Anafronil

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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 Anafronil

Property Description
Active ingredient Clomipramine Hydrochloride
Form Oral formulations (Tablets, Capsules)
Pharmacological class Tricyclic Antidepressant (TCA)
Common use Modulating brain chemistry
Origin Synthetic dibenzazepine derivative

Clomipramine Hydrochloride: What Type of Medicine Is Anafronil?

Anafronil is a well-known brand of a synthetic, prescription-only medicine (POM) whose active component is Clomipramine Hydrochloride, classified pharmacologically as a Tricyclic Antidepressant (TCA). This medication belongs to a fundamental class of psychotropic medication specifically designed to influence chemical activity within the Central Nervous System (CNS). This compound is clinically recognized for its potent ability to block the reuptake of both serotonin and norepinephrine. Its structure is that of a tricyclic compound and dibenzazepine derivative, which imparts a broader range of effects on various brain receptors compared to newer agents.


Composition and Form: What Is Anafronil Made Of?

Anafronil is formulated as a single active ingredient product, containing only Clomipramine Hydrochloride. The medicine is intended for oral administration and is supplied as various oral formulations, most commonly as capsules or tablets. A distinctive feature is the availability of both immediate-release and specialized sustained-release tablets, which are pharmaceutically designed to release the active component slowly over time. This controlled release characteristic is key for maintaining steady drug levels, a requirement for long-term use in conditions requiring continuous mood stabilization.


General Purpose: What Is the Overall Benefit of This TCA?

The general purpose of Anafronil, stemming from its designation as an antidepressant agent, is to help stabilize mood and improve emotional balance. A typical use scenario involves its application in managing severe, long-term mood imbalances where persistent modulation of chemical messengers is necessary. By influencing the availability of key chemical messengers in the brain, Anafronil provides a foundational pharmacological approach intended to alleviate the psychological and physical manifestations associated with conditions that affect mental well-being.

Regulatory References

  1. Clomipramine Hydrochloride Capsules - DailyMed (NIH)

What side effects are possible with Anafronil?

Possible side effects and safety information

The safety profile of Anafronil (Clomipramine Hydrochloride) is defined by officially documented adverse reactions categorized by frequency and the physiological systems affected. Regulatory documents classify the most frequent effects as Very Common (occurring in 1 in 10 patients or more) and Common (occurring in 1 in 100 to less than 1 in 10 patients).

Very Common adverse effects typically involve the Nervous System (e.g., dizziness, tremor, somnolence, headache) and the Gastrointestinal System (e.g., dry mouth, constipation, nausea). Other frequent effects include excessive sweating and sexual dysfunction, such as ejaculation failure.

The official labeling highlights several Serious Adverse Reactions. These include a risk of seizures, which is documented as being dose-dependent and increasing with higher plasma concentrations. There is also a mandated warning regarding the potential for suicidal thoughts and behavior, particularly in children, adolescents, and young adults during the start of treatment or following dose changes. Serious Cardiac Disorders, such as arrhythmias and QTc prolongation, are also noted.

Safety Considerations

The safety profile includes specific notes for certain populations. Older adults may have an increased susceptibility to anticholinergic effects and orthostatic hypotension. The medicine is formally contraindicated for use within fourteen days of stopping a Monoamine Oxidase Inhibitor (MAOI) due to the risk of Serotonin Syndrome. These classifications and restrictions structure the official understanding of the medicine's risk profile.

Overdose and Emergency Response

Overdose and when to seek help

Overdose scope

Feature Official Regulatory Statement
Documented overdose presentations Overdose may manifest with symptoms including confusion, extreme drowsiness, convulsions (seizures), mydriasis, muscle rigidity, restlessness, severe sweating, and loss of coordination.
Physiological systems affected The Central Nervous System (CNS) is affected, potentially progressing to coma, and the Cardiovascular system, which can result in dysrhythmias and severe hypotension.
Population-specific overdose notes Overdose in children must be regarded as serious. Elderly patients are specifically noted as susceptible to adverse effects like increased agitation and confusion.
Emergency-response statements Seek emergency medical attention immediately. Call the Poison Help line or emergency services (e.g., 911) at once.
When immediate medical help is required Immediate medical help is required if the affected person has collapsed, had a seizure, has trouble breathing, or cannot be awakened.

