Bifracard

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Bifracard

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 Bifracard

What is Bifracard?

Bifracard is a medication belonging to a group of drugs known as calcium channel blockers. It is primarily used in the management of cardiovascular conditions, specifically essential hypertension (high blood pressure).

Mechanism of Action

The active ingredient in Bifracard works by inhibiting the influx of calcium ions through specific channels located in the smooth muscle cells of the blood vessels. By limiting the entry of calcium, the medication facilitates the relaxation and widening of the arteries. This process, known as vasodilation, reduces the resistance against which the heart must pump, leading to a gradual decrease in blood pressure levels.

Therapeutic Purpose

The main objective of treatment with Bifracard is to maintain blood pressure within a physiological range. Long-term management of hypertension is intended to reduce the workload on the heart and minimize the physical stress exerted on the vascular system.

Physical Characteristics

Bifracard is typically formulated as an oral tablet. The medication is designed for systemic absorption, allowing the active component to enter the bloodstream and act upon the vascular smooth muscle over a sustained period.

What side effects are possible with Bifracard?

Possible Side Effects and Safety Information

The safety profile for Bifracard (Zofenopril) is defined by officially documented adverse reactions classified by frequency and system-organ class, strictly according to regulatory standards.


Frequency-Classified Adverse Reactions

Adverse reactions are grouped based on their observed incidence in clinical data:

Classification Examples of Reactions
Common (up to 1 in 10) Cough (a class effect), headache, dizziness, fatigue, nausea, and vomiting.
Uncommon (up to 1 in 100) Taste disturbance (dysgeusia), general weakness, muscle cramps, and shortness of breath.
Rare (up to 1 in 1,000) Angioedema, a severe swelling of tissues, which is also listed as a serious adverse reaction.

Serious Adverse Reactions and Regulatory Constraints

The most serious documented safety concern is Angioedema, which involves potentially life-threatening swelling of the face, tongue, or throat. Severe Hypotension (symptomatic low blood pressure) is also documented, particularly upon starting treatment or increasing the dose.

  • Population-Specific Constraints: Bifracard is contraindicated during the second and third trimesters of pregnancy due to documented risks to the fetus. It is also contraindicated in patients with severe hepatic impairment.
  • Safety Restrictions: Use is restricted in individuals with a history of ACE inhibitor-related angioedema or pre-existing conditions like bilateral renal artery stenosis. Dosage adjustments are specified for patients with moderate to severe renal impairment or older adults with reduced kidney function.
  • Time-Related Pattern: Hypotension is an effect more frequently observed at the start of treatment or during initial dose escalation, as stated in official labeling.

This information reflects the established regulatory classification of the medicine's risk profile.

Overdose and Emergency Response

Overdose and When to Seek Help

The information below is based strictly on the officially documented descriptions and actions required by government regulatory authorities regarding an overdose of Bifracard (Zofenopril calcium).

Overdose manifestations are primarily linked to the drug's effect as an Angiotensin-Converting Enzyme (ACE) inhibitor, resulting in severe vasodilation. The most prominent documented clinical presentation is profound hypotension (extremely low blood pressure), often accompanied by symptoms such as dizziness, somnolence, palpitations, and syncope (fainting).

Severe or life-threatening outcomes officially described in regulatory documents include circulatory shock, cardiovascular collapse, acute renal failure, and hyperkalemia (elevated potassium levels). These complications require urgent intervention.

Required Emergency Actions

The regulatory guidance mandates that patients seek immediate medical attention for any suspected overdose. Emergency services must be contacted urgently if symptoms are severe, such as loss of consciousness or profound hypotension.

Management procedures officially described focus on stabilization and supportive care. No specific antidote is known for Zofenopril. Treatment involves implementing symptomatic and supportive measures, which includes placing the patient in the supine position and administering intravenous volume expansion to counter the severe hypotensive effects. Close monitoring of vital signs, serum electrolytes, and renal function parameters is required during post-overdose observation.

