Motilium

Motilium

domperidone

Manufacturer:

Johnson & Johnson
Full Prescribing Info
Contents
Domperidone.
Action
Pharmacology: Mechanism of actions: Domperidone is a dopamine antagonist with antiemetic properties. Domperidone does not readily cross the blood-brain barrier. It seldom causes extrapyramidal side effects, but does cause a rise in prolactin levels. Its antiemetic effect may be due to a combination of peripheral (gastrokinetic) effects and antagonism of central dopamine receptors in the chemoreceptor trigger zone which lies in the area postrema and is regarded as being outside the blood-brain barrier. It also antagonizes the behavioral effects of dopamine much more effectively when administered intracerebrally than when given systemically. These findings, together with the low concentrations found in the brain, indicate a predominantly peripheral effect of domperidone on dopamine receptors. Studies in humans have shown intravenous and oral domperidone to increase lower oesophageal pressure, improve antroduodenal motility and accelerate gastric emptying. Domperidone has no effect on gastric secretion.
Indications/Uses
Symptomatic treatment of the dyspeptic symptom complex that may be associated with delayed gastric emptying such as epigastric sense of fullness, abdominal distension or swelling, or epigastric pain or discomfort. Treatment of acute symptoms of nausea and vomiting. There is insufficient evidence to support the use of domperidone in childhood gastrooesophageal reflux disease. Domperidone may be suitable for chemotherapy- or radiotherapy-induced nausea and vomiting or post-operative nausea and vomiting.
Dosage/Direction for Use
Chronic dyspepsia: 1 tablet three times daily, 15-30 mins before meal and once again before bed-time (when necessary).
Nausea and vomiting: 1 tablet three times daily, before meal and before bed-time.
The max dose is 30 mg daily.
Children: Nausea & vomiting due to chemotherapy and irradiation: 2.5 ml/10 kg body weight, 3-4 times daily before meal and before bed-time.
Overdosage
Overdose has been reported primarily in infants and children.
Symptoms: May include agitation, altered consciousness, convulsion, disorientation, somnolence and extrapyramidal reactions.
Treatment: There is no specific antidote to domperidone. Anticholinergics, anti-Parkinsonian agents may be helpful in controlling the extrapyramidal reactions. Close observation and supportive therapy is recommended. For advice on the management of overdose please contact the National Poisons Centre.
Contraindications
Known hypersensitivity to domperidone or any of the excipients; Prolactin-releasing pituitary tumour (prolactinoma); Co-administration with potent CYP3A4 inhibitors has been shown to increase domperidone concentrations to the point where QT interval prolongation may occur. Examples of potent CYP3A4 inhibitors include some azole antifungals (eg, intraconazole, voriconazole, posaconzazole), some macrolide antibiotics (eg, clarithromycin, telithromycin), and some protease inhibitors (ritonavir, saquinavir, telaprevir); MOTILIUM should not be used whenever stimulation of gastrointestinal motility might be dangerous such as in the presence of gastrointestinal haemorrhage, mechanical obstruction, or perforation; Patients with moderate or severe hepatic impairment.
Special Precautions
Cardiovascular effects: MOTILIUM should be used with caution in older patients or those with current or history of cardiac disease. An increase in the risk of serious ventricular arrhythmias and sudden cardiac death has been reported in epidemiology studies.
Drug interaction potential: The main metabolic pathway of domperidone is through CYP3A4. In vitro and human data show that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone. Co-administration of domperidone with potent CYP3A4 inhibitors which have been shown to cause QT interval prolongation is contraindicated. Caution should be exercised when domperidone is co-administered with potent CYP3A4 inhibitors which have not been shown to cause QT interval prolongation such as indinavir and patients should be monitored closely for signs or symptoms of adverse reactions.
Adverse Reactions
Immune System Disorders: Very rare: Anaphylactic Reaction (including Anaphylactic Shock).
Psychiatric Disorders: Very rare: Agitation, Nervousness.
Nervous System Disorders: Very rare: Dizziness, Extrapyramidal Disorder, Convulsion.
Cardiac Disorders: Very rare: Sudden Cardiac Death, Serious Ventricular Arrhythmias.
Investigations: Very rare: Liver Function Test Abnormal, Blood Prolactin Increased.
Skin and Subcutaneous Tissue Disorders: Very rare: Angioedema, Urticaria.
Renal and Urinary Disorders: Very rare: Urinary Retention.
Reproductive System and Breast Disorders: Rare: Gynecomastia, Amenorrhea.
Drug Interactions
Concomitant administration of anticholinergic drugs may antagonize the anti‐dyspeptic effect of MOTILIUM.
If administered prior to atropine, domperidone reduces the relaxant effect of atropine upon the lower esophageal sphincter but has no reversing effect if atropine is administered first. The main metabolic pathway of domperidone is through the cytochrome P450 isoenzyme CYP3A4. In vitro and human data show that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone.
When domperidone was co‐administered with potent CYP3A4 inhibitors which have been shown to cause QT- interval prolongation, clinically relevant changes in QT intervals were observed.
Caution should be exercised when domperidone is co‐administered with potent CYP3A4 inhibitors which have not been shown to cause QT interval prolongation or drugs which have been shown to cause QT interval prolongation.
MOTILIUM has gastro‐kinetic effects, it could influence the absorption of concomitantly orally administered drugs, particularly those with sustained‐release or enteric‐coated formulations. However, in patients already stabilized on digoxin or paracetamol, concomitant administration of domperidone did not influence the blood levels of these drugs.
Domperidone has been used with: neuroleptics, without potentiation of their activity; dopaminergic agonists (bromocriptine, L‐dopa) for suppression of unwanted peripheral effects such as digestive disorders, nausea and vomiting, without affecting their central activity.
Storage
Store in temperatures 30°C or below.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories
ATC Classification
A03FA03 - domperidone ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Presentation/Packing
Tab 10 mg x 10 x 10's. Syr 1 mg/mL x 60 mL x 1's.
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