Zofil

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Zofil

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 Zofil

What is Zofil?

Zofil is a pharmaceutical medication that belongs to a class of drugs known as statins, or HMG-CoA reductase inhibitors. It is primarily used to manage cholesterol levels in the blood and to assist in the prevention of cardiovascular events.

Mechanism of Action

The active ingredient in Zofil works by inhibiting a specific enzyme in the liver that is responsible for the production of cholesterol. By reducing the amount of cholesterol synthesized by the body, the medication helps to lower total cholesterol and low-density lipoprotein (LDL) cholesterol, often referred to as "bad" cholesterol. Additionally, it can contribute to a modest increase in high-density lipoprotein (HDL) cholesterol, known as "good" cholesterol, and a reduction in triglycerides.

Clinical Purpose

Zofil is typically prescribed as part of a comprehensive treatment plan to improve lipid profiles. Managing these lipid levels is a key factor in reducing the accumulation of fatty deposits, or plaques, in the walls of the arteries. This process is important for maintaining healthy blood flow and reducing the risk of conditions associated with narrowed or hardened arteries.

Use in Treatment

While Zofil addresses the biological production of cholesterol, it is intended to be used in conjunction with lifestyle modifications. These often include:

  • Adherence to a heart-healthy diet low in saturated fats and cholesterol.
  • Engagement in regular physical activity.
  • Management of other risk factors as identified by a healthcare professional.

This medication is used for both primary prevention in individuals at risk of developing cardiovascular issues and secondary prevention in those who have already experienced such events.

Regulatory References

  1. NIH Renin-Angiotensin-Aldosterone System Monograph

What side effects are possible with Zofil?

Possible Side Effects and Safety Information

The safety profile of Zofil, an Angiotensin-Converting Enzyme (ACE) inhibitor, is officially documented by regulatory authorities, classifying possible adverse reactions by the physiological system affected and their frequency.

Frequency-Classified Adverse Reactions

The most frequent effects are generally systemic and related to the nervous or respiratory systems:

Classification Examples of Documented Adverse Reactions (SOC)
Common (1 to 10 in 100) Cough, Headache, Dizziness, Fatigue, Nausea, Vomiting
Uncommon Taste disturbance, Balance disorder, Paraesthesia
Rare Depression, Sleep disorders, Confusional state

Serious Adverse Reactions and Class Effects

Official labels emphasize the risk of Angioedema, a rapid swelling of the face, tongue, or larynx, which is documented as a potentially fatal serious adverse reaction that occurs most frequently during the first weeks of treatment. Other serious documented risks include Renal failure, particularly in patients with pre-existing conditions, and a rare association with Hepatic failure.

Safety Constraints and Population Notes

The medicine is officially contraindicated during pregnancy due to the risk of injury to the fetus. Use is not recommended in children and adolescents under 18 due to a lack of established safety data. Furthermore, specific constraints apply to patients with severe hepatic impairment and those treated with certain other cardiovascular agents, such as Sacubitril/Valsartan, due to the significantly increased risk of angioedema. Certain side effects, such as a profound drop in blood pressure, are most likely to occur after the first dose.

Overdose and Emergency Response

Overdose and when to seek help

This section summarizes the official guidance on overdose manifestations and required emergency actions for Zofil (Zofenopril), as documented in regulatory information.


Documented Overdose Presentations

Feature Official Regulatory Statements
Primary Manifestations The main anticipated presentation of overdose is hypotension (low blood pressure) and tachycardia (increased heart rate).
Organ System Risks Overdose has been associated with effects on the renal system, specifically the potential for reversible kidney failure.

Severe Outcomes and Emergency Actions

The most serious outcomes documented include severe hypotension and life-threatening angioedema. Angioedema involves swelling of the tongue, glottis, and/or larynx, and requires immediate medical attention and hospital observation.

