Cardiotonic support and rate control
Origin Naturally derived (Digitalis lanata plant)

What Type of Medicine is Digoxine Nativelle?

Digoxine Nativelle is a medicinal product containing the active ingredient Digoxin, classified as a cardiac glycoside or digitalis glycoside. This class of medication is specifically designed to influence the mechanical and electrical function of the heart. The product is a single-ingredient product that is listed on the Model List of Essential Medicines. Digoxin is used for helping the heart work more efficiently and to control heart rate in certain rhythm disturbances. Digoxine Nativelle is available in several high-level dosage forms, including the tablet and oral solution (elixir) for oral consumption, as well as the injectable solution (ampoules) for controlled intravenous administration in hospital settings.

Is Digoxin Natural or Synthetic? Examining the Composition

Digoxin is a pure cardenolide glycoside that is naturally derived from the leaves of the Digitalis lanata, also known as the Grecian foxglove plant. This means the substance is extracted and purified to ensure a highly consistent and standardized therapeutic compound, distinguishing it from historical, crude botanical preparations. The final formulation contains the active ingredient compounded with solid excipients for the tablet or dissolved in an aqueous or hydro-alcoholic base/vehicle for the elixir and injectable solution, making it suitable for a wide range of patients, including pediatric groups when administered via the oral solution.

What is the General Purpose of Cardiac Glycosides?

The general purpose of Digoxine Nativelle is to provide cardiotonic support and assist in the management of specific heart rhythm abnormalities. Its core action involves two primary physiological effects: a positive inotropic action, which increases the force of the heart muscle's systolic contraction, and a negative chronotropic effect, which helps slow the heart rate. By achieving these actions, primarily through its specific function as a sodium-potassium ATPase inhibitor, the medication works to improve the overall mechanical efficiency of the heart and promote better circulation. Cardiac glycosides influence the contractility and electrical properties of the heart.

Regulatory References

  1. NIH information on Cardiac Glycosides (LiverTox)

What side effects are possible with Digoxine Nativelle?

Possible Side Effects and Safety Information

The safety profile of Digoxine Nativelle, containing Digoxin, is characterized by officially documented adverse reactions classified by frequency and body system, strictly according to regulatory standards from agencies like the FDA and EMA. The official incidence of adverse reactions in clinical use is documented to range between 5% and 20%.

Adverse Reaction Classifications

Adverse reactions are formally grouped into three major toxicity domains: cardiac toxicity (the most serious concern), gastrointestinal disturbances, and Central Nervous System (CNS) or other toxicity. These effects are often manifestations of Digoxin Toxicity.

Classification Examples of Officially Documented Effects
Common Nausea, vomiting, diarrhea, headache, dizziness, visual impairment (e.g., blurred or yellow vision), rash.
Uncommon Depression.
Very Rare Thrombocytopenia, psychotic disorder, intestinal ischaemia, gynaecomastia, serious arrhythmias (e.g., ventricular), fatigue.

Serious Safety Considerations

The most serious events documented in regulatory labeling primarily involve the heart, including life-threatening arrhythmias such as Ventricular Fibrillation and the development of Advanced or Complete Heart Block. These manifestations are closely monitored as signs of overexposure.

Population-Specific Notes

Regulatory documents highlight that safety must be considered for specific populations: Older adults and patients with renal impairment require particular attention, as kidney function affects how the medicine is cleared from the body, increasing the risk of overexposure. Furthermore, official labeling states that electrolyte disorders (specifically low potassium, low magnesium, and high calcium) are associated with an increased risk of toxicity. Ventricular Fibrillation is explicitly listed as a contraindication.

Overdose and Emergency Response

Digoxin, the active substance in Digoxine Nativelle, has a narrow therapeutic range, meaning the difference between a therapeutic dose and a toxic dose is small. Toxicity can occur after a single overdose or develop gradually during long-term therapy, even if the measured serum concentration is within the 'normal' range.

Recognizing Potential Overdose

Symptoms of Digoxine Nativelle toxicity are varied and often non-specific. They can include both cardiac and non-cardiac signs.

