Drug reference

Domperidone + Omeprazole

Proton Pump Inhibitor · Anti-reflux, Anti-ulcer, Prokinetic

Also known as Ocid-D, Omez-D, Razo-D, Gerd-D, Peptard-D, Dompan-OM

Proton Pump InhibitorAnti-reflux, Anti-ulcer, ProkineticATC A02BC01 (Omeprazole) and A03FA03 (Domperidone) - FDC does not have a unique ATC code

CDSCO approvedSchedule HATC A02BC01 (Omeprazole) and A03FA03 (Domperidone) - FDC does not have a unique ATC code

Pharmacokineticsplasma · t hours

ONSET: 2h · Omeprazole: Acid suppression begins within 0.5-3.5 hours. Domperidone: 30-60 minutes.
PEAK: 2h · Omeprazole: Plasma peak concentrations achieved within 0.5-3.5 hours. Domperidone: Plasma peak concentrations achieved within 1 hour.
t½: 45min · Omeprazole: 0.5-1 hour (plasma elimination). Domperidone: 7-9 hours.
DURATION: 7h · Omeprazole: Acid suppression lasts up to 72 hours despite short plasma half-life. Domperidone: Prokinetic and antiemetic effects last 6-8 hours.

EXCRETION

—

not curated

INTERACTIONS

4 major

incl. contraindicated

PREGNANCY

C (for both omeprazole and domperidone)

FDA category + note

Top interactionssee all 12 →

AtazanavirContraindicatedTextbookG&G 14e · p1245-1266
LedipasvirSevereTextbookG&G 14e · p1238, p1242
RilpivirineSevereTextbookG&G 14e · p1245-1266
VelpatasvirSevereTextbookG&G 14e · p1239, p1242

Mechanism

Omeprazole, a proton pump inhibitor, irreversibly blocks the H+/K+-ATPase enzyme system at the secretory surface of the gastric parietal cells, thereby inhibiting the final step in gastric acid production. Domperidone, a peripheral dopamine D2 receptor antagonist, primarily acts as a prokinetic agent by enhancing gastric and intestinal motility, and as an antiemetic by blocking dopamine receptors in the chemoreceptor trigger zone, providing relief from reflux and nausea often associated with acid reflux disease. Combination rationale: This fixed-dose combination provides comprehensive treatment for gastroesophageal reflux disease and dyspepsia by targeting both acid secretion and gastric motility. Omeprazole effectively reduces gastric acid production, alleviating acid-related symptoms. Domperidone complements this action by enhancing gastric emptying and reducing reflux of gastric contents, as well as providing antiemetic relief, thus addressing multiple facets of these gastrointestinal conditions simultaneously.

Indications

Gastroesophageal Reflux Disease (GERD) with associated symptoms like nausea, vomiting, or epigastric discomfortDyspepsia with predominant reflux symptoms or delayed gastric emptyingErosive esophagitis

Dosing

Adult: Standard oral dose is one capsule once daily, typically 20mg Omeprazole (enteric coated) and 10mg Domperidone (immediate release) or 30mg Domperidone (sustained release), taken 15-30 minutes before breakfast. Higher strengths like Omeprazole 40mg + Domperidone 30mg SR are also available.
Pediatric: Generally not recommended for use in children due to limited safety and efficacy data, particularly for domperidone. Individual components may be used separately under specialist guidance.
Renal adjustment: For domperidone, the dosing interval should be increased in patients with severe renal impairment (e.g., CrCl < 30 mL/min). Omeprazole generally does not require dose adjustment in renal impairment.
Hepatic adjustment: Domperidone is contraindicated in moderate to severe hepatic impairment. Omeprazole may require dose reduction in severe hepatic impairment, although specific guidelines vary.
Geriatric: Use with caution in elderly patients due to increased risk of cardiac adverse effects, particularly QT prolongation with domperidone. Lower doses may be considered, and cardiac status should be monitored.
Max dose: Generally, one capsule per day of the standard strength FDC is the maximum recommended dose.