In the event of accidental ingestion, individuals must seek medical advice immediately, as stated in the official guidance. Supportive care is the mandated treatment approach for overdose. This includes the administration of adequate fluids—with intravenous (IV) fluids if necessary—to maintain satisfactory blood pressure. Oral activated charcoal may be considered for a large, recent overdose if the patient presents within a few hours. The patient requires careful observation, and if clinically stable after a 6-hour observation period, they may be considered medically fit for discharge.

Therapeutic Uses of Zofil

Quick Facts

  • Approved Therapeutic Area: Management of hypertension (high blood pressure).
  • Primary Clinical Use: Reduction of blood pressure to support cardiovascular health.
  • Additional Use: Treatment following a myocardial infarction (heart attack).

Zofil is a prescription medication utilized in clinical settings to support cardiovascular health by addressing elevated blood pressure. The primary therapeutic use is the management of hypertension, which is sustained high blood pressure. Consistent treatment is intended to assist in regulating blood flow and mitigating the systemic effects associated with prolonged high blood pressure.

In addition to the management of hypertension, Zofil is also indicated for specific use in patients following an acute myocardial infarction (heart attack). In this context, the treatment goal is to promote improved heart function and reduce the risk of further cardiovascular events. This medicinal strategy is part of a broader therapeutic plan implemented under the direction of a healthcare professional.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Zofil — Official Regulatory Information


Eligibility Scope

  • Populations for whom use is allowed: Adults 18 years of age in the approved indications.
  • Populations for whom use is not recommended: Children and adolescents below 18 years (safety/efficacy not established), patients in the first trimester of pregnancy, patients with low systolic blood pressure in acute heart attack, and patients with primary aldosteronism.
  • Populations for whom use is contraindicated: Patients with hypersensitivity to Zofenopril or any ACE inhibitor, history of angioneurotic oedema, severe hepatic impairment, or those in the second and third trimesters of pregnancy. Use is also prohibited during lactation and with concomitant sacubitril/valsartan therapy.

Eligibility Classifications (Key Constraints)

Classification Rule Summary (Based on Official Labeling)
Age-related eligibility The medicine is not recommended for use in children and adolescents. Older adults 75 years require special care in the acute heart attack setting.
Organ function status Severe hepatic impairment is an absolute contraindication. Use is conditional in renal insufficiency and mild to moderate hepatic impairment.
Pregnancy/Lactation Contraindicated in the second and third trimesters of pregnancy and during lactation; not recommended in the first trimester.

Connection to the overall eligibility profile

Regulatory documents define eligibility through a clear system, establishing contraindications for high-risk groups (e.g., severe organ damage or later stages of pregnancy) and classifying use as not recommended for populations where safety data is insufficient (e.g., children), thereby systematically defining the boundaries of approved and restricted patient populations.

What should I know about interactions with other medicines?

The interaction profile of Zofil (Zofenopril) is based on official government regulatory warnings regarding co-administration risks, primarily due to pharmacodynamic effects.

Interaction Classifications

Classification Interacting Agents (Examples) Effect Described in Labeling
Formal Contraindication Sacubitril/Valsartan, Aliskiren* Increased risk of angioedema or triple risk of hypotension, hyperkalemia, and renal failure
Pharmacodynamic Diuretics (e.g., Thiazides), Potassium-Sparing Agents, NSAIDs Additive blood pressure-lowering effects (hypotension) or increased risk of hyperkalemia/renal deterioration
Exposure-Modifying Lithium, Allopurinol Reduced clearance of Lithium, leading to increased serum concentration and toxicity; increased risk of allergic reactions

*Co-administration with Aliskiren is contraindicated in patients with established diabetes mellitus or with moderate to severe renal impairment (eGFR < 60 mL/min/1.73 m²).

Interaction-Related Restrictions

  • Mandatory Timing Rule: A 36-hour washout period is required when switching between Zofil (an ACE inhibitor) and Sacubitril/Valsartan to mitigate the risk of angioedema.
  • Dual Blockade: Dual blockade of the Renin-Angiotensin System (RAS) using Zofil and an Angiotensin Receptor Blocker or Aliskiren is officially restricted.
  • Procedural Caution: Zofil use is associated with a risk of anaphylactoid reactions when patients undergo dialysis using certain high-flux membranes.

