Schedule H

Oral, Intramuscular (Depot)

• Tablet 0.5 mg

• Tablet 1 mg

• Tablet 3 mg

• Injection (Flupentixol Decanoate) 20 mg/mL (IM depot)

• Injection (Flupentixol Decanoate) 40 mg/mL (IM depot)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Schizophrenia (Acute and Chronic) — Oral Route

Parameter Dosing Details

Starting dose 3 mg/day in 2–3 divided doses

Titration Increase by 3 mg every 2–3 days based on response and tolerability

Usual maintenance dose 3–9 mg/day in 2–3 divided doses

Maximum dose 18 mg/day

Key Clinical Notes:

• Oral formulation suitable for initial stabilization before switching to depot

• Higher doses required for predominantly positive symptoms

• Monitor for extrapyramidal symptoms throughout treatment

1. Schizophrenia (Maintenance Therapy) — IM Depot Route

Parameter Dosing Details

Starting dose 20 mg IM (test dose recommended in antipsychotic-naive patients)

Titration Increase by 20 mg increments every 2–3 weeks based on response

Usual maintenance dose 20–80 mg IM every 2–4 weeks

Maximum dose 120 mg every 4 weeks

Key Clinical Notes:

• Preferred for maintenance therapy and relapse prevention in non-adherent patients

• Not suitable for acute psychotic agitation due to slow onset of action

• Administer deep IM into gluteal muscle; rotate injection sites

• Overlap with oral antipsychotic for 1–2 weeks when initiating depot

1. Depression with Anxiety (Low-dose Therapy)

Parameter Dosing Details

Starting dose 0.5 mg once daily in the morning

Titration May increase to 0.5 mg twice daily after 3–5 days if needed

Usual maintenance dose 0.5–1 mg/day

Maximum dose 1 mg/day

Key Clinical Notes:

• Indicated for non-psychotic depressive states with prominent anxiety or restlessness

• Commonly used in elderly and somatizing patients in Indian practice

• Not a substitute for standard antidepressants in moderate-to-severe depression

• Avoid use beyond 4–6 weeks without reassessment

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Notes

Behavioural and Psychological Symptoms of Dementia (BPSD) (OFF-LABEL) 0.5–1 mg/day orally Short-term only (maximum 6 weeks) Specialist (geriatric psychiatry) only; Evidence: Indian geriatric psychiatry protocols; Use with extreme caution — increased mortality risk in dementia patients

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

⛔ NOT APPROVED for routine paediatric use in India.

Secondary Indications — Paediatric Doses (Off-label, if any)

Indication Age Dosing Notes

Adolescent Schizophrenia (OFF-LABEL) ≥12 years Starting: 0.5–1 mg/day; Titration: Increase by 0.5 mg every 5–7 days; Maximum: 3 mg/day Child psychiatrist supervision mandatory

Severe Behavioural Disorders with Aggression (OFF-LABEL) ≥12 years Starting: 0.25–0.5 mg/day; Titration: Cautious increments; Maximum: 1–2 mg/day; Duration: Short-course only (maximum 6 weeks) Specialist only; Evidence: Indian institutional protocols

Safety Monitoring Required:

• Weekly EPS assessment during titration

• Dystonia monitoring (especially in adolescent males)

• Sedation and cognitive function assessment

• Weight monitoring

• ECG if cardiac risk factors present

⚠️ Use below 12 years: Not recommended except under strict specialist paediatric psychiatry supervision with documented justification.

Mild to moderate impairment No dose adjustment required

Hemodialysis Not significantly removed; no supplemental dosing required

• Known hypersensitivity to flupentixol or other thioxanthenes

• Pheochromocytoma (risk of hypertensive crisis)

• Comatose states or severe CNS depression

• Circulatory collapse

• History of neuroleptic malignant syndrome

• Concurrent use with other depot antipsychotics

• Elderly patients — increased sensitivity to adverse effects

• Parkinson's disease or parkinsonian features — may exacerbate motor symptoms

• History of seizures or epilepsy — lowers seizure threshold

• Cardiovascular disease or risk factors for QT prolongation

• Diabetes mellitus — may alter glycaemic control

• Pre-existing hyperprolactinaemia

• Prostatic hypertrophy or urinary retention

• Hepatic impairment

• Avoid abrupt withdrawal — risk of rebound psychosis and withdrawal symptoms

Parameter Details

Risk category Limited human data; use with caution

Recommendation Use only if benefit clearly outweighs risk, particularly for schizophrenia treatment continuation

Preferred alternatives Haloperidol (better established pregnancy profile in Indian practice)

Monitoring Fetal growth surveillance; neonatal monitoring for extrapyramidal symptoms and withdrawal if used near term

Parameter Details

Compatibility Use with caution — excreted in breast milk

Expected levels in milk Low (specific quantification limited)