Pharmacokinetics

Onset

Omeprazole: Acid suppression begins within 0.5-3.5 hours. Domperidone: 30-60 minutes.

Peak effect

Omeprazole: Plasma peak concentrations achieved within 0.5-3.5 hours. Domperidone: Plasma peak concentrations achieved within 1 hour.

Duration

Omeprazole: Acid suppression lasts up to 72 hours despite short plasma half-life. Domperidone: Prokinetic and antiemetic effects last 6-8 hours.

Half-life

Omeprazole: 0.5-1 hour (plasma elimination). Domperidone: 7-9 hours.

Bioavailability

Omeprazole: ~30-40% (first dose), increasing to ~60% with repeat dosing. Domperidone: ~15% (oral).

Protein binding

Omeprazole: ~95%. Domperidone: 91-93%.

Metabolism

Omeprazole: Extensively hepatic via cytochrome P450 system (primarily CYP2C19 and CYP3A4). Domperidone: Extensively hepatic via CYP3A4.

Excretion

Omeprazole: Primarily renal (approx. 80%) as metabolites, remainder in faeces. Domperidone: Approximately 31% in urine and 66% in faeces over several days, predominantly as metabolites.

Contraindications

Hypersensitivity to omeprazole, domperidone, or any excipients
Patients with known prolongation of cardiac conduction intervals (e.g., QTc)
Patients with underlying cardiac diseases such as congestive heart failure, bradycardia, or significant electrolyte disturbances
Moderate to severe hepatic impairment
Prolactin-secreting pituitary tumour
Gastrointestinal haemorrhage, mechanical obstruction, or perforation

Side effects

Common

HeadacheNauseaDiarrheaAbdominal painFlatulenceDry mouthDizzinessRash

Serious

QT prolongation
Torsades de Pointes
Serious ventricular arrhythmias
Extrapyramidal symptoms (rare, particularly in children and young adults)
Anaphylactic reactions
Liver dysfunction
Long-term use of PPIs: increased risk of bone fractures, Clostridium difficile infection, hypomagnesemia

Pregnancy & lactation

Pregnancy

C (for both omeprazole and domperidone)

Lactation

Both omeprazole and domperidone are excreted into breast milk. Domperidone is generally not recommended during breastfeeding due to potential cardiac risks to the infant, especially premature babies. Omeprazole use should be approached with caution, and its necessity weighed against potential risks.

Drug interactions

Atazanavir

Contraindicated

Textbook

Substantially reduced atazanavir concentrations, leading to loss of antiviral effectiveness.

Proton pump inhibitors should be avoided in patients receiving atazanavir without ritonavir.

Source: G&G 14e · p1245-1266

Ledipasvir

Severe

Textbook

Reduced ledipasvir concentrations, potentially leading to treatment failure/relapse.

If PPIs must be used, their doses should not exceed the equivalent of 20 mg omeprazole once daily. Omeprazole must be administered simultaneously with LDV/SOF in the fasted state.

Source: G&G 14e · p1238, p1242

Rilpivirine

Severe

Textbook

Reduced absorption and plasma concentrations of rilpivirine, potentially leading to loss of efficacy.

Should not be given with proton pump inhibitors.

Source: G&G 14e · p1245-1266

Velpatasvir

Severe

Textbook

Reduced velpatasvir concentrations, potentially leading to treatment failure.

PPI doses should not exceed the equivalent of 20 mg omeprazole daily. SOF/VEL should be taken with food 4 hours prior to a PPI dose. Velpatasvir requires acidic gastric pH.

Source: G&G 14e · p1239, p1242

Aceclofenac + Paracetamol

Moderate

Textbook

Increased risk of small intestine damage, despite reducing duodenal and gastric ulceration.

Consider the overall GI risk, including small intestine, when coadministering.

Source: G&G 14e · p834

Aceclofenac

Moderate

Textbook

Increased risk of small intestine damage, despite reducing duodenal and gastric ulceration.

Consider the overall GI risk, including small intestine, when coadministering.