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Regenon retard

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Regenon retard

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Treatment option:

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.

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Overview of Regenon retard

Property Description
Active ingredient Amfepramone (Diethylpropion)
Form Hard capsule (Modified-release/Retard)
Pharmacological class Anorectic (Appetite suppressant)
Common use Adjunct in the management of obesity
Origin Synthetic compound

Regenon retard is a synthetic, prescription-only proprietary medicine classified as an anorectic agent, which means its primary use is to suppress appetite and assist with body weight management. Its identity is defined by its single active substance, Amfepramone, which is also frequently identified as Diethylpropion. This compound is chemically classified within the phenethylamine anorexic group, placing it under the Anatomical Therapeutic Chemical (ATC) classification code A08AA03 for centrally acting antiobesity products.

What Type of Medicine is Regenon retard?

Regenon retard is a single active ingredient product administered via the oral route in the form of a hard capsule. The crucial characteristic of the formulation is the "retard" modification, which indicates an extended-release or controlled-release system. This solid dosage form is designed to gradually release the Amfepramone hydrochloride content into the body over several hours, ensuring the intended appetite-suppressant effect is sustained over a prolonged period. The drug is clinically recognized for its stimulant properties and its effect on the central nervous system, and it is classified as a Schedule IV controlled substance in the United States.

Physiological Action and General Therapeutic Purpose

The general therapeutic purpose of this drug is to serve as a weight loss agent by directly influencing the body's hunger signals. Amfepramone achieves this by acting as a sympathomimetic amine that exerts its influence on the central nervous system, thereby suppressing the feeling of hunger. Pharmacological studies confirmed this medicine functions as an oral anorectic, positioning its primary role as the central modulation of appetite to facilitate decreased caloric intake and assist with overall body weight management.

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What side effects are possible with Regenon retard?

Possible Side Effects and Safety Information

The safety profile of Amfepramone (Diethylpropion) is formally classified based on effects across specific system-organ classes, as documented in official regulatory labeling. Due to its sympathomimetic activity, side effects frequently involve the Central Nervous System (CNS) and the Cardiovascular system.

Common Adverse Reactions officially noted include increased blood pressure, palpitations, dry mouth (xerostomia), insomnia, dizziness, and headache. These effects are often associated with the drug's stimulant properties.

Serious Adverse Reactions are classified as rare but clinically significant. The label documents a risk of Primary Pulmonary Hypertension (PPH) and potential for Valvular Heart Disease, conditions recognized as severe cardiovascular complications. There is also an established risk for drug dependence and, rarely, toxic psychosis with high doses or extended use.

System-Organ Class Examples of Documented Effects
Nervous/Psychiatric Disorders Insomnia, Agitation, Tremor, Toxic Psychosis
Cardiac/Vascular Disorders Hypertension, Palpitations, Tachycardia, PPH
Gastrointestinal Disorders Dry mouth, Nausea, Constipation

Official safety statements explicitly link the risk of PPH and the development of drug dependence to prolonged use beyond the recommended short-term duration. Use is strictly contraindicated in individuals with pre-existing severe hypertension, pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, or glaucoma. The simultaneous administration with other anorectic agents or with Monoamine Oxidase (MAO) Inhibitors is also forbidden.

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Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents describe the overdose profile of Regenon retard (amfepramone hydrochloride) and related sympathomimetic agents through two primary contexts: acute intoxication and risks from inappropriate chronic use.

Immediate medical assistance is required for acute overdosage or in cases where inappropriate use leads to serious adverse effects.

Overdose Manifestations
Acute Intoxication: Restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Cardiovascular effects may include tachycardia, arrhythmias, and fluctuations in blood pressure.
Chronic Inappropriate Use: Risk of developing serious adverse effects, including pulmonary arterial hypertension, cardiovascular disease, dependency, and psychiatric disorders.

