INN monograph
Esomeprazole/Itopride
Proton pump inhibitor (PPI) · POM
Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Proton pump inhibitor (PPI))
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- [Esomeprazole] Hypersensitivity to PPIs.
- Caution with rilpivirine and some antivirals (gastric pH). [Itopride] Hypersensitivity to the active substance or excipients.
- Additional absolute contraindications are indication- and product-specific — consult SmPC.
Precautions
- Warnings Allergy alert : Do not use if you are allergic to esomeprazole.
- Esomeprazole may cause severe skin reactions.
- Symptoms may include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical help right away.
Point of care
Dosing
Adult
Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days may take 1 to 4 days for full effect 14-Day Course of Treatment • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition .
Paediatric
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Renal
Rare AIN; otherwise minimal renal dosing issues.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Severe hepatic impairment: dose reduction for some agents.
Safety
Drug interactions
- Step-down after healing peptic disease.
- Test-and-treat or empiric strategies per local dyspepsia pathways.
- Review chronic PPI prescriptions for deprescribing eligibility.
Safety
Adverse effects
- [Esomeprazole] Headache, diarrhoea, abdominal pain.
- Serious: severe hypomagnesaemia, interstitial nephritis, C. difficile association, subacute cutaneous lupus (rare). [Itopride] Adverse reactions vary by agent.
- Counsel on common predictable effects and serious warning symptoms (allergy, severe rash, jaundice, unusual bleeding, severe GI symptoms, neurological changes).
- Report suspected ADRs via national pharmacovigilance channels.
Use
Indications
- Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn
- this drug may take 1 to 4 days for full effect Clinical selection for Esomeprazole/Itopride should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Proton pump inhibitor (PPI).
- Confirm site-specific dose, duration and monitoring before prescribing.
Pharmacology
Mode of action
Combination product.
Full mechanism text
Combination product. Component mechanism (Esomeprazole): A proton pump inhibitor. PPIs irreversibly inhibit the gastric H+/K+-ATPase (proton pump) in parietal cells, suppressing basal and stimulated acid secretion — the most potent pharmacological acid suppression.
ADME
Pharmacokinetics & PD
| Onset | 1–2 hours; full acid suppression days |
|---|---|
| Duration | 24 hours+ (irreversible pump inhibition) |
| Route | ORAL / IV |
| Metabolism | (polymorphisms affect levels). Short plasma |
| Half-life | but prolonged pharmacodynamic effect. |
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| Esoxium IT | Independent / Registered Supplier | Standard Commercial Pack | — |
| Sompraz IT | Sun Pharmaceuticals Ltd | Standard Commercial Pack | — |
Special populations
Pregnancy & lactation
Pregnancy
[Esomeprazole] Often used when indicated; omeprazole has substantial human data — still risk–benefit. [Itopride] Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist.
Lactation
Generally considered acceptable; infant exposure low.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Proton pump inhibitor (PPI))
Last reviewed: 01 Aug 2026
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.