Generic Anafranil (Clomipramine HCI)

Introduction

Anafranil, whose active ingredient is clomipramine HCl, is a tricyclic antidepressant (TCA) formulated as oral tablets available in 10 mg, 25 mg, and 50 mg strengths. The drug belongs to the dibenzazepine class of antidepressants and is FDA-approved for the treatment of obsessive-compulsive disorder (OCD) and for augmentation of major depressive disorder (MDD) when first-line agents are insufficient. It is also authorized in several jurisdictions for panic disorder, chronic anxiety, and depressive illness with prominent anxiety features. In clinical practice, clomipramine is sometimes employed off-label for conditions such as body-dysmorphic disorder, post-traumatic stress disorder (PTSD), and certain chronic pain syndromes, although these uses lack formal regulatory endorsement.

What is Anafranil?

Anafranil is a branded formulation of the chemical clomipramine hydrochloride, a synthetic tricyclic antidepressant first synthesized in the s. Marketed under brand names such as Anafranil (by Roche) and the generic designation clomipramine, the medication is supplied as film-coated tablets for oral administration. The drug’s development built on earlier TCAs like imipramine, with structural modifications that increase serotonergic activity, making it particularly effective for obsessive-compulsive pathology.

How Anafranil Works

Clomipramine exerts its therapeutic effect primarily by inhibiting the reuptake of serotonin (5-HT) and, to a lesser extent, norepinephrine (NE) at presynaptic neuronal terminals. By blocking the serotonin transporter (SERT), the drug raises synaptic 5-HT concentrations, which is thought to normalize hyperactive cortico-striatal-thalamo-cortical circuits implicated in OCD. The secondary norepinephrine blockade contributes to mood-elevating properties and may improve anxiety symptoms.

Pharmacokinetic characteristics include:

• Absorption: Peak plasma concentrations occur 2-4 hours after oral dosing.
• Distribution: The drug is widely distributed, crossing the blood-brain barrier and binding to plasma proteins (≈ 80 %).
• Metabolism: Hepatic metabolism through cytochrome P450 enzymes (primarily CYP2D6) produces active metabolites such as desmethylclomipramine.
• Elimination: The elimination half-life averages 20-30 hours, allowing once-daily dosing after titration.

These properties explain the gradual onset of therapeutic benefit, typically observed after 4-6 weeks of consistent dosing.

Conditions Treated with Anafranil

Obsessive-Compulsive Disorder (OCD)

Clomipramine is the only TCA with FDA approval specifically for OCD. Its potent serotonergic inhibition reduces intrusive thoughts and compulsive behaviors by modulating the orbitofrontal-striatal circuitry.

Major Depressive Disorder (MDD) - Augmentation

When selective serotonin reuptake inhibitors (SSRIs) provide an incomplete response, clomipramine can be added to enhance serotonergic tone, leading to improved mood and functional outcomes.

Panic Disorder and Chronic Anxiety

The drug’s anxiolytic effect derives from combined serotonin and norepinephrine blockade, offering relief for recurrent panic attacks and generalized anxiety when first-line agents are inadequate.

Off-Label and Investigational Uses of Anafranil

• Body-Dysmorphic Disorder (BDD): Small open-label studies suggest clomipramine may reduce preoccupations with perceived physical defects, likely via its serotonergic action.
• Post-Traumatic Stress Disorder (PTSD): Preliminary trials have investigated clomipramine as an adjunct to trauma-focused psychotherapy, reporting modest symptom improvement.
• Chronic Neuropathic Pain: A limited number of case series indicate that clomipramine’s norepinephrine reuptake inhibition can modulate pain pathways, though evidence remains sparse.

These applications are not approved by regulatory agencies such as the FDA or EMA. Patients should only consider off-label use under direct supervision of a qualified healthcare professional, as safety and efficacy have not been definitively established.

Is Anafranil the Right Medication for You?

Anafranil is best suited for adults with a confirmed diagnosis of OCD, or depressive or anxiety disorders that have not responded adequately to first-line therapies. It is particularly valuable when a high degree of serotonergic activity is desired.

Contraindications include:

• Known hypersensitivity to clomipramine or other TCAs.
• Recent myocardial infarction or severe cardiac conduction disorders.
• Concurrent use of monoamine oxidase inhibitors (MAOIs) within the past 14 days.

Patients with uncontrolled hypertension, glaucoma, prostatic hypertrophy, or seizure disorders require careful risk-benefit assessment before initiation.

Risks, Side Effects, and Interactions

Common

• Dry mouth - May be alleviated with frequent sips of water or sugar-free lozenges.
• Constipation - Increase dietary fiber and fluid intake; consider mild laxatives if needed.
• Somnolence - Avoid operating heavy machinery until the effect is known.
• Weight gain - Monitor body weight and adjust diet accordingly.

Rare

• Orthostatic hypotension - Rise slowly from seated or lying positions; monitor blood pressure.
• Sexual dysfunction - May include decreased libido or erectile difficulties.
• Blurred vision - Report persistent changes to a clinician.