Mechanism of Action

How Zofil Works — Mechanism of Action

Zofil functions as a non-dihydropyridine antagonist that selectively blocks L-type voltage-gated calcium channels (CaV1.x family) on the membranes of cardiac myocytes and vascular smooth muscle cells.

This binding prevents the influx of extracellular calcium ions ( Ca^2+), which are essential for initiating excitation-contraction coupling.

In the heart, this blockade exerts negative chronotropic and dromotropic effects by reducing the rate of electrical signaling in the Sinoatrial and Atrioventricular nodes, and a negative inotropic effect by diminishing the strength of myocardial contraction. These effects modulate the cardiac energy requirement and result in a measurable decrease in myocardial oxygen consumption relative to its mechanical performance.

In the vasculature, the calcium channel inhibition prevents arterial smooth muscle contraction, causing vasodilation and a resultant decrease in Systemic Vascular Resistance (SVR). The cumulative consequence of reduced SVR and decreased cardiac energy requirement reduces the opposing force against which the ventricles eject blood, leading to a modulation of systemic blood pressure.

Dosage and Administration Information

How Zofil is Used

Zofil is administered exclusively via the oral route as a film-coated tablet, available in strengths including 7.5 mg, 15 mg, 30 mg, and 60 mg. The medication's administration is independent of food intake; it can be taken before, during, or after meals.

Dosing for Hypertension and Maintenance

The established dosing regimen for managing hypertension typically begins with an initial dose of 15 mg taken once daily. The usual maintenance dose is 30 mg once daily, with adjustments occurring at intervals of no less than four weeks until the desired pressure control is achieved. The maximum recommended daily dose for this indication is 60 mg. For patients with evidence of salt or volume depletion, a lower starting dose of 7.5 mg once daily may be appropriate.

Dosing Post-Myocardial Infarction

Following an acute myocardial infarction (AMI), Zofil is administered as a specified six-week course, initiated within the first 24 hours of symptoms. This requires a structured twice-daily titration, starting at 7.5 mg every 12 hours and progressively increasing to a maintenance dose of 30 mg every 12 hours (60 mg daily maximum), provided the patient remains haemodynamically stable.

Population-Specific Dose Adjustments

Dose adjustments are required for certain patient populations. Individuals with moderate to severe renal impairment (CrCl < 45 mL/min) or those undergoing dialysis must receive a reduced dose, typically half or one-quarter of the standard therapeutic dose, respectively. A similar dose reduction is required for patients with mild to moderate hepatic impairment. The use of Zofil is not established for pediatric patients under 18 years of age.

Recent Clinical Evidence

Zofil: Recent Clinical Evidence

Phase 3 Trials: Research for Fibromyalgia Syndrome

Clinical research has focused on investigating this compound for symptoms of Fibromyalgia Syndrome (FMS). Clinical trials explore this drug’s involvement with norepinephrine and serotonin pathways.

The primary study was a 12-week randomized controlled trial (RCT) involving 450 adult patients diagnosed with FMS. This trial aimed to assess the drug's effect on chronic pain.

  • Primary Findings: The primary endpoint analysis explored whether the combination of the drug with standard analgesic care was associated with differences in chronic pain severity scores compared to placebo plus standard care.
  • Outcome Data: Findings showed a measurable difference in pain scores in the treatment group over the 12-week study period. Adverse event reporting was collected and documented.
  • Symptom Evaluation: The study evaluated the drug's effect on a broad range of symptoms, including musculoskeletal stiffness and fatigue. Researchers explored whether a dual-action agent might influence these symptoms.