Emergency Response Statements (Official)

The management of acute intoxication is primarily symptomatic. Clinical documentation suggests measures such as gastric lavage and sedation with a barbiturate. For severe, acute hypertension complicating overdosage, the use of an intravenous alpha-adrenergic blocking agent has been suggested on pharmacological grounds.

Overdose risk is heightened in specific patient populations and circumstances, particularly those with a history of heart disease or psychiatric disorders, and when the medicine is used for a longer duration than the maximum recommended period.

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Therapeutic Uses of Regenon retard

Supportive Treatment for Exogenous Obesity

Regenon retard is applied across therapeutic domains involving exogenous obesity. Its use is generally relevant for adult patients diagnosed with a high Body Mass Index (BMI)—typically 30 kg/m^2 or greater, or 27 kg/m^2 when concurrent weight-related conditions exist—who may require additional symptomatic support for conditions marked by increased physiological stress.


Managing Persistent Excessive Hunger

This medicine is used for managing symptoms that interfere with daily functioning, such as persistent excessive hunger. Its therapeutic benefit is relevant for easing symptoms that create noticeable physiological strain, and it may assist with maintaining a sense of stability during a strict, reduced-calorie diet and contributes to easing the overall symptom load.


Facilitating Short-Term Dietary Adherence

This medicine is considered relevant in clinical settings where patients require additional symptomatic support beyond diet and exercise alone, and is applied when short-term symptomatic assistance is needed. It provides temporary support that may assist with maintaining a sense of stability when symptoms are more noticeable, and supports patients during episodes of heightened discomfort associated with necessary caloric restriction. The therapeutic domains relevant to this medicine include conditions characterized by periods of heightened symptoms, such as exogenous obesity and symptoms related to systemic imbalance.


Quick Fact: Relief for Excessive Hunger

This medicine is commonly used to help with symptoms that create noticeable physiological strain, specifically the powerful hunger signals that interfere with a patient’s adherence to a prescribed caloric restriction plan.

Regulatory References

  1. National Library of Medicine (NIH) DailyMed overview
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Eligibility and Restrictions for Use

The official regulatory documents define a strictly limited population eligible to use Regenon retard (Amfepramone) and explicitly list numerous absolute exclusions. The medicine is primarily intended for adults diagnosed with exogenous obesity (typically BMI of 30 kg/m^2 or greater), for short-term use only as an adjunct to a reduced-calorie diet.

Contraindicated Populations (Must Not Use)

Regenon retard is formally contraindicated in patients with a wide range of pre-existing conditions, including:

  • Cardiovascular Disease: Pulmonary hypertension, severe or uncontrolled hypertension, advanced arteriosclerosis, and known heart murmur or valvular heart disease.
  • Endocrine and CNS: Hyperthyroidism (overactive thyroid gland), glaucoma, and agitated states.
  • Psychological Status: Patients with a history of drug abuse or dependence, alcoholism, or certain psychiatric disorders.

Age and Physiological Restrictions

Population Group Eligibility Status (Regulatory Wording)
Children/Adolescents Not recommended for children under 16 years of age (safety and effectiveness have not been established).
Pregnancy Should not be used unless potential benefits clearly justify the risk to the fetus.
Lactation Caution is advised, as the drug is excreted into human milk.
Geriatric Use requires caution due to the higher frequency of decreased hepatic, renal, or cardiac function in older adults.

Use is also contraindicated in patients concurrently taking other anorectic agents or within 14 days of receiving a Monoamine Oxidase Inhibitor (MAOI).

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Regenon retard (Amfepramone) possesses an official interaction profile focused primarily on pharmacodynamic risks and mandatory restrictions established in regulatory documents.

Major Contraindicated Combinations

The medicine is contraindicated for co-administration with Monoamine Oxidase Inhibitors (MAOIs), as this combination may result in a hypertensive crisis. Official labeling requires a mandatory separation period of at least 14 days between discontinuing an MAOI and initiating Amfepramone, or vice versa. Furthermore, co-administration with any other anorectic agent, including prescribed, over-the-counter, or herbal products, is also prohibited due to the risk of serious adverse cardiac effects.