Serious

• Cardiac arrhythmias - TCAs can prolong the QT interval; patients with pre-existing heart disease require ECG monitoring.
• Serotonin syndrome - Symptoms include agitation, hyperthermia, hyperreflexia; seek emergency care if suspected.
• Seizures - Higher doses lower seizure threshold; avoid in patients with epilepsy unless essential.

Drug-Drug Interactions

• MAOIs - Combined use can precipitate hypertensive crisis; a 14-day washout is mandatory.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) - May increase clomipramine plasma levels, raising toxicity risk.
• Other serotonergic agents (SSRIs, SNRIs, tramadol) - Heighten serotonin syndrome potential.

Drug-Food Interactions

• Alcohol - Potentiates sedative effects; limit or avoid consumption.
• Caffeinated beverages - May exacerbate anxiety or insomnia; monitor tolerance.

Use: Dosing, Missed Dose, Overdose

Standard dosing begins with 25 mg once daily, usually administered in the evening to mitigate daytime drowsiness. The dose may be increased by 25 mg increments every 2-3 weeks, targeting a typical therapeutic range of 50-250 mg per day, divided into one or two doses based on tolerability.

Missed dose: If a dose is forgotten and more than 6 hours have elapsed, skip the missed dose and resume the regular schedule. Doubling the dose to “make up” is discouraged.

Overdose: Symptoms may include severe drowsiness, cardiac conduction abnormalities, seizures, or hypotension. Immediate medical attention is essential; contact emergency services or a poison control center. Gastric decontamination (e.g., activated charcoal) is most effective within the first hour after ingestion.

Practical precautions:

• Take tablets with food to reduce gastrointestinal irritation.
• Avoid alcohol and sedating antihistamines while initiating therapy.
• Do not drive or operate hazardous equipment until the drug’s effect on alertness is known.

FAQ

• What should I do if I travel internationally with Anafranil?

  • Ensure you carry the medication in its original labeled packaging, along with a copy of the prescription (if required). Store tablets in a cool, dry place and avoid exposing them to temperatures above 30 °C.

• Can Anafranil be taken with grapefruit juice?

  • Grapefruit juice inhibits CYP3A4 but clomipramine is primarily metabolized by CYP2D6; therefore, a significant interaction is unlikely. Nevertheless, moderate consumption is advisable.

• How does the tablet appearance differ between manufacturers?

  • Roche-branded Anafranil tablets are typically white, film-coated, and imprinted with “ANA 25”. Generic clomipramine tablets may vary in color (white or off-white) and imprint according to the licensed supplier.

• Are there any special storage requirements for clomipramine tablets?

  • Tablets should be stored at room temperature (15-30 °C), protected from moisture and direct sunlight. Do not refrigerate unless instructed by the supplier.

• Will Anafranil show up on a standard drug test?

  • Routine workplace drug screens do not detect clomipramine. Specialized forensic testing could identify the compound, but it is uncommon.

• Is it safe to use clomipramine during pregnancy?

  • Category C: animal studies have shown some risk, and human data are limited. Use only if the potential benefit justifies the potential risk, under close medical supervision.

• Can I switch from an SSRI to Anafranil without a washout period?

  • A short overlap (1-2 weeks) is generally recommended to minimize serotonin syndrome risk, especially with high-dose SSRIs. Clinical guidance should be obtained before transitioning.

• What is the difference between immediate-release and extended-release clomipramine?

  • Currently, only immediate-release tablets are commercially available. Extended-release formulations are under investigation but not yet approved.

• How long does it take for Anafranil to reach steady-state concentration?

  • Steady-state is typically achieved after 4-5 half-lives, equating to approximately 5-7 days of consistent dosing.

• Does clomipramine interact with over-the-counter antihistamines?

  • First-generation antihistamines (e.g., diphenhydramine) have anticholinergic effects that can amplify clomipramine-related dry mouth, constipation, and sedation. Use with caution.

Glossary

Serotonin Reuptake Inhibition

The process by which a drug blocks the serotonin transporter, preventing reabsorption of serotonin into the presynaptic neuron, thereby increasing its availability in the synaptic cleft.

Cytochrome P450 2D6 (CYP2D6)

A liver enzyme responsible for metabolizing many drugs, including clomipramine. Genetic variations can affect drug clearance, influencing efficacy and toxicity.

Orthostatic Hypotension

A drop in blood pressure that occurs when a person stands up quickly, leading to dizziness or fainting. TCAs can cause this effect by antagonizing α-adrenergic receptors.

Serotonin Syndrome

A potentially life-threatening condition resulting from excessive serotonergic activity, characterized by agitation, hyperthermia, tremor, and autonomic instability.

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Disclaimer

The information presented about Anafranil is intended for educational purposes and does not replace professional medical advice. Treatment choices, including any off-label applications, must be made under the guidance of a qualified healthcare provider. Readers are presumed to be responsible adults capable of making informed health decisions. Our online pharmacy supplies Anafranil to individuals who may have limited access through traditional pharmacy channels or who seek affordable generic alternatives. Always consult a physician before initiating, modifying, or discontinuing any medication.