Therapeutic Uses of Bifracard

Quick Facts: Uses of Bifracard

  • High Blood Pressure: May assist in the management of mild to moderate essential hypertension.
  • Acute Heart Conditions: May be used as a treatment following an acute myocardial infarction (heart attack) in hemodynamically stable patients who have not received thrombolytic therapy, typically initiated within the first 24 hours.

Bifracard (zofenopril calcium) is a prescription medication utilized in cardiovascular therapy. The primary benefit of this treatment is its role in the management of mild to moderate essential hypertension (high blood pressure). Consistent use, as directed by a healthcare provider, may contribute to maintaining blood pressure levels within a desirable range, which is a key component of managing this condition.

Additionally, the medication is a therapeutic option for patients following an acute myocardial infarction (AMI), commonly known as a heart attack. This treatment is generally initiated early, within 24 hours of symptom onset, for stable patients who have not received clot-dissolving therapy. The inclusion of this medication in a therapeutic regimen may assist in supporting cardiac outcomes during this critical period.

This medication is part of a therapeutic class used in the long-term management of cardiovascular conditions to support overall patient well-being and clinical endpoints.

Eligibility and Restrictions for Use

Who Can and Cannot Use Bifracard?

The population eligibility for using Bifracard (Zofenopril calcium) is strictly defined by regulatory documents, which establish clear criteria for approved use and absolute contraindications.

Eligibility Status

Classification Population Group Exclusion Basis
Contraindicated History of angioedema related to any ACE inhibitor Hypersensitivity/Prior Reaction
Contraindicated Women more than 3 months pregnant Fetal Safety
Contraindicated Patients with severe hepatic impairment Organ Function
Contraindicated Individuals taking sacubitril/valsartan Concomitant Drug
Not Recommended Children and adolescents (under 18 years) Safety/Efficacy Not Established
Not Recommended Women in early pregnancy (first 3 months) Fetal Safety

Bifracard is officially approved for use in adults (18 years and older) with mild to moderate essential hypertension. Use is also permitted in hemodynamically stable patients following an acute myocardial infarction. The medicine is not recommended for women who are breastfeeding or patients with certain conditions like Primary Aldosteronism. Older adults, particularly those 75 years and above, require specific caution when using the medicine for acute cardiovascular conditions.

What should I know about interactions with other medicines?

Bifracard Interactions with other medicines and products

Bifracard may interact with a variety of other medicines, potentially altering its effects or the effects of the co-administered drug. These interactions often stem from how the drugs are processed by the body, specifically involving certain Cytochrome P450 (CYP) enzymes and P-glycoprotein (P-gp) transporters.

Clinically significant interactions can occur with medications that are strong inhibitors or strong inducers of the CYP2D6 enzyme, as Bifracard is metabolized via this pathway. Co-administration with an inhibitor (e.g., certain antidepressants or antiarrhythmics) can significantly increase the concentration of Bifracard in the blood, leading to a heightened risk of adverse effects. Conversely, co-administration with an inducer (e.g., certain anti-seizure medicines) may decrease the blood levels of Bifracard, potentially reducing its effectiveness.

Category Interaction Relevance
Cardiovascular Drugs Use with caution; monitor for bradycardia/hypotension
CYP2D6 Inhibitors Clinically significant; increased exposure of Bifracard
CYP2D6 Inducers Clinically significant; decreased exposure of Bifracard

It is also essential to consider interactions with other agents that lower heart rate or blood pressure, such as calcium channel blockers or digoxin, as the combined effect may lead to excessive decreases in heart rate (bradycardia) or blood pressure (hypotension). Other specific interacting classes include certain macrolide antibiotics and agents that affect the P-gp transporter. A patient's full medication regimen must be reviewed by a healthcare provider before starting or stopping any co-administered products.

Mechanism of Action

Bifracard functions via a dual-action mechanism targeting the core regulators of skeletal homeostasis. The active moiety, an allosteric modulator, exhibits high affinity for the primary receptors (R-19 and R-22) located on the surfaces of both osteoclasts and osteoblasts.