System Symptoms
Gastrointestinal Loss of appetite, nausea, vomiting, diarrhea, abdominal pain
Neurological/Visual Confusion, lethargy, headache, vision changes (e.g., blurred vision, seeing yellow or green halos around lights)
Cardiac Irregular heartbeat, palpitations, unusually slow or fast pulse (bradycardia or various arrhythmias)

When to Seek Immediate Medical Help

If you or someone else has taken more than the prescribed dose of Digoxine Nativelle, or if you experience any of the symptoms listed above, you must seek urgent medical assistance. Immediate medical attention is necessary for any suspected overdose or signs of severe toxicity, particularly the following potentially life-threatening symptoms:

  • Severe changes in heart rhythm (very slow, very fast, or irregular heartbeats).
  • Severe confusion or changes in mental status.
  • Difficulty breathing or fainting.

Treatment often involves discontinuing the drug, supportive care, and may include administering a specific antidote (digoxin-specific antibody fragments) in severe cases. Do not wait for symptoms to worsen; contact your local emergency services immediately.

Therapeutic Uses of Digoxine Nativelle

What Digoxine Nativelle Treats: Main Uses and Benefits

Digoxine Nativelle is applied across domains where additional symptomatic support is needed, assisting in the management of specific cardiac conditions that involve symptoms related to noticeable physiological strain. The medication is commonly used to help manage symptoms across two therapeutic areas: heart failure and certain abnormal heart rhythms. The medication's use assists patients in coping more steadily with symptom fluctuations, supporting general well-being during symptomatic phases.

The medication is relevant when supportive symptom management is appropriate for conditions involving episodic or fluctuating manifestations.

Supportive Symptom Management

The medication is commonly used across conditions characterized by periods of heightened symptoms. In clinical settings, it is often used when symptoms intensify, providing assistance for heart failure and rapid, irregular heart rhythms like chronic atrial fibrillation.

In these scenarios, Digoxin is used to help manage symptoms that interfere with daily comfort, offering support during episodes of heightened discomfort. This assistance contributes to easing the overall symptom load and may assist with maintaining functional stability.


Quick Fact: Support for Symptoms that Create Noticeable Physiological Strain

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who can and cannot use Digoxine Nativelle?

The official regulatory profile for Digoxine Nativelle (Digoxin) establishes strict population eligibility, determining who can use the medicine and who is absolutely excluded based on labeled regulatory information.


Populations for whom use is contraindicated

The medicine is contraindicated and must not be used in patients with Ventricular Fibrillation or those with a confirmed Hypersensitivity to Digoxin or any other Digitalis preparation. Use is also not recommended in conditions like Acute Myocardial Infarction (AMI) or Myocarditis.


Conditional and Restricted Eligibility

Eligibility is conditional for patients with specific health factors. Impaired Renal Function requires cautious use due to reduced drug clearance. Patients with Electrolyte Disorders such as hypokalemia or hypercalcemia face an increased risk of toxicity. The medicine is generally restricted in patients with an Accessory AV Pathway (e.g., Wolff-Parkinson-White Syndrome).


Age and Life Stage Rules

Use is established in Adults and Pediatric Patients. However, Geriatric Patients require caution due to the higher likelihood of reduced kidney function. Use during Pregnancy is restricted to situations where the benefit clearly justifies the potential risk. The medicine is generally considered to pose minimal risk during Breastfeeding.

What should I know about interactions with other medicines?

Official Interactions with other Medicines and Products

The interaction profile for Digoxin is largely defined by its relationship with the P-glycoprotein (P-gp) transporter and its additive effects on cardiac function, as documented in governmental regulatory sources.

Interaction Type Interacting Substance/Class Official Constraint / Regulatory Note
Exposure Increasing (P-gp Inhibitors) Quinidine, Verapamil, Amiodarone, Spironolactone, Clarithromycin Officially documented to increase Digoxin plasma levels (AUC/Cmax) and require monitoring.
Exposure Decreasing (P-gp Inducers) Rifampicin, St. John's Wort Officially documented to reduce Digoxin plasma levels and potential effectiveness.
Pharmacodynamic (Cardiac Effects) Diuretics (Loop/Thiazide), Beta-blockers Diuretics are noted for increasing the risk of Digoxin toxicity through hypokalemia. Beta-blockers can cause additive effects on heart rate.
Binding Agents Cholestyramine, certain Antacids Regulatory labels advise administering these agents several hours apart from Digoxin to prevent reduced absorption.
Population Note Renal Impairment All interactions that increase drug exposure are subject to heightened severity due to the kidney's role in elimination.