Preferred alternatives Risperidone or olanzapine (better established safety data)

Infant monitoring Sedation, feeding difficulties, irritability, developmental milestones

Parameter Recommendation

Starting dose Half the usual adult dose (e.g., 0.25–0.5 mg/day for depression; 1.5 mg/day for psychosis)

Titration Very slow; increase at intervals of 7–10 days

Maximum dose Generally ≤6 mg/day oral; depot use generally avoided

Extra risks Falls, orthostatic hypotension, extrapyramidal symptoms, QT prolongation, cognitive impairment, increased stroke risk

Interacting Drug/Class Effect Management

CNS depressants (benzodiazepines, opioids, alcohol) Additive sedation; respiratory depression risk Avoid or use significantly reduced doses

QT-prolonging drugs (macrolides, fluoroquinolones, amiodarone, haloperidol) Additive QT prolongation; risk of torsades de pointes Avoid combination; if unavoidable, perform ECG monitoring

Levodopa / Dopamine agonists Pharmacological antagonism; reduced antiparkinsonian effect Avoid combination

Lithium Increased risk of neurotoxicity and severe EPS Avoid or use with extreme caution; monitor neurological status

Interacting Drug/Class Effect Management

Antihypertensives (especially alpha-blockers) Enhanced hypotensive effect Monitor blood pressure; dose adjustment may be needed

Carbamazepine, phenytoin CYP enzyme induction; reduced flupentixol levels Monitor clinical response; may need dose increase

SSRIs Variable effect; possible increased EPS or serotonergic symptoms Monitor for movement disorders

Metformin / Insulin Possible alteration of glycaemic control Monitor blood glucose

Anticholinergics Additive anticholinergic effects Monitor for constipation, urinary retention, cognitive impairment

• Extrapyramidal symptoms (tremor, rigidity, bradykinesia)

• Akathisia

• Sedation

• Dry mouth

• Constipation

• Orthostatic hypotension

• Weight gain

• Hyperprolactinaemia (galactorrhoea, menstrual irregularities)

• Blurred vision

Adverse Effect Clinical Action

Neuroleptic malignant syndrome (hyperthermia, severe rigidity, autonomic instability, altered consciousness) Immediate discontinuation; supportive care; ICU admission

Tardive dyskinesia Reduce dose or discontinue; may be irreversible with prolonged use

QT prolongation / Torsades de pointes Discontinue; ECG monitoring; cardiology consultation

Seizures Discontinue; evaluate underlying cause

Agranulocytosis (very rare) Discontinue; haematology consultation

Hepatotoxicity (rare) Discontinue; monitor LFTs

Phase Parameters

Baseline ECG (QTc — especially if cardiac risk factors or high dose planned), CBC, LFTs, renal function, fasting glucose, weight/BMI

After initiation/dose change Weekly for first month: EPS assessment, orthostatic blood pressure, sedation level

Long-term Every 3–6 months: weight/BMI, fasting glucose, lipid profile; Periodic: prolactin (if symptomatic), EPS/tardive dyskinesia screening; Annual: ECG (if on depot or high doses)

• Fluanxol (Lundbeck)

• Depixol (Lundbeck) — depot formulation

• Flupentixol (various generics)

• Anxol (Sun Pharma)

• Flupen (Intas)

• Not included in NLEM 2022

• Not under NPPA price control

1. Dual utility: Low-dose flupentixol (0.5–1 mg/day) is widely used in India for depression with anxiety — this is distinct from its antipsychotic use and should not be confused with standard antidepressant therapy.

1. Depot advantage: Flupentixol decanoate is particularly valuable for chronic schizophrenia patients with poor medication adherence — consider early transition to depot for relapse prevention.

1. Not for emergencies: Depot formulation has slow onset (peak effect 1–2 weeks) — do not use for acute psychotic agitation; use short-acting IM or oral antipsychotics for acute control.

1. EPS risk is dose-dependent: Higher doses significantly increase extrapyramidal symptoms — use lowest effective dose, particularly in elderly and long-term therapy.

1. Gradual discontinuation: Taper over 2–4 weeks before stopping to prevent rebound psychosis and withdrawal symptoms.

1. QTc monitoring: Perform baseline ECG before initiating depot therapy or when combining with other QT-prolonging medications.

flupentixol; schizophrenia; typical-antipsychotic; thioxanthene; depot-injection; EPS-risk; QT-prolongation; depression-anxiety; elderly-caution; psychiatry-specialist; non-NLEM

RxIndia v1.0 — 12 Jan 2025

• CDSCO approved product labelling

• Indian Pharmacopoeia

• National Formulary of India (NFI)

• API Textbook of Medicine

• AIIMS Psychiatry Department protocols

• Indian Psychiatric Society clinical practice guidelines

• Goodman & Gilman's The Pharmacological Basis of Therapeutics