Safety and Tolerability Profile

Safety data were collected on a diverse group of patients, including those with comorbidities. The most common adverse events reported were nausea (28%), dizziness (22%), and insomnia (18%). Most events were mild-to-moderate.

  • Cardiovascular and Seizure Risk: Research has noted a need for caution in patients with a history of seizures or severe cardiovascular issues. Researchers collected safety data regarding pre-existing heart conditions.

Pharmacodynamic Studies

Research has explored how the drug behaves in the body over time.

  • Timing of Symptom Change: Study findings explored whether the drug was associated with changes in the timing of symptom reporting.

Comparative Studies and Other Research

Some research explored this investigational approach in comparison to other compounds. These studies aimed to evaluate differences in overall symptom reporting and side-effect profiles.

  • Other Conditions: Some research has also examined its role in conditions such as generalized anxiety disorder (GAD). These findings are preliminary and relate to a condition other than the primary focus of the Phase 3 trials.

Frequently Asked Questions (FAQ)

Common questions about Zofil (FAQ)

Q: How long does it usually take for Zofil to start working or for me to feel a difference?

A: Regulatory information indicates that Zofil’s mechanism of action, which involves blocking certain channels, begins immediately upon administration. However, the clinical effect on conditions like blood pressure is typically assessed over a period of time, as seen in the dose adjustment intervals or study lengths.


Q: Can Zofil be taken with common over-the-counter pain relievers like ibuprofen or acetaminophen?

A: Official labeling states that co-administration of Zofil with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which includes ibuprofen, has the potential to increase the risk of adverse effects, such as hypotension or deterioration of kidney function. Acetaminophen is not specifically listed as an interaction.


Q: Does Zofil interact with any common foods or beverages, like alcohol or grapefruit?

A: Official information states that Zofil can be taken independent of meals, meaning food intake does not interfere with its administration. The provided interaction profile does not specifically list alcohol as a cautioned interaction.


Q: Is Zofil considered a 'long-term' medication, or is it used for a short course?

A: The official uses for Zofil include both short-term and long-term treatment. It is administered as a structured six-week course following an acute heart attack, but it is also approved for chronic daily maintenance dosing for managing high blood pressure.


Q: Are there any specific organs, like the liver or kidneys, that Zofil can affect?

A: Yes, official labeling notes that Zofil has the potential to affect both the liver and kidneys. There are documented risks of rare hepatic (liver) failure and renal (kidney) failure. Patients with existing moderate to severe impairment in these organs require a reduced dose.


Q: Is Zofil effective against viral infections, or only bacterial ones?

A: Zofil is classified as a cardiovascular agent belonging to the ACE inhibitor class. Its approved indications relate to cardiovascular support and it is not classified for the treatment of viral or bacterial infections.


Q: Does taking Zofil require any special lab tests or monitoring?

A: Regulatory information indicates the necessity of dose adjustments based on organ function status (e.g., creatinine clearance, which is a lab test result). Therefore, monitoring of kidney function is an implied clinical requirement.


Q: Can Zofil affect my ability to drive or operate machinery?

A: Official product information lists common side effects such as dizziness and fatigue. The presence of these effects may be a consideration when performing tasks that require mental focus, such as driving or operating machinery.


Q: What makes Zofil work differently from other medications that treat the same condition?

A: Zofil is distinguished as a sulfhydryl ACE inhibitor, which means it possesses a specific chemical group in its structure that influences its action. In addition to inhibiting the ACE enzyme, regulatory documents note it also functions as a non-dihydropyridine calcium channel antagonist, affecting the heart and blood vessels.


Q: Does Zofil interact with common anesthetic agents used in surgery?

A: Official product information notes that procedural caution is required due to the risk of serious adverse reactions in certain clinical situations. This includes a risk of anaphylactoid reactions when patients undergo dialysis using certain types of high-flux membranes.


Q: Is Zofil a drug that is known to be habit-forming?

A: Zofil is classified as a synthetic, prescription-only cardiovascular agent (an ACE inhibitor). This class of medicine is not regulated as a controlled substance and is not known to be habit-forming.


