Generic: Domperidone Maleate  |  Dosage Form: Tablet  |  Manufacturer: Pristine Pharmaceuticals Ltd

Indications

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.

Dosage & Administration

Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.

The usual recommended oral dose of Domperidone is as follows:

• Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
• Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.

In dyspeptic symptom:

• Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
• Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.

In acute and sub-acute conditions (mainly in acute nausea and vomiting):

• Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
• Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).

By rectum in suppositories:

• Adults (including elderly): 30-60 mg every 4-8 hours.
• Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
• The maximum period of treatment is 12 weeks.

Interaction

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.

Contraindications

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).

Side Effects

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.

Precautions & Warnings

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.

Overdose Effects

Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal reactions, especially in children. In case of overdosage, the administration of activated charcoal, and close observation of the patients are recommended. Anticholinergic, antiparkinson drugs or antihistamines with anticholinergic properties may be helpful in controlling the extrapyramidal reactions.

Therapeutic Class

Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs

Storage Conditions

Store below 30°C, Protected from light & moisture. Keep out of children's reach.