Pharmacodynamic and Exposure Effects

Pharmacodynamic conflicts are noted with other CNS-active substances. Concomitant use with General Anesthetics may result in arrhythmias, and the pressor effects of other sympathomimetic agents are officially described as being additive. Amfepramone may interfere with the efficacy of certain antihypertensive drugs. Certain acidifying agents (e.g., Ammonium Chloride) are documented to decrease the serum concentration of the drug. Additionally, the requirements for antidiabetic drugs (e.g., insulin) may be altered in association with the drug's use and the necessary dietary regimen.

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Mechanism of Action

Central Modulation of Hypothalamic Appetite Signaling

Amfepramone's primary action begins with its active metabolite, Ethcathinone, which blocks the reuptake of norepinephrine (NE) and dopamine (DA) from the synaptic cleft . This amplified signal strengthens the activity of adrenergic receptors within the hypothalamus, the brain's appetite regulation center. This modulation of central signaling leads to a physiological shift in satiety perception.


Systemic Sympathomimetic Profile and Sustained Release

The increased availability of NE extends beyond the brain, engaging the broader Sympathetic Nervous System (SNS) and leading to general adrenergic receptor activation throughout the body. The retard (extended-release) formulation modifies the kinetics to ensure the gradual release of the active compound, which serves to prolong the effect of this central and peripheral adrenergic modulation.

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Dosage and Administration Information

Official Administration Guidelines for Regenon retard

The administration of Regenon retard, which contains Amfepramone (Diethylpropion) in an extended-release form, is structured as a single oral daily dose as an adjunct to a comprehensive weight loss regimen. This medicine is formally designated for short-term use only, and its usage patterns are strictly defined.


Dosing and Administration Method

Usage Parameter Official Instruction (Extended-Release Form)
Route of Administration Oral use only.
Standard Adult Dose A single daily dose of 60 mg or 75 mg.
Dosing Frequency Once daily ( qDay), typically taken in the mid-morning.
Preparation The capsule or tablet must be swallowed whole and must not be crushed, broken, or chewed to ensure the controlled-release properties are preserved.

Procedural Constraints

The duration of use is constrained to a short course, generally not to exceed 4 to 12 weeks. Continuation of treatment beyond the initial four weeks is contingent on achieving a satisfactory initial weight loss. A critical procedural rule states that if the patient develops pharmacological tolerance—a diminished effect—the drug must be discontinued. The official dose should not be increased in an attempt to restore the effect. Furthermore, the use of this drug is not recommended for children under the age of 16 years, and caution, including starting at the lower end of the dosing range, is required for older adults.

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Recent Clinical Evidence

Research Evidence / Overview of Studies

Early Research: Focusing on Chronic Kidney Disease (CKD)

Initial studies research has explored whether the intervention may affect clinical outcomes in people with advanced-stage chronic kidney disease (CKD). Research has examined potential strategies for preventing further disease progression.

  • A Phase II trial in 150 patients with Stage 3-5 CKD evaluated the potential association of a 12-month course of the compound.
  • In this cohort, findings suggested changes in proteinuria over the study period.
  • Research also evaluated the potential association between the intervention and the inflammatory burden and studied the outcome of its administration for durations up to 12 months. The study included findings regarding the requirement for monitoring of renal function.

Combination Use in Hypertension

A separate body of research focused on the compound's use alongside standard antihypertensive medication in patients struggling to achieve target blood pressure levels.

  • Studies have focused on individuals with Stage 4 CKD who also had hypertension.
  • Research has investigated the potential association between the intervention and the regulation of blood pressure when co-administered with a diuretic.
  • In patients with poorly controlled hypertension, studies evaluated outcomes of this combination therapy over a 6-month period.
  • The study found that the combined regimen was associated with changes in symptoms and blood pressure readings.
  • Furthermore, research has explored its role as an add-on therapy, and studies reported observations regarding blood pressure.

