Usage
Domperidone + Sucralfate is prescribed for the treatment of peptic ulcers, gastroesophageal reflux disease (GERD), indigestion, acidity, and nausea/vomiting associated with these conditions. It falls under the pharmacological classifications of gastrointestinal agents, antiemetics, and mucosal protectants. The combination works by protecting the stomach lining and promoting ulcer healing (sucralfate) while also reducing nausea and vomiting (domperidone).
Alternate Names
There are no widely recognized alternate names for the combination itself. However, the individual components have various international and regional variations. Domperidone may be known as Motilium in some regions. Brand names for the combination product vary depending on the manufacturer and country, and include Domsafe and Sucrafil D.
How It Works
Sucralfate: This agent acts locally in the stomach, forming a viscous, adhesive paste that binds to the ulcer base, creating a protective barrier against gastric acid, pepsin, and bile salts. This promotes ulcer healing and reduces pain. It has limited systemic absorption, and what is absorbed is primarily excreted renally.
Domperidone: This is a dopamine antagonist that acts primarily on peripheral dopamine D2 receptors in the chemoreceptor trigger zone (CTZ) located outside the blood-brain barrier. It blocks dopamine’s action in the CTZ, preventing nausea and vomiting. It increases lower esophageal sphincter pressure, and improves gastric emptying. Domperidone undergoes hepatic metabolism primarily via CYP3A4.
Dosage
Standard Dosage
Adults:
The typical adult dose is 1 gram of sucralfate and 10 mg of domperidone, administered orally, 15-30 minutes before meals and at bedtime for 4-8 weeks for active duodenal ulcer and up to 1 year for prophylaxis.
Children:
Dosage in children must be determined by a physician. Recommendations range from 200-80 mcg/kg/dose of domperidone and 40-80 mg/kg/day of sucralfate given three to four times daily.
Special Cases:
- Elderly Patients: Begin therapy at the lower end of the dosing range and monitor renal function.
- Patients with Renal Impairment: Use with caution. Sucralfate contains aluminum, which can accumulate in renal failure. Dosage adjustments may be required.
- Patients with Hepatic Dysfunction: Domperidone should be used with caution in patients with moderate to severe hepatic impairment due to the risk of increased serum concentrations. Dosage adjustments may be needed.
- Patients with Comorbid Conditions: Use with caution in patients with cardiac conditions. Domperidone has been linked to QT interval prolongation.
Clinical Use Cases
The combination is primarily used for peptic ulcer disease and associated symptoms. Dosage does not typically vary for clinical settings like intubation, surgery, or ICU use.
Dosage Adjustments
Always consider renal and hepatic function when prescribing this combination. Dosage modifications are based on individual patient factors and clinical response. Monitor electrolyte levels in patients with renal impairment.
Side Effects
Common Side Effects:
Constipation, dry mouth, headache, dizziness, drowsiness, diarrhea, and abdominal discomfort.
Rare but Serious Side Effects:
Allergic reactions (rash, itching, swelling), irregular heartbeat (QT prolongation), extrapyramidal symptoms (tremors, muscle rigidity).
Long-Term Effects:
Hyperprolactinemia and associated side effects such as galactorrhea, gynecomastia, and menstrual irregularities may be seen with long-term domperidone use.
Adverse Drug Reactions (ADR):
Severe allergic reactions (anaphylaxis), cardiac arrhythmias, neuroleptic malignant syndrome.
Contraindications
Hypersensitivity to domperidone or sucralfate, gastrointestinal hemorrhage, mechanical bowel obstruction, prolactinoma, QT prolongation, concomitant use of strong CYP3A4 inhibitors.
Drug Interactions
Domperidone interacts with CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin) and inducers (rifampin, phenytoin). Sucralfate can reduce the absorption of other drugs; administer other medications at least 2 hours apart. Antacids may decrease sucralfate’s effectiveness.
Pregnancy and Breastfeeding
Domperidone is generally considered safe during pregnancy. However, it is excreted in breast milk. Consult a physician before using during breastfeeding.
Drug Profile Summary
- Mechanism of Action: Sucralfate: Mucosal protectant; Domperidone: Dopamine antagonist.
- Side Effects: Constipation, dry mouth, headache, dizziness, extrapyramidal symptoms (rare).
- Contraindications: Hypersensitivity, GI bleeding, obstruction, prolactinoma, QT prolongation.
- Drug Interactions: CYP3A4 inhibitors/inducers, antacids.
- Pregnancy & Breastfeeding: Relatively safe in pregnancy, excreted in breast milk.
- Dosage: Adults: 1g sucralfate + 10mg domperidone 15-30 minutes before meals and at bedtime; Pediatric dosage varies.
- Monitoring Parameters: ECG (for QT prolongation), renal function tests (for aluminum accumulation).
Popular Combinations
Frequently combined with proton pump inhibitors (PPIs) or H2 blockers in managing peptic ulcer disease.
Precautions
Screen for allergies, cardiac conditions, and renal/hepatic dysfunction. Caution advised in elderly patients. Avoid alcohol.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Domperidone + Sucralfate?
A: Adults: 1g sucralfate and 10mg domperidone 15-30 minutes before meals and at bedtime. Pediatric doses are weight-based and require physician guidance.
Q2: How does sucralfate work?
A: It creates a protective barrier over ulcers, promoting healing and reducing pain.
Q3: How does domperidone work?
A: It blocks dopamine receptors, primarily in the chemoreceptor trigger zone, thus alleviating nausea and vomiting.
Q4: What are the common side effects?
A: Constipation, dry mouth, headache, and dizziness are frequently reported.
Q5: Can this combination be used during pregnancy?
A: Domperidone is generally considered low risk, but consult a physician before use.
Q6: Are there any serious drug interactions?
A: Yes, interactions with strong CYP3A4 inhibitors and antacids are notable.
Q7: Who should not take this medication?
A: Individuals with hypersensitivity, GI bleeding, obstruction, prolactinoma, or long QT syndrome.
Q8: What precautions should be taken with this drug?
A: Caution in patients with renal or hepatic impairment and the elderly. Monitor for cardiac arrhythmias.
Q9: How long should this medication be taken?
A: The duration of therapy depends on the indication and response. Ulcer treatment typically lasts 4-8 weeks, while prophylaxis can extend up to a year.
Q10: Should it be taken with food?
A: No, Domperidone + Sucralfate should be taken on an empty stomach, 15-30 minutes before meals.
