Prochlorperazine

Registered South African indications:

• Labyrinthine disorders
• Antiemetic
• Psychosis

Contraindications

• Known hypersensitivity to the active ingredient or any of its excipients 
• Children (inj, sup)

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• QT prolongation
• Bradycardia
• Hypokalaemia
• Coma
• Parkinson's disease
• Hypothyroidism
• Cardiac failure
• Phaeochromocytoma
• Myasthenia gravis
• Prostate hypertrophy
• Glaucoma 
• Blood dycrasias
• Hypotension
• Epilepsy
• Unexplained fever
• Autonomic dysfunction
• As monotherapy with predominently depressive symptoms
• Stroke risk factors
• Dementia-related psychosis
• Venous thromboembolism
• Diabetes mellitus
• May impair ability to drive or operate machinery

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

Prevention of nausea and vomiting

• Oral (tab): 5-10mg, 8-12hrly

Treatment of nausea and vomiting

• Oral (tab): 20mg immediately; 10mg 2hrs later if needed
• Rectal (sup): 25mg, further doses to be given orally
• IM: 12.5mg, further doses to be given orally

Labyrinthine disorders

• Oral (tab): Initial: 5mg, 8hrly; Increase to 30mg, dly; After several weeks decrease to 5mg, dly

Psychoses including schizophrenia and mania

• Oral (tab): Initial: 12.5mg, 12hrly for 7 days; Maintenance: 75-100mg, dly
• Rectal (sup): 25mg, 8-12hrly
• IM (inj): 12.5-25mg, 8-12hrly

Tablet: Up-titrate dosage in psychosis if needed by 12.5mg at 4-7 day intervals until maintenance dosage achieved

Tablet: For psychosis: after some weeks, attempt should be made to reduce the maintenance dosage

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

Nausea and vomiting
Labyrinthine disorders 
Psychoses including schizophrenia and mania   

Younger than 1 year

• Not established for use 

Older than 1 year

• Oral (tab): 0.25mg/kg, 8-12hrly
• Rectal (sup): 0.25mg/kg, 8-12hrly

Not recommended for use in children below 10kg

Pregnancy

• Caution
• There is inadequate evidence of the safety of prochlorperazine in human pregnancy. There is evidence of harmful effects in animals. Prochlorperazine should be avoided in pregnancy unless considered essential. Neuroleptics may occasionally prolong labour and at such a time should be withheld until the cervix is dilated 3-4cm. Possible adverse effects on the neonate include lethargy or paradoxical hyperexcitability, tremor and a low Apgar score
• Neonates exposed to antipsychotics (including prochlorperazine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or 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, newborns should be monitored carefully

Breastfeeding

• Caution; not recommended 
• Phenothiazines may be excreted in breast milk, breastfeeding should be suspended during treatment

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended
  Consider lower end of dosage range; Titrate dose gradually, monitor closely

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Acute dystonia
• Dyskinesias
• Oculogyric crisis
• Akathisia
• Tremor
• Rigidity
• Akinesia 
• Tardive dyskinesia
• Insomnia
• Agitation 
• Seizures
• Neuroleptic malignant syndrome 

Cardiovascular Disorders

• QT prolongation 
• ST depression
• U-Wave and T-Wave changes
• Ventricular arrhythmias 
• Atrial arrhythmias
• A-V block
• Ventricular tachycardia
• Ventricular fibrillation
• Cardiac arrest 
• Hypotension
• Venous thromboembolism
• Pulmonary embolism 
• Deep vein thrombosis 

Respiratory Disorders

• Respiratory depression 
• Nasal stuffiness 

Gastrointestinal Disorders

• Dry mouth 

Hepatobiliary Disorders

• Jaundice

Endocrine and Metabolic Disorders 

• Hyperprolactinaemia 
• Galactorrhoea
• Gynaecomastia
• Amenorrhoea
• Impotence
• Hyponatraemia
• Intolerance to glucose 
• Hyperglycaemia

Skin and Subcutaneous Tissue Disorders

• Contact skin sensitisation 
• Rashes 
• Photosensitivity 

Immune, Blood and Lymphatic System Disorders

• Angioedema
• Urticaria
• Leukopenia
• Agranulocytosis 

Sensory Disorders

• Ocular changes
• Metallic greyish-mauve coloration of exposed skin 

Others 

• Drug withdrawal syndrome (neonates)

• Adrenaline
• Central nervous system depressants
• Anticholinergics
• Antacids
• Anti-parkinson drugs
• Lithium
• Dopaminergics
• Antidiabetic agents
• Antihypertensives
• Amphetamine
• Clonidine
• Metoclopramide
• Guanethidine
• Desferrioxamine
• QT prolonging agents
• Agents causing electrolyte imbalance
• Agents with myelosuppressive potential

None routine. Specific cases may require

• Full blood count
• Blood glucose
• Cardiac function
• Hepatic function
• Renal function

Effects on the ability to drive and use machines:

• Patients should be warned about drowsiness during the early days of treatment and advised not to drive or operate machinery

Prochlorperazine exhibits antidopaminergic and antiemetic effects, which can be attributed to its dopamine blockade in the chemoreceptor trigger zone. It also blocks anticholinergic and alpha-adrenergic receptors, which results in sedation, muscle relaxation and hypotension.

Tablet 5mg

• Mitil (Pharmacare)
• Scripto-metic (Adcock)
• Stemetil (Sanofi) originator

Suppositories 5mg

• Stemetil (Sanofi) originator

Suppositories 25mg

• Stemetil (Sanofi) originator

Injection (per ml) 12.5mg

• Stemetil 1.25% M/V Inj 1(Sanofi) originator