Анафранил

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Анафранил

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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 Анафранил

Quick Facts

Property Description
Active ingredient Clomipramine Hydrochloride
Form Film-coated tablets, Capsules, Solution for injection
Pharmacological class Tricyclic Antidepressant (TCA)
Common use Supporting mood regulation and emotional stability
Origin Synthetic

Clomipramine Hydrochloride: Identity and Pharmacological Class

Анафранил is a synthetic, psychotropic medication classified as a Tricyclic Antidepressant (TCA). Its therapeutic action is delivered by the active ingredient, Clomipramine Hydrochloride, a well-established tricyclic compound. This class of antidepressive agents is recognized for comprehensive effects on the central nervous system. Clomipramine is noted for its clinical utility and established role in conditions requiring substantial modulation of neurochemical signaling.

Composition and Available Drug Forms

The medicine is a single-ingredient product, with its therapeutic efficacy residing solely in Clomipramine Hydrochloride. To suit various treatment requirements, Анафранил is available in diverse drug forms: most commonly as film-coated tablets and capsules for oral dosage, where the compound is held in a solid oral matrix. Additionally, a sterile solution for injection is manufactured, allowing for parenteral dosage in specific clinical settings. This dual formulation strategy is a key characteristic, permitting initiation of therapy followed by a transition to oral maintenance.

General Purpose: How Analfranil Supports Emotional Balance

The general purpose of Анафранил is to assist in achieving and maintaining emotional stability and mood regulation. Its fundamental action contributes to restoring chemical balance by inhibiting the reuptake of key neurotransmitters. This capability makes it suitable for individuals requiring support for conditions where emotional distress is linked to imbalances in these signaling systems, serving as a tool for the stabilization of psychological equilibrium.

Regulatory References

  1. WHO Model List of Essential Medicines - Clomipramine

What side effects are possible with Анафранил?

Possible Side Effects and Safety Information

The officially documented safety profile for Анафранил (Clomipramine Hydrochloride) is defined by categories of adverse reactions and strict safety constraints established in regulatory documents such as the FDA Prescribing Information and the European Summary of Product Characteristics (SmPC).

Frequency and System Classification

Adverse reactions are classified by frequency and associated with specific system-organ classes. Very Common side effects, which affect more than 1 in 10 patients, typically include Anticholinergic effects like dry mouth and constipation, alongside CNS disturbances such as somnolence, dizziness, and tremor. Common reactions include tachycardia, postural hypotension, vomiting, and sexual dysfunction. These effects are generally associated with the Nervous System, Gastrointestinal, and Cardiovascular systems.

Serious Adverse Reactions and Safety Constraints

The regulatory profile explicitly identifies clinically significant events. Serious adverse reactions documented include the risk of seizures and potentially life-threatening cardiac arrhythmias. A serious safety concern involves the risk of Serotonin Syndrome when Clomipramine is used with other serotonergic agents. Furthermore, the official label includes a warning regarding the increased risk of suicidal thinking and behavior in children, adolescents, and young adults during the initial treatment phases.

Population-Specific and Time-Related Notes

The label mandates specific safety considerations for patient groups. Older adults are noted to have heightened susceptibility to anticholinergic and orthostatic hypotensive effects, often leading to confusion. Safety constraints dictate that the medicine is formally contraindicated during the acute recovery period following a myocardial infarction and in combination with Monoamine Oxidase Inhibitors (MAOIs). Many adverse reactions are noted to be most pronounced at the start of treatment or following a dose increase.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Анафранил (Clomipramine) overdose describes a potentially fatal, severe medical emergency primarily involving the Central Nervous System (CNS) and the Cardiovascular System.

Documented Clinical Manifestations

Overdose may present with serious signs of CNS depression, including drowsiness, stupor, and coma, alongside signs of CNS excitation, such as convulsions, agitation, and enhanced reflexes. Cardiovascular effects include tachycardia, hypotension, and clinically significant QTc prolongation and arrhythmias, which may escalate to cardiac arrest. Additional documented manifestations include features of Serotonin Syndrome, respiratory depression, hyperpyrexia (fever), and oliguria (decreased urine output).

