Anafronil SR

Clomipramine Hydrochloride

Method of action: Antidepressant, Psychoanaleptics

Treatment option: Osteochondritis Dissecans, Cataplexy, Narcolepsy, Obsessive Compulsive Personality Disorder, Sedation, Phobia

Medically reviewed

Rosario Oropesa

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 SR

Property	Description
Active Ingredient	Clomipramine Hydrochloride
Form	Sustained-Release (SR) Oral Tablet
Pharmacological Class	Tricyclic Antidepressant (TCA)
Functional Grouping	Non-selective Monoamine Reuptake Inhibitor (NSRI)
Origin	Synthetic Dibenzazepine derivative

Defining Anafronil SR: Substance and Classification

Anafronil SR is a specific synthetic psychoactive medication containing Clomipramine Hydrochloride as its active ingredient. Structurally, the compound is classified as an agent belonging to the class of Tricyclic Antidepressants (TCAs), reflecting its chemical origin as a Dibenzazepine derivative. Functionally, the drug is grouped under the Non-selective Monoamine Reuptake Inhibitors (NSRIs), which means it influences multiple neurotransmitter systems. This broad inhibitory profile is a differentiating factor, setting it apart from newer pharmaceutical agents that target only a single monoamine. Clomipramine is an established medicine used in clinical practice.

What is the Significance of the Sustained-Release (SR) Formulation?

The medication is administered as an Oral Tablet in a specific Sustained-Release (SR) formulation, which denotes a modified-release preparation designed for continuous patient management. This form is engineered to gradually release the Clomipramine Hydrochloride into the systemic circulation over an extended period. The SR mechanism is designed to minimize fluctuations in plasma concentration, thereby supporting stable drug kinetics. This sustained-release approach allows for achieving steady drug levels, which can be utilized in chronic therapeutic contexts.

What General Purpose Does Clomipramine Serve?

The general purpose of this psychotropic agent is to act as a modulator of brain neurochemistry by performing monoamine reuptake inhibition, thereby increasing the functional availability of key chemical messengers, principally Serotonin and, to a lesser extent, Norepinephrine. This mechanism helps to regulate neurobiological processes related to emotional stability and certain behavioral health contexts. The role of Clomipramine in stabilizing underlying neurochemical factors characterizes its function as a central nervous system regulator.

Regulatory References

WHO List of Essential Medicines

What side effects are possible with Anafronil SR?

Official Safety Profile of Anafronil SR

The safety profile of Anafronil SR (Clomipramine Hydrochloride) is structured according to official regulatory classifications that detail expected reactions, serious risks, and population-specific considerations.

Adverse reactions are officially categorized by frequency, with Very Common (10%) effects including dry mouth, somnolence, fatigue, dizziness, tremor, nausea, constipation, hyperhidrosis, and sexual dysfunction. Reactions classified as Common (1% to <10%) include headache, weight gain, orthostatic hypotension, tachycardia, and blurred vision. These frequently reported effects primarily reflect the drug’s anticholinergic and sedative properties, impacting the nervous, gastrointestinal, and cardiovascular systems.

Serious Adverse Reactions are explicitly documented and include the risk of suicidal thoughts and behavior (suicidality) in specific younger populations, seizures (which are dose-dependent), and severe cardiotoxicity, such as QTc interval prolongation. The risk of Serotonin Syndrome is also noted, particularly when the medicine is co-administered with other agents that affect serotonin levels.

Regulatory documents also detail population-specific safety considerations. Older adults may have an increased risk of confusion, sedation, and orthostatic hypotension. Furthermore, the label notes that the risk of suicidality may be elevated during the initial phases of treatment and following dose changes. Use is formally contraindicated with Monoamine Oxidase Inhibitors (MAOIs) and during the acute recovery period following a myocardial infarction.

Overdose and Emergency Response

Anafronil SR overdose is officially documented as a potentially severe or life-threatening event requiring immediate medical attention. The clinical presentation is characterized by profound effects on the central nervous system (CNS) and the cardiovascular system, as detailed in regulatory documents.

Documented manifestations of overdose include critical CNS symptoms such as seizures, muscle rigidity, stupor, and coma. Systemic signs like fever and mydriasis (widened pupils) may also be present. The most serious outcomes described in regulatory documents involve cardiotoxicity, including severe arrhythmias, QTc interval prolongation, hypotension that can lead to shock, and respiratory depression or apnoea. The potential for Serotonin syndrome is also officially noted as a severe complication.

