Schedule H

Oral

Form Strengths

Capsules 10 mg, 20 mg

Tablets 10 mg, 20 mg, 60 mg

Oral Solution 20 mg/5 mL (limited availability)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Major Depressive Disorder (MDD) — Adults

Parameter Dosing

Starting dose 20 mg once daily (morning)

Titration Increase after 3–4 weeks if inadequate response

Usual maintenance dose 20–40 mg/day

Maximum dose 80 mg/day

Clinical Notes:

• Administer in the morning to minimise insomnia

• Elderly or debilitated patients: Consider initiating at 10 mg/day

• Clinical improvement may take 2–4 weeks; full effect by 6–8 weeks

1. Obsessive-Compulsive Disorder (OCD) — Adults

Parameter Dosing

Starting dose 20 mg once daily

Titration Increase by 20 mg at 2-week intervals based on response

Usual maintenance dose 40–60 mg/day

Maximum dose 80 mg/day

Clinical Notes:

• Higher doses typically required compared to depression

• Therapeutic response may take 4–6 weeks to manifest

• Continue treatment for at least 12 months after symptom control

1. Bulimia Nervosa — Adults

Parameter Dosing

Starting dose 60 mg once daily

Titration Not applicable (fixed-dose regimen)

Usual maintenance dose 60 mg/day

Maximum dose 60 mg/day

Clinical Notes:

• Clinical benefit usually apparent within 4 weeks

• Combine with psychological therapy for optimal outcomes

• Monitor weight and electrolytes regularly

1. Premenstrual Dysphoric Disorder (PMDD) — Adults

Regimen Dosing

Continuous dosing 20 mg once daily throughout the menstrual cycle

Intermittent dosing 20 mg once daily from day 14 of cycle until first day of menses

Titration May increase in 10 mg increments if needed

Maximum dose 80 mg/day (rarely required)

Clinical Notes:

• Intermittent dosing may be preferred for mild-moderate symptoms

• Assess response over 2–3 cycles before dose adjustment

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Panic Disorder — OFF-LABEL Starting: 10 mg/day; Titrate to 20–40 mg/day Long-term Evidence: Meta-analyses; Indian psychiatric practice

Post-Traumatic Stress Disorder (PTSD) — OFF-LABEL Starting: 10–20 mg/day; Titrate to 40–60 mg/day Long-term Specialist only; Response typically by 4–6 weeks

Generalised Anxiety Disorder — OFF-LABEL Starting: 10 mg/day; Titrate to 20–40 mg/day Long-term Specialist only; Consider if SSRIs preferred over benzodiazepines

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Major Depressive Disorder (Age ≥8 years)

Parameter Dosing

Starting dose 10 mg once daily

Titration Increase to 20 mg/day after 1–2 weeks based on tolerance

Usual maintenance dose 10–20 mg/day

Maximum dose 20 mg/day (up to 30 mg/day under specialist supervision)

Safety Notes:

• Enhanced suicidality monitoring essential in first 4 weeks

• Counsel caregivers regarding behavioural changes

• Weekly follow-up initially recommended

1. Obsessive-Compulsive Disorder (Age ≥7 years)

7–12 years 10 mg/day 20–30 mg/day 60 mg/day

≥13 years 10–20 mg/day 20–60 mg/day 80 mg/day

Safety Notes:

• Clinical improvement may take 4–6 weeks

• Monitor for behavioural activation, agitation

• Assess growth velocity with prolonged use

Secondary Indications — Paediatric (Off-label)

Indication Dose Duration Notes

Irritability in Autism Spectrum Disorder — OFF-LABEL Starting: 2.5–5 mg/day; Titrate to 10–20 mg/day Variable Specialist only; Limited evidence base

Selective Mutism — OFF-LABEL Starting: 5–10 mg/day; Max 20 mg/day Variable Specialist only; Used in child psychiatry practice

⚠️ Not recommended in children below 7 years except under specialist psychiatric supervision

• Known hypersensitivity to fluoxetine or any excipients

• Concurrent use with MAO inhibitors (including moclobemide, linezolid, methylene blue)

• Use within 14 days of discontinuing MAOIs

• Concurrent use within 5 weeks before starting MAOIs (due to long half-life)

• Concomitant use with thioridazine (QT prolongation risk)

• Concomitant use with pimozide (QT prolongation risk)

• History of seizures or epilepsy (may lower seizure threshold)

• Bipolar disorder (risk of manic switch; screen before initiation)

• Suicidal ideation, especially in adolescents and young adults (<25 years)

• Diabetes mellitus (may alter glycaemic control)

• Cardiac disease or risk factors for QT prolongation

• Concurrent antiplatelet/anticoagulant therapy (bleeding risk)

• History of bleeding disorders

• Narrow-angle glaucoma

• Hyponatraemia or risk factors (elderly, diuretic use)

• Electroconvulsive therapy (ECT) patients

Aspect Recommendation

Overall safety Use only if benefits clearly outweigh risks; not absolutely contraindicated

Trimester-specific concerns First trimester: Potential cardiac malformation risk (controversial); Third trimester: Neonatal adaptation syndrome, persistent pulmonary hypertension (PPHN)

Preferred alternatives Sertraline (more safety data in pregnancy) under specialist guidance

When to use When maternal mental health risk is significant and untreated depression poses greater harm

Monitoring Fetal growth scans; neonatal observation for withdrawal symptoms, respiratory distress, feeding difficulties

Aspect Recommendation

Compatibility Generally compatible; low levels in breast milk

Milk levels Low (infant receives approximately 1.5–6% of maternal weight-adjusted dose)

Preferred alternatives Sertraline (lowest milk-plasma ratio among SSRIs)