Required Emergency Actions

Regulatory labeling mandates that any suspected overdose must receive immediate medical attention. The patient must be hospitalised and kept under close surveillance for a minimum of 72 hours, with continuous monitoring of cardiac function required due to the risk of relapse. Treatment is officially classified as solely symptomatic and supportive, as no specific antidote is known. Accidental ingestion in children is explicitly noted as a highly serious circumstance.

Therapeutic Uses of Анафранил

What Анафранил Treats: Main Uses and Benefits

Анафранил (Clomipramine Hydrochloride) is a medication used for managing conditions that involve emotional and psychological distress, making it applicable to conditions marked by severe, disruptive symptom patterns. Its primary therapeutic domain is defined by its application in specific clinical indications.

The medication is relevant for use in conditions such as Obsessive-Compulsive Disorder (OCD), Major Depressive Disorder, and certain Panic Disorders. These are clinical situations where supportive symptom management is appropriate, particularly when symptoms create noticeable functional strain.

Managing Core Symptom Domains

Анафранил may assist with easing the overall symptom burden associated with intrusive thoughts, compulsive behaviors, and severe mood imbalance. It is often applied during phases of increased distress or discomfort. The medication is used to address symptom clusters that may become intense or disruptive. This medication is relevant for managing symptoms that interfere with daily comfort and supports a sense of psychological equilibrium during difficult episodes.


Quick Fact: Relief for Obsessive and Anxious Symptoms

Focus Benefit Provided
OCD Symptoms May assist with easing the time burden of ritualistic activities.
Depressive Distress Contributes to improved comfort during episodes of heightened discomfort.
Panic Attack Severity Helps manage symptoms related to heightened physiological activity.

Eligibility and Restrictions for Use

The use of Анафранил (Clomipramine) is strictly governed by population eligibility rules established by regulatory authorities.

Absolute Contraindications

The medicine is contraindicated and must not be used by patients with a known hypersensitivity to Clomipramine or any other tricyclic antidepressant (TCA) of the dibenzazepine group. Use is also prohibited for individuals in the acute recovery period following a myocardial infarction and for those concurrently taking, or within 14 days of discontinuing, a Monoamine Oxidase Inhibitor (MAOI). Regulatory labeling also contraindicates use in cases of severe liver disease and certain pre-existing cardiac conditions, such as congenital long QT syndrome.

Age and Physiological Restrictions

Eligibility is defined by age. It is not recommended for children under 10 years of age, though it is approved for use in adolescents aged 10 and older for certain indications like Obsessive-Compulsive Disorder (OCD). Older adults may use the medicine but require conditional eligibility with careful monitoring. Use requires caution in patients with non-severe hepatic or renal impairment, and those with pre-existing cardiovascular disorders. Additionally, use is generally not recommended during pregnancy and lactation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Clomipramine Hydrochloride is defined by documented pharmacokinetic and pharmacodynamic effects, strictly adhering to regulatory classifications.

Interaction Classifications

Classification Details
Contraindicated Combinations Co-administration is prohibited with Monoamine Oxidase Inhibitors (MAOIs), including Linezolid and Intravenous Methylene Blue. Other drugs such as Pimozide, Thioridazine, and Sotalol are contraindicated due to the risk of QTc prolongation.
Timing Requirements A washout period of at least 14 days is required when switching between Clomipramine and an MAOI. A separation of at least 5 weeks may be necessary after discontinuing Fluoxetine before initiating Clomipramine treatment.

Exposure-Modifying Substances

Pharmacokinetic interactions occur with substances that affect hepatic metabolism. Inhibitors of CYP2D6 (e.g., Fluoxetine) or other hepatic enzymes (e.g., Cimetidine) can increase Clomipramine's plasma concentration. Conversely, Hepatic Enzyme Inducers (e.g., Phenobarbital) may reduce exposure. The drug may also increase the plasma concentration of other highly protein-bound drugs, such as Warfarin.

