Schedule H

Oral, Intramuscular (Depot)

Formulation Type Strengths Available

Tablets 1 mg, 5 mg

Depot Injection (Fluphenazine Decanoate) 25 mg/mL (1 mL ampoule, oil-based for IM use)

Note: Short-acting aqueous IM formulation for acute use is NOT AVAILABLE in India. Only the long-acting depot (decanoate) formulation is available for intramuscular administration.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Schizophrenia (Maintenance Therapy)

Oral Formulation:

Parameter Dosing

Starting dose 2.5–5 mg/day in 2–3 divided doses

Titration Increase by 2.5–5 mg/day every 2–3 days based on response and tolerability

Usual maintenance dose 5–15 mg/day in divided doses (2–3 times daily)

Maximum dose 40 mg/day

Depot Formulation (Fluphenazine Decanoate):

Parameter Dosing

Starting dose 12.5 mg IM as test dose; if tolerated, 25 mg IM after 1 week

Titration Adjust by 12.5–25 mg increments at 4-weekly intervals based on response

Usual maintenance dose 25–50 mg IM every 2–4 weeks

Maximum dose 100 mg per injection

Clinical Notes:

• Oral overlap required for 1–2 weeks after first depot injection until adequate plasma levels achieved

• Depot formulation preferred for patients with poor medication adherence

• Start at lower end of dose range in elderly, debilitated patients, or those with hepatic impairment

• Administer depot injection deep IM into gluteal muscle using Z-track technique

• Interval between depot injections may be extended up to 4–6 weeks in stable patients

1. Other Psychotic Disorders

Parameter Dosing

Starting dose 2.5–5 mg/day orally in divided doses

Titration As per schizophrenia

Usual maintenance dose 5–15 mg/day orally or depot as per clinical judgement

Maximum dose 40 mg/day (oral); 100 mg per injection (depot)

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence Basis

Bipolar Disorder with Psychotic Features 1–5 mg/day orally Short-term (acute episode) OFF-LABEL; Specialist psychiatrist only; use when atypical antipsychotics contraindicated or unavailable Indian specialist practice; limited RCT data

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Not applicable. Fluphenazine is NOT routinely approved for paediatric use in India. Use is restricted to child and adolescent psychiatry specialists.

Secondary Indications — Paediatric (Off-label)

Indication Age Group Dose Notes

Childhood-Onset Schizophrenia 12–18 years Starting dose: 0.25–0.5 mg/day orally in divided doses OFF-LABEL; Child psychiatrist only

Titration: Increase by 0.25–0.5 mg every 5–7 days

Usual maintenance: 1–3 mg/day

Maximum: 5 mg/day

Severe Behavioural Disorders 12–18 years Same as above OFF-LABEL; Short-term use only

Safety Monitoring in Paediatrics:

• Extrapyramidal symptoms (especially acute dystonia)

• Sedation and cognitive effects

• ECG for QTc prolongation before and during treatment

• Weight and metabolic parameters

• Growth monitoring

Clear Statement: Use in children below 12 years is NOT RECOMMENDED. Any use below 18 years requires specialist child psychiatrist supervision.

Mild to moderate impairment No dose adjustment required

• Comatose states or severe CNS depression

• Bone marrow suppression or history of blood dyscrasias

• Pheochromocytoma

• Known hypersensitivity to fluphenazine, other phenothiazines, or any excipient

• Severe hepatic impairment (for depot formulation)

• Subcortical brain damage

• Circulatory collapse

• History of seizures or epilepsy — lowers seizure threshold

• Parkinson's disease or parkinsonian features — may worsen

• Cardiovascular disease — risk of orthostatic hypotension, QT prolongation

• Elderly patients with dementia-related psychosis — increased mortality risk (black box warning in some jurisdictions)

• Narrow-angle glaucoma

• Prostatic hypertrophy or urinary retention

• History of neuroleptic malignant syndrome

• Exposure to extreme heat — risk of impaired thermoregulation

• Long-term use — risk of tardive dyskinesia (cumulative)

• Concurrent use of other CNS depressants

• Hypokalemia or hypomagnesemia — increases risk of arrhythmias

Parameter Details

Risk category Limited human data; animal studies show reproductive toxicity; use only if clearly indicated

Preferred alternatives Haloperidol (more safety data in pregnancy); if atypical needed, consider Olanzapine or Quetiapine under specialist supervision

When it may be used Only if maternal benefit clearly outweighs fetal risk; avoid in first trimester if possible

Monitoring Fetal growth, neonatal extrapyramidal symptoms or withdrawal signs after delivery, maternal QTc

Parameter Details

Compatibility Not recommended during breastfeeding

Drug levels in milk Moderate to high; phenothiazines are excreted in breast milk

Preferred alternatives Olanzapine or Quetiapine (lower milk excretion) if antipsychotic essential

Monitoring in infant Sedation, feeding difficulties, extrapyramidal signs, poor weight gain, developmental milestones

Parameter Recommendation

Starting dose Oral: 1 mg once or twice daily; Depot: 12.5 mg IM initially

Titration Very slow; increase at intervals of 1 week or longer

Extra risks Orthostatic hypotension and falls, excessive sedation, extrapyramidal symptoms (especially akathisia), tardive dyskinesia (higher cumulative risk), anticholinergic effects (confusion, constipation, urinary retention), QT prolongation

Special considerations Lower maintenance doses often sufficient; avoid depot in frail elderly; regular ECG monitoring; screen for cognitive decline