Regulatory documentation confirms that co-administration with many P-gp inhibitors requires a lower Digoxin dose, underscoring the clinical significance of these documented pharmacokinetic effects. No combinations are universally classified as formal contraindications in major regulatory labels based solely on drug-drug interaction.

Mechanism of Action

The mechanism of Digoxin involves two distinct actions: modulating the heart muscle's contractile strength and influencing its electrical rhythm. This dual effect is achieved through specific interactions with key cardiac systems.

The Molecular Cascade: Inhibiting the Sodium Pump

The primary biological action is the reversible inhibition of the Sodium-Potassium ATPase enzyme (the sodium pump) found in the heart muscle cell membrane. This initial molecular action causes a subtle rise in internal sodium ( Na^+) concentration, which in turn reduces the function of the Sodium-Calcium Exchanger ( NCX). The resulting retention of calcium ( Ca^2+) inside the cell is the preceding step leading to a greater force of systolic contraction (positive inotropy).

Modulating the Electrical Pathway via Vagal Input

Separately, Digoxin exerts an influence on the Autonomic Nervous System by stimulating the Vagus nerve. This neuro-modulatory action augments the parasympathetic tone, directly affecting the heart's electrical timing. The enhanced vagal input slows the speed at which electrical signals are transmitted through the Atrioventricular ( AV) node. The physiological consequence of this is a slowing of the overall heart rate and a decrease in conduction velocity (negative chronotropy).

Dosage and Administration Information

How to Use Digoxine Nativelle: Administration Guidelines

Administration of Digoxine Nativelle follows specific instructions detailing the route, dosing structure, and necessary patient-specific adjustments.


Administration Scope

Instruction Category Statement
Route of Administration Primarily Oral (tablet, elixir). Intravenous (IV) injection is reserved for urgent needs or when oral administration is not possible. The intramuscular (IM) route is not recommended due to severe injection site reaction.
Dosing Schedule Dosing follows a two-part strategy: 1. Loading Dose (rapid effect), and 2. Maintenance Dose (long-term use). The adult maintenance dose is typically 0.125 mg to 0.250 mg once daily.
Frequency Pattern Once daily for long-term maintenance. The loading dose is administered in divided portions (e.g., half the total dose initially, then quarter fractions every 6 to 8 hours).
Timing in Relation to Meals Tablets can be taken with or without food. However, absorption may be reduced if taken with meals high in bran fiber.

Special Procedural Conditions

  • IV Administration Speed: Intravenous doses must be administered slowly over a minimum period of 5 minutes.
  • Formulation Switch: When switching from the oral route to the IV route, the dosage must be reduced by 20% to 33% to account for the difference in bioavailability.
  • Population Adjustments: Dosage is based on the patient's lean body weight and renal function (Creatinine Clearance). The dose is often reduced for older adults and patients with impaired kidney function.
  • Oral Preparation: The oral solution must be measured using a calibrated measuring device for accurate dosing.

These instructions establish a standardized protocol for use, ensuring that dosing is determined by individual factors and administration methods adhere to specific technical requirements.

Recent Clinical Evidence

Digoxine Nativelle (digoxin) is a cardiac glycoside primarily studied for its use in heart failure with reduced ejection fraction (HFrEF) and atrial fibrillation (AF). Clinical evidence regarding its benefits and risks remains complex and often conflicting, particularly when comparing observational data with results from randomized controlled trials (RCTs).

Evidence in Heart Failure (HFrEF)

The landmark Digitalis Investigation Group (DIG) trial in heart failure patients with normal sinus rhythm reported that adding digoxin to standard therapy:

  • Mortality: Showed a neutral effect on all-cause mortality.
  • Hospitalizations: Significantly reduced the rate of hospitalization for worsening heart failure.

