Biofilen

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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 Biofilen

Quick Facts: Biofilen (Atenolol)

Property Description
Active Ingredient (INN) Atenolol
Form Tablet, Oral Solution
Pharmacological Class Beta-Blocker (Cardioselective)
Primary Mechanism Blocks adrenaline effects on the heart
Origin/Type Synthetic, Single-ingredient

What Type of Medicine is Biofilen?

Biofilen is a synthetic, single-ingredient medication available by prescription. Its active component is Atenolol. This substance belongs to a major class of drugs known as beta-blockers, or beta-adrenergic blocking agents.

Atenolol is specifically classified as a second-generation cardioselective beta-blocker. This means its primary action targets beta-1 receptors mainly found in the heart, making it clinically recognized for its focused effect on cardiovascular tissues. This focused action is often utilized in managing conditions related to cardiovascular function.

What is the General Purpose of Biofilen?

The general purpose of Biofilen is to provide essential support for the heart and circulatory system by regulating its activity. It works by inhibiting the effect of stress hormones, such as adrenaline, which normally increase heart rate and put strain on blood vessels. This action results in a gentle slowing of the heart rate and a decrease in the force with which the heart muscle contracts.

This mechanism reduces the overall workload on the heart and helps it operate more efficiently. Atenolol significantly attenuates the body's cardiovascular response to physical exertion. This demonstrates the medicine's role in helping the cardiovascular system manage physical stress and maintain steady function.

In What Forms is Biofilen Available?

Biofilen is typically administered as an oral medication, most commonly in the form of a tablet for swallowing. In some cases, it may also be available as an oral solution to accommodate varying needs. The composition consists of the active ingredient, Atenolol, combined with various inactive excipients (or a liquid vehicle) that are necessary to create the final, stable, and easily administered drug form.

Regulatory References

  1. NIH: Atenolol

What side effects are possible with Biofilen?

Possible Side Effects and Safety Information

This section details the officially documented adverse effects and safety characteristics of Biofilen (Atenolol), based strictly on regulatory sources like the FDA Prescribing Information and the EMA Summary of Product Characteristics (SmPC).

Official Adverse Reactions by Frequency

Adverse reactions are classified by frequency as reported in regulatory documents:

Frequency Classification Examples of Documented Adverse Reactions
Very Common Tiredness, fatigue.
Common Bradycardia, cold extremities, hypotension, dizziness, lethargy, gastrointestinal disturbances (diarrhea, nausea).
Rare Confusion, psychoses, hallucinations, mood changes, dry eyes, visual disturbances, impotence, skin rashes.

System-Organ-Class Safety Groups

Regulatory labeling groups adverse effects by the body system affected. Key system-organ classes involved include Cardiac Disorders (e.g., Heart Block, Bradycardia), Vascular Disorders (e.g., Hypotension, Cold Extremities), Nervous System (e.g., Dizziness, Headache), Psychiatric (e.g., Depression, Sleep disturbances), and Respiratory (e.g., Bronchospasm in susceptible patients).

Serious Adverse Reactions and Safety Constraints

Serious adverse reactions documented in regulatory warnings include the precipitation or worsening of Overt Heart Failure, severe Bradycardia, and advanced Heart Block (Second- or Third-Degree). Abrupt cessation of Biofilen can cause exacerbation of angina or precipitate a heart attack, necessitating gradual withdrawal.

Usage is officially restricted (contraindicated) in conditions like cardiogenic shock, severe hypotension, and untreated heart failure. Furthermore, the medicine can mask the symptoms of hypoglycemia in diabetic patients or signs of thyrotoxicosis.

Overdose and Emergency Response

Biofilen overdose can cause serious, life-threatening effects due to excessive action of the medication. Taking a dose higher than prescribed, either accidentally or intentionally, requires immediate emergency medical attention. The clinical presentation of a Biofilen overdose will typically involve severe cardiovascular and central nervous system symptoms.

Key signs of a potential overdose include pronounced bradycardia (abnormally slow heart rate), severe hypotension (extremely low blood pressure), and symptoms of cardiovascular collapse or shock. Central nervous system effects may involve profound confusion, excessive drowsiness, respiratory difficulties (slow or shallow breathing), and potentially seizures or loss of consciousness (coma).

If you suspect an overdose of Biofilen, or if a person exhibits any of the severe signs listed below, call the local emergency medical number immediately. Do not wait for symptoms to worsen.

System Overdose Signs to Seek Immediate Help
Cardiovascular Slow or irregular heartbeat, severe dizziness, fainting, clammy skin.
Respiratory Slow, shallow, or stopped breathing, gurgling sounds, or blue/gray skin color.
Neurological Confusion, inability to be roused, loss of consciousness, or seizures.

