Haloperidol

Registered South African indications:

• Psychotic disorders
• Childhood behavioural and movement disorders

Contraindications

• Hypersensitivity to haloperidol or to any of the excipients
• In patients with Parkinson’s disease
• Severe toxic central nervous system (CNS) depression
• Comatose states
• In patients with bone-marrow suppression
• In patients with phaeochromocytoma
• Dementia with Lewy bodies
• Progressive supranuclear palsy
• Known QTc interval prolongation or congenital long QT syndrome
• Recent acute myocardial infarction
• Uncompensated heart failure
• History of ventricular dysrhythmia or torsades de pointes
• Uncorrected hypokalaemia
• Concomitant treatment with medicines that prolong the QT interval

Cautions

• Pregnancy
• Breastfeeding 
• Renal impairment 
• Hepatic impairment 
• Elderly 
• Dementia-related psychosis
• Risk factors for arrhythmias
• Risk factors for cerebrovascular disease
• Seizure disorder
• Risk factors for seizures 
• Hypothyroidism
• Risk factors for venous thromboembolism
• Abrupt withdrawal
• Depression
• Pheochromocytoma
• May impair ability to drive and operate machinery

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

Acute and chronic schizophrenia
Mania and hypomania
Organic psychoses
Agitation in psychotic illness

• IM: 2-10mg; Repeat doses may be given hourly until symptoms are controlled, or at intervals of 4-8hrs as needed; Max dose: Up to 30mg
• Oral (tab, cap): 0.5-5mg, twice or three times daily; Doses of up to 100-200mg daily may be required

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IV route may be used if necessary, with similar dosage and frequency

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Maximum dose of 30mg intramuscularly may be required for emergency control of very severely disturbed patients​

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When oral maximum improvement is reached, the oral dose should be gradually reduced to the lowest effective maintenance dose

Paed. forms avail. in SA and covered in this monograph: tab, cap, inj

Aggressivity
Mood lability
Difficulty sustaining attention
Poor frustration tolerance

Younger than 3 years

• Not established for use

Older than 3 years

• Oral (tab,cap): Maintenance dosage: 0.025-0.05mg/kg/day in 2-3 divided doses; Daily dose maybe increased by 0.5mg increments at 5-7 day intervals, up to a maximum of 0.15mg/kg/day​

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Children are more sensitive to haloperidol and require adjustment of the starting dose

Pregnancy

• Caution
• A moderate amount of data on pregnant women (more than 400 pregnancy outcomes) indicate no malformative or foeto/neonatal toxicity of haloperidol. However, there have been isolated case reports of birth defects following foetal exposure to haloperidol, mostly in combination with other medicinal products. Animal studies have shown reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of haloperidol during pregnancy
• Newborn infants exposed to antipsychotics (including haloperidol) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal Breastfeeding withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, it is recommended that newborn infants be monitored carefully

Breastfeeding

• Caution; not recommended
• Haloperidol is excreted in human milk. Small amounts of haloperidol have been detected in plasma and urine of breastfed newborns of mothers treated with haloperidol. There is insufficient information on the effects of haloperidol in breastfed infants. A decision must be made whether to discontinue breastfeeding or to discontinue haloperidol therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended 

Elderly

• Caution; dose adjustment recommended
  Limit use for elderly with clinical dementia-related psychosis
  Max: 5mg/24hrs 
  Elderly patients have an increased risk of severe extrapyramidal adverse effects, moreover, the risk associated with antipsychotic therapy overweighs its clinical benefits; Non-pharmacologic interventions should be tried before initiating an antipsychotic

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Agitation
• Insomnia
• Depression
• Psychotic disorder
• Confusion
• Restlessness
• Extrapyramidal symptoms 
• Headache
• Bradykinesia
• Hypokinesia
• Hypertonia
• Somnolence
• Gait disturbance
• Masked facies
• Tremor
• Dizziness
• Convulsion
• Akinesia
• Cogwheel rigidity
• Sedation
• Motor dysfunction
• Neuroleptic malignant syndrome
• Nystagmus
• Anxiety
• Catatonic-like states
• Delirium
• Neonatal drug withdrawal syndrome 

