EMANERA 20/MG HARD CAP 28/CAP

Indications

Approved Uses

GERD (including symptomatic GERD), treatment of erosive reflux esophagitis, maintenance of healing of erosive esophagitis, in combination with appropriate antibiotics for Helicobacter pylori eradication to reduce duodenal ulcer recurrence, prevention/risk reduction of NSAID-associated gastric ulcer in at-risk patients, and pathological hypersecretory conditions including Zollinger-Ellison syndrome.

Dosage & Administration

Dosing by Condition

Symptomatic GERD: 20 mg once daily for 2-4 weeks (may extend to 4-8 weeks if needed). Erosive esophagitis (healing): 20-40 mg once daily for 4-8 weeks. Maintenance of healed erosive esophagitis: 20 mg once daily. H. pylori eradication: 20 mg twice daily with antibiotics (e.g., amoxicillin + clarithromycin) for 7-14 days per local resistance/guidelines. NSAID-associated gastric ulcer risk reduction: 20 mg once daily (some labels allow 20-40 mg) for the duration of NSAID therapy (often up to 6 months in trials). Zollinger-Ellison: start 40 mg twice daily and titrate to acid control.

Initial Dose

20mg once daily (for GERD/symptomatic reflux)

Maintenance Dose

20mg once daily for maintenance of healed erosive esophagitis.

Maximum Dose

For Zollinger-Ellison Syndrome, doses up to 80mg three times daily have been used; for severe liver impairment, the maximum dose is 20mg per day.

Children's Dosage

Not approved for children under 12 years for capsules; use oral suspension for 1 month and older with weight-based dosing.

How to Take

Take orally, preferably at least 1 hour before a meal (commonly before breakfast). Swallow the gastro‑resistant capsule whole with water; do not crush or chew. If unable to swallow, the capsule may be opened and the enteric-coated granules/pellets sprinkled on a spoonful of applesauce (or mixed with water per product instructions) and swallowed immediately without chewing; do not store the mixture.

Safety & Warnings

Contraindications

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

Age Restriction

Not approved for use under 12 years of age for capsules; pediatric use of oral suspension starts at 1 month depending on indication.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically important interactions include: clopidogrel (reduced activation/antiplatelet effect via CYP2C19 inhibition-avoid or use alternative PPI if needed), high-dose methotrexate (possible increased levels/toxicity-consider temporary PPI hold), warfarin (possible ↑INR-monitor), digoxin (↑absorption esp. with hypomagnesemia-monitor), tacrolimus (↑levels-monitor), diazepam (↑levels via CYP2C19-monitor), cilostazol (↑exposure-consider dose adjustment), and reduced absorption of pH-dependent drugs (e.g., ketoconazole/itraconazole, iron salts); antiretrovirals: nelfinavir and rilpivirine are contraindicated, and atazanavir exposure may be reduced (avoid/seek specialist advice).

Food Interaction

Food can reduce/delay absorption; administer on an empty stomach, ideally at least 1 hour before a meal (commonly before breakfast).

Special Populations

Children

Not approved for children under 12 years for capsules; use oral suspension for 1 month and older with weight-based dosing.

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

Patient Counseling

Take on an empty stomach, ideally ≥1 hour before a meal (often before breakfast). Swallow the capsule whole with water; do not crush/chew. If you cannot swallow it, open the capsule and swallow the granules with a spoonful of applesauce (or water per instructions) immediately without chewing. Use only as prescribed; seek care for persistent/severe diarrhea, signs of low magnesium (cramps, palpitations), rash, or new/worsening kidney symptoms; long-term use may be associated with low magnesium, vitamin B12 deficiency, and fracture risk in susceptible patients.

Pharmacology

Mechanism of Action

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

Onset of Action

Initial acid suppression begins within ~1 hour of a dose, with maximal effect after ~3-5 days of once-daily dosing.

Duration of Effect

Approximately 24 hours per dose (