When to Seek Urgent Help

The official labeling explicitly mandates that immediate medical help must be sought. Emergency services or the poison control helpline should be contacted immediately if a person has collapsed, had a seizure, has trouble breathing, or can’t be awakened. Management procedures detailed in regulatory documents emphasize symptomatic and supportive care, as no specific antidote is known. This includes strict protocols for controlling convulsions and managing severe low blood pressure.

Therapeutic Uses of Anafronil SR

What Anafronil SR Treats: Main Uses and Benefits

Anafronil SR (Clomipramine) is commonly used across therapeutic domains where additional supportive symptom management is needed. It is applicable within clinical settings that involve acute or disruptive symptom patterns, such as those that interfere with daily functioning. The application of this medication is generally relevant in situations involving heightened discomfort or tension.

The medication is commonly used to help with managing the symptoms of Obsessive-Compulsive Disorder (OCD), is used in the management of chronic and severe Major Depressive Disorder (MDD), and serves to moderate episodes of intense Panic Disorder and Phobias. It is also applied in specialized contexts, assisting with the neurological symptom of cataplexy and for providing supportive relief for specific chronic neuropathic pain syndromes.

It is used to address groups of symptoms that create noticeable interference with daily stability and contributes to easing the overall symptom load.

The central therapeutic benefit helps address symptom clusters that may become intense or disruptive, offering symptomatic relief that assists with maintaining functional stability during periods of heightened discomfort.

Quick Fact: Relief for Obsessive-Compulsive Symptoms
Anafronil SR assists with managing the intensity of recurrent obsessions and compulsive rituals, supporting patients during difficult episodes by easing distress.

Eligibility and Restrictions for Use

Who Can and Cannot Use Anafronil SR?

Eligibility for Anafronil SR (Clomipramine Hydrochloride) is determined by regulatory agencies based on specific population categories, co-existing conditions, and age. This information defines use restrictions and absolute contraindications.

Contraindicated Populations (Must Not Use)

Prohibition	Population/Condition
Co-Medication	Patients currently taking, or within 14 days of discontinuing, a Monoamine Oxidase Inhibitor (MAOI).
Acute Events	Patients in the acute recovery period following a myocardial infarction (MI).
Allergy	Individuals with known hypersensitivity to Clomipramine or other Tricyclic Antidepressants (TCAs).

Age and Special Population Restrictions

Population Group	Eligibility Status
Pediatric Use	Approved for Obsessive-Compulsive Disorder (OCD) in children 10 years of age and older. Use in children under 10 is not established.
Older Adults	Use requires lower initial doses and careful monitoring due to potential for increased sensitivity.
Pregnancy Status	Classified as Pregnancy Category C; use is generally restricted unless the potential benefit justifies the potential risk to the fetus.
Lactation Status	The medicine is excreted in breast milk and is not recommended for use in breastfeeding patients.

Conditions Requiring Caution

Use requires caution or specific dose adjustment in patients with impaired liver or kidney function, a history of seizure disorder, or pre-existing cardiovascular disorders, as documented in the prescribing information.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents detail the required restrictions and necessary monitoring for combining Anafronil SR (clomipramine HCl) with other medicinal products. These requirements are primarily based on pharmacokinetic changes (effects on drug levels) and pharmacodynamic changes (additive effects on the body).

Contraindicated and Restricted Combinations

Monoamine Oxidase Inhibitors (MAOIs): Clomipramine is officially contraindicated for use with any MAOI, including selective and reversible MAO-A inhibitors. Treatment with clomipramine must not be started within 14 days before or after discontinuing a non-reversible MAOI due to the risk of severe reactions.
Serotonergic Agents: Co-administration with other serotonergic medicines (such as SSRIs, SNRIs, tryptophan, or St. John's wort) is a documented concern due to the increased risk of Serotonin Syndrome.
QTc Prolonging Drugs: Use with medications known to prolong the QTc interval is restricted or requires avoidance because of the heightened risk of cardiac rhythm disturbances.

Pharmacokinetic Interaction Requirements

Clomipramine's metabolism by specific liver enzymes (CYP P450) dictates several interaction constraints:

CYP Inhibitors (e.g., Cimetidine, some SSRIs): These medicines can increase the concentration of clomipramine in the body, which may necessitate monitoring and potentially adjustments to manage the elevated levels.
CYP Inducers (e.g., Rifampin, Phenobarbital): These can decrease clomipramine's concentration, potentially leading to a reduced effect.