Overdose classifications (high-level)

Classification Type Official Regulatory Statement
Severity classification Overdose is associated with potentially life-threatening outcomes, including fatal cardiovascular and CNS events.
Overdose-context constraints No specific antidote is known for clomipramine. Treatment procedures are primarily symptomatic and supportive.

Connection to the overall overdose profile

Regulatory documents define the overdose profile by the acute risk of severe cardiotoxicity and CNS depression. The presence of life-threatening manifestations such as cardiac arrest, severe hypotension, and coma is the direct basis for the mandated instruction to seek emergency medical attention immediately. Management officially relies on rigorous supportive treatment with continuous cardiac and neurological monitoring.

Therapeutic Uses of Anafronil

What Anafronil Treats: Main Uses and Benefits

This medication is commonly used to address the symptomatic burden of Obsessive-Compulsive Disorder (OCD) in adults and children (10 years and older). It helps ease the intensity of intrusive, unwanted thoughts and may assist in easing the symptomatic burden of repetitive, intentional rituals. This medication is also relevant for easing symptoms in severe mood conditions (like Major Depressive Disorder), Panic Disorder, and specialized conditions like Cataplexy associated with Narcolepsy.

Anafronil is applied in clinical settings marked by severe, long-term mood imbalances or when a patient requires additional symptomatic support for conditions characterized by periods of heightened symptoms. The therapeutic benefit contributes to easing the overall symptom load and may support patients in maintaining functional stability when symptoms interfere with daily functioning. It is also used in therapeutic contexts requiring support for persistent discomfort, such as neuropathic pain and certain types of chronic headache, and is relevant for easing symptoms related to physical discomfort.

“The medication supports patients during difficult episodes by easing distress and may help patients cope more steadily with symptom fluctuations.”


Quick Fact: Relief for Obsessive and Compulsive Manifestations

Anafronil is commonly used across therapeutic domains involving heightened physiological activity and helps address symptom clusters that become more disruptive during flare-ups, offering symptomatic relief that supports general well-being during symptomatic phases.

Eligibility and Restrictions for Use

Population Eligibility Rules for Anafronil (Clomipramine)

Official regulatory guidelines strictly define the populations permitted, restricted, or prohibited from using Anafronil, based on absolute contraindications and physiological status.

Eligibility Status Key Regulatory Criteria
Use is Contraindicated (Must Not Use) Patients with a recent myocardial infarction (MI), certain cardiac conduction disorders (e.g., heart block), severe liver disease, narrow-angle glaucoma, or untreated urinary retention. Use is also prohibited if the patient has a known hypersensitivity to clomipramine or other tricyclic antidepressants (TCAs), or is taking a Monoamine Oxidase Inhibitor (MAOI) [Source 1.2, 2.3].
Use is Conditional or Restricted Older adults (65 years and older) require close monitoring. Patients with renal impairment or pre-existing cardiovascular insufficiency should use the medicine with caution [Source 1.8, 2.7]. Use during pregnancy and lactation is generally not recommended [Source 1.7].
Approved Age Group The medicine is approved for Obsessive-Compulsive Disorder (OCD) in patients 10 years of age and older. Use is not established below this age threshold. For non-OCD indications, use is not recommended in adolescents under 18 [Source 1.6, 1.7].

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Clomipramine Hydrochloride (Anafronil) establishes mandatory restrictions and documented risks when co-administered with specific substances or classes of medicines. This information is derived exclusively from government prescribing labels.


