Domperidone SEDICO: The Complete Guide to Uses, Dosage, and Critical Safety Warnings

Disclaimer: This information is provided for educational purposes only and is not a substitute for professional medical advice. Always consult a licensed physician or pharmacist before starting, stopping, or changing any medication.

Domperidone SEDICO® (Domperidone)

Summary

Domperidone, the active ingredient in Domperidone SEDICO, is a medication used for the short-term relief of nausea and vomiting. It functions as a prokinetic agent by enhancing gastrointestinal motility and as an antiemetic by blocking dopamine receptors. Due to cardiovascular safety concerns, its use is restricted to specific conditions and should be administered at the lowest effective dose for the shortest possible duration under medical supervision.

Manufacturer

SEDICO Pharmaceutical Co., 6th October City, Egypt.

Category & Active Ingredient

• Category: Antiemetic, Prokinetic Agent (Dopamine D2 Receptor Antagonist).
• Active Ingredient: Domperidone.

Available Forms & Strengths in Egypt

Domperidone SEDICO is available in the following forms:

• Tablets: 10 mg.
• Oral Suspension: 5 mg / 5 ml.
• Suppositories: 10 mg, 30 mg, and 60 mg (Note: availability of all suppository strengths may vary).

Properties and Mechanism of Action

Domperidone is a selective dopamine D2 receptor antagonist. Its primary actions are:

• Prokinetic Effect: By blocking dopamine receptors in the upper gastrointestinal tract, it increases lower esophageal sphincter pressure, enhances gastric contractions, and accelerates gastric emptying.
• Antiemetic Effect: It blocks dopamine receptors in the chemoreceptor trigger zone (CTZ), an area in the brainstem that controls nausea and vomiting. As domperidone does not readily cross the blood-brain barrier, it has minimal effects on dopamine receptors in the brain, reducing the risk of central nervous system side effects compared to other agents.

Pharmacokinetics

• Absorption: Rapidly absorbed after oral or rectal administration. Peak plasma concentrations are reached within 30-60 minutes (oral).
• Bioavailability: Oral bioavailability is low (~15%) due to extensive first-pass metabolism in the gut wall and liver.
• Metabolism: Extensively metabolized by the CYP3A4 enzyme in the liver.
• Elimination Half-life: Approximately 7.5 hours.
• Excretion: Primarily eliminated in feces (66%) and urine (33%).

Indications

Domperidone is indicated for the short-term treatment and relief of symptoms of nausea and vomiting. Its use for chronic motility disorders like gastroparesis or reflux is no longer recommended in many regions due to safety concerns.

Dosage and Administration

Important: Treatment should be at the lowest effective dose for the shortest possible duration (typically not exceeding one week).

• Adults and Adolescents (12 years and older, and weighing 35 kg or more):
  • Tablets: 10 mg (1 tablet) up to three times daily.
  • Oral Suspension: 10 ml (10 mg) up to three times daily.
  • Suppositories: 30-60 mg twice daily.
• Children (under 12 years or weighing less than 35 kg): Use is highly restricted and generally not recommended due to cardiac risks. Dosage must be determined by a physician.

Domperidone should be taken 15-30 minutes before meals for optimal effect.

Contraindications

Domperidone should not be used in patients with:

• Known hypersensitivity to domperidone.
• Conditions where stimulating gastric motility could be harmful (e.g., gastrointestinal hemorrhage, mechanical obstruction, or perforation).
• A prolactin-releasing pituitary tumor (prolactinoma).
• Moderate to severe hepatic impairment.
• Known existing prolongation of cardiac conduction intervals (QTc prolongation), significant electrolyte disturbances, or underlying cardiac diseases such as congestive heart failure.
• Concomitant use with potent CYP3A4 inhibitors or QT-prolonging drugs.

Warnings & Precautions

• Cardiovascular Risk: Domperidone is associated with a small increased risk of serious ventricular arrhythmias or sudden cardiac death, particularly in patients older than 60 years, those taking daily doses greater than 30 mg, or those taking other QT-prolonging drugs.
• Renal Impairment: In patients with severe renal impairment, the elimination half-life is increased. A dose reduction or decreased frequency may be required.
• CYP3A4 Inhibitors: Avoid co-administration with potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) as this significantly increases domperidone levels and the risk of QTc prolongation.

Drug Interactions

• QT-Prolonging Drugs: Co-administration is contraindicated.
• Potent CYP3A4 Inhibitors: (e.g., azole antifungals, macrolide antibiotics, protease inhibitors) - Contraindicated.
• Antacids & Anti-secretory agents: These reduce oral bioavailability and should not be taken simultaneously. Take domperidone before meals and antacids after meals.
• Anticholinergics: May antagonize the prokinetic effects of domperidone.

Side Effects

• Common: Dry mouth.
• Uncommon: Anxiety, agitation, nervousness, decreased libido, headache, somnolence, diarrhea.
• Rare/Frequency not known:
  • Endocrine: Hyperprolactinemia, which can lead to galactorrhea (milk production), gynecomastia (breast enlargement in men), and amenorrhea (absence of menstruation).
  • Cardiovascular: Serious ventricular arrhythmias, QTc prolongation, sudden cardiac death.
  • Nervous System: Extrapyramidal symptoms (dystonic reactions), seizures.
  • Allergic: Anaphylactic shock, angioedema, urticaria.

Use in Pregnancy & Lactation

• Pregnancy: There is limited data on use in pregnant women. It should be used only if the potential benefit justifies the potential risk to the fetus, and after consulting a physician.
• Lactation: Domperidone is excreted in breast milk. Due to the potential risk of cardiac side effects in the infant, breastfeeding is not recommended during treatment.

Overdose

• Symptoms: Drowsiness, disorientation, and extrapyramidal reactions, especially in children.
• Management: There is no specific antidote. Treatment is symptomatic and supportive. Gastric lavage and administration of activated charcoal may be useful. Close cardiac monitoring (ECG) is recommended.

Storage

• Store all forms below 30°C, protected from light and moisture.
• Suppositories may require storage in a cool place (e.g., below 25°C or as specified on the package).
• Keep out of reach of children.

Presentation / Package

• Tablets: Blister packs of 20 or 100 tablets.
• Oral Suspension: Bottles of 120 ml.
• Suppositories: Packs containing suppositories of various strengths.

Frequently Asked Questions (FAQ)

Q1: Can Domperidone be used for motion sickness?

A: No, domperidone is not effective for preventing motion sickness.

Q2: Is Domperidone safe for long-term use?

A: No. Due to the risk of cardiac side effects, treatment should be for the shortest possible duration, typically no longer than one week.

Q3: Why should I take Domperidone before meals?

A: Taking it 15-30 minutes before meals allows it to start working on improving stomach motility, which helps with digestion and reduces nausea associated with eating.

Q4: Can I use Domperidone for bloating and indigestion?

A: While it has been used for these symptoms in the past, current guidelines restrict its use to nausea and vomiting due to safety concerns. Consult your doctor for safer alternatives for chronic indigestion.

References

1. European Medicines Agency (EMA). (2014). "Restrictions on the use of domperidone-containing medicines".
2. British National Formulary (BNF), "Domperidone".
3. Martindale: The Complete Drug Reference.
4. SEDICO Official Product Information Leaflet.