Infant monitoring Observe for irritability, poor feeding, excessive sedation, sleep disturbances

Aspect Recommendation

Starting dose 10 mg once daily

Titration Slow titration over 2–4 weeks; clinical response may be delayed

Key risks Hyponatraemia (SIADH), falls, QTc prolongation, confusion, bleeding (especially with NSAIDs/anticoagulants)

Maximum dose Usually limit to 40 mg/day unless specialist-supervised

Monitoring Serum sodium at baseline and periodically; ECG if cardiac risk factors present

Interacting Drug/Class Effect Recommendation

MAO inhibitors (phenelzine, tranylcypromine, moclobemide) Serotonin syndrome (potentially fatal) Contraindicated; 14-day washout before/5-week washout after fluoxetine

Thioridazine QT prolongation, torsades de pointes Contraindicated

Pimozide QT prolongation, ventricular arrhythmia Contraindicated

Linezolid, methylene blue (IV) Serotonin syndrome Avoid; if essential, discontinue fluoxetine first

Tamoxifen Reduced conversion to active metabolite (CYP2D6 inhibition) Avoid combination; consider alternative SSRI (escitalopram)

Triptans (sumatriptan, etc.) Serotonin syndrome risk Use with caution; monitor closely

Tramadol Serotonin syndrome; reduced analgesic effect Avoid if possible; use alternative analgesic

Interacting Drug/Class Effect Recommendation

NSAIDs, Aspirin Increased GI bleeding risk Use PPI cover if combination necessary

Warfarin Elevated INR; bleeding risk Monitor INR closely; adjust warfarin dose

Other serotonergic drugs (TCAs, trazodone, St. John's Wort) Serotonin toxicity risk Monitor for symptoms

CYP2D6 substrates (metoprolol, propranolol, carvedilol) Increased substrate levels Monitor for toxicity; consider dose reduction

Lithium Increased lithium toxicity risk Monitor lithium levels; watch for neurotoxicity

Phenytoin, carbamazepine Altered antiepileptic levels Monitor drug levels and seizure control

Antipsychotics (haloperidol, risperidone) Elevated antipsychotic levels (CYP2D6 inhibition) Monitor for EPS and other adverse effects

• Nausea, dyspepsia, diarrhoea

• Headache

• Anxiety, nervousness, restlessness

• Insomnia or disturbed sleep

• Sexual dysfunction (delayed ejaculation, anorgasmia, decreased libido)

• Dry mouth

• Excessive sweating

• Tremor

• Fatigue, asthenia

• Anorexia, weight loss (initially)

Adverse Effect Clinical Action

Serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability) Discontinue immediately; supportive care; consider cyproheptadine

Suicidal ideation/behaviour (especially <25 years) Close monitoring; consider discontinuation; psychiatric consultation

Seizures Discontinue; evaluate risk factors

QT prolongation, torsades de pointes Discontinue; ECG monitoring; correct electrolytes

Hyponatraemia (SIADH) Check sodium; fluid restrict; discontinue if severe

Severe bleeding (GI, intracranial) Discontinue; supportive management

Mania/hypomania Discontinue; reassess diagnosis; consider mood stabiliser

Akathisia (severe restlessness) Dose reduction or discontinuation; consider beta-blocker

Phase Parameters

Baseline Psychiatric assessment including suicidality screening; serum sodium (elderly); ECG (if cardiac risk factors); weight; BMI

After initiation/dose change Behaviour changes and suicidality (weekly for first 4 weeks, especially in <25 years); serum sodium (elderly or symptomatic); adherence and tolerability

Long-term Periodic mood and symptom assessment; weight monitoring; sexual function enquiry; serum sodium annually in elderly; bone density consideration with prolonged use

Brand Name Manufacturer

Flunil Intas

Prozac Eli Lilly

Fludac Cadila

Floxipac Lupin

Depnil Micro Labs

Fludep Sun Pharma

Flutine Torrent

Fluox Ranbaxy

• Available in both generic and branded formulations

• FDCs with olanzapine available for bipolar depression (specialist use)

• NLEM status: Fluoxetine 20 mg capsule/tablet included in NLEM 2022

• Available in government supply under mental health programmes

1. Morning dosing preferred: Administer in the morning to minimise sleep disturbance; evening dosing may worsen insomnia

1. Long half-life advantage: Fluoxetine and norfluoxetine have half-lives of 1–4 days and 7–15 days respectively — this reduces withdrawal symptoms but requires longer washout before switching drugs

1. OCD requires higher doses: Unlike depression, OCD typically requires 40–60 mg/day with evaluation at 4–6 weeks before dose escalation

1. Youth suicidality monitoring: In patients under 25 years, close monitoring for suicidal ideation is essential during weeks 1–4 of treatment

1. CYP2D6 inhibition: Fluoxetine is a potent CYP2D6 inhibitor — avoid with tamoxifen; consider interactions with beta-blockers, antipsychotics, and codeine

1. Not ideal for rapid switching: Due to long half-life, fluoxetine is not suitable when rapid drug washout is required (e.g., before MAOIs or other antidepressant switches)

fluoxetine; SSRI; depression; OCD; bulimia; anxiety; paediatric-use; pregnancy-caution; NLEM-India; CYP2D6-inhibitor; QT-caution; psychiatry

RxIndia v1.0 — 10 Jan 2025

• CDSCO Approved Formulations List

• Indian Pharmacopoeia

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine

• AIIMS Psychiatry Drug Formulary

• Indian Psychiatric Society Clinical Practice Guidelines

• IAP Guidelines (paediatric dosing)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• International RCT/meta-analyses (off-label indications only — clearly marked)