Domperidone

Registered South African indications:

• Nausea and vomiting
• Delayed gastric emptying

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients
• Moderate or severe hepatic impairment
• Prolactinoma
• Gastrointestinal haemorrhage
• Gastrointestinal mechanical obstruction or perforation
• QT prolongation or risk factors thereof
• Cardiovascular disease
• Coadministration with QT prolonging agents
• Coadministration with CYP3A4 inhibitors

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment
• Mild hepatic impairment
• Children
• High doses _2,3,4,U2D
• Lactose intolerance (tab)
• Galactosaemia (tab)
• Glucose-galactose malabsorption (tab)
• Fructose intolerance (sus)

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

Short-term management of delayed gastric emptying of functional origin with gastro-oesophageal reflux and/or dyspepsia
Nausea and vomiting of central or local origin
Post-cytotoxic chemotherapy/radiotherapy nausea and vomiting
Facilitation of radiological examination of the upper gastrointestinal tract

• Oral (tab, sus): 10mg, 8hrly; Max: 30mg/24hrs; Max treatment duration: 1 week

Take dosages 15-30min before meals

If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed - the dose should not be doubled to make up for a missed dose

Paed. forms avail. in SA and covered in this monograph: sus

Short-term management of delayed gastric emptying of functional origin with gastro-oesophageal reflux and/or dyspepsia
Nausea and vomiting of central or local origin
Post-cytotoxic chemotherapy/radiotherapy nausea and vomiting
Facilitation of radiological examination of the upper gastrointestinal tract

Younger than 12 years (<35kg)

• Oral (sus): 0.25mg/kg, 8hrly; Max: 0.75mg/kg (max: 35mg)/24hrs; Max treatment duration: 1 week

Older than 12 years (>35kg)

• See adult dosage

Take dosages 15-30min before meals

If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed - the dose should not be doubled to make up for a missed dose

Pregnancy 

• Caution
• There are limited post-marketing data on the use of domperidone in pregnant women. Studies in animals have shown reproductive toxicity at maternally toxic doses. Domperidone should only be used during pregnancy when justified by the anticipated therapeutic benefit

Breastfeeding

• Caution; not recommended
• Domperidone is excreted in human milk and breastfed infants receive less than 0.1 % of the maternal weight-adjusted dose. Occurrence of adverse effects, in particular, cardiac effects cannot be excluded after exposure via breast milk. A decision should be made whether to discontinue breastfeeding or to discontinue/abstain from domperidone therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Caution should be exercised in case of QTc prolongation risk factors in breastfed infants

Renal Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; dose adjustment recommended

Hepatic Impairment

• Mild: Caution; no dose adjustment recommended
• Moderate to severe: Contraindicated 

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Loss of libido
• Anxiety
• Somnolence
• Headache
• Agitation
• Nervousness
• Extrapyramidal disorders
• Seizures
• Asthenia

Cardiovascular Disorders

• Ventricular arrhythmias
• QT prolongation
• Torsade de pointes
• Sudden cardiac death

Gastrointestinal Disorders

• Dry mouth
• Diarrhoea

Hepatobiliary Disorders

• Abnormal liver function tests 

Genitourinary Disorders

• Galactorrhoea
• Breast pain
• Breast tenderness
• Gynaecomastia
• Amenorrhoea

Endocrine and Metabolic Disorders

• Increased blood prolactin 

Skin and subcutaneous tissue disorder

• Rash
• Pruritus
• Urticaria
• Angioedema

Immune, Blood and Lymphatic System Disorders

• Anaphylactic reactions 

Sensory Disorders

• Oculogyric crisis

• QT prolonging agents
• CYP3A4 inhibitors
• Agents that cause bradycardia
• Potassium-depleting agents
• Macrolides
• Antacids
• Antisecretory agents
• Anticholinergic agents
• Protease inhibitors

• Renal function
• ECG

Domperidone is a dopamine antagonist. It facilitates gastric emptying and decreases small bowel transit time by increasing esophageal and gastric peristalsis and by lowering esophageal sphincter pressure. The antiemetic properties of domperidone are related to its dopamine receptor blocking activity at both the chemoreceptor trigger zone and at the gastric level. Domperidone also promotes the release of prolactin from the pituitary.

Tablet 10mg

• Bio Domperidone (Biotech)
• Motilium (Janssen) originator
• Vomi-Guard (Camox)
• Vomidon (Be-Tabs)

Suspension (per ml) 1mg

• Motilium (Janssen) originator