Other Documented Interactions

Co-administration with other serotonergic drugs (e.g., Triptans, St. John’s Wort) presents a documented risk of Serotonin Syndrome. Alcohol (Ethanol) may exaggerate the CNS depressant response. Population notes indicate that CYP2D6 Poor Metabolizers and Elderly subjects are at risk of elevated plasma concentrations.

Mechanism of Action

Clomipramine, a tertiary amine tricyclic compound, modulates central nervous system signaling by interacting with several molecular targets. Its primary biological target is the Sodium-dependent Serotonin Transporter (SERT), where it functions as a reuptake inhibitor, blocking the presynaptic neuron's capacity to internalize serotonin (5-HT). This inhibition results in an immediate increase in the concentration of 5-HT within the synaptic cleft. The active metabolite, desmethylclomipramine, also inhibits the Norepinephrine Transporter (NET), contributing to the elevation of synaptic norepinephrine (NE) levels.

Downstream cellular consequences of this monoamine reuptake blockade involve chronic adaptive changes. Sustained increases in synaptic monoamines lead to the desensitization of somatodendritic 5-HT1A autoreceptors and beta-adrenergic receptors, altering neuronal firing rates and neurotransmitter release over time. Clomipramine is also an antagonist at multiple other receptors, including muscarinic cholinergic receptors (mAChRs), histamine H1 receptors (H1Rs), and alpha1-adrenergic receptors. System-level physiological modulation arises from the combined actions of acute monoamine reuptake inhibition and chronic receptor desensitization.

Dosage and Administration Information

How to Use Anafranil (Clomipramine)

The administration of Anafranil follows a structured approach that defines the route, dose, and schedule of administration, ensuring a standardized method of intake. The primary form of use is the oral route, utilizing capsules or tablets. A solution for injection is also manufactured, reserving intravenous (IV) administration for severe clinical situations or when the oral route is not feasible.

Administration and Dosage Structure

Anafranil is typically initiated with a low oral dose, such as 25 mg once daily, followed by a period of gradual titration. The dose is cautiously increased over the first two weeks, often aiming for approximately 100 mg daily for adults. The maximum daily dose is generally established at 250 mg.

Administration Parameter Description
Dosing Frequency Initial titration uses divided doses; maintenance often consolidates to a single daily dose at bedtime.
Timing with Food Initial divided doses are generally taken with meals to minimize gastrointestinal discomfort.
Geriatric Patients Lower initial doses (e.g., 10 mg) and slower, more cautious titration are typically followed.

During the titration phase, the total daily dose is typically administered in divided portions; however, the maintenance dose may be unified and taken once daily, usually at bedtime. Prolonged-release tablets, when utilized, are swallowed whole without crushing or chewing. Discontinuation of treatment involves a gradual dose reduction (tapering) to prevent effects associated with abrupt cessation.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Анафранил

The research available for Анафранил (Clomipramine) summarizes the formal studies where the compound was evaluated in specific clinical contexts. This overview describes the research that was conducted, the patterns that were monitored, and the areas where data remain uncertain in the evidence landscape. The information is derived only from authoritative governmental and peer-reviewed scientific sources.


Evidence for Use in Obsessive-Compulsive Disorder (OCD)

Research into this area primarily consists of Randomized Controlled Trials (RCTs), where research examined the compound in studies exploring how symptoms change over time compared to a placebo or other active compounds. These studies focused on measuring changes in the core symptoms of OCD and were applied in trials assessing short-term or episodic symptom patterns. Research reports described data showing patterns related to measured changes when compared to groups receiving placebo. Outcomes related to systemic or functional imbalance were tracked among participants over defined time intervals, typically ranging from 10 to 12 weeks. Scientific analyses suggest that the evidence quality varies across studies, with some potentially carrying a risk of bias.


Evidence for Use in Panic Disorders

Research examined the compound in Controlled Trials for conditions associated with acute or disruptive episodes. These studies monitored outcomes related to physical discomfort and physiological strain, tracking the frequency and intensity of panic attacks, as well as associated anxiety symptoms. Studies reported how symptoms evolved in the observed populations, documenting measured changes during study periods. However, existing data show that high patient dropout rates were observed in some studies, which may affect how the results apply to the studied populations. Furthermore, research findings were mixed regarding the optimal amount of medication necessary to observe these changes.


