ANAFRANIL 25/MG FC TAB 30/FC TAB

Indications

Approved Uses

Obsessive-compulsive disorder (OCD

Off-Label Uses

Off-label examples: neuropathic/chronic pain syndromes, premature ejaculation, body dysmorphic disorder, trichotillomania; (note: depression and panic disorder are established indications in many references/regions rather than off-label).

Dosage & Administration

Dosing by Condition

OCD (adults): start 25 mg/day, increase gradually (often over ~2 weeks) to ~100 mg/day; usual maintenance 100-150 mg/day; maximum 250 mg/day; give in divided doses initially with meals, then may give once daily at bedtime when tolerated.

Initial Dose

25 mg/day, taken with meals; increase gradually over 2 weeks

Maintenance Dose

100-150 mg/day in divided doses or as a single bedtime dose

Maximum Dose

250mg daily for adults; for children, the lesser of 3mg/kg or 200mg daily.

Children's Dosage

Approved for OCD in children 10 years and older. Initial dose is 25mg daily, gradually increased to a maximum of 3mg/kg/day or 100mg/day (whichever is less) over two weeks. May be further increased to a maximum of 3mg/kg/day or 200mg/day (whichever is less).

Dose Adjustment Notes

Titrate gradually to improve tolerability; during early titration use divided doses with meals, then consider once‑daily bedtime dosing when stable; use lower starting doses and slower titration in older adults and use caution in hepatic impairment.

How to Take

Oral film‑coated tablet: swallow whole with water (do not crush/chew unless specifically directed); during initiation/titration give in divided doses with meals to reduce GI upset; once tolerated/at maintenance, the total daily dose may be taken once daily at bedtime to reduce daytime sedation.

Side Effects

Common Side Effects

Dry mouth, constipation, nausea, dizziness, somnolence/drowsiness, tremor, increased sweating, blurred vision, weight gain, urinary hesitancy/retention, fatigue, headache, sexual dysfunction.

Safety & Warnings

Contraindications

Hypersensitivity to clomipramine/TCAs; concomitant use with MAO inhibitors or within 14 days of stopping an MAOI (and vice versa); acute recovery period after myocardial infarction; concomitant use with linezolid or IV methylene blue (unless no alternatives and with close monitoring).

Warnings & Precautions

Key warnings/precautions: boxed warning for suicidality (monitor closely, especially during initiation/dose changes); seizure risk (dose-dependent); serotonin syndrome with serotonergic agents; cardiovascular risk (conduction abnormalities/QT prolongation-consider baseline ECG in at-risk patients); mania/hypomania in bipolar disorder; anticholinergic effects (urinary retention, constipation; caution in narrow-angle glaucoma/BPH); orthostatic hypotension; hepatic impairment (caution); renal impairment (caution); avoid abrupt discontinuation (taper).

Age Restriction

Approved for OCD in patients aged 10 years and older; safety/efficacy not established in children <10 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions include: MAOIs/linezolid/IV methylene blue (contraindicated-serotonin syndrome); other serotonergic drugs (SSRIs/SNRIs, triptans, tramadol) (serotonin syndrome risk); CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) and CYP inhibitors like cimetidine (↑ clomipramine levels/toxicity); CYP inducers (e.g., carbamazepine, phenobarbital) (↓ levels); QT-prolonging/antiarrhythmic drugs (additive arrhythmia risk); CNS depressants/alcohol (↑ sedation); anticholinergics (additive anticholinergic effects); warfarin (possible altered anticoagulant effect-monitor INR).

Interaction Severity

MAJOR/Contraindicated: MAOIs (and within 14 days), linezolid, IV methylene blue (serotonin syndrome/hypertensive crisis); significant QT‑prolonging drugs (additive arrhythmia risk). MODERATE: SSRIs/SNRIs and other serotonergic drugs; strong CYP2D6/CYP inhibitors (e.g., fluoxetine/paroxetine) increasing levels; CNS depressants; anticholinergics; sympathomimetics; anticoagulants (monitor INR).

Food Interaction

May take with food/meals to reduce gastrointestinal upset; no routine food restrictions are required-avoid grapefruit juice only as a precaution due to potential CYP-mediated increases in levels (cranberry juice is not a standard interaction).

Alcohol Interaction

Dangerous

Special Populations

Breastfeeding

Caution

Children

Approved for OCD in children 10 years and older. Initial dose is 25mg daily, gradually increased to a maximum of 3mg/kg/day or 100mg/day (whichever is less) over two weeks. May be further increased to a maximum of 3mg/kg/day or 200mg/day (whichever is less).

Elderly

Start at 10-25 mg/day; titrate slowly; maximum dose typically 75-100 mg/day; monitor cardiac function and orthostatic blood pressure

Kidney Impairment

No specific renal dose adjustment is established; use with caution in severe renal impairment and monitor for adverse effects.

Liver Impairment

Use with caution in hepatic impairment; consider lower starting dose/slower titration and monitor clinically (and LFTs if indicated); avoid use or use only with extreme caution in severe hepatic impairment.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually (individualized-often over weeks) to reduce discontinuation symptoms (e.g., nausea, headache, malaise, irritability, insomnia).

Overdose

Overdose can cause life-threatening TCA toxicity: CNS depression/coma, seizures, anticholinergic effects, hypotension, and cardiac conduction abnormalities/arrhythmias (QRS widening, QT prolongation); management is emergency care with airway/ventilation, continuous ECG monitoring, activated charcoal if appropriate, and IV sodium bicarbonate for QRS widening/ventricular arrhythmias, plus supportive care (dialysis is not effective).

Patient Counseling

Take exactly as prescribed and do not stop abruptly; may take several weeks to improve (OCD often 6-12 weeks for full effect); take with meals during titration and may be moved to bedtime once tolerated; may cause drowsiness/dizziness and orthostatic hypotension-avoid driving until effects known; avoid alcohol; manage dry mouth/constipation with hydration and fiber; seek urgent help for suicidal thoughts, severe agitation, serotonin syndrome symptoms, or palpitations/syncope; check with a clinician before combining with other antidepressants/serotonergic drugs or St. John’s wort.

Monitoring Requirements

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

Pharmacology

Mechanism of Action

Tricyclic antidepressant that inhibits serotonin reuptake strongly and norepinephrine reuptake to a lesser extent; desmethylclomipramine contributes relatively more NE reuptake inhibition; also has anticholinergic (muscarinic), antihistaminic (H1), and alpha‑1 adrenergic blocking activity.

Half-Life

Parent drug (Clomipramine): 19-37 hours; Active metabolite (Desmethylclomipramine): 54-77 hours.

Metabolism

Extensive hepatic metabolism; major pathways include CYP2D6 (key), with contributions from CYP1A2, CYP3A4, and CYP2C19; active metabolite: desmethylclomipramine (norclomipramine).

Protein Binding

High protein binding approximately 97% (primarily to albumin

Product Information

Available Dosage Forms

Capsules (25 mg, 50 mg, 75 mg

Composition per Dose

Each film-coated tablet: 25 mg clomipramine hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-TCA

Controlled Substance

No

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