NEXIUM 20/MG 28/TAB

Indications

Approved Uses

Gastroesophageal reflux disease (GERD), erosive esophagitis, Helicobacter pylori eradication (in combination therapy), prevention of NSAID-associated gastric ulcers, Zollinger-Ellison syndrome, peptic ulcer disease

Dosage & Administration

Dosing by Condition

GERD (symptomatic reflux, no esophagitis): 20 mg once daily for 2-4 weeks (may extend to 4-8 weeks based on response).
Erosive esophagitis (healing): 20-40 mg once daily for 4-8 weeks (40 mg commonly used for more severe disease).
Erosive esophagitis (maintenance): 20 mg once daily (duration individualized; reassess need periodically).
H. pylori eradication: 20 mg twice daily as part of combination therapy (e.g., with amoxicillin + clarithromycin or other guideline-recommended regimens) for 10-14 days depending on local resistance/guideline.
NSAID-associated ulcer prevention (at-risk patients on NSAIDs): 20 mg once daily for the duration of NSAID therapy (reassess periodically).
Zollinger-Ellison syndrome: 40 mg twice daily initially; titrate to control (some patients require higher doses).

Initial Dose

20mg once daily (for GERD/symptomatic reflux)

Maintenance Dose

20mg once daily.

Maximum Dose

Typical max for common indications: 40 mg/day; for Zollinger-Ellison syndrome, individualized higher doses are used (commonly up to 160 mg/day in divided doses; higher doses have been reported under specialist supervision).

Children's Dosage

Children 1-11 years (body weight <20kg): 10mg once daily; body weight ≥20kg: 10-20mg once daily. Adolescents 12-17 years: 20-40mg once daily depending on indication

Dose Adjustment Notes

Severe hepatic impairment (Child‑Pugh C): do not exceed 20 mg/day. No dose adjustment is required in renal impairment; in Zollinger-Ellison syndrome doses are individualized/titrated to acid control.

How to Take

Oral gastro‑resistant tablet: take once daily on an empty stomach, ideally at least 1 hour before food (commonly 30-60 minutes before breakfast); swallow whole with water-do not crush or chew. If swallowing is difficult, the gastro‑resistant tablet may be dispersed in non‑carbonated water and taken immediately (do not use applesauce instructions unless the product is a capsule/granules formulation).

Side Effects

Common Side Effects

Headache, diarrhea, nausea, flatulence, abdominal pain, constipation, dry mouth.

Side Effect Frequency

Common (≥1% to <10%): headache, abdominal pain, diarrhea, nausea, flatulence, constipation. Less common/rare but clinically important: rash/pruritus, dizziness, insomnia, peripheral edema, elevated liver enzymes; rare/serious class effects include hypomagnesemia, acute interstitial nephritis, severe cutaneous reactions (e.g., SJS/TEN), and SCLE; fracture risk is associated with long-term/high-dose use.

Safety & Warnings

Contraindications

Hypersensitivity to esomeprazole/other PPIs/any excipients; concomitant use with rilpivirine-containing products; concomitant use with nelfinavir.

Warnings & Precautions

May mask gastric malignancy-evaluate alarm symptoms; C. difficile-associated diarrhea risk; hypomagnesemia with prolonged use (consider monitoring if long-term/with diuretics/digoxin); osteoporosis-related fracture risk with long-term/high-dose use; vitamin B12 deficiency with long-term use; fundic gland polyps with use >1 year; acute interstitial nephritis; lupus erythematosus; false elevation/interpretation issues with chromogranin A testing (hold PPI before testing when appropriate).

Age Restriction

Pediatric use approved from 1 year of age for specific indications; not approved for infants <1 year.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: clopidogrel (reduced activation/antiplatelet effect-avoid or use alternative PPI), warfarin (↑INR-monitor), high-dose methotrexate (↑levels-consider holding PPI), digoxin (↑absorption-monitor), drugs needing acidic pH (e.g., ketoconazole/itraconazole-↓absorption), antiretrovirals: rilpivirine and nelfinavir (contraindicated), atazanavir (avoid/↓levels), tacrolimus (↑levels-monitor), CYP2C19 substrates (e.g., diazepam-↑levels), CYP inducers (rifampin, St John’s wort-↓esomeprazole exposure).