Evidence Gaps and Areas of Uncertainty

Scientific reviews highlight several key areas where the research evidence remains limited or uncertain. The core evidence for depression and, to some extent, OCD includes many older trials, where the evidence quality varies across studies due to the standards of the time when the research was conducted. Additionally, long-term effects are not fully established for continuous treatment over many years, as follow-up durations were limited in the primary efficacy studies. Overall, the results apply only to the populations studied in the formal trials, and comparative evidence is lacking against certain contemporary treatments.

Frequently Asked Questions (FAQ)

Common questions about Анафранил (FAQ)


Q: What are the main conditions Анафранил is approved to treat?

Official regulatory documents state that Anafranil is approved to treat specific conditions, but indications vary by country. In the United States, it is officially approved for treating obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). Other authoritative international agencies, such as those in the UK and Australia, also include approvals for conditions like Major Depressive Disorder and Cataplexy associated with narcolepsy.


Q: Why is Анафранил sometimes mentioned for obsessive-compulsive disorder (OCD)?

Anafranil (Clomipramine) is notable for OCD because it is the only Tricyclic Antidepressant (TCA) approved by the US FDA for this specific indication. Its inclusion on regulatory lists for OCD is based on the results of controlled clinical studies that examined its use for this disorder.


Q: Does Анафранил start working immediately or does it take time?

While the medication begins affecting brain chemistry immediately, the full therapeutic effects are not typically seen right away. Studies summarized in regulatory information suggest that it generally takes 6 to 12 weeks of continuous treatment to achieve the full beneficial response for conditions like OCD.


Q: What should I expect in the first week of taking Анафранил?

The initial phase of treatment involves a gradual dose increase, known as titration. Official product information notes that many common side effects, such as dry mouth, drowsiness (somnolence), and constipation, are usually most pronounced at the start of treatment or following a dose increase.


Q: Can Анафранил cause weight gain?

Yes, weight gain is a documented common side effect of Anafranil (Clomipramine). This information is included in the official adverse reactions section of the medication’s safety profile, which summarizes findings from clinical trials.


Q: Are there any long-term side effects associated with Анафранил use?

Regulatory summaries indicate that the long-term effects are not fully established for continuous use over many years, as the main efficacy studies had limited follow-up durations. However, all documented adverse effects, including serious reactions, remain a consideration throughout chronic use.


Q: Are there any common foods or supplements that should be avoided with Анафранил?

Regulatory warnings indicate that co-administration of Alcohol (Ethanol) may intensify the drug’s central nervous system depressant effects. The supplement St. John's Wort is also listed as presenting an increased risk of Serotonin Syndrome when combined with the medication. No common food restrictions are officially mandated beyond these warnings.


Q: What is the difference between Анафранил and other common SSRI antidepressants?

Anafranil (Clomipramine) is classified as a Tricyclic Antidepressant (TCA), not a Selective Serotonin Reuptake Inhibitor (SSRI). Its unique mechanism involves inhibiting the reuptake of both serotonin and norepinephrine, as well as affecting several other receptors. This broader receptor action results in a distinct therapeutic and side effect profile compared to SSRIs.


Q: Can people with high blood pressure use Анафранил?

Official warnings advise that use requires caution in patients with pre-existing cardiovascular disorders. The drug is known to cause postural hypotension (a drop in blood pressure when standing up) and may affect heart rhythm.


Q: Is Анафранил suitable for older adults?

Official guidelines state that older adults require conditional eligibility for use, which includes close supervision. Regulatory information specifies that lower initial doses and a slower, more cautious titration schedule are necessary for this population due to an increased risk of specific side effects like confusion and orthostatic hypotension.


Q: Are there specific symptoms that mean I should contact a healthcare provider about Анафранил?

Official safety information notes that certain serious reactions may necessitate immediate consultation with a healthcare provider. These include symptoms of Serotonin Syndrome (e.g., severe agitation, fever, very fast heart rate), the occurrence of a seizure, or new/worsening suicidal thoughts or behavior.


