Domperidone Maleate
Indications
Domperidone Maleate is used for:
Domperidone Maleate is indicated in-
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
Eructation, flatulence, early satiety
Nausea and vomiting
Heartburn with or without regurgitations of gastric contents in the mouth
Non-ulcer dyspepsia
Acute nausea and vomiting of the functional, organic, infectious, dietetic origin or induced by radiotherapy or drug therapy or induced in migraine.
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies
Adult Dose
Child Dose
Renal Dose
Administration
Contra Indications
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
Precautions
Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
Pregnancy-Lactation
Domperidone given to animals at doses up to 160 mg/kg/day did not produce teratogenic effects. However, as most medicines, domperidone should only be used during the first trimester of pregnancy if this is justified by the anticipated therapeutic benefit. Up to now, there has been no evidence of any increase in the risk of malformations in humans. The drug is excreted in breast milk of lactating rats. In women, domperidone concentrations in breast milk is 4 times lower than corresponding plasma concentrations. It is not known whether this is harmful to the newborn. Therefore nursing is not recommended for mothers who are taking domperidone, unless the expected benefits outweigh any potential risk. Effects on ability to drive and use machines: Domperidone does not affect the mental alertness.
Interactions
Concomitant administration of anticholinergic drugs may antagonise the antidyspeptic effect of domperidone: Antacids and antisecretory drugs should not be given simultaneously with domperidone 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: azole antifungals, macrolide antibiotics. HIV protease inhibitors, nefazodone, etc. Theoretically, since domperidone 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 stabilised on digoxin or paracetamol, concomitant administration of domperidone did not influence the blood levels of these drugs.
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.
Adverse Effects
Side effects of Domperidone Maleate :
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 case this hyperprolactinaemia may give rise to neuroendocrinological phenomena such as galactorrhoea 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.