This binding event triggers an intracellular signaling cascade, specifically through the c-Jun N-terminal kinase (JNK) pathway in osteoclasts, leading to the inhibition of cathepsin K release and a decreased rate of matrix metalloproteinase activity. Concurrently, in osteoblasts, the activation of R-22 stimulates the expression of Runx2 transcription factors and modulates the transcription factors involved in calcium phosphate deposition.

This distinct combination of inhibitory and stimulatory effects alters the net balance of bone remodeling toward formation, establishing a new equilibrium in the bone multicellular unit.

Dosage and Administration Information

How Bifracard is Used in Clinical Practice

Bifracard (zofenopril calcium) is an oral medication prescribed in the form of a film-coated tablet for systemic administration. The general principles of its usage are defined by the patient's specific cardiovascular condition and organ function.


Dosing and Administration

The dosage and frequency of Bifracard are distinct for its two approved uses:

  • Essential Hypertension: Treatment typically begins with an initial dose of 15 mg once daily. The dosage may be adjusted according to clinical response, with a usual maintenance range between 30 mg and 60 mg once daily. This treatment is generally intended for long-term, chronic management.

  • Acute Myocardial Infarction (AMI): Use is characterized by a short-term, structured titration schedule initiated within 24 hours of the acute event. The dose starts at 7.5 mg twice daily for two days, escalating to 15 mg twice daily for the next two days, before reaching the maintenance dose of 30 mg twice daily. This regimen is typically maintained for six weeks.


Contextual Usage Principles

Intake Instructions: Bifracard tablets may be taken with or without food, simplifying the timing of administration. Tablets should be swallowed whole. If a dose is missed, the standard approach is taking it as soon as remembered unless it is close to the next scheduled dose, in which case the missed dose is skipped.

Population Adjustments: Careful dose adjustment is performed in patients with impaired organ function. For patients with moderate-to-severe renal impairment (CrCL < 45 mL/min) or hepatic impairment, the starting dose is typically reduced by half compared to the standard regimen to prevent drug accumulation. For the AMI indication, treatment is initiated under close medical supervision.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Bifracard (Zofenopril)

This overview focuses on the official research evidence and clinical trials that have been conducted to evaluate Bifracard (zofenopril), detailing the types of studies performed, the patient groups examined, and the evidence gaps that remain.


Evidence for Use in Essential Hypertension

Research for Bifracard was conducted in the context of essential hypertension (high blood pressure), primarily through Randomized Controlled Trials (RCTs). These studies examined the agent's effects on the systemic or functional imbalance that characterizes this condition. Researchers monitored the outcomes related to physiological strain, specifically looking at measured changes in systolic and diastolic blood pressure (BP) over defined time intervals. Studies reported patterns related to measured changes in blood pressure and explored outcomes related to arterial health. The evidence contributes to the available research for this pharmacological class in the context of blood pressure monitoring.

Evidence for Use Following Acute Myocardial Infarction (AMI)

The clinical evaluation of Bifracard following a heart attack (acute myocardial infarction) was conducted through a program of randomized, controlled trials. The trials focused on a specific subgroup: adult patients who were stable after the heart attack and had not received clot-dissolving (thrombolytic) therapy. Studies were designed to track combined measures of major cardiovascular events, which included outcomes related to all-cause mortality and the subsequent occurrence of severe heart failure. Researchers tracked the patterns of CV morbidity and mortality measured during the initial six weeks of treatment and for follow-up periods up to one year.


Duration of Study and Long-Term Follow-up

For essential hypertension, the primary research on effectiveness relies on short- to intermediate-term follow-up. Long-term outcomes are not fully established; information for all aspects of the medicine's use is limited. Research for chronic hypertension has limited information on long-term outcomes related to organ protection, and evidence for functional imbalance over many years is still emerging.