Cardiovascular Disorders

• Tachycardia
• Ventricular fibrillation
• Torsade de pointes
• Ventricular tachycardia
• Extrasystoles
• Orthostatic hypotension
• Hypotension
• QT prolongation
• Oedema

Respiratory Disorders

• Dyspnoea
• Bronchospasm
• Laryngeal oedema
• Laryngospasm
• Increased depth of respiration
• Nasal congestion

Gastrointestinal Disorders

• Constipation
• Dry mouth
• Salivary hypersecretion
• Nausea and vomiting
• Diarrhoea
• Dyspepsia

Hepatobiliary Disorders

• Impaired hepatic function 
• Hepatitis
• Jaundice
• Acute hepatic failure
• Cholestasis

Genitourinary Disorders

• Urinary retention
• Erectile dysfunction
• Menstrual disorder
• Sexual dysfunction
• Priapism
• Decreased libido 
• Loss of libido 

Endocrine and Metabolic Disorders

• Hyperprolactinaemia
• Inappropriate antidiuretic hormone secretion
• Hypoglycaemia
• Anorexia
• Hyponatremia
• Amenorrhoea
• Dysmenorrhoea
• Galactorrhoea
• Breast discomfort
• Breast pain
• Menorrhagia
• Gynaecomastia
• Hypothermia
• Hyperthermia

Musculoskeletal Disorders

• Torticollis
• Muscle rigidity
• Muscle spasms
• Musculoskeletal stiffness
• Trismus
• Muscle twitching
• Involuntary muscle contractions

Skin and Subcutaneous Tissue Disorders

• Rash
• Photosensitivity reaction
• Urticaria
• Pruritus
• Hyperhidrosis
• Leukocytoclastic vasculitis
• Exfoliative dermatitis 
• Diaphoresis
• Deposition of pigment in skin
• Erythema multiforme
• Contact sensitivity
• Maculopapular and acneiform skin reaction
• Loss of hair
• Injection site reaction

Immune, Blood and Lymphatic System Disorders

• Leukopenia
• Agranulocytosis
• Neutropenia
• Pancytopenia
• Thrombocytopenia
• Hypersensitivity
• Anaphylactic reaction
• Aplastic anaemia
• Facial oedema

Sensory Disorders

• Visual disturbances
• Blurred vision 
• Deposition of pigment in eyes
• Mydriasis
• Miosis

• QT prolonging agents 
• Agents causing electrolyte imbalances 
• CYP450 inducers
• CYP450 inhibitors
• Carbamazepine
• Phenobarbital
• Rifampicin
• Central nervous system depressants 
• Analgesics
• Methyldopa
• Sympathomimetics
• Alpha blockers
• Beta blockers 
• Antimuscarinics
• Levodopa
• Tricyclic antidepressants
• Lithium
• Phenindione
• Anticonvulsants

• Neurological examination

Specific cases may require

• ECG
• Electrolytes
• Weight
• Vital signs
• Full blood count
• Ophthalmic examination

Haloperidol Tablet, Capsule 0.5mg - EML (Primary)

Haloperidol depresses the central nervous system at the subcortical level of the brain, midbrain, and brain stem reticular formation. It antagonises the actions of glutamic acid within the extrapyramidal system and blocks catecholamine receptors. It also inhibits the reuptake of various neurotransmitters in the midbrain, and appears to have a strong central antidopaminergic and weak central anticholinergic activity. Haloperidol directly affects the chemoreceptor trigger zone (CTZ) through the blocking of dopamine receptors in the CTZ.

Capsule 0.5mg 

• Serenace (Pfizer) originator (Discontinued: 26/02/2021)

Tablet 1.5mg

• Haloperidol 1.5 Oethmaan (Oethmaan Biosims)
• Tamide (Pharmacare)

Tablet 5mg 

• Gulf Haloperidol (Gulf Drug)
• Haloperidol 5 Oethmaan (Oethmaan Biosims)
• Sandoz Haloperidol 5 (Sandoz)
• Serenace (Pfizer) originator (Discontinued: 26/02/2021)
• Tamide (Pharmacare)

Injection (per 1ml) 5mg

• Serenace (Pfizer) originator (Discontinued: 26/02/2021)

Injection (per 2m) 20mg

• Serenace (Pfizer) originator (Discontinued: 26/02/2021)