1. The dyspeptic symptom complex that is often associated with delayed
gastric emptying, gastro esophageal reflux and esophagitis:
- Epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain, bloating, eructation, flatulenc
- Nausea and vomiting
- Heart burn with or without regurgitations of gastric contents in the mouth.
2. Nausea and vomiting of functional, organic, infectious or dietetic origin or
induced by radiotherapy or drug therapy. A specific indication is nausea
and vomiting induced by dopamine agonists, as used in Parkinson’s disease
(such as L-dopa and bromocriptine).
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Contraindications
Domperidone is contraindicated in patients with known intolerance to the drug. Domperidone should not be used whenever stimulation of gastric motility might be dangerous, e.g. in the presence of gastro-intestinal hemorrhage. Mechanical obstruction or perforation. Domperidone is also contra-indicated in patients with a prolactin-releasing pituitary tumor (prolactinoma).
Adverse reactions
Side effects are rare; exceptionally some transient intestinal cramps have been reported. Extrapyramidal phenomena are rare in young children and exceptional in adults; they reverse spontaneously and completely as soon as the treatment is stopped. As the pituitary gland is located outside the blood-brain barrier, Domperidone may induce an increase in the plasma prolactin level. In rare areas, this hyperprolactinaemia may give rise to neuro-endocrinological phenomena such as galactorrhea and gynaecomastia. When the blood-brain barrier is immature (as in infants) or impaired, the possible occurrence of neurological side effects cannot be totally excluded. Rare allergic reactions, such as rash and urticaria, have also been reported.
Warnings and Precautions
When antacids or antisecretory agents are used concomitantly, they should be taken after meals and not before meals, i.e. they should not be taken simultaneously with domperidone tablets and suspension.
Use in infants
Because the metabolic and blood-brain barrier functions are not fully developed during the first months of life, any drug should be given to infants with great caution and under close medical supervision. Since the typical absence of neurological side effects with domperidone is mainly due to its poor penetration through the blood-brain barrier, the possible occurrence of such effects cannot be totally excluded in infants under 1 year of age.
Use in liver disorders
Since domperidone is highly metabolized in the liver. Domperidone should be used with caution in patients with hepatic impairment.
Use in kidney disorders
In patients with severe renal insufficiency (serum creatinine> 6 mg/100 ml, i.e. > 0.6 mmol/l) the elimination half life of domperidone was increased from 7.4 to 20.8 hours, but plasma drug levels were lower than in healthy volunteers. Since very little unchanged drug is excreted via the kidneys, it is unlikely that the dose of a single acute administration needs to be adjusted in patients with renal insufficiency. However, on repeated administration, the dosing frequency should be reduced to once or twice daily, depending on the severity of the impairment, and the dose may need to be reduced. Generally, patients on prolonged therapy should be reviewed regularly.
Interactions
Concomitant administration of anticholinergic drugs may antagonize the anti-dyspeptic effect of domperidone. Antacids and antisecretory drugs should not be given simultaneously with domperidone tablets and suspension as they lower its oral bioavailability. The main metabolic pathway of domperidone is through CYP3A4, in vitro data suggest that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone. Examples of CYP3A4 inhibitors include the following:
· Azole antifungals
· Macrolides antibiotics
· HIV protease inhibitors
· Nefazodone
Theoretically, since domperidone has gastrokinetic 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 did not influence the blood levels of these drugs. Domperidone may also be associated with:
· Neuroleptics, the action of which it does not potentiate,
· Dopaminergic agonists (bromocriptine, L-dopa), whose unwanted peripheral effects such as digestive disorders, nausea and vomiting it suppresses without counteracting their central properties.
Dosage and Administration
- Chronic dyspepsia (mainly oral administration)
Adults: 10 mg (1 tablet, or 10 ml) 3 times daily, 15-30 minutes before meal and if necessary once more before retiring.
Children: oral suspension: 2.5 ml per 10 kg body weight. 3 times daily, before meals and, if necessary once more in the evening.
When results are not satisfactory, the above dosage may be doubled in adults and children over 1 year of age.
- Acute and subacute conditions (particularly nausea and vomiting)
Adults: 20 mg (2 tablets, or 20 ml, 3-4 times daily before meals and before bedtime.
Children: Oral: 5 ml per 10 kg body weight, 3-4 times daily before meals and before bedtime.
Overdosage
Symptoms of overdosage may include drowsiness, disorientation and extra pyramidal reactions, especially in children. In case of overdosage, the administration of activated charcoal, and close observation of the patient are recommended. Anticholinergic, anti-Parkinson drugs or antihistamines with anticholinergic properties may be helpful in controlling the extrapyramidal reactions.
Storage
Store at room temperature. Protect from light. Store in a cool dry place.
Keep all medicines out of the reach of children.
Presentation
Domperidone tablets, blister of 5 x 10’s
Domperidone suspension, bottle of 120 ml |
