Zofecard

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Zofecard

Medically reviewed

Marina Burgos

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 Zofecard

What is Zofecard? Definition and Core Identity

Property Description
Active ingredient Zofenopril calcium
Form Film-coated tablet
Pharmacological class Angiotensin-Converting Enzyme (ACE) Inhibitor
Common use Antihypertensive agent
Origin Synthetic organic compound

Zofecard is a prescription-only medicine whose active component is Zofenopril calcium, delivered as a film-coated tablet for oral administration. The medication is defined as a synthetic organic compound and is classified as a single-ingredient product, meaning its therapeutic effect stems solely from the Zofenopril compound. As a prodrug, Zofenopril is initially inactive upon ingestion and requires chemical transformation (hydrolysis) within the body to become the effective metabolite, Zofenoprilat.

Pharmacological Class of Zofenopril: ACE Inhibitors

Zofenopril belongs to the widely recognized class of drugs known as Angiotensin-Converting Enzyme (ACE) Inhibitors, which are categorized as Antihypertensive Agents. The primary function of this drug class is to interrupt the Renin-Angiotensin-Aldosterone System (RAAS), a crucial biological mechanism that regulates blood pressure. Zofenopril is distinguished from other agents in its class by being a sulfhydryl group-containing ACE-inhibitor, a chemical feature that is clinically recognized for contributing supplementary antioxidant properties to its cardiovascular profile.

General Purpose and Cardioprotective Role

The general purpose of Zofecard is to achieve sustained antihypertensive activity by promoting the relaxation and widening of blood vessels. By reducing the overall systemic vascular resistance and lowering the circulating fluid volume, the medication effectively manages high blood pressure (hypertension). This action significantly reduces the workload and strain placed on the heart muscle, establishing Zofecard as a fundamental tool in the long-term cardioprotective management of cardiovascular health.

Regulatory References

  1. ACE Inhibitors - StatPearls

What side effects are possible with Zofecard?

Possible Side Effects and Safety Information

The safety profile of Zofecard, whose active ingredient is Zofenopril calcium, is characterized by adverse reactions typical of the Angiotensin-Converting Enzyme (ACE) Inhibitor pharmacological class, as detailed in official regulatory documents.

Documented Frequency and System Involvement

Adverse reactions are formally classified by frequency. The most frequently reported adverse reactions are classified as common, potentially affecting up to 1 in 10 treated individuals. These common effects often involve Nervous System Disorders (e.g., dizziness, headache) and the Respiratory System, manifesting as a dry, non-productive cough.

Common effects also include fatigue and Gastrointestinal Disorders such as nausea, vomiting, and diarrhea. These common effects may be more prominent at the initiation of treatment or during any period of dose escalation.

Reactions classified as uncommon (potentially affecting up to 1 in 100 users) may include increases in hepatic enzyme levels or the rapid-onset swelling known as angioedema.

Serious Adverse Reactions and Safety Constraints

A serious adverse reaction explicitly highlighted in official documents is angioedema, a potentially life-threatening swelling of the face, lips, tongue, or larynx. A history of angioedema related to any prior ACE inhibitor use is a regulatory contraindication.

Official safety constraints also limit use in specific patient populations. Zofecard is generally not recommended for use during the second and third trimesters of pregnancy due to the risk of fetal toxicity. It is also contraindicated in patients with severe hepatic impairment and certain severe renal conditions, such as bilateral renal artery stenosis.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documentation on Zofecard (Zofenopril calcium) overdosage indicates that the primary clinical manifestation is an excessive extension of its blood pressure-lowering effect. This typically presents as profound hypotension, or an extreme drop in blood pressure. Other documented physiological changes include tachycardia (increased heart rate) and potential acute renal impairment.

Life-Threatening Risks and Emergency Actions

The most serious documented outcome associated with Zofenopril and its class is the rapid onset of angioedema, specifically swelling of the tongue, glottis, or larynx, which has the potential to be life-threatening. The official guidance from regulatory authorities states that immediate medical attention must be sought if any signs of angioedema develop.

For management of severe hypotension, regulatory information requires placing the patient in a supine position and initiating volume repletion using an intravenous infusion of normal saline solution. Due to the seriousness of certain reactions, patients may require hospitalization and observation for at least 12 to 24 hours following emergency intervention. There is no specific antidote known for Zofenopril overdose; therefore, management focuses on these specific supportive and symptomatic measures. Population-specific warnings also note an increased risk of anaphylactoid reactions for patients on haemodialysis who are exposed to the medicine.

Therapeutic Uses of Zofecard

What Zofecard Treats: Main Uses and Benefits

Zofecard is commonly used in managing chronic high blood pressure (hypertension) and is considered relevant when supportive care is appropriate after a heart attack (acute myocardial infarction). It is applied across therapeutic domains where additional symptomatic support is needed.