Mechanism of Action

Dual Action on Serotonin and Norepinephrine Systems

The drug's primary mechanism involves the simultaneous blockade of the Serotonin Transporter (SERT) and the Norepinephrine Transporter (NET). This action prevents the reabsorption of both Serotonin and Norepinephrine, instantly boosting the concentration of these key signaling molecules in the synaptic cleft. This mechanism initiates a time-dependent process that modulates pathways that govern alertness and executive function.

Neuroplasticity and Long-Term Cellular Adjustment

The persistent increase in synaptic Serotonin and Norepinephrine activity causes nerve cells to slowly adjust their sensitivity over several weeks. This neuroplastic process involves the downregulation or desensitization of certain receptors. This adaptive change contributes to the time-dependent alteration of neuronal communication and influences the final systemic consequences by modulating the sensitivity to overactive or dysregulated signaling patterns.

Off-Target Receptor Blockade

The molecule also acts as a non-selective antagonist on several other receptor families, notably the Histamine (H1), Muscarinic Acetylcholine, and Alpha-1 Adrenergic receptors. This secondary mechanism operates in parallel with the primary dual reuptake inhibition, directly influencing autonomic nervous system activity and central alertness. This broad engagement across multiple mechanistic domains results in the compound's complete set of physiological consequences.

Dosage and Administration Information

How to Use Anafronil SR

Clomipramine (Anafronil SR) is administered through the oral route, available as a Sustained-Release (SR) tablet intended for continuous patient management. The process of administration involves a structured, gradual escalation of dosage known as titration.

Dosing Patterns and Administration

The treatment typically begins with a low starting dose for adults, such as 25 mg daily for Obsessive-Compulsive Disorder (OCD), or 50 mg to 75 mg daily for depression or phobic states. The dose is then gradually increased, or titrated, over several weeks to a maintenance range, which may extend up to a maximum daily dose of 250 mg for adults.

In the initial titration phase, the total daily dose is often given in divided portions to support tolerability, and the medication is often taken with meals to potentially reduce gastrointestinal effects. Once a therapeutic level is reached, the total daily dose is commonly converted to a single administration once daily, usually taken at bedtime. The sustained-release tablet formulation is designed to be swallowed whole and is not chewed to ensure proper drug delivery over time.

Population-Specific Usage

Specific dosage modifications are utilized for certain patient groups. For older adults, the starting dose is lower, often 10 mg daily, and is slowly increased to an optimal maintenance range of 30 mg to 75 mg daily. In pediatric patients (ages 10-17) treated for OCD, the starting dose is 25 mg daily, with a maximum set at 3 mg/kg daily or 200 mg daily, whichever amount is smaller. Procedurally, a 14-day medication-free interval is observed when switching between clomipramine and a Monoamine Oxidase Inhibitor (MAOI) intended for psychiatric disorders.

Recent Clinical Evidence

Anafronil SR: Recent Clinical Evidence

Evidence for Use in Obsessive-Compulsive Disorder (OCD)

The most extensive research for Anafronil SR (Clomipramine) was evaluated in the context of Obsessive-Compulsive Disorder (OCD) using Randomized Controlled Trials (RCTs), systematic reviews, and meta-analyses. Researchers examined how changes in OCD symptom intensity and variability evolved over time, collecting data during periods of heightened symptom activity. The findings describe patterns observed in the studies where individuals who received the compound had different measured outcomes compared to placebo over initial, short-term assessment periods. Research also explored outcomes when compared to other antidepressant compounds, but findings were mixed regarding specific differences.

Evidence for Other Conditions and Special Populations

The compound was also studied for conditions beyond OCD, primarily based on older trial structures. Research was observed in the context of Major Depressive Disorder (MDD), and smaller clinical trials have examined the compound’s role in Cataplexy associated with Narcolepsy. Research was evaluated in the pediatric population (children and adolescents) with OCD, relying on short-term studies to provide insight into measured symptom changes for this age group. The compound was studied for outcomes related to physical discomfort in the context of chronic pain syndromes. However, for many of these secondary uses, current research does not include recent large-scale comparative studies.