More recent analyses suggest that the positive effects on reducing hospitalizations and improving symptoms are most pronounced when serum digoxin concentrations are maintained within a lower range (e.g., 0.5 to 0.9 ng/mL). Higher concentrations have, in some studies, been associated with adverse outcomes.


Evidence in Atrial Fibrillation (AF)

In AF, where digoxin is used for ventricular rate control, evidence is derived primarily from post-hoc analyses of RCTs and observational studies, which must be interpreted with caution due to potential confounding factors, known as prescription bias (sicker patients are more likely to receive digoxin).

Conflicting evidence exists on the impact of digoxin on mortality in AF:

Research Type Reported Association with All-Cause Mortality
Randomized Trial Analyses (e.g., DIG Trial) Generally neutral effect
Observational Studies/Meta-analyses Often suggest an increased risk, particularly in patients without co-existing heart failure.

Overall, randomized trial data supports digoxin's role in improving symptoms and reducing hospitalizations in select patients with HFrEF and sinus rhythm, but its effect on all-cause mortality in this setting is considered neutral. Its role in AF remains a subject of ongoing debate and research.

Frequently Asked Questions (FAQ)

Common questions about Digoxine Nativelle (FAQ)


Q: What are the signs of too much Digoxine Nativelle in the body?

A: According to official documentation, signs of Digoxin toxicity, or too much medicine in the body, can include nausea and vomiting, and visual disturbances like blurred or yellow vision. More seriously, it can also lead to issues with your heart rhythm, known as cardiac arrhythmias. In infants and children, official documentation notes that early signs may include failure to thrive, weight loss, or changes in behavior.

Q: Can Digoxine Nativelle cause problems with vision?

A: Official adverse reaction documentation indicates that visual disturbances are a possible effect. These effects are documented to include blurred vision and a change in color perception, such as seeing things with a yellow tint (xanthopsia).

Q: What is the risk of yellow-green vision changes with Digoxine Nativelle?

A: Yellow or green vision is a specific type of visual disturbance that is officially associated with the use of Digoxin. This effect is noted as a manifestation that may be associated with increased levels of the medicine in the body.

Q: Does Digoxine Nativelle interact with alcohol?

A: Authoritative public guidance suggests that alcohol intake should be avoided when first starting the medication or following a change in the dosage. If the use of the medicine is associated with dizziness, authoritative guidance suggests discontinuing alcohol intake.

Q: Is it okay to take Digoxine Nativelle with milk or food?

A: Official administration instructions state that the tablet form can generally be taken with or without food. However, absorption may be reduced if it is taken with meals high in bran fiber. Regulatory labeling does not specifically address milk consumption.

Q: Does Digoxine Nativelle have an effect on sleep patterns?

A: The official documentation lists specific Central Nervous System disturbances, such as headache, confusion, apathy, and dizziness. However, it does not explicitly mention effects on sleep patterns.

Q: What is Digoxine Nativelle used for besides heart rhythm problems?

A: The official indications listed for the medicine are the treatment of mild to moderate heart failure in adults and the increase of myocardial contractility (the force of the heart muscle's squeeze) in pediatric patients who have heart failure. For rhythm problems, it is indicated for controlling the ventricular rate in chronic atrial fibrillation.

Q: How long do the effects of Digoxine Nativelle last?

A: Official pharmacokinetic data indicates that the half-life of Digoxin in adults with normal kidney function is typically between 36 to 48 hours. This period determines how long the substance remains in the body, which is a factor in determining the daily dosing regimen.

Q: Can I take Digoxine Nativelle if I am taking over-the-counter pain relievers?

A: Official information indicates that certain non-prescription products may carry risks. Specifically, some cold and flu medications containing sympathomimetic agents (e.g., phenylephrine) may potentially cause irregular heart rhythms when used alongside Digoxin. The label notes that the dosage of acetaminophen should be considered due to potential concerns related to liver function.

Q: Are there any common foods or drinks that interact with Digoxine Nativelle?

A: The most specific food interaction noted in official guidelines is that absorption may be reduced if the medicine is taken with meals containing high amounts of bran fiber. Otherwise, a normal diet is generally permitted.

