Clotiapine

Registered South African indications:

• Psychosis
• Sedation

Contraindications

• Pregnancy
• Breastfeeding
• Hypersensitivity to the active ingredient or to any of its excipients
• Comatose states
• Central nervous system depression
• History of seizures
• Large doses
• Abrupt change of dose

Cautions

• Renal impairment
• Hepatic impairment
• Elderly
• Intra-arterial injection
• Alcoholic intoxication
• Cardiovascular dysfunction
• Cerebral vascular insufficiency
• Cerebral sclerosis
• Prostatic enlargement
• Glaucoma
• Paralytic ileus
• Epilepsy
• Postencephalitic states
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: inj, tab

Psychosis
-With manic, paranoid or hallucinatory symptoms
Sedation

• Oral (tab): Initial: 120-160mg/day in 2-3 divided doses; Maintenance: 20-40mg, dly; Max: 360mg/24hrs
• IV/IM: Initial: 120-160mg/day in 2-3 divided doses; Maintenance: 20-40mg, dly; Max: 360mg/24hrs

Not established for use in children below 16 years

Pregnancy

• Contraindicated
• Safety in pregnancy has not been established

Breastfeeding

• Contraindicated
• Safety in breastfeeding has not been established

Renal Impairment

• eGFR ≥11- 89ml/min/1.73 m²: No dose adjustment recommended
• eGFR ≤10ml/min/1.73 m²/ ESRD: Caution; dose adjustment recommended
  Initial: 80-120mg in divided doses; Titrate over 1-2 weeks; Max: 360mg/24hrs 

Hepatic Impairment

• Mild (Child-Pugh class A): Caution; no dose adjustment recommended
  Initial: 80-120mg; Titrate gradually; Max: 360mg/24hrs 
  Closely monitor liver function
• Moderate to severe (Child-Pugh class B and C): Caution; dose adjustment recommended
  Initial: 40-80mg; Titrate over 3-4 weeks; Max: 180mg/24hrs 

Elderly

• Caution; no dose adjustment recommended
  Not recommended. Consider alternative (well-studied) atypical antipsychotic

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Paroxysmal dyskinesia
• Hypokinesia
• Tremor
• Rigidity
• Akathisia
• Sedation
• Agitation
• Confusion
• Hyperkinesia

Cardiovascular Disorders

• Labile blood pressure
• Orthostatic hypotension

Gastrointestinal Disorders

• Dry mouth
• Paralytic ileus
• Gastroenteritis

Skin and Subcutaneous Tissue Disorders

• Oedema
• Rash
• Hyperpyrexia
• Sweating

Immune, Blood and Lymphatic System Disorders

• Thrombocytopaenia

Sensory Disorders

• Disturbance of accomodation

• Central nervous system depressants
• Antihistamines
• Monoamine oxidase inhibitors
• Antihypertensives
• Lithium

Blood pressure

Clotiapine is a major tranquiliser with a chemical structure which differs completely from that of traditional tranquilisers. It exerts a strong sedative effect which changes into a mild or even pronounced antipsychotic effect later during treatment.

Tablet 40mg

• Etomine (Pharmaco) originator

Injection (per 4ml) 40mg 

• Etomine (Pharmaco) originator