Omidon Pediatric Drops

Indications

Domperidone is indicated for managing a range of dyspeptic symptoms commonly linked to delayed gastric emptying, gastroesophageal reflux, and esophagitis. These include:

• A sensation of fullness in the upper abdomen
• Abdominal distension and pain
• Eructation and flatulence
• Early satiety
• Nausea and vomiting
• Heartburn, potentially accompanied by regurgitation of gastric contents
• Non-ulcer dyspepsia

Additionally, it is effective for acute nausea and vomiting due to functional, organic, infectious, or dietary causes, as well as those induced by radiotherapy or medication, including migraines.

In patients with Parkinson’s disease, Domperidone addresses nausea and vomiting caused by dopamine agonist therapies. It also aids in accelerating barium transit during follow-through radiological studies.

Pharmacology

Domperidone functions as a dopamine antagonist, primarily blocking dopamine receptors in the Chemoreceptor Trigger Zone (CTZ) and the stomach. Its gastroprokinetic effects enhance gastrointestinal motility by inhibiting dopamine receptors. Due to its limited ability to cross the blood-brain barrier, Domperidone minimizes the risk of psychotropic and neurological side effects. It promotes normal motility and tone in the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis, and regulates pyloric contractions. Additionally, Domperidone increases esophageal peristalsis and lower esophageal sphincter pressure, reducing the likelihood of gastric regurgitation.

Dosage & Administration

Domperidone should be administered 15-30 minutes prior to meals, and if needed, before bedtime. The standard oral dosages are:

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

For dyspeptic symptoms:

• Adults: 10-20 mg (1-2 tablets or 10-20 ml suspension) every 6-8 hours.
• Children: 0.2-0.4 mg/kg (2-4 ml suspension or 0.4-0.8 ml pediatric drops) every 6-8 hours.

For acute conditions (such as nausea and vomiting):

• Adults: 20 mg (2 tablets or 20 ml suspension) every 6-8 hours.
• Children: 0.2-0.4 mg/kg every 6-8 hours (maximum treatment duration of 12 weeks).

Rectal administration (suppositories):

• Adults: 30-60 mg every 4-8 hours.
• Children: Maximum daily dose of 30 mg for those weighing 10 to 25 kg, potentially divided throughout the day. Treatment duration should not exceed 12 weeks.

Always follow your healthcare provider’s advice regarding medication use.

Interactions

The effectiveness of Domperidone may be reduced by concomitant use of anticholinergic medications. Antacids and antisecretory drugs should not be taken simultaneously with Domperidone, as they can decrease its bioavailability. Domperidone metabolism primarily occurs via CYP3A4; drugs that inhibit this enzyme may raise plasma levels of Domperidone. Examples include azole antifungals and macrolide antibiotics. Domperidone can affect the absorption of orally administered drugs, particularly those that are sustained release or enteric coated. However, studies have shown no significant impact on blood levels of digoxin or paracetamol when used together.

Domperidone does not enhance the effects of neuroleptics and can mitigate peripheral side effects of dopaminergic agonists, such as nausea and vomiting, without interfering with their central actions.

Contraindications

Domperidone is contraindicated in patients with known hypersensitivity to the drug and should not be used in neonates. It is also inadvisable for patients with gastrointestinal conditions where stimulation could be dangerous (e.g., gastrointestinal hemorrhage, mechanical obstruction, or perforation) and in individuals with prolactin-secreting pituitary tumors (prolactinomas).

Side Effects

Side effects are uncommon; however, some transient intestinal cramps may occur. Extrapyramidal symptoms are rare in adults and primarily affect young children but typically resolve completely upon discontinuation. Domperidone may elevate plasma prolactin levels, occasionally leading to side effects like galactorrhea and gynecomastia. Neurological side effects may be more likely in infants due to an immature blood-brain barrier. Rare allergic reactions, including rash and urticaria, have also been noted.

Pregnancy & Lactation

Animal studies show no teratogenic effects at high doses, but Domperidone should only be used during the first trimester if the benefits outweigh risks. Current data do not indicate an increased risk of malformations in humans. Domperidone is present in breast milk, but concentrations are significantly lower than in maternal plasma, and it is unknown whether this poses risks to newborns. Nursing is generally not recommended while using Domperidone unless the expected benefits justify potential risks.

Precautions & Warnings

Caution is advised when administering Domperidone to children due to the heightened risk of extrapyramidal reactions. Given that Domperidone is metabolized in the liver, it should be used with care in patients with hepatic impairment.

Use in Special Populations

Infants: Caution is paramount when prescribing to infants, given the potential for neurological side effects. Liver Disorders: Use cautiously in patients with liver impairment due to high hepatic metabolism. Kidney Disorders: In severe renal insufficiency, Domperidone’s half-life may increase. While the initial dose may not need adjustment, long-term treatment should involve reduced dosing frequency.

Overdose Effects

Overdose may result in drowsiness, disorientation, and extrapyramidal reactions, especially in children. In case of overdose, activated charcoal administration and close patient monitoring are recommended. Anticholinergic, antiparkinson, or antihistamines with anticholinergic properties may help manage extrapyramidal symptoms.

Therapeutic Class

Motility Stimulants, Dopamine Antagonists, Prokinetic Agents

Storage Conditions

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