Interaction Severity

"CONTRAINDICATED/AVOID: ["Rilpivirine-containing products (marked reduction in absorption with acid suppression)
Nelfinavir (reduced exposure and efficacy with PPIs)"], "MAJOR/CLINICALLY SIGNIFICANT (avoid or manage closely): ["Clopidogrel (possible reduced antiplatelet effect via CYP2C19 inhibition-prefer alternative PPI or assess risk/benefit)
Atazanavir (and other pH-dependent antiretrovirals; reduced absorption-generally avoid with PPIs)"], "MODERATE (monitor/adjust as needed): ["Warfarin (monitor INR on initiation/discontinuation)
High-dose methotrexate (consider temporary PPI interruption; monitor toxicity)
Tacrolimus (monitor levels)
Digoxin (monitor levels/clinical effect, especially with hypomagnesemia risk)
Azole antifungals such as ketoconazole/itraconazole (reduced absorption due to higher gastric pH)
Iron salts (reduced absorption possible with increased gastric pH)"]

Food Interaction

Food can delay absorption and reduce peak levels; take on an empty stomach, ideally 30-60 minutes (up to 1 hour) before a meal for best effect.

Special Populations

Pregnancy

No human data; animal studies show no direct harm.

Breastfeeding

Caution

Children

Children 1-11 years (body weight <20kg): 10mg once daily; body weight ≥20kg: 10-20mg once daily. Adolescents 12-17 years: 20-40mg once daily depending on indication

Elderly

Standard adult dosing; no routine dose adjustment required

Kidney Impairment

No adjustment needed.

Liver Impairment

Mild to moderate impairment: no adjustment needed. Severe impairment (Child-Pugh Class C): maximum dose 20mg/day

Storage & Patient Advice

Stopping the Medicine

If used long-term, consult a clinician before stopping; consider tapering/step-down to reduce rebound acid hypersecretion.

Overdose

Overdose usually causes non-specific symptoms (e.g., GI upset, dizziness/drowsiness, headache); no specific antidote-manage with supportive care and seek urgent medical advice; hemodialysis is unlikely to be useful.

Patient Counseling

Take on an empty stomach 30-60 minutes (up to 1 hour) before a meal; swallow the gastro‑resistant tablet whole (do not crush/chew). If you have trouble swallowing, disperse the tablet in non‑carbonated water and drink immediately. Benefit builds over several days; seek care for severe/persistent diarrhea. Tell your clinician if you use clopidogrel, warfarin, methotrexate, tacrolimus, digoxin, or HIV medicines (especially rilpivirine/nelfinavir). With long-term use, discuss risks such as low magnesium, vitamin B12 deficiency, and fractures; report muscle cramps/weakness or palpitations.

Monitoring Requirements

With prolonged therapy: monitor magnesium (especially if also on diuretics or digoxin), consider vitamin B12 status in long-term use, and monitor for renal injury if symptoms suggest acute interstitial nephritis; assess for C. difficile-associated diarrhea if severe/persistent diarrhea occurs.

Pharmacology

Mechanism of Action

Prodrug that irreversibly inhibits the gastric parietal cell H+/K+-ATPase (proton pump), blocking the final step of gastric acid secretion.

Onset of Action

Begins within ~1 hour; noticeable symptom relief may occur the first day, with maximal acid suppression after 3-4 days of once-daily dosing.

Duration of Effect

Approximately 24 hours per dose.

Half-Life

1-1.5 hours.

Bioavailability

Oral bioavailability is ~64% after a single 20 mg dose and increases to ~89% after repeated once-daily dosing.

Metabolism

Extensively hepatic metabolism via CYP2C19 (primary) and CYP3A4 (secondary).

Protein Binding

97%

Product Information

Available Dosage Forms

For this product: gastro‑resistant (delayed‑release) tablet. Esomeprazole is also available in other markets as delayed‑release capsules/granules for oral suspension and as IV injection/infusion, but those are different presentations from this SFDA-registered tablet.

Composition per Dose

Each gastro-resistant tablet: 20mg esomeprazole (as esomeprazole magnesium trihydrate)

Generic Availability

Yes

OTC Alternatives

OTC options for mild/intermittent symptoms include antacids (e.g., aluminum/magnesium hydroxide, calcium carbonate) and H2-receptor antagonists (e.g., famotidine); in some countries OTC PPIs (e.g., omeprazole/esomeprazole 20 mg) are available, but this SFDA product is prescription-only.

Gi Condition

Acid Reflux/GERD, Ulcer

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