Clopixol Depot

 200 mg/ml Injection
Lundbeck Pharmaceuticals Ltd.

200 mg ampoule: ৳ 433.00 (2 x 5: ৳ 4,330.00)

Indications

Oral Zuclopenthixol (dihydrochloride)

  • Schizophrenia and other chronic psychotic disorders.
  • Acute bipolar mania (clinically accepted off-label use).

Zuclopenthixol Acetate (IM, short‑acting)

  • Acute psychosis with severe agitation or aggression.
  • Acute mania and severe behavioral disturbances in psychiatric emergencies.

Zuclopenthixol Decanoate (Depot IM, long‑acting)

  • Maintenance treatment of schizophrenia and paranoid psychoses, especially in patients with poor adherence to oral therapy.
  • Long-term management of aggressive or violent behavior associated with psychotic disorders.

 

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

 

Dosage & Administration

Oral (Zuclopenthixol Hydrochloride)

  • Starting dose (Adults): 10–20 mg/day in divided doses.
  • Titration: Increase by 10–20 mg every 2–3 days based on clinical response.
  • Maintenance: 20–60 mg/day; maximum 100 mg/day in divided doses.
  • Elderly: Start at 25–50% of the adult dose; titrate more slowly with close monitoring.

IM Short-acting (Zuclopenthixol Acetate)

  • Used for rapid sedation in acute psychotic agitation.
  • Initial dose: 50–150 mg IM; may be repeated after 2–3 days if necessary.
  • Maximum total dose: 400 mg/week; not intended for continuous or maintenance therapy.

IM Depot (Zuclopenthixol Decanoate)

  • Initial dose: 100–200 mg IM; overlap with oral therapy for 1–2 weeks during initiation.
  • Maintenance: 200–500 mg every 2–4 weeks.
  • Maximum dose: 600 mg per injection; some patients may require up to 600 mg weekly based on clinical response.

Special Populations

  • Children: Not recommended for use in individuals under 18 years of age.
  • Hepatic Impairment: Use with caution; monitor liver function tests regularly.
  • Renal Impairment: No specific dosage adjustment required, but close clinical monitoring is advised.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Mechanism of Action (MOA)

Zuclopenthixol is a typical thioxanthene antipsychotic that antagonizes dopamine D₁ and D₂ receptors, plus α₁-adrenergic and 5-HT₂ receptors, with minor histamine H₁ antagonism. By blocking dopamine transmission in limbic and mesolimbic pathways, it reduces psychotic symptoms. α₁ blockade contributes sedation and hypotension, while D₂ blockade underlies extrapyramidal effects and prolactin elevation.

Pharmacokinetics
  • Absorption: Oral bioavailability ~49%; peak plasma levels in 3–6 hours
  • Distribution: High protein binding (~98%); large volume of distribution
  • Metabolism: Primarily hepatic via CYP2D6 and CYP3A4 enzymes
  • Elimination: Mostly excreted in feces via bile; less than 10% in urine
  • Half-life:
    • Oral: ~20 hours
    • Acetate (IM): 48–72 hours (peak); short-term
    • Decanoate (IM): Half-life ~19 days; steady release over weeks
Pregnancy Category & Lactation
  • Pregnancy: Category C. Use only if potential benefits justify potential risks. Neonates may experience extrapyramidal symptoms or withdrawal if exposed in the third trimester.
  • Lactation: Excreted in breast milk in small amounts. Breastfeeding is not recommended unless benefits outweigh potential risks; monitor infants for sedation or feeding problems.
Therapeutic Class
  • Class: Typical antipsychotic (first-generation antipsychotic)
  • Subclass: Thioxanthene derivative
Contraindications
  • Hypersensitivity to zuclopenthixol or any of its components
  • Comatose states or severe CNS depression
  • Existing QT interval prolongation or arrhythmia
  • Severe hypotension or circulatory collapse
  • Acute alcohol, barbiturate, or opioid intoxication
  • Parkinson’s disease (relative contraindication)
Warnings & Precautions
  • Risk of neuroleptic malignant syndrome (NMS): monitor for fever, rigidity, confusion
  • Extrapyramidal symptoms (EPS): including dystonia, akathisia, and tardive dyskinesia
  • Sedation and orthostatic hypotension: increased fall risk in elderly
  • QT prolongation: caution with cardiac disease or electrolyte imbalance
  • Metabolic effects: weight gain, hyperglycemia, and lipid changes possible
  • Hematologic risks: rare cases of leukopenia, neutropenia, or agranulocytosis
  • Seizure threshold may be lowered
  • Hyperprolactinemia: menstrual irregularities, galactorrhea, sexual dysfunction
Side Effects

Common:

  • Drowsiness, sedation
  • Dry mouth, constipation
  • Dizziness, fatigue
  • Extrapyramidal symptoms (tremor, rigidity)
  • Orthostatic hypotension
  • Increased salivation

Less Common/Rare:

  • Tardive dyskinesia
  • Neuroleptic malignant syndrome
  • Weight gain, hyperglycemia
  • QT prolongation, arrhythmia
  • Agranulocytosis, leukopenia
  • Elevated liver enzymes
  • Photosensitivity reactions
Drug Interactions
  • CNS depressants (alcohol, benzodiazepines, opioids): enhanced sedation
  • QT-prolonging drugs (e.g., antiarrhythmics, macrolides): increased cardiac risk
  • CYP2D6 and CYP3A4 inhibitors (e.g., fluoxetine, erythromycin): may increase plasma levels
  • Antihypertensives: additive hypotensive effect
  • Levodopa and dopamine agonists: antagonistic effects
  • Lithium: increased risk of neurotoxicity
Recent Updates or Guidelines
  • Long-acting injection forms emphasized in clinical guidelines for non-adherent schizophrenia patients
  • Ongoing monitoring recommendations include ECG (QT interval), metabolic screening, and CBC during long-term use
  • Not FDA-approved in the U.S. but widely used internationally
Storage Conditions
  • Tablets: Store below 25°C in a dry place, protected from light
  • Acetate/Decanoate Injections: Store at 15–30°C; do not freeze; protect from light
  • Use aseptic technique when drawing from vials; discard unused portions after opening
Available Brand Names