NEXIUM 40/MG TAB 14/TAB

Indications

Approved Uses

GERD (including symptomatic GERD) and erosive reflux esophagitis (healing and maintenance); eradication of Helicobacter pylori in combination therapy to reduce duodenal ulcer recurrence; treatment/prevention of NSAID‑associated gastric ulcer; pathological hypersecretory conditions including Zollinger-Ellison syndrome.

Dosage & Administration

Dosing by Condition

Symptomatic GERD: 20 mg once daily for 2-4 weeks. Healing of erosive esophagitis: 20-40 mg once daily for 4-8 weeks. Maintenance of healed erosive esophagitis: 20 mg once daily. H. pylori eradication: esomeprazole 20 mg twice daily as part of triple therapy (with appropriate antibiotics) for 10-14 days. NSAID‑associated gastric ulcer risk reduction: 20-40 mg once daily (commonly 20 mg daily). Zollinger-Ellison syndrome: start 40 mg twice daily and titrate; doses up to 240 mg/day may be used in divided doses.

Initial Dose

40mg once daily for healing of erosive esophagitis.

Maintenance Dose

20mg once daily for maintenance of healed erosive esophagitis.

Maximum Dose

Routine max: 40 mg/day for most indications; Zollinger-Ellison: up to 240 mg/day under specialist supervision; severe hepatic impairment: max 20 mg/day.

Children's Dosage

Children 1-11 years (body weight <20kg): 10mg once daily; (body weight ≥20kg): 10-20mg once daily. Adolescents 12-18 years: 20-40mg once daily

Dose Adjustment Notes

Severe hepatic impairment (Child‑Pugh C): do not exceed 20 mg/day. No dose adjustment is required in renal impairment or mild-moderate hepatic impairment. In Zollinger-Ellison syndrome, titrate to clinical response.

How to Take

Take orally once daily, preferably in the morning at least 30-60 minutes before food. Swallow the gastro‑resistant tablet whole with water; do not crush or chew. If swallowing is difficult, the tablet may be dispersed in half a glass of non‑carbonated water, stirred, and swallowed immediately (then rinse the glass with water and drink).

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (≥1%): headache, abdominal pain, diarrhea, nausea, flatulence, constipation, dry mouth.

Safety & Warnings

Contraindications

Hypersensitivity to esomeprazole/other substituted benzimidazoles (PPIs) or excipients; concomitant use with nelfinavir; concomitant use with rilpivirine-containing products.

Warnings & Precautions

May mask gastric malignancy (evaluate alarm symptoms); C. difficile-associated diarrhea risk; long-term use: hypomagnesemia (monitor esp. with diuretics/digoxin), osteoporosis-related fractures, vitamin B12 deficiency, fundic gland polyps; acute interstitial nephritis; cutaneous/systemic lupus erythematosus (discontinue if suspected).

Age Restriction

Approved for short-term treatment of GERD in children 1 year and older.

Drug Interactions

Drug Interactions

Key clinically relevant interactions include: clopidogrel (reduced activation via CYP2C19 inhibition-avoid/consider alternative PPI), warfarin (INR changes-monitor), diazepam/phenytoin (increased levels-monitor), high-dose methotrexate (increased exposure-consider temporary PPI hold), digoxin (increased exposure esp. with hypomagnesemia-monitor), tacrolimus (increased levels-monitor), atazanavir/nelfinavir/rilpivirine (reduced antiviral exposure-avoid; nelfinavir/rilpivirine contraindicated), ketoconazole/itraconazole/iron salts (reduced absorption), rifampin and St. John’s Wort (reduced PPI exposure via enzyme induction).

Interaction Severity

CONTRAINDICATED/AVOID: nelfinavir; rilpivirine-containing products; (also avoid atazanavir where possible due to reduced absorption). AVOID/USE ALTERNATIVE: clopidogrel (reduced activation via CYP2C19 inhibition-prefer pantoprazole if PPI needed). MONITOR/CAUTION: warfarin (INR), high‑dose methotrexate (consider temporary PPI interruption), tacrolimus (levels), digoxin (levels), drugs needing acidic pH for absorption (e.g., ketoconazole/itraconazole, iron salts).

Food Interaction

Food reduces/delays absorption; administer on an empty stomach, ideally 30-60 minutes before a meal.

Special Populations

Pregnancy

Caution

Children

Children 1-11 years (body weight <20kg): 10mg once daily; (body weight ≥20kg): 10-20mg once daily. Adolescents 12-18 years: 20-40mg once daily

Elderly

Standard adult dosing; no routine dose adjustment required

Kidney Impairment

No dose adjustment needed; use caution in severe renal impairment due to limited experience.

Liver Impairment

Mild-to-moderate impairment: No adjustment needed. Severe impairment (Child-Pugh Class C): Do not exceed a maximum dose of 20mg daily.

Storage & Patient Advice

Stopping the Medicine

May be stopped, but after prolonged use consider tapering/step-down to reduce rebound acid hypersecretion; consult clinician if long-term/high-dose or symptoms recur.

Patient Counseling

Take on an empty stomach 30-60 minutes before a meal, at the same time daily. Swallow whole; do not crush/chew; if needed, disperse in non‑carbonated water and drink immediately. Seek care for persistent/severe diarrhea, signs of low magnesium (cramps, palpitations, seizures), or kidney issues (reduced urine, swelling). Tell your clinician about all medicines-especially clopidogrel, warfarin, HIV antivirals (e.g., rilpivirine/nelfinavir/atazanavir), and high‑dose methotrexate. With long-term use, discuss monitoring (magnesium ± B12) and fracture risk in high‑risk patients.

Monitoring Requirements

Long-term therapy: check magnesium periodically (especially if also on diuretics/digoxin) and consider vitamin B12 assessment if prolonged use/risk factors; monitor for C. difficile-associated diarrhea if persistent diarrhea occurs; monitor renal function if acute interstitial nephritis suspected; if on warfarin, monitor INR/PT when starting/stopping or changing dose.

Pharmacology

Mechanism of Action

Suppresses gastric acid secretion by specific 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; maximal effect typically occurs after 2-4 days of once‑daily dosing. Tmax is about 1-2 hours.

Duration of Effect

Approximately 24 hours of acid suppression with once‑daily dosing (with greater effect after several days of continuous therapy).

Half-Life

Approximately 1 to 1.5 hours.

Bioavailability

The AUC after administration of a single 40 mg dose of esomeprazole is decreased by 43-53% after food intake; bioavailability increases with repeated dosing.

Metabolism

Extensively metabolized in the liver primarily by CYP2C19 and CYP3A4.

Excretion

Approximately 80% of an oral dose is excreted in urine as inactive metabolites and the remainder in feces (minimal unchanged drug).

Protein Binding

Approximately 97%.

Product Information

Available Dosage Forms

Gastro‑resistant (delayed‑release) tablet; delayed‑release capsule; granules/packets for oral suspension; powder for solution for injection/infusion (IV).

Composition per Dose

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

Generic Availability

Yes

Gi Condition

Acid Reflux/GERD, Ulcer

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