Long-Term Follow-up and Research Uncertainties

The majority of the highest-quality efficacy trials was observed in acute treatment phases, typically lasting only a few weeks. The evidence base contributes to understanding symptom patterns over these short durations, with some studies evaluated over extended periods for relapse prevention. A significant limitation is that follow-up durations were limited in many studies, meaning there is limited information for long-term outcomes regarding the overall durability of the measured effect. Furthermore, long-term effects are not fully established for any indication, and data for certain groups remain insufficient regarding outcomes such as sustained functional stability or recovery.

Key Studies & References

Clomipramine dose-effect study in patients with depression: clinical end points and pharmacokinetics (Danish University Antidepressant Group)

Frequently Asked Questions (FAQ)

Common questions about Anafronil SR (FAQ)

Q: What is Anafronil SR?

Anafronil SR is the brand name for a sustained-release formulation of clomipramine, a tricyclic antidepressant (TCA). It is primarily used to treat obsessive-compulsive disorder (OCD), but may also be prescribed for depression, panic disorder, and chronic pain conditions.

Q: How does Anafronil SR work?

Anafronil SR works primarily by increasing the levels of serotonin and, to a lesser extent, norepinephrine in the brain. These neurotransmitters are thought to be unbalanced in conditions like OCD and depression. By blocking their reuptake into nerve cells, clomipramine helps to restore this balance, which leads to an improvement in symptoms.

Q: How long does it take for Anafronil SR to start working?

While some people may notice minor improvements within the first week or two, the full therapeutic benefit of Anafronil SR typically takes several weeks to months to become evident. For the treatment of OCD, it may take 10 to 12 weeks or longer to achieve the maximum effect. It is important to continue taking the medication as prescribed, even if immediate relief is not experienced.

Q: What are the common side effects of Anafronil SR?

Common side effects of Anafronil SR often include dry mouth, drowsiness, dizziness, constipation, blurred vision, weight gain, and sweating. Some patients may also experience sexual side effects. These are often most noticeable when starting the medication and may lessen over time as the body adjusts. If side effects are persistent or severe, they should be discussed with a healthcare provider.

Q: Can Anafronil SR be stopped suddenly?

No, Anafronil SR should not be stopped suddenly. Abrupt discontinuation can lead to withdrawal symptoms, which may include dizziness, nausea, headache, difficulty sleeping, and irritability. When stopping treatment, the dose should be gradually reduced under the guidance of a healthcare provider to minimize these effects. This process is called tapering.

Q: Is Anafronil SR safe to take during pregnancy?

Using Anafronil SR during pregnancy should be carefully evaluated. Clomipramine is generally not recommended unless the potential benefit justifies the potential risk to the fetus. It can be associated with withdrawal symptoms in newborns if taken during the third trimester. A healthcare provider will weigh the benefits of continued treatment against the potential risks and may recommend alternative treatments or monitoring.

Q: What should I avoid while taking Anafronil SR?

While taking Anafronil SR, you should generally avoid alcohol as it can increase the sedative effects of the medication. Caution should also be used when operating machinery or driving until you know how the medication affects you, due to the risk of dizziness or drowsiness. Additionally, you should inform your healthcare provider about all other medications and supplements you are taking, especially other drugs that affect serotonin levels, as this can increase the risk of serotonin syndrome.

Q: What is Serotonin Syndrome?

Serotonin syndrome is a potentially serious condition that can occur when there is too much serotonin activity in the central nervous system. It is most often linked to combining medications that increase serotonin. Symptoms can range from mild (tremor, diarrhea) to severe (fever, seizures, irregular heartbeat). If symptoms of confusion, agitation, hallucinations, rapid heartbeat, or muscle rigidity are noticed, immediate medical attention is necessary.

How should Anafronil SR be stored and disposed of?

Official Storage and Disposal Requirements

Anafranil SR (Clomipramine SR) must be stored and disposed of strictly according to official regulatory labeling to ensure product stability and safety.

Storage Domain	Regulatory Requirement
Temperature	Store at room temperature, generally not exceeding 25 C (77 F), and keep from freezing (Source: NIH/MedlinePlus).
Protection	Keep the container tightly closed and store the medicine in its original package to protect it from moisture and direct light (Source: FDA/HPRA).
Child Safety	Mandatory to store the product out of the sight and reach of children due to the serious risk associated with accidental ingestion (Source: HPRA SmPC).
Disposal	Do not discard unused or expired medicine in household trash or wastewater. Disposal of the product must be carried out in accordance with local regulatory requirements (Source: EC/FDA).