Q: Is Анафранил a controlled substance?

Based on regulatory classifications in the United States, Anafranil (Clomipramine) is not scheduled as a controlled substance.


Q: What is the average time it takes to see the full effect of Анафранил?

Clinical data summarized in regulatory documents indicate that achieving the full therapeutic response for its labeled indication typically requires 6 to 12 weeks of continuous treatment.


Q: Is it normal to feel anxious when first starting Анафранил?

Yes, anxiety and agitation are officially documented as side effects of Anafranil in the official adverse reactions data. These types of central nervous system disturbances may occur, particularly during the initial phase of treatment.


Q: Is Анафранил used for chronic pain?

The medication is not officially indicated for pain in the US. However, some international regulatory agencies, such as the TGA (Australia) and MHRA (UK), have approved it for specific uses including the treatment of chronic pain.


Q: Are there any known interactions between Анафранил and common cold medicines?

Caution is advised regarding sympathomimetic agents, which are found in some cold medicines (e.g., decongestants). Official warnings note that combining these can increase the risk of adverse cardiovascular events, such as high blood pressure and an increased heart rate.


Q: Why is monitoring sometimes needed while taking Анафранил?

Monitoring is often necessary because Anafranil can affect the cardiovascular system. Official safety information indicates that a baseline ECG (a test of heart activity) may be required, particularly for older patients. Plasma drug levels may also be monitored to ensure the concentration remains within the established therapeutic range.


Q: Can Анафранил affect driving ability?

Official warnings note that patients are cautioned against driving or operating hazardous machinery until the drug's effects on them are fully known. This is because documented side effects, including somnolence (drowsiness), dizziness, and blurred vision, can significantly impair performance.


Q: What should I do if I suspect an interaction between Анафранил and another drug?

Official patient counseling information notes that suspected drug interactions may require consultation with a healthcare provider or pharmacist for guidance.


Q: Is it possible to develop a tolerance to Анафранил over time?

Tolerance (a diminished therapeutic effect) to the anticataplectic effects of the drug has been documented in clinical research in that specific area. This may result in the need for dose adjustments over time to maintain efficacy in those cases.


Q: Can Анафранил cause changes in vision?

Yes, official documents list blurred vision as a common side effect of Anafranil. This is categorized as an anticholinergic effect, which relates to the way the drug interacts with specific receptors in the body.


Q: Is Анафранил used to treat depression in all countries?

No. While the US FDA approves it specifically for OCD, many other international regulatory agencies, including those in the UK, Australia, and Japan, have approved it for the treatment of Major Depressive Disorder.


Q: What evidence supports the use of Анафранил for narcolepsy-associated cataplexy?

The use of Anafranil for this condition is supported by its approval from several major international regulatory agencies, such as the TGA (Australia) and the MHRA (UK), for the treatment of cataplexy associated with narcolepsy.


Q: Why are baseline tests sometimes required before starting Анафранил?

Regulatory warnings state that baseline tests, specifically an Electrocardiogram (ECG), are recommended. This is to screen for and monitor pre-existing cardiac conditions (such as congenital long QT syndrome) which are identified as risk factors for serious adverse reactions, especially in older patients.


Q: Is it common for Анафранил to cause sweating?

Yes, official adverse reaction data confirms that sweating (diaphoresis) is listed as a common side effect of Anafranil (Clomipramine).

How should Анафранил be stored and disposed of?

How to Store and Dispose of Anafranil (Clomipramine Hydrochloride)

Anafranil tablets and capsules must be stored according to strict regulatory conditions to maintain stability.

Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature, 25 C (77 F), with permitted excursions up to 30 C (86 F).
Container Keep the medication in its original container and ensure the container is tightly closed to protect it from moisture and light.
Child Safety The medication must be kept out of the reach and sight of children.

Disposal Instructions

To dispose of unused or expired Anafranil, utilize a medicine take-back program if one is available. Regulatory guidelines advise against flushing the medication down the toilet or disposing of it in household trash unless otherwise instructed by an official source.

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

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