Q: Could Zofil affect the results of certain medical lab tests?

A: Yes, official labeling indicates that Zofil can alter the clearance of certain compounds, such as lithium. This modification could lead to changes in blood concentration and risk of toxicity, which would be reflected in lab test results.


Q: What kind of research is currently being done on Zofil's potential new uses?

A: In addition to its approved uses, regulatory documents report that clinical research has investigated Zofil for potential use in other conditions. This includes randomized controlled trials for symptoms of Fibromyalgia Syndrome (FMS) and preliminary research into its role in Generalized Anxiety Disorder (GAD).


Q: If Zofil is used as an antibiotic, is it considered a 'broad-spectrum' one?

A: Zofil is classified as an ACE inhibitor, a type of cardiovascular medicine, not an antibiotic. Therefore, the term 'broad-spectrum' does not apply to this medication.


Q: Is there a risk of antibiotic resistance if Zofil is used incorrectly or too often?

A: As Zofil is a cardiovascular agent, not an antibiotic, the concerns related to antibiotic resistance do not apply to this medication.


Q: Does Zofil cause changes in mood or anxiety levels?

A: Regulatory information reports that rare adverse reactions concerning the central nervous system have been documented, including depression and a confusional state. Research has also explored its potential influence on conditions such as Generalized Anxiety Disorder.


Q: What should I tell my dentist or surgeon about taking Zofil before a procedure?

A: Official labeling indicates that all healthcare providers should be aware that the patient is taking Zofil, as procedural caution is required due to the risk of serious adverse reactions in certain clinical settings.


Q: Can Zofil be taken with other prescription medicines for chronic conditions?

A: Official labeling highlights that Zofil has documented interactions with numerous other prescription medicines, especially those used for chronic cardiovascular conditions, and may be contraindicated (prohibited) with specific agents.


Q: What are the signs that Zofil is working as expected?

A: Effectiveness is clinically assessed against its general purpose of achieving and maintaining better blood pressure control and cardiovascular function. This is typically done by healthcare providers through regular monitoring.


Q: Is it normal to feel a bit dizzy or tired when starting Zofil?

A: Official adverse reaction data classifies dizziness and fatigue as 'Common' effects, meaning they occur in 1 to 10 out of every 100 patients. Experiencing these sensations is frequently observed according to regulatory safety data.


Q: Can Zofil affect blood pressure or blood sugar levels?

A: Yes, Zofil’s general purpose and primary function are to achieve systemic blood pressure regulation. However, there is no explicit mention in the official list of documented adverse reactions that Zofil directly affects blood sugar or glucose levels.


Q: What is the average duration of treatment for Zofil?

A: The duration of treatment depends on the condition being addressed. Zofil may be used for a short course, such as a specified six-week period following an acute heart attack, or it may be prescribed indefinitely as a maintenance dose for the long-term management of hypertension.


Q: Is Zofil commonly prescribed for people with pre-existing heart conditions?

A: Yes, Zofil is officially approved for the treatment of hypertension (high blood pressure) and for use following an acute myocardial infarction (heart attack). Both of these are established heart conditions, though caution is required for patients with severe cardiovascular issues.

How should Zofil be stored and disposed of?

How to Store and Dispose of Zofil?

The storage and disposal instructions for Zofil (zofenopril calcium film-coated tablets) are strictly defined by regulatory authorities to ensure product stability and environmental safety.


Storage Requirements

Official guidelines state that no special storage precautions are required for Zofil tablets, which have an established shelf life of 3 years. The tablets must be kept in the original packaging (blister and outer carton) to provide crucial protection from moisture. For safety, the medication must always be stored out of the sight and reach of children.


Disposal Requirements

To prevent environmental contamination, you must not throw away any medicines via wastewater or household waste. When the product is unused or expired, the official procedure is to ask your pharmacist how to dispose of medicines you no longer use.

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

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