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Domperidone Maleate

Generic Medicine
Indications

Domperidone Maleate is indicated for the following:

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 (belching), Flatulence, Early satiety
  • Nausea and vomiting
  • Heartburn with or without regurgitation of gastric contents into the mouth
  • Non-ulcer dyspepsia

Acute Nausea and Vomiting of: Functional, organic, infectious, or dietetic origin,  Induced by radiotherapy or drug therapy, Induced in migraine.

Parkinson's Disease: For dopamine-agonist-induced nausea and vomiting.

Radiological Studies: Speeding barium transit in follow-through radiological studies.

Pharmacology

Domperidone is a dopamine antagonist that primarily blocks dopamine receptors in the Chemoreceptor Trigger Zone (CTZ) and the stomach. Its ability to improve gastrointestinal movement comes from this receptor-blocking action, which enhances the motility of the digestive tract. Because Domperidone only weakly crosses the blood-brain barrier, it has minimal impact on dopamine receptors in the brain, avoiding psychotropic or neurological side effects. Domperidone helps restore normal movement and muscle tone in the upper gastrointestinal tract. It supports faster gastric emptying, promotes peristalsis in the antrum and duodenum, and regulates the contraction of the pylorus. Additionally, it increases esophageal peristalsis and strengthens the lower esophageal sphincter, helping prevent the backflow of stomach contents into the esophagus.

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 tablets 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 symptoms:

  • Adults: 10-20 mg (1-2 tablets 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, the 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 is 30 mg for those weighing 10 to 25 kg. The dose may be divided throughout the day if necessary.
  • The maximum period of treatment is 12 weeks.
Interactions

Taking Domperidone together with anticholinergic drugs may reduce its digestive benefits. Antacids and antisecretory medications should not be taken at the same time, as they can lower the oral absorption of Domperidone. Domperidone is primarily metabolized through CYP3A4, so drugs that strongly inhibit this enzyme, such as azole antifungals, macrolide antibiotics, HIV protease inhibitors, or nefazodone, may increase blood levels of Domperidone. Because Domperidone affects gastrointestinal motility, it could theoretically alter the absorption of other oral drugs, especially sustained-release or enteric-coated forms. However, in patients already stabilized on digoxin or paracetamol, Domperidone does not significantly change their blood levels.

  • Domperidone does not enhance the effects of neuroleptics.
  • It can reduce unwanted peripheral effects like digestive disturbances, nausea, or vomiting of dopaminergic agonists (e.g., bromocriptine, L-dopa) without interfering with their central effects.
Contraindications

Domperidone should not be used by patients with known hypersensitivity to it or in neonates. It is contraindicated in conditions where gastrointestinal stimulation could be dangerous, such as gastrointestinal hemorrhage, obstruction, or perforation. It is also contraindicated in patients with prolactin-secreting pituitary tumors (prolactinoma).

Side Effects

Side effects are uncommon. Some patients may experience transient intestinal cramps. Extrapyramidal reactions are rare in children and extremely rare in adults; they disappear completely once the treatment is stopped. Domperidone may raise plasma prolactin levels because the pituitary gland lies outside the blood-brain barrier. Rarely, this may lead to galactorrhea or gynecomastia. Neurological side effects are possible in infants or patients with impaired blood-brain barrier. Allergic reactions such as rash or urticaria have been reported rarely.

Pregnancy & Lactation

Animal studies with doses up to 160 mg/kg/day did not show teratogenic effects. In humans, Domperidone should only be used in the first trimester if clearly justified by the expected benefits. No evidence currently suggests an increased risk of birth defects. Domperidone is present in breast milk at lower concentrations than in plasma; potential harm to the newborn is unknown, so breastfeeding is generally not recommended unless benefits outweigh risks. Domperidone does not affect mental alertness, so driving or operating machines is generally safe.

Precautions & Warnings

Domperidone should be used with caution in children due to a higher risk of extrapyramidal reactions from an underdeveloped blood-brain barrier. Patients with liver impairment should also use it cautiously, as the drug is highly metabolized in the liver.

Special Populations

In infants, the metabolic and blood-brain barrier systems are immature, so Domperidone must be given with great caution under close medical supervision. In liver disorders, caution is required due to high hepatic metabolism. In severe kidney disorders, the elimination half-life increases, so dosing frequency may need adjustment for repeated use. Patients on prolonged therapy should be monitored regularly.

Overdose Effects

Symptoms of overdose may include drowsiness, disorientation, and extrapyramidal reactions, especially in children. Treatment may involve activated charcoal and close observation. Anticholinergic or antiparkinson medications may help manage extrapyramidal reactions.

Therapeutic Class

Motility Stimulants , Motility stimulants / Dopamine antagonist, Prokinetic drugs

Storage Conditions

tore below 30°C. Protect from light and moisture. Keep out of children's reach.

Common Questions

What is Domperidone Maleate for?

What does Domperidone Maleate do?

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Can Domperidone Maleate be taken during pregnancy?

No available drugs found

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