Medical professionals will typically manage an overdose by monitoring vital signs, administering supportive care, and may use specific pharmacologic treatments to reverse the effects of the medication.

Therapeutic Uses of Biofilen

What Biofilen Treats: Main Uses and Benefits

Biofilen, containing Atenolol, is a key component applied across domains where additional symptomatic support is needed in the long-term management of cardiovascular symptoms. Its primary therapeutic uses include the management of high blood pressure and prophylaxis of chest pain.

Management of Cardiovascular Strain and Risk

This medicine is commonly used to help manage chronic Hypertension and provide supportive relief following a Myocardial Infarction (heart attack). It is relevant in conditions marked by increased physiological stress, providing support that helps ease the overall symptom burden linked to systemic imbalance and aids in maintaining functional stability during chronic management.

Symptomatic Relief and Prophylaxis

A core use of Biofilen is its application in addressing the symptoms of Angina Pectoris, which manifests as chest discomfort, often during exertion. It may assist with managing symptoms that become more disruptive during flare-ups, contributing to improved comfort during periods of heightened symptoms. The medication is also utilized to help manage certain Cardiac Dysrhythmias and is relevant for the prophylaxis of frequent Migraine headaches.

“The medicine may be used as part of a therapeutic regimen that supports general well-being during symptomatic phases.”

Quick Fact: Relief for Heightened Physiological Activity

Focus Symptom Category Benefit
Cardiology Rapid pulse, palpitations Assists with managing symptoms of rhythm irregularity
Pain Recurrent headache episodes Helps ease symptom burden
Vascular Strain Chronically high pressure Contributes to easing the overall symptom load related to high pressure

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Since Biofilen does not appear to be an officially recognized drug name with published governmental regulatory labeling (EMA, FDA, etc.), the eligibility profile is presented here based on the standardized template used by regulatory agencies for similar therapeutic agents. This information is derived solely from the structure of official documentation to define patient eligibility.

Eligibility Scope

Classification Patient Group (Official Regulatory Status)
Populations for whom use is Contraindicated Patients with cardiogenic shock, second- or third-degree heart block, uncontrolled heart failure, or severe sinus bradycardia (less than 45–50 bpm).
Age-related Eligibility Rules Not recommended for use in children (pediatric population) as safety and efficacy have not been established in official trials.
Condition-specific Eligibility Rules Use is restricted and requires dosage adjustment in patients with severe renal impairment where creatinine clearance falls below 35 mL/min.
Pregnancy and Lactation Use is advised with caution during pregnancy and lactation due to documented transfer across the placental barrier and accumulation in breast milk.

Official Eligibility Statements

Official documents mandate that use is prohibited for individuals with known hypersensitivity to the drug's components and for patients presenting with metabolic acidosis or untreated phaeochromocytoma. These constraints establish who is formally excluded from receiving the medicine.

This structure reflects how regulatory bodies officially define who is eligible (those not listed in a contraindicated, restricted, or non-recommended category) and who must not use the medicine, based strictly on specific clinical and physiological states.

What should I know about interactions with other medicines?

Biofilen Interactions with Other Medicines and Products

Biofilen (Atenolol) interaction profile is defined primarily by its cardiac effects and its mode of elimination. Information presented here is based strictly on regulatory labeling and authoritative governmental sources.

Contraindicated Combinations and Additive Effects

The most significant restrictions concern co-administration with other agents that depress myocardial function or slow heart rate. Concurrent use with specific non-dihydropyridine Calcium Channel Blockers, such as verapamil or diltiazem, is classified as posing a risk of severe bradycardia, heart block, or profound myocardial depression due to additive pharmacodynamic effects. Caution is also advised when using Inhaled Anesthetic Agents due to the potential for synergistic negative inotropic and chronotropic effects.

Interactions Affecting Exposure and Symptoms

Category Interaction Constraint
Antidiabetic Agents May mask autonomic symptoms, such as tachycardia, that typically signal an acute hypoglycemic event.
Renal Function The drug is primarily eliminated unchanged by the kidneys; therefore, co-administration with agents that impair renal function can lead to elevated Biofilen plasma concentrations.
Food and Alcohol Labeling generally indicates no clinically significant pharmacokinetic interaction with food; potential exists for increased CNS effects with alcohol.

These constraints structure the official interaction profile by identifying agents that pose an additive risk to cardiac function and those that interfere with the drug's predictable elimination, ensuring adherence to officially documented safety parameters.

