NEXIUM 40/MG 28/TAB

Indications

Approved Uses

GERD (including symptomatic GERD), healing of erosive esophagitis, maintenance of healed erosive esophagitis, H. pylori eradication to reduce duodenal ulcer recurrence (in combination with antibiotics), risk reduction of NSAID‑associated gastric ulcer, and pathological hypersecretory conditions including Zollinger‑Ellison syndrome.

Dosage & Administration

Dosing by Condition

Healing of erosive esophagitis: 20 mg or 40 mg once daily for 4-8 weeks
Maintenance of healed erosive esophagitis: 20 mg once daily (duration per prescriber; commonly up to 6 months or longer if clinically indicated)
Symptomatic GERD (no erosive disease): 20 mg once daily for 2-4 weeks (may extend to 4-8 weeks based on response)
H. pylori eradication (to reduce duodenal ulcer recurrence): 20 mg twice daily with appropriate antibiotics for 10-14 days (regimen varies by local guideline/resistance patterns)
Risk reduction of NSAID-associated gastric ulcer: 20 mg once daily for the duration of NSAID therapy (often up to 6 months in trials)
Zollinger-Ellison / pathological hypersecretory conditions: 40 mg twice daily initially; adjust based on acid control (doses up to 240 mg/day have been used)

Initial Dose

40mg once daily (for GERD/erosive esophagitis)

Maintenance Dose

20mg once daily for maintenance of healed erosive esophagitis.

Maximum Dose

Standard indications: typically up to 40 mg/day (some regimens use 40 mg twice daily for specific indications such as refractory GERD/eradication regimens per local protocols); Zollinger-Ellison: individualized, commonly up to 120 mg/day, with higher doses (up to 240 mg/day) reported/used in some patients under specialist supervision.

Children's Dosage

Delayed-release capsules not established in pediatric patients; for patients 12-17 years, 20-40 mg once daily for up to 8 weeks for healing of EE.

Dose Adjustment Notes

Severe hepatic impairment (Child‑Pugh C): do not exceed 20 mg/day. Mild-moderate hepatic impairment: no adjustment. Renal impairment: no adjustment. Hypersecretory states (e.g., Zollinger‑Ellison): titrate to clinical response.

How to Take

Take orally on an empty stomach, ideally 30-60 minutes before a meal. Swallow the gastro‑resistant tablet whole with water; do not crush or chew. If unable to swallow, the tablet may be dispersed in non‑carbonated water and swallowed immediately (do not chew the granules).

Side Effects

Common Side Effects

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

Safety & Warnings

Contraindications

Contraindicated in patients with hypersensitivity to esomeprazole/other substituted benzimidazoles (PPIs) or excipients; contraindicated with rilpivirine-containing products; avoid/contraindicated with nelfinavir due to reduced antiviral exposure.

Warnings & Precautions

Precautions: evaluate for alarm features/malignancy if symptoms persist (PPIs may mask gastric cancer); risk of C. difficile diarrhea; monitor/consider magnesium (especially prolonged use or with diuretics/digoxin); consider fracture risk and calcium/vitamin D status in long-term/high-dose users; consider B12 deficiency with long-term use; watch for acute interstitial nephritis; lupus (cutaneous/systemic) has been reported; use caution and dose-limit in severe hepatic impairment.

Age Restriction

Safety and effectiveness in pediatric patients have not been established for delayed-release capsules; for delayed-release oral suspension, approved for short-term treatment of GERD in patients 1-11 years and healing of EE in patients 12-17 years; not established for patients <1 year.

Drug Interactions

Drug Interactions

Key interactions: clopidogrel (reduced activation via CYP2C19 inhibition-avoid or use alternative PPI if needed), high-dose methotrexate (possible increased levels-consider temporary PPI hold), digoxin (increased exposure via higher gastric pH), warfarin (possible INR increase-monitor), tacrolimus (possible increased levels-monitor), antiretrovirals affected by gastric pH (rilpivirine contraindicated; nelfinavir avoid/contraindicated; atazanavir reduced absorption-avoid or manage per HIV guidance), drugs needing acidic pH (e.g., ketoconazole/itraconazole, iron salts-reduced absorption), and other CYP2C19 substrates with narrow margin (e.g., diazepam, citalopram, cilostazol-may increase exposure).