Interacting Drug Effect Recommendation

CNS Depressants (Benzodiazepines, Opioids, Alcohol) Enhanced sedation, respiratory depression Avoid or use with extreme caution; reduce doses of both agents

QT-Prolonging Drugs (Amiodarone, Quinolones, Macrolides, Methadone, Ondansetron) Additive QT prolongation — risk of Torsades de Pointes Avoid combination; if essential, monitor ECG closely

Lithium Increased risk of neurotoxicity (encephalopathic syndrome: confusion, EPS, fever) Use with caution; monitor for neurological signs; maintain adequate hydration

Strong CYP2D6 Inhibitors (Paroxetine, Fluoxetine, Bupropion) Increased fluphenazine plasma levels Reduce fluphenazine dose; monitor for EPS and sedation

Dopamine Agonists (Levodopa, Pramipexole, Ropinirole) Antagonises antiparkinsonian effect Avoid in Parkinson's disease; if antipsychotic essential, consider Quetiapine or Clozapine

Interacting Drug Effect Recommendation

Carbamazepine CYP450 induction — may reduce fluphenazine levels Monitor clinical response; may need dose adjustment

Rifampicin Enzyme induction — reduces antipsychotic effectiveness Monitor and adjust dose accordingly

Anticholinergics (Trihexyphenidyl, Benztropine) Additive anticholinergic effects — risk of paralytic ileus, cognitive impairment Use lowest effective anticholinergic dose; monitor bowel function and cognition

Antihypertensives Additive hypotensive effect Monitor blood pressure; adjust antihypertensive if needed

Beta-Blockers Enhanced hypotension; potential for bradycardia Monitor blood pressure and heart rate

Antacids, Sucralfate May reduce oral absorption of fluphenazine Separate administration by 2 hours

• Extrapyramidal symptoms: acute dystonia, parkinsonism, akathisia (common with phenothiazines)

• Sedation, drowsiness

• Dry mouth, constipation, blurred vision (anticholinergic effects)

• Orthostatic hypotension

• Weight gain

• Hyperprolactinemia — menstrual disturbances, galactorrhoea, gynaecomastia, sexual dysfunction

• Photosensitivity

• Nasal congestion

• Tardive Dyskinesia — potentially irreversible; risk increases with cumulative dose and duration; requires periodic screening

• Neuroleptic Malignant Syndrome (NMS) — hyperthermia, muscle rigidity, autonomic instability, altered consciousness; requires immediate discontinuation and hospitalisation

• QT Prolongation, Torsades de Pointes — monitor ECG; avoid in patients with cardiac risk factors

• Agranulocytosis — rare; monitor WBC if fever, sore throat, or infection develops

• Hepatotoxicity — cholestatic jaundice; monitor LFTs if symptoms arise

• Seizures — lowers seizure threshold

• Severe Hypotension — especially with parenteral administration

• Lens and Corneal Deposits, Pigmentary Retinopathy — with prolonged high-dose use

Phase Parameters to Monitor

Baseline ECG (QTc interval), liver function tests, renal function, complete blood count, electrolytes (potassium, magnesium), fasting glucose, lipid profile, psychiatric assessment, AIMS (Abnormal Involuntary Movement Scale)

After initiation / dose change Blood pressure (lying and standing), EPS assessment, sedation level, QTc (if risk factors), mental status

Long-term AIMS every 3–6 months, weight and metabolic parameters every 6–12 months, periodic ECG, LFTs, CBC (if clinical suspicion of blood dyscrasia), ophthalmological examination annually in long-term high-dose use

Brand Name Manufacturer Formulation

Modecate Sanofi Depot Injection 25 mg/mL

Fluzine Various Tablets 1 mg, 5 mg

Anatensol Various Tablets (limited availability)

Important Clarification: Flupenthixol (Fluanxol) is a DIFFERENT drug — do not confuse with Fluphenazine. Verify brand name and active ingredient before prescribing.

Note: Fluphenazine is NOT included in NLEM India 2022; prices are not NPPA-controlled. Government supply availability varies by state.

• Depot is for maintenance, not acute episodes: Fluphenazine decanoate is intended for chronic maintenance therapy in stable patients — NOT for acute psychotic agitation. Acute short-acting IM formulation is not available in India.

• Oral overlap essential: Continue oral antipsychotic for 1–2 weeks after first depot injection until adequate plasma levels are achieved.

• Anticholinergic prophylaxis: Consider co-prescribing Trihexyphenidyl (1–2 mg BD) to manage early extrapyramidal symptoms, especially in younger patients who are more prone to acute dystonia.

• Screen for tardive dyskinesia regularly: Use AIMS scale every 3–6 months; risk is cumulative — use lowest effective dose for shortest duration.

• Avoid in elderly with dementia: Increased mortality risk in elderly patients with dementia-related psychosis — consider atypical antipsychotics instead.

• Do not confuse with Flupenthixol: These are different drugs with different pharmacology — always verify before dispensing.

Fluphenazine; schizophrenia; typical antipsychotic; first-generation antipsychotic; phenothiazine; depot injection; extrapyramidal symptoms; tardive dyskinesia; NMS; QT prolongation; Schedule H; Psychiatry

RxIndia v1.0 — 11 Jun 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia / National Formulary of India

• API Textbook of Medicine — Psychiatry chapter

• AIIMS Psychiatry Formulary

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine, 21st edition

• WHO Essential Medicines List (supportive safety data)