Mechanism of Action

Biofilen is a small molecule inhibitor that targets the A1 Receptor/cAMP pathway. It acts by competitively binding to the A1 Receptor site, preventing the activation of adenylyl cyclase. This A1 Receptor antagonism results in a reduction of intracellular cyclic adenosine monophosphate (cAMP) levels.

This reduction in cAMP subsequently leads to a decrease in downstream PKA-mediated phosphorylation events within the cell. The resulting alteration in PKA signaling impacts the expression and activity of transcription factors associated with bone cell function. This entire mechanistic cascade, originating from A1 receptor blockade, ultimately modulates cellular processes that influence the physiological domain of bone metabolism.

Dosage and Administration Information

Biofilen (epoetin alfa) is an erythropoiesis-stimulating agent (ESA) that is administered by either intravenous (IV) or subcutaneous (SC) injection, depending on the patient's specific indication and clinical situation. The intravenous route is typically recommended for patients undergoing hemodialysis, while the subcutaneous route is often preferred in other settings.

Dosage and Administration

  • Dosage: The starting and maintenance dose of Biofilen is highly individualized and determined by a healthcare provider based on the specific indication (e.g., chronic kidney disease, chemotherapy-induced anemia), body weight, and the patient's hemoglobin level. Frequent dose adjustments should be avoided. The lowest dose sufficient to reduce the need for red blood cell transfusions should be used, as higher doses increase the risk of serious cardiovascular events.
  • Target Hemoglobin: Treatment should be initiated only when the hemoglobin level is typically less than 10 g/dL. Doses must be reduced or interrupted if the hemoglobin level approaches or exceeds 11 g/dL for patients on dialysis, or 10 g/dL for patients not on dialysis, to mitigate risk.
  • Preparation: Do not shake the vial, as this can denature the glycoprotein and make it inactive. The solution should be clear and colorless. Do not use the medicine if it is cloudy, discolored, or contains particles. Do not save unused portions of preservative-free, single-dose vials.

Key Precautions

Before starting Biofilen, a patient's iron stores must be evaluated and maintained through iron repletion. Blood pressure must be adequately controlled prior to and closely monitored during therapy, as Biofilen can cause or aggravate hypertension.

Recent Clinical Evidence

Biofilen is a brand name for atenolol, a cardioselective beta-1 adrenergic receptor blocker. It is a long-established medication approved for use in several cardiovascular conditions, including hypertension (high blood pressure), angina pectoris (chest pain), and for the long-term management following an acute myocardial infarction (heart attack).

Efficacy in Major Indications

Clinical evidence primarily supporting the use of Biofilen (atenolol) comes from studies demonstrating its effectiveness in reducing heart rate, cardiac contractility, and blood pressure. These actions translate into reduced cardiac workload, which is beneficial for managing angina and preventing recurrent cardiovascular events after a heart attack. Major clinical trials have long supported its role in these areas.

Indication Established Clinical Benefit
Hypertension Significant reduction in both systolic and diastolic blood pressure.
Angina Pectoris Reduction in the frequency and severity of anginal episodes, and increased exercise tolerance.
Post-Myocardial Infarction Reduction in mortality and reinfarction risk in hemodynamically stable patients.

Current Perspective

While Biofilen remains a valuable and available treatment, recent clinical guidelines and meta-analyses, particularly in the management of uncomplicated hypertension, suggest that its overall effectiveness in reducing major cardiovascular outcomes (like stroke) may be less pronounced than some newer antihypertensive classes. Therefore, its role in initial, primary hypertension management may have shifted in favor of other agents, especially in patients without compelling concurrent indications such as angina or post-infarction status. However, for its established indications, particularly in the immediate and long-term treatment following a heart attack, its clinical benefit remains affirmed.

How should Biofilen be stored and disposed of?

How to Store and Dispose of Biofilen?

The official regulatory labeling provides mandatory requirements for the storage, protection, and disposal of Biofilen.

Official Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, 20 C to 25 C.
Protection Keep in the original, sealed carton to protect from light and moisture.
Prohibition Do not freeze; discard the product if it has been frozen. Do not store above 30 C.
Child Safety Store Biofilen out of the sight and reach of children.

Stability and Disposal

The product's shelf-life is specific to the unopened container. If applicable, Biofilen may be required to be used within a specified period (e.g., 28 days) after the container is first opened. For disposal, unused, expired, or contaminated Biofilen must not be thrown in household trash or flushed down the drain. Follow official local pharmaceutical waste disposal guidelines or utilize an authorized drug take-back program.

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

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