Regulatory Restrictions

Category Restriction/Outcome
Monoamine Oxidase Inhibitors (MAOIs) Contraindicated. Must not be co-administered. A mandatory washout period of at least 14 days is required when switching between Anafronil and a non-reversible MAOI.
QTc-Prolonging Agents Contraindicated with drugs like Pimozide and Thioridazine due to the official risk of serious cardiac arrhythmias.

Documented Pharmacokinetic and Pharmacodynamic Risks

Co-administration with potent CYP2D6 inhibitors (e.g., Fluoxetine) and CYP1A2 inhibitors (e.g., Fluvoxamine) is documented to increase the plasma concentrations and systemic exposure of Anafronil and its metabolite. This is a pharmacokinetic interaction requiring cautious use.

Simultaneous use with other serotonergic agents (e.g., Triptans, SSRIs) is associated with an increased regulatory risk of Serotonin Syndrome (a pharmacodynamic effect). Additive CNS depression is documented when Anafronil is combined with alcohol or other CNS depressants. Furthermore, regulatory documents note that elderly patients are documented to have significantly higher steady-state plasma concentrations, increasing the potential for interaction severity.

Mechanism of Action

How Anafranil Works

Anafranil (clomipramine) influences central nervous system function through a dual biological mechanism involving the inhibition of key chemical reuptake transporters and the antagonism of various neuroreceptors.

Inhibition of Serotonin and Norepinephrine Reuptake Transporters

The primary action involves the drug and its active metabolite binding to the reuptake transporters for the neurotransmitters serotonin ( 5-HT) and norepinephrine ( NE). By blocking the reabsorption mechanisms of the Serotonin Transporter (SERT) and the Norepinephrine Transporter (NET), clomipramine causes a sustained increase in the concentration of these signaling chemicals in the synaptic cleft. This leads to altered neuronal signaling patterns and subsequent long-term changes in receptor sensitivity.

Antagonism of Peripheral and Central Receptors

In addition to its reuptake inhibition, the drug acts as an antagonist (blocker) at several other cellular communication sites, including mathbfH1 (histamine), mathbfM1 (muscarinic cholinergic), and mathbfalpha1 (adrenergic) receptors. This broad receptor blockade affects various systems, resulting in physiological consequences such as changes in levels of arousal and alterations to autonomic nervous system activity.

Dosage and Administration Information

How Anafronil is Used: Official Administration Guidelines

Anafronil (Clomipramine Hydrochloride) is administered exclusively via the oral route using capsules or tablets. The administration follows a structured protocol requiring careful adjustment over time to establish a stable maintenance dose.


Official Dosing and Frequency Patterns

The initiation of treatment requires a gradual dose increase, known as titration, beginning with a low starting dose, such as 25 mg daily. The dosage is incrementally raised over several weeks until the therapeutic maintenance range is reached, typically 100 mg to 150 mg daily for adults. The maximum daily dose for most adult indications is strictly capped at 250 mg.

Classification Administration Principle
Route of Administration Oral (via capsule or tablet)
Frequency Pattern Once daily or in divided daily doses
Time of Day Total daily dose may be taken as a single dose at bedtime

Administration Requirements and Adjustments

Administration of the medicine may be done with or without food, although initial doses are often suggested to be taken with meals for better tolerance. Tablets and capsules must be swallowed whole with water; specifically, sustained-release tablets must not be crushed or chewed to preserve their intended release characteristics.

Procedural adjustments are required for specific populations. Older adults typically start at a lower initial dose (e.g., 10 mg daily) and have a lower maximum daily limit, usually 75 mg to 100 mg. Furthermore, treatment is typically long-term, and cessation of the medicine must be accomplished via a gradual dose reduction (tapering) process, rather than abrupt discontinuation.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Anafronil (Clomipramine)


Evidence for Use in Obsessive-Compulsive Disorder (OCD)

The research for clomipramine in Obsessive-Compulsive Disorder (OCD) is based primarily on short-term Randomized Controlled Trials (RCTs). These studies were conducted to examine how symptoms change over defined time intervals, typically lasting around 8 to 12 weeks. Researchers monitored changes in the intensity of both obsessive thoughts and compulsive behaviors using standardized tools, such as the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).