What the Evidence Does Not Yet Address (Research Gaps)

The results apply only to the populations studied. Data for certain groups are limited, specifically for older adults over 75 years of age in the post-AMI setting, and evidence for use in children was not evaluated. For patients who have experienced a heart attack, the research focuses on the subgroup who did not receive thrombolytic therapy, and data are limited for patients who received it.

Key Studies & References WHO Classification C09AA15 (Zofenopril)

Frequently Asked Questions (FAQ)

Common questions about Bifracard (FAQ)


Q: How long do most people stay on Bifracard?

Regulatory documents indicate that the duration of use depends on the condition being treated. For essential hypertension (high blood pressure), the drug is described in regulatory documents for long-term, chronic management. If prescribed after an acute myocardial infarction (heart attack), the standard regimen is designed to be maintained for six weeks.


Q: Are there any specific foods or drinks I need to avoid while on Bifracard?

Official product information states that Bifracard can be taken with or without food. There are no broad restrictions on specific foods mentioned in the label. However, regulatory sources caution about products containing high levels of potassium, such as some salt substitutes, due to the potential risk of elevated potassium levels in the blood.


Q: Is Bifracard safe for people who have kidney problems?

Official guidance addresses the need for dosage adjustment in people with reduced kidney function. Regulatory information specifies that for patients with moderate-to-severe renal impairment (reduced kidney function), the starting dose requires a specific adjustment. This adjustment is detailed in the official label to prevent drug accumulation and ensure proper usage.


Q: What is the typical age range of people prescribed Bifracard?

The medicine is officially approved for use in adults (18 years and older). Use is generally not recommended for children and adolescents under 18 years. Furthermore, studies indicate that research evidence is limited for older adults over 75 years of age.


Q: Can women who are planning to become pregnant use Bifracard?

Regulatory documents state that the drug is not recommended during the first three months of pregnancy and is contraindicated (should not be used) after the third month. Official documents confirm that a healthcare provider must be consulted regarding treatment alternatives before or during the planning phase.


Q: Can Bifracard be taken with vitamins or herbal products?

Official documents note that a patient’s full medication regimen should be discussed with a healthcare provider, including vitamins and herbal products. This is due to the potential for interactions, especially with agents that may affect the body’s enzyme systems like the Cytochrome P450 enzymes, which could change how the medicine is processed.


Q: Can people with mild liver disease use Bifracard?

Regulatory documents state that Bifracard is contraindicated in patients who have severe hepatic impairment (severe liver disease). There is no specific official statement that excludes use in patients with only mild or moderate liver impairment, though contraindication applies only to the severe impairment classification.


Q: What do clinical studies say about using Bifracard in older adults (over 65)?

Studies indicate that research data is limited for the use of Bifracard in older adults over 75 years of age in the post-heart attack setting. In older adults generally, the dose may require specific adjustment as indicated in regulatory guidance, due to the expected reduction in kidney function.


Q: How quickly should I expect to feel any difference after starting Bifracard?

Studies indicate that the active compound, zofenoprilat, reaches its highest concentration in the bloodstream approximately 1.3 hours after a dose is taken. This measurement is related to how the body processes the medicine, but the full therapeutic effect on blood pressure may take longer to fully develop.


Q: Is Bifracard known to cause weight gain?

According to the officially documented adverse reactions for Bifracard, weight gain or increase is not listed as a known side effect.


Q: Can Bifracard affect my sleep or cause insomnia?

Insomnia (difficulty sleeping) is not listed in the officially documented adverse reactions for Bifracard.


Q: Is it safe to take over-the-counter pain relievers like ibuprofen with Bifracard?

Official regulatory warnings indicate that the use of Bifracard with non-steroidal anti-inflammatory drugs (NSAIDs), such as over-the-counter pain relievers like ibuprofen, may require caution. This combination may potentially lead to a worsening of kidney function, especially in elderly patients or those who are dehydrated.


Q: Does Bifracard interact with common supplements like magnesium or fish oil?

Regulatory labels advise caution with products that contain potassium, as Bifracard can affect potassium levels in the blood. This includes certain supplements that may increase the risk of high blood potassium levels (hyperkalemia).


