INN monograph
Esomeprazole/Levofloxacin/ Amoxicillin
Beta-lactam antibiotic — penicillin · POM
Source-linked · Updated 03 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Beta-lactam antibiotic — penicillin)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- History of serious immediate hypersensitivity (e.g. anaphylaxis, angioedema, urticaria) to any penicillin.
- Caution with prior severe cephalosporin reaction (cross-reactivity risk).
- Avoid in infectious mononucleosis if using aminopenicillins (rash risk).
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
Renal excretion dominant — reduce dose or extend interval in significant renal impairment; risk of accumulation and seizures at high levels.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Low intrinsic hepatotoxicity; cholestatic hepatitis rare (notably flucloxacillin/co-amoxiclav patterns for related agents).
Safety
Drug interactions
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Esomeprazole, Levofloxacin, Amoxicillin.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- Common: gastrointestinal upset, diarrhoea, mild rash.
- Serious: anaphylaxis, Stevens–Johnson syndrome / TEN (rare), antibiotic-associated colitis (including C. difficile), interstitial nephritis, haematological reactions with prolonged high dose.
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/Levofloxacin/ Amoxicillin should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Beta-lactam antibiotic — penicillin.
- Confirm site-specific dose, duration and monitoring before prescribing.
Pharmacology
Mode of action
The antibiotics act against helicobacter pylori and proton pump inhibitors reduce the acid in the stomach and help to heal the ulcer.
Full mechanism text
The antibiotics act against helicobacter pylori and proton pump inhibitors reduce the acid in the stomach and help to heal the ulcer. Hence, the combination is more effective than single antibiotic or a proton pump inhibitor alone.
ADME
Pharmacokinetics & PD
| Onset | Within 1 hour (oral); faster IV |
|---|---|
| Duration | 4–8 hours typical (agent/formulation dependent) |
| Route | ORAL / PARENTERAL (agent-dependent) |
| Elimination | is predominantly renal (glomerular filtration and tubular secretion). Dose adjustment is often required in severe renal impairment. Probenecid reduces tubular secretion and prolongs levels. |
| Half-life | differ by agent and salt/ester. Most penicillins distribute widely into extracellular fluid; CSF penetration is poor unless meninges are inflamed. |
Full PK/PD text
Absorption, protein binding and half-life differ by agent and salt/ester. Most penicillins distribute widely into extracellular fluid; CSF penetration is poor unless meninges are inflamed. Elimination is predominantly renal (glomerular filtration and tubular secretion). Dose adjustment is often required in severe renal impairment. Probenecid reduces tubular secretion and prolongs levels.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| ESOSE HP KIT | DAIMA BIASHARA / Wholesale Import | — | 3,544.44 |
Special populations
Pregnancy & lactation
Pregnancy
Penicillins are generally considered compatible in pregnancy when clearly indicated (decades of clinical use). Prefer agents with the best safety record for the indication; confirm current SmPC.
Lactation
[From component Levofloxacin] 8.3 Nursing Mothers Based on data on other fluoroquinolones and very limited data on levofloxacin, it can be presumed that levofloxacin will be excreted in human milk. Because of the potential for serious adverse reactions from levofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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 (Beta-lactam antibiotic — penicillin)
Clinical review date not recorded.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.