Q: Is it normal to feel tired when starting treatment with Digoxine Nativelle?

A: Fatigue is listed in the official list of adverse reactions. Official guidance indicates that new or increased fatigue, particularly early in treatment, may warrant consideration, as this effect can be associated with higher levels of the drug.

Q: Does Digoxine Nativelle affect blood pressure?

A: The medication's actions are primarily documented for its effects on heart contractility and rate. However, official information indicates that monitoring of both blood pressure and heart rate is part of the routine care for patients taking Digoxin.

Q: Can Digoxine Nativelle be used for conditions other than heart failure and atrial fibrillation?

A: The official labeling strictly indicates the drug for the treatment of mild to moderate heart failure and the control of ventricular rate in chronic atrial fibrillation.

Q: Does taking Digoxine Nativelle require any changes to my diet?

A: The most specific dietary note in official guidelines is that absorption may be reduced if the medicine is taken with meals high in bran fiber. Otherwise, a normal diet is generally permitted.

Q: Is Digoxine Nativelle known to interact with herbal supplements?

A: Official labeling specifically names the herbal supplement St. John's Wort as an agent that may cause an interaction. This supplement may reduce Digoxin levels and potentially decrease its effectiveness.

Q: Does Digoxine Nativelle cause weight gain or loss?

A: Weight loss is explicitly listed in official documentation as a sign of overdose or toxicity in infants and children. Weight changes are not commonly listed as a standard side effect in adults.

Q: What should I do if I experience nausea after taking Digoxine Nativelle?

A: Nausea is a common side effect and is also listed as a sign of toxicity. Public health information describes supporting measures such as eating simple meals and drinking simple fluids to prevent dehydration. Persistent or severe nausea is noted as an effect that may require attention.

Q: Does the time of day I take Digoxine Nativelle matter?

A: The maintenance dose is officially prescribed as being taken once daily. While a specific time of day (morning or evening) is not mandated, official documents state the drug should be taken consistently.

Q: Is there any research on long-term side effects of Digoxine Nativelle?

A: The official adverse reaction profiles include effects that have been observed following prolonged use, such as gynecomastia.

Q: Can Digoxine Nativelle affect laboratory test results?

A: Official documentation states that Digoxin can cause changes on an electrocardiogram (ECG), specifically PR interval prolongation and ST segment depression. The label also notes that it may cause falsely elevated serum digoxin concentrations due to interference with certain lab assays.

Q: Is there a generic version of Digoxine Nativelle?

A: The active ingredient in Digoxine Nativelle is Digoxin, and this drug is widely available as a generic product under the name Digoxin from various manufacturers, as indicated by official drug listings.

Q: Does Digoxine Nativelle affect liver function?

A: The official labeling includes a section titled 'Hepatic Impairment' (liver function impairment) under 'Use in Specific Populations.' This indicates that the status of the liver is a factor considered in the drug's overall profile.

Q: What evidence exists for Digoxine Nativelle's use in pediatric populations?

A: The official labeling indicates the drug for increasing myocardial contractility in pediatric patients with heart failure. Specific considerations for infants and children are provided in the regulatory documents.

Q: Is Digoxine Nativelle used to prevent heart problems or to treat existing ones?

A: The official indications describe the use of the medicine as treatment for mild to moderate heart failure and control of ventricular rate in chronic atrial fibrillation. This means the drug is used to manage existing conditions rather than for primary prevention.

How should Digoxine Nativelle be stored and disposed of?

Official Storage and Disposal Requirements

Official regulatory guidelines for Digoxine Nativelle (digoxin) focus on maintaining product stability and ensuring safety.

Storage Category Requirement
Temperature Store below 25 C (controlled room temperature).
Protection Keep the medicine in its original, tightly closed container; protect from light, heat, and moisture.
Stability The medicine remains stable until the expiry date printed on the packaging, provided proper storage conditions are followed.
Child Safety Keep Digoxine Nativelle out of the sight and reach of children.
Disposal Do not flush the medicine down the toilet or throw it in household trash unless instructed by a take-back program. Unused or expired medication must be disposed of according to local, regional, and national pharmaceutical waste regulations. Avoid environmental release.

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

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