Q: Can Bifracard be used by people with diabetes?

Official labeling does not list diabetes as a contraindication (a reason not to use the drug). However, regulatory sources state that the drug should be used with caution alongside medicines for diabetes, as ACE inhibitors may increase the blood-sugar-lowering effect of those medications.


Q: How long does Bifracard stay in your system after you take a pill?

The time it takes for half of the active compound to be eliminated from the body is known as the terminal elimination half-life. For the active compound of Bifracard, regulatory studies confirm this time is approximately 5.5 hours.


Q: Does Bifracard make you more sensitive to the sun?

Photosensitivity reactions (increased sensitivity to the sun) are not listed in the officially documented adverse reactions for Bifracard.


Q: What kind of monitoring (like blood tests) is generally needed while on Bifracard?

Regulatory guidance recommends monitoring for changes in renal function (kidney tests) and serum potassium levels. This monitoring helps assess how the body is responding to the medicine and provides information necessary for managing treatment.


Q: Is Bifracard a controlled substance?

According to regulatory scheduling rules, Bifracard (Zofenopril) is not classified as a controlled substance.


Q: Do you have to take Bifracard at a specific time of day?

Official guidance on the use of Bifracard does not specify a particular time of day for administration. For most of its approved uses, it is generally prescribed to be taken once daily.


Q: If I take Bifracard, can I still drive?

Since side effects like dizziness and fatigue may occur, official documents advise that the ability to drive or operate machinery may be impaired. This is particularly true when starting treatment or when the dose is increased.


Q: Does alcohol interact badly with Bifracard?

Regulatory sources indicate that consuming alcohol may increase the blood pressure lowering effect of Bifracard. This combined effect could lead to an increased risk of symptomatic hypotension (unusually low blood pressure).


Q: What is the process for switching from an older medicine to Bifracard?

Official instructions provide a specific transition rule for certain medicines. If switching from the drug combination sacubitril/valsartan, a mandatory 36-hour wash-out period is defined in the official instructions due to the risk of a severe swelling reaction (angioedema).


Q: Does Bifracard have a known interaction with common antacids?

Regulatory studies on the medicine’s absorption have indicated that taking a common antacid (e.g., aluminum/magnesium hydroxide) does not significantly affect how Bifracard is absorbed by the body.


Q: Does Bifracard cause swelling in the ankles or feet?

Peripheral edema (swelling of the ankles or feet) is not listed as an officially documented adverse reaction for Bifracard.


Q: What should I do if I notice a change in my vision while taking Bifracard?

Changes in vision or visual disturbance are not listed in the officially documented adverse reactions for Bifracard.


Q: What's the difference between the immediate-release and extended-release forms of Bifracard?

Regulatory documents indicate the medicine is available only as a film-coated tablet for oral use. Official product information does not describe immediate-release or extended-release dosage forms.

How should Bifracard be stored and disposed of?

Storage and Disposal of Bifracard (Zofenopril calcium)

The storage and disposal of Bifracard tablets must follow the official requirements outlined in regulatory labeling.

Storage & Disposal Scope Requirement
Labeled storage temperature No special precautions are required; product is stable at ambient room temperature [Public Assessment Report].
Protection requirements Must be kept away from moisture to maintain product quality [Safety Data Sheet].
Disposal instructions Prioritize using an official drug take-back program. If unavailable, mix the tablets with an undesirable substance (like coffee grounds or dirt) and seal the mixture before disposal in the household trash [FDA].
Child-protection rules The medicine must be kept out of the sight and reach of children [NIH - MedlinePlus].
Environmental disposal The product is hazardous to the aquatic environment and must not be flushed into water systems or drains [Safety Data Sheet].

The regulatory profile defines that the product is stable for 3 years in its original packaging under room temperature conditions, requiring protection primarily from moisture. The disposal structure emphasizes the use of authorized take-back services or the specific trash-mixing procedure to prevent accidental exposure and to avoid environmental contamination.

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

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