Omidon Pediatric Drops

Indications

Omidon is recommended for:

• Dyspeptic symptom complex: Often related to delayed gastric emptying, gastroesophageal reflux, and esophagitis. This includes:
  • A sense of fullness in the upper abdomen, abdominal bloating, upper abdominal pain
  • Belching, gas, early feeling of fullness
  • Nausea and vomiting
  • Heartburn, with or without regurgitation of stomach contents
  • Non-ulcer indigestion
• Acute nausea and vomiting: For cases arising from functional, organic, infectious, dietary causes, or induced by radiotherapy, drug therapy, or migraine.
• Parkinson’s disease: Helps manage dopamine-agonist-induced nausea and vomiting.
• Radiological studies: Used to accelerate barium movement during follow-through radiological exams.

Pharmacology

Domperidone is a dopamine receptor antagonist that primarily targets receptors in the Chemoreceptor Trigger Zone (CTZ) and stomach. It promotes gastrointestinal motility by blocking dopamine receptors that influence gut movement. Due to its limited ability to cross the blood-brain barrier, domperidone generally avoids psychotropic or neurological side effects. This action aids in restoring normal gastrointestinal function, enhancing stomach emptying, and promoting coordinated esophageal and gastric muscle movements. It also increases esophageal peristalsis and the pressure at the lower esophageal sphincter, helping to prevent stomach content regurgitation.

Dosage & Administration

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

• Adults: 10-20 mg (1-2 tablets or 10-20 ml suspension) every 6-8 hours, with a maximum daily dose of 80 mg.
• Children: 2-4 ml suspension per 10 kg body weight, or 0.4-0.8 ml pediatric drops per 10 kg body weight, every 6-8 hours.

For dyspeptic symptoms:

• Adults: 10-20 mg every 6-8 hours.
• Children: 0.2-0.4 mg/kg body weight every 6-8 hours.

For acute nausea and vomiting:

• Adults: 20 mg every 6-8 hours.
• Children: 0.2-0.4 mg/kg every 6-8 hours (maximum treatment duration for acute nausea and vomiting is 12 weeks).

For rectal use (suppositories):

• Adults: 30-60 mg every 4-8 hours.
• Children: Maximum daily dose of 30 mg for those weighing 10-25 kg, with doses divided as needed. Treatment period is up to 12 weeks.

Interactions

• With anticholinergic drugs: May counteract domperidone’s dyspeptic effect.
• Antacids and acid suppressors: Should not be taken at the same time, as they reduce domperidone’s bioavailability.
• CYP3A4 inhibitors: Caution is advised as they can increase domperidone levels. Examples include azole antifungals, macrolide antibiotics, and HIV protease inhibitors.

Domperidone may influence the absorption of other medications, especially those with delayed-release or enteric coatings. However, it has shown no significant impact on drugs like digoxin or paracetamol in stabilized patients.

Contraindications

Domperidone is not recommended for individuals with known hypersensitivity to it, neonates, or those with conditions where gastrointestinal stimulation could be harmful, such as gastrointestinal bleeding, blockage, or perforation. It is also contraindicated in patients with prolactin-secreting pituitary tumors (prolactinomas).

Side Effects

Side effects are uncommon but may include:

• Temporary intestinal cramps
• Rare extrapyramidal symptoms in young children, which resolve after discontinuation
• Increases in prolactin levels, potentially leading to galactorrhea and gynecomastia
• Rare allergic reactions like rash or hives

Pregnancy & Lactation

In animal studies, domperidone showed no teratogenic effects even at high doses. However, its use in the first trimester should be reserved for cases where benefits justify the risk. Although detected in breast milk at low concentrations, breastfeeding while on domperidone is generally discouraged unless benefits outweigh potential risks.

Special Precautions

• Children: Extra caution is advised for young children due to the possibility of extrapyramidal effects.
• Liver conditions: Caution is advised for patients with liver impairment due to domperidone’s high metabolism rate in the liver.

Use in Specific Populations

• Infants: Due to an underdeveloped blood-brain barrier, infants may have an increased risk of neurological side effects.
• Liver impairment: Patients with hepatic issues should use domperidone with caution.
• Kidney impairment: Patients with severe renal insufficiency may require a reduced dose frequency.

Overdose Management

Overdose symptoms may include drowsiness, confusion, and extrapyramidal effects. Treatment may involve activated charcoal, observation, and possibly anticholinergic, antiparkinson, or antihistamine medications to manage symptoms.

Storage

Store below 30°C, shielded from light and moisture. Keep out of reach of children.