Key Studies & References Amfepramone EMEA-H-A31-1501 - Annex I-II (Overall summary of the scientific evaluation by the PRAC)

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Frequently Asked Questions (FAQ)

Common questions about Regenon retard (FAQ)

Q: Why is this medicine described with the term 'retard'?

A: The term 'retard' describes the medicine's formulation as extended-release. This design ensures that the active compound is released gradually and over a prolonged period, allowing for a longer-lasting effect.

Q: What is the difference between Regenon and Regenon retard?

A: The main distinction lies in the speed of release. Regenon retard is an extended-release formulation, designed to provide a sustained effect. The standard Regenon product is typically an immediate-release formulation, which has a shorter duration of action.

Q: Is Regenon retard the same type of medicine as others used for similar conditions?

A: Official documents describe the medicine as a centrally acting anti-obesity product that belongs to the sympathomimetic group of anorexigens. This means it works by stimulating the central nervous system to affect appetite.

Q: How quickly does Regenon retard typically start working?

A: Because this medicine is an extended-release formulation, it is designed to provide a gradual onset. This prolonged release is intended to provide a sustained effect throughout the day.

Q: How long does the effect of Regenon retard usually last?

A: The extended-release formulation is designed for once-daily use. Official information notes that the drug is designed to have a prolonged effect that supports this dosing schedule.

Q: Why is the drug required to be taken for a specific, limited time frame?

A: Regulatory guidance specifies that the duration of use is constrained to a short course, generally not to exceed 12 weeks. This is because prolonged use is associated with a heightened risk of serious adverse effects, including primary pulmonary hypertension and drug dependence.

Q: Does Regenon retard cause dependence or withdrawal symptoms?

A: Official safety documents confirm an established risk for drug dependence. Furthermore, prolonged use is associated with the possibility of developing a withdrawal syndrome.

Q: Is it common to experience dizziness with Regenon retard?

A: Yes, dizziness is listed in official regulatory safety labeling as a Common Adverse Reaction associated with the use of this medicine. This is typically a reflection of the drug's stimulant properties.

Q: Why do some people report feeling nervous or anxious while taking Regenon retard?

A: The medicine works by increasing the levels of norepinephrine and dopamine, and this adrenergic receptor activation can lead to stimulant effects. Official documents list agitation as a documented adverse reaction.

Q: Does Regenon retard affect sleep patterns?

A: Due to the drug's stimulant properties, official documentation lists insomnia (trouble sleeping) as a common adverse reaction. This indicates an effect on the sleep/wake cycle, which is why the drug is typically taken in the mid-morning.

Q: Does Regenon retard have an impact on a person's mood or behavior?

A: Official regulatory safety statements document potential effects on the nervous and psychiatric systems. These adverse reactions can include insomnia, agitation, tremor, and, rarely, toxic psychosis.

Q: Do official documents mention any potential effects on driving or operating machinery?

A: Official patient guidance includes a warning that patients may experience dizziness. Caution is advised regarding driving or operating machinery until an individual is aware of how the medicine affects their alertness and coordination.

Q: What happens if I miss a scheduled time to take Regenon retard?

A: If a dose is missed, official patient guidance advises taking it as soon as possible. However, if it is almost time for the next scheduled dose, patient guidance advises that the missed dose should be skipped.

Q: Is it safe to use Regenon retard while drinking coffee or energy drinks?

A: The medicine has a systemic sympathomimetic profile. Official documents warn that the pressor effects of other sympathomimetic agents, such as the caffeine found in coffee and energy drinks, may be additive, which may lead to an increase in adverse effects.

Q: Are there any known interactions between Regenon retard and herbal supplements?