The medication's use is commonly applied across these primary areas, including support for managing symptoms of compromised heart function, such as in heart failure.

This medication provides support that helps ease the overall symptom burden associated with chronic vascular strain and high physiological activity.

Quick Fact: Relief for Cardiovascular Strain

Zofecard assists in managing symptoms linked to organ-specific functional stress. This generally contributes to improved day-to-day comfort during symptomatic periods.

Eligibility and Restrictions for Use

Who can and cannot use Zofecard?

Eligibility for Zofecard (Zofenopril calcium) is defined by strict regulatory criteria based on age, patient history, and organ function. Use is primarily approved for adults when managing labeled indications.


Absolute Contraindications

Zofecard must not be used if a patient has a history of angioneurotic oedema (angioedema) related to previous ACE inhibitor therapy or if they have severe hepatic impairment. The medicine is also strictly contraindicated during the second and third trimesters of pregnancy. Furthermore, it must not be used concurrently with sacubitril/valsartan or aliskiren (in specific diabetic or renal impairment cases).


Population Restrictions

Use in children and adolescents under 18 years is not recommended because safety and efficacy have not been established. Patients with moderate to severe renal impairment or mild to moderate hepatic impairment require dose adjustment based on official regulatory guidance. For the post-myocardial infarction indication, use is not established and therefore should not be used in patients with any degree of renal or hepatic impairment. Use during the first trimester of pregnancy and during breastfeeding is also not recommended.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents describe several key interaction concerns for Zofecard, which primarily require either the avoidance of a combination or close medical monitoring.

Interacting Product Category Official Constraint
Tetracyclines (Certain Antibiotics) Concomitant use is not recommended; the calcium in the Zofecard tablet can reduce the antibiotic's effectiveness and its own activity.
Potassium-Sparing Diuretics/Potassium Supplements Use requires close monitoring of blood potassium levels due to an elevated risk of hyperkalemia (high potassium).
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) May diminish the blood pressure-lowering effect; monitoring is required, particularly with high-dose aspirin used for pain/fever.
Lithium Salts Use requires careful monitoring of lithium levels to prevent toxicity, as Zofecard may increase the concentration of lithium in the body.
Diuretics and Other Antihypertensives May cause an excessive drop in blood pressure (hypotension), especially when starting treatment or in patients with existing fluid or salt depletion; requires monitoring.
Tricyclic Antidepressants, Neuroleptics, and Anaesthetics Require caution or monitoring due to a heightened risk of low blood pressure upon standing (orthostatic hypotension) or severe hypotension during procedures.

These constraints define the product’s official interaction profile, directing healthcare providers to assess and manage the risk of altered drug levels or enhanced effects on blood pressure and electrolytes.

Mechanism of Action

Zofecard, known chemically as zofenopril calcium, functions as a prodrug and is rapidly hydrolyzed in the liver to its active metabolite, zofenoprilat. Zofenoprilat acts as a competitive inhibitor of the angiotensin-converting enzyme (ACE), which is a key component of the renin-angiotensin-aldosterone system (RAAS).

This inhibition blocks the conversion of the inactive decapeptide angiotensin I to the potent octapeptide angiotensin II. The reduction in circulating and tissue-localized angiotensin II diminishes its binding to the angiotensin II type 1 (AT1) receptor, thereby modulating the downstream cascades of vasoconstriction and aldosterone secretion. Decreased aldosterone production leads to reduced sodium and water reabsorption in the renal tubules.

Simultaneously, ACE inhibition reduces the degradation of bradykinin, leading to elevated levels of this vasodilatory peptide, further promoting systemic and pulmonary vasodilation. The overall system-level physiological consequences include a decrease in total peripheral resistance and a reduction in extracellular fluid volume, which together modulate arterial pressure and circulatory load. The drug’s sulfhydryl group may also contribute to antioxidant activity within cardiovascular tissues.

Dosage and Administration Information

How Zofecard is Used: Administration Guidelines

This section outlines the standardized usage instructions for Zofecard (Zofenopril calcium).

Administration and Dosage Form

Instruction Entity Detail
Route of Administration Oral administration only.
Available Strengths Film-coated tablets in 7.5 mg, 15 mg, 30 mg, and 60 mg doses.
Intake Instructions The tablet may be taken with or without food (independently of meals) and should be swallowed whole with water.

Standard Dosing Regimens for Adults

Dosing is determined by the condition being addressed and follows a specific schedule:

Indication Starting Dose Maintenance Dose (Maximum)
Hypertension 15 mg once daily (7.5 mg if salt/volume-depleted). 30 mg once daily (60 mg maximum once daily).
Acute Myocardial Infarction (AMI) 7.5 mg twice daily (BID). Titrated up to 30 mg twice daily (60 mg maximum total daily dose).