Interaction Severity

"Contraindicated / avoid: ["Rilpivirine (acid suppression markedly reduces absorption)
Nelfinavir (reduced antiviral exposure)"], "Major / clinically significant (avoid or use alternative when possible): ["Clopidogrel (CYP2C19 inhibition may reduce antiplatelet effect; consider alternative PPI such as pantoprazole if PPI needed)"], "Moderate (monitor/adjust as needed): ["Warfarin (monitor INR)
High-dose methotrexate (consider temporary PPI interruption; monitor toxicity)
Tacrolimus (monitor levels)
Atazanavir (reduced absorption; avoid or specialist management)
Digoxin (possible increased exposure; monitor in high-risk patients)"], "Absorption-reducing interactions (separate/monitor efficacy): ["Ketoconazole/itraconazole/posaconazole (reduced absorption)
Iron salts (reduced absorption)"]

Food Interaction

Take on an empty stomach, preferably 30-60 minutes before meals.

Special Populations

Pregnancy

Not assigned (risk cannot be ruled out)

Children

Delayed-release capsules not established in pediatric patients; for patients 12-17 years, 20-40 mg once daily for up to 8 weeks for healing of EE.

Elderly

Standard adult dosing; no routine dose adjustment required

Kidney Impairment

No adjustment needed.

Liver Impairment

Mild-moderate hepatic impairment (Child-Pugh A/B): no adjustment; severe impairment (Child-Pugh C): do not exceed 20 mg/day.

Storage & Patient Advice

Stopping the Medicine

Can be stopped when clinically appropriate, but after prolonged use consider tapering/step-down to reduce rebound acid hypersecretion and symptom recurrence.

Patient Counseling

Take on an empty stomach 30-60 minutes before a meal; swallow the gastro‑resistant tablet whole (do not crush/chew). Not for immediate relief-use consistently as prescribed. Seek care for severe/persistent diarrhea, signs of low magnesium (cramps, palpitations, seizures), or kidney issues (reduced urine, swelling). Tell your clinician about all medicines, especially clopidogrel, warfarin, digoxin, and HIV antivirals (rilpivirine/nelfinavir).

Monitoring Requirements

Long-term therapy: consider serum magnesium (especially if on diuretics/digoxin) and vitamin B12 if prolonged use; monitor for C. difficile-associated diarrhea if persistent diarrhea occurs; check renal function if acute interstitial nephritis suspected; monitor INR if co-administered with warfarin; consider bone health/fracture risk in high-risk patients.

Pharmacology

Mechanism of Action

Suppresses gastric acid secretion by specific, irreversible inhibition of the H+/K+-ATPase enzyme system (the proton pump) in the gastric parietal cell, blocking the final step in acid production.

Onset of Action

Acid suppression begins within ~1 hour of a dose, but maximal effect typically requires 2-3 days of once-daily dosing; symptom relief may lag and varies by condition.

Duration of Effect

Up to 24 hours.

Half-Life

1-1.5 hours.

Bioavailability

Approximately 64% after a single 40 mg dose and about 89% after repeated once-daily dosing.

Metabolism

Hepatic metabolism primarily via CYP2C19 and CYP3A4 (CYP2C19 is the major pathway; CYP3A4 contributes).

Excretion

Primarily excreted as inactive metabolites: ~80% in urine and ~20% in feces.

Protein Binding

Approximately 97% plasma protein binding.

Product Information

Available Dosage Forms

Oral delayed‑release (gastro‑resistant) tablets/capsules and delayed‑release granules/packets for oral suspension; intravenous powder for solution for injection/infusion is also available in some markets.

Composition per Dose

Each gastro-resistant tablet: 40mg esomeprazole (as esomeprazole magnesium trihydrate)

Generic Availability

Yes

Gi Condition

Acid Reflux/GERD

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