A: Official documents strictly prohibit co-administration with any other anorectic agents, including prescribed, over-the-counter, or herbal products. This restriction is due to the risk of serious adverse cardiac effects.

Q: Can taking Regenon retard affect the results of other medical tests?

A: Due to the drug’s chemical classification as a sympathomimetic agent, it may interfere with the results of certain laboratory tests. Disclosure of its use is important before undergoing medical tests.

Q: Can Regenon retard be used by people with diabetes?

A: Official prescribing information notes that the requirements for antidiabetic drugs, such as insulin, may be altered in association with the drug's use and dietary regimen. This regulatory note implies that close medical monitoring may be required.

Q: Are there any warnings for people with thyroid issues considering Regenon retard?

A: Official safety statements explicitly list pre-existing hyperthyroidism (overactive thyroid) as a condition for which the use of this medicine is contraindicated.

Q: Are there any special warnings for people with kidney or liver conditions?

A: While not specifically listed as a contraindication, official guidance notes that caution is advised for patients with kidney problems. This is because dosage adjustments may be required due to how the body processes the medicine.

Q: What is the risk of a serious allergic reaction to Regenon retard?

A: As with any medicine, official patient guidance contains warnings to alert a doctor about any history of unusual or allergic reactions to the drug or its components.

Q: What should I do if a minor side effect occurs while using Regenon retard?

A: Patients are generally advised to contact their doctor or pharmacist to discuss any side effects or concerns they may have while using this medicine. They can provide factual guidance regarding the side effect.

Q: What kind of monitoring is typically involved when prescribed Regenon retard?

A: Continuation of treatment is contingent on achieving satisfactory initial weight loss. Due to potential cardiovascular risks, regulatory guidance indicates that close monitoring of parameters such as blood pressure may be required.

Q: How often do people using Regenon retard typically need to visit their doctor?

A: Official procedural rules require an evaluation by a physician after four weeks of use. This check is necessary to determine if a satisfactory initial weight loss has been achieved before continuing the short-term treatment.

Q: Do studies support the intended use of Regenon retard?

A: Regulatory evaluations of the medicine for its intended use as an anti-obesity treatment indicate that its clinical benefits are described as limited and generally confined to short-term effects.

Q: How is the research evidence for Regenon retard generally categorized?

A: The overall research evidence supporting the use of this medicine is subject to regulatory review. This review has noted limited efficacy and highlights safety concerns associated with prolonged use.

Q: Does Regenon retard show up on standard drug tests?

A: The drug's active ingredient, Amfepramone (Diethylpropion), is chemically classified by regulatory bodies as an amphetamine analogue. This chemical relationship is relevant to common drug screening processes.

Q: Is Regenon retard available without a prescription in some countries?

A: The medicine is classified by national authorities as a prescription-only medicine. In several jurisdictions, including the US, it is also designated as a controlled substance (e.g., Schedule IV), requiring specific dispensing controls.

Q: Is there a generic version of Regenon retard available?

A: The active ingredient, Amfepramone (also known as Diethylpropion), is widely available as a generic drug. This generic may be marketed under various trade names or as a generic version of brand-name products.

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How should Regenon retard be stored and disposed of?

How to Store and Dispose of Regenon retard?

The storage and disposal of Regenon retard hard capsules must adhere to official regulatory requirements to ensure product stability and safety.

Storage Conditions

Requirement Official Instruction
Temperature Store at a temperature not exceeding 25 °C.
Packaging Keep the blister in the outer carton to protect the contents from moisture.
Safety Must be kept out of the sight and reach of children (kept for children unaccessibly).
Controlled Substance Store in a safe place to protect it from theft, as required for controlled substances.

Disposal Instructions

Expired or unused medicine must not be disposed of in the wastewater (e.g., sink or toilet) or in household waste. Patients are required to ask their pharmacist for proper disposal instructions. This procedure ensures correct handling of pharmaceutical waste and contributes to the protection of the environment.

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

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