ANAFRANIL 10MG TAB

Indications

Approved Uses

Obsessive-compulsive disorder (OCD).

Off-Label Uses

Off-label uses include panic disorder/phobias, neuropathic pain/chronic pain, cataplexy (narcolepsy), premature ejaculation, and pediatric nocturnal enuresis (specialist use).

Dosage & Administration

Dosing by Condition

OCD (adults): start 25 mg/day; increase gradually over ~2 weeks to ~100 mg/day (often in divided doses with meals during titration); usual effective range 100-250 mg/day; maximum 250 mg/day. (This product is 10 mg tablets, which may be used for low starting doses or sensitive patients.)

Maintenance Dose

100-150mg/day for depression; 100-250mg/day for OCD

Maximum Dose

250 mg per day for adults; 200 mg per day (or 3 mg/kg) for children/adolescents.

Dose Adjustment Notes

Titrate gradually to minimize adverse effects. Consider lower starting doses and slower titration in older adults and in hepatic impairment; use caution in renal impairment (no routine specific adjustment, but monitor tolerability).

How to Take

Oral: swallow the coated tablet whole with water; take with food (especially during initiation/titration) to reduce GI upset. Doses are often divided with meals during titration; once stable, the total daily dose may be given as a single bedtime dose if tolerated to reduce daytime sedation.

Side Effects

Common Side Effects

Common: dry mouth, constipation, nausea, dizziness, somnolence/drowsiness, tremor, sweating, blurred vision, weight gain/increased appetite, fatigue, headache, orthostatic hypotension, urinary hesitancy/retention, and sexual dysfunction.

Side Effect Frequency

Very common (>10%): anticholinergic/CNS effects such as dry mouth, somnolence/drowsiness, dizziness, constipation, nausea, tremor, sweating; weight gain and sexual dysfunction are also commonly reported. Common (1-10%): blurred vision, urinary hesitancy/retention, headache, orthostatic hypotension/tachycardia, insomnia/anxiety, vomiting/diarrhea. Uncommon/rare (<1%): seizures, clinically significant arrhythmias/QT prolongation, hepatotoxicity, blood dyscrasias (e.g., agranulocytosis), serotonin syndrome, severe skin reactions.

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to clomipramine/TCAs; concomitant use with MAOIs or within 14 days of stopping an MAOI (and vice versa); use during the acute recovery period after myocardial infarction.

Warnings & Precautions

Key warnings/precautions: monitor for clinical worsening/suicidality (especially early and in younger patients); seizure risk (dose-related); cardiovascular risk (consider baseline ECG in patients with cardiac disease/risk and avoid other QT-prolonging factors); serotonin syndrome with serotonergic drugs/MAOIs; mania/hypomania activation in bipolar disorder; anticholinergic effects (urinary retention, angle-closure glaucoma risk); hepatic impairment caution; taper to discontinue.

Age Restriction

Pediatric: OCD only in patients ≥10 years; safety/efficacy not established <10 years. Not approved for depression in pediatric patients (<18 years). Pediatric dosing applies only to OCD.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major/contraindicated: MAOIs (including linezolid and IV methylene blue) due to serotonin syndrome risk-require appropriate washout. Other clinically important interactions: other serotonergic drugs (SSRIs/SNRIs, tramadol, triptans) ↑ serotonin syndrome risk; CYP2D6 inhibitors (e.g., fluoxetine/paroxetine) ↑ clomipramine levels/toxicity; QT-prolonging/antiarrhythmic drugs ↑ arrhythmia risk; CNS depressants/alcohol ↑ sedation; anticholinergics ↑ anticholinergic effects; cimetidine may ↑ levels; enzyme inducers (e.g., rifampin) may ↓ levels.

Interaction Severity

MAJOR/contraindicated: MAO inhibitors (and linezolid or IV methylene blue) due to serotonin syndrome risk; avoid within appropriate washout periods. MODERATE/clinically significant: other serotonergic drugs (SSRIs/SNRIs/triptans, etc.), strong CYP2D6 inhibitors (e.g., fluoxetine/paroxetine) increasing clomipramine levels, QT-prolonging/antiarrhythmic agents (additive arrhythmia risk), CNS depressants/alcohol (additive sedation), and other anticholinergics (additive anticholinergic toxicity).

Alcohol Interaction

Dangerous

Special Populations

Breastfeeding

Caution

Liver Impairment

Use with caution in hepatic impairment; consider lower starting dose/slower titration and monitor (no specific fixed adjustment; avoid or use only with extreme caution in severe hepatic impairment).

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually (individualized-commonly over at least 2-4 weeks when feasible) to reduce discontinuation symptoms (e.g., dizziness, nausea, headache, irritability, insomnia).

Overdose

Overdose may cause life-threatening TCA toxicity: CNS depression/coma, seizures, anticholinergic effects, hypotension, and cardiac conduction abnormalities/arrhythmias (e.g., QRS widening, QT prolongation). Management: immediate emergency care with airway/ventilation support, continuous ECG monitoring, activated charcoal if appropriate, and IV sodium bicarbonate for QRS widening/ventricular arrhythmias; avoid physostigmine unless directed by a toxicologist.

Patient Counseling

Take exactly as prescribed and do not stop abruptly; benefits may take several weeks. Take with food to reduce stomach upset; it may cause drowsiness-avoid driving/operating machinery until effects are known and avoid alcohol. Rise slowly to reduce dizziness; maintain oral hygiene for dry mouth/constipation. Seek urgent care for suicidal thoughts, severe agitation/serotonin syndrome symptoms, chest pain/palpitations/fainting, or urinary retention.

Monitoring Requirements

Monitor clinical response and suicidality (especially early and after dose changes); blood pressure/orthostasis and anticholinergic effects; consider baseline and follow-up ECG in patients with cardiac disease/risk factors or when using higher doses; consider liver function tests if clinically indicated; monitor weight and for seizure risk in predisposed patients.

Pharmacology

Mechanism of Action

Tricyclic antidepressant: inhibits serotonin reuptake strongly and norepinephrine reuptake to a lesser extent; its metabolite desmethylclomipramine is more noradrenergic. Also has anticholinergic (muscarinic), antihistaminic (H1), and alpha-1 adrenergic blocking activity.

Onset of Action

Some symptom improvement may be seen within 1-2 weeks; clinically meaningful response typically occurs within 2-4 weeks; full therapeutic effect for OCD may take 6-12 weeks.

Duration of Effect

Approximately 24 hours per dose after steady state (supports once-daily dosing after titration in many patients); clinical symptom benefits persist only with continued daily dosing and may take weeks to develop.

Metabolism

Extensive hepatic metabolism; major pathways involve CYP2D6, CYP2C19, and CYP3A4 (with contribution from CYP1A2), forming the active metabolite desmethylclomipramine (norclomipramine) and other metabolites.

Protein Binding

Approximately 97-98% protein bound (mainly to plasma proteins such as albumin).

Product Information

Available Dosage Forms

Coated tablet (oral).

Composition per Dose

Each coated tablet: 10mg clomipramine hydrochloride

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-TCA

Controlled Substance

No

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.