In these trials, findings describe patterns observed in the studies where measurements of obsessive and compulsive symptom scores were reported in comparison to baseline. Some trials included a comparison group receiving an inactive control (placebo). There is limited information for long-term outcomes that explore sustained patterns or the prevention of symptom return (relapse prevention) over many months.


Evidence for Use in Major Depressive Disorder (MDD)

Clomipramine was studied for Major Depressive Disorder (MDD). The evidence structure includes older historical controlled trials and subsequent analyses. These studies explored symptom severity in patients with MDD, often focusing on outcomes reflecting daily functioning or activity level. The research examined symptom change using various rating scales, such as the Hamilton Depression Rating Scale (HDRS).

Findings describe patterns related to changes in mood symptom scores observed in some studies during the acute treatment period. However, evidence is limited when considering the availability of recent, large-scale RCTs that directly compare clomipramine against newer pharmacological options. Because the evidence base is primarily historical, certainty remains low for this evidence structure when evaluated against modern trial standards.


What is Still Uncertain About Anafronil Research

Several areas of uncertainty exist within the body of research for clomipramine. A key limitation is that evidence quality varies across studies, with many findings derived from historical trials that do not use current standardized trial methodologies. Additionally, comparative evidence is lacking in large-scale, modern trials against some of the newer agents widely used today. Finally, for most indications, there is limited information for long-term outcomes and functional stability.

Key Studies & References

  1. NICE Guideline CG31: Obsessive-compulsive disorder and body dysmorphic disorder: treatment
  2. Clomipramine for Obsessive-Compulsive Disorder - StatPearls (NIH)

Frequently Asked Questions (FAQ)

Common questions about Anafronil (FAQ)


Q: What is the generic name for Anafranil?

According to official regulatory documents, the active ingredient in Anafranil is Clomipramine Hydrochloride. This is the recognized generic name for the medicine.


Q: Where in the brain does Anafranil work?

Official product information indicates that Anafranil influences specific behaviors through its effects on the central nervous system. Its primary action is understood to involve blocking the reabsorption (reuptake) of the chemical messengers serotonin (5 -HT) and norepinephrine ( NE), altering chemical signals in the brain.


Q: How quickly does Anafranil start working for OCD?

Regulatory information indicates that the onset of noticeable therapeutic effect may take several weeks. Clinical trials for Obsessive-Compulsive Disorder (OCD) typically lasted for 8 to 10 weeks to measure the drug's effectiveness.


Q: What should I do if I miss a dose of Anafranil?

Regulatory guidance specifies that if a dose is missed, it can be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. Two doses should not be taken at the same time to make up for a single missed dose.


Q: What is the starting dose for Anafranil?

Official labeling states that treatment begins with a low daily dose, which is then gradually increased over time as directed by a healthcare professional. A lower initial dose is generally used for older adults, reflecting the need for cautious, individualized dosing.


Q: What are the storage requirements for Anafranil?

Anafranil must be stored at Controlled Room Temperature, which is typically between 20^circ and 25 C. The medicine must be kept in a tight, light-resistant container, as required by regulatory specifications for product stability.

How should Anafronil be stored and disposed of?

Official Storage and Disposal Instructions

Anafranil (clomipramine hydrochloride) must be stored according to specific regulatory requirements to maintain product stability.

Requirement Official Condition (Regulatory Basis)
Storage Temperature Controlled Room Temperature (20^circ to 25 C / 68^circ to 77 F)
Protection Protect from moisture; Dispense in a tight, light-resistant container.
Child Safety Keep out of the sight and reach of children; use a child-resistant closure.
Disposal Dispose of unused product according to local regulations, using drug take-back programs or authorized methods.

Storage outside the permitted range (15^circ to 30 C) is not recommended, and disposal via wastewater or household waste is generally prohibited unless following official household discard instructions (e.g., mixing with unappealing substances). The container specifications ensure the product is shielded from light and moisture.

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

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