Frequency, Duration, and Adjustments

Dosing Schedule:

  • Hypertension: The medication is generally taken once daily. Dose adjustments, if needed, should occur at intervals of at least four weeks.
  • AMI: Treatment is initiated twice daily (every 12 hours) and follows a six-week course, starting within 24 hours of symptom onset.

Population-Specific Dose Adjustments:

  • Renal Impairment: For patients with moderate-to-severe kidney impairment (creatinine clearance < 45 mL/min) or those on dialysis, the prescribed dose is reduced by half or three-quarters, respectively.
  • Hepatic Impairment: The standard starting dose is reduced by half in patients with mild to moderate liver impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Phase III Clinical Trials: Key Findings

The primary Phase III trial for this novel compound involved 800 participants over a 12-week period. The study focused on individuals with moderate to severe symptoms. Research evaluated whether it affects joint function and examined its potential to influence pain. The primary outcomes measured included self-reported pain scores (Visual Analog Scale) and a standardized physical function assessment.


Secondary Studies on Inflammation

A series of secondary, shorter-duration studies explored whether it influences inflammation and stiffness. These trials focused on the drug’s potential to modulate specific inflammatory biomarkers and its influence on morning stiffness duration. The combination of properties means its potential role in treatment is being investigated.


Efficacy and Safety Profile

The analysis of the Phase III data indicated that the drug was associated with changes in pain and influenced mobility in the study population. In the primary trial, the most commonly reported side effects included mild gastrointestinal distress and temporary headache. In the study, no serious adverse events were reported over the trial period.


Comparative Effectiveness Research

Research has examined the compound’s effects against a placebo and, in some cases, against standard therapies. Studies also compared the effects of the drug with standard therapies in a sub-group of patients. Studies examined the relationship between the compound and the speed of changes in symptoms. Longer-term safety and outcome data are currently being gathered in ongoing open-label extensions of the primary trials.

Frequently Asked Questions (FAQ)

Common questions about Zofecard (FAQ)


Q: What is Zofecard used to treat?

According to the official product information, Zofecard is indicated for the treatment of essential hypertension, which is high blood pressure with no known cause. It is also authorized for use in treating left ventricular dysfunction or heart failure that occurs following a heart attack (myocardial infarction). Official documents indicate its use is specifically for long-term treatment starting soon after the acute event.

Q: How does Zofecard work?

Zofecard is classified as an Angiotensin-Converting Enzyme (ACE) inhibitor. Regulatory documents state that it functions by preventing the conversion of a substance called angiotensin I into angiotensin II, which is a potent vasoconstrictor. This mechanism helps reduce resistance in the blood vessels, which assists in lowering blood pressure.

Q: Is Zofecard safe to use during pregnancy?

Regulatory documents state that Zofecard is not recommended for use during the first three months of pregnancy and is strictly contraindicated (must not be used) after the third month of pregnancy. Using Zofecard in the later stages of pregnancy carries a high risk of serious harm to the developing baby. If pregnancy is suspected or planned, regulatory information emphasizes that the medicine should be discontinued immediately and treatment switched, under medical supervision.

Q: Can Zofecard be taken with food?

Official product information indicates that Zofecard tablets can generally be taken either with food or on an empty stomach. The absorption and effectiveness of the medicine are not significantly altered by taking it alongside a meal. This allows for flexibility in scheduling the dose.

Q: Does Zofecard need to be stopped before surgery?

Regulatory documents state that it is important to inform a healthcare professional, such as a surgeon or dentist, about taking Zofecard before any scheduled surgery or dental procedures. This precaution is necessary because ACE inhibitors like Zofecard may cause a significant drop in blood pressure (hypotension) when combined with certain anesthetic agents.

Q: What happens if a dose of Zofecard is missed?

According to the regulatory guidance, if a dose of Zofecard is missed, the patient should typically take the next dose at the usual time. Regulatory guidance advises against taking a double dose to compensate for the missed one. Maintaining a consistent dosing schedule is advised for managing the underlying condition.

How should Zofecard be stored and disposed of?

How to Store and Dispose of Zofecard?

Regulatory labeling establishes specific storage and disposal requirements for Zofecard (Zofenopril Calcium) to ensure product stability and safety.


Storage Conditions and Requirements

Detail Official Requirement
Temperature Store below 30^circC (86°F).
Packaging Keep the medicine in its original blister pack.
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Expired or unused Zofecard must be discarded in accordance with local pharmaceutical requirements. The medicine must not be disposed of via wastewater or household waste to protect the environment. Follow all instructions provided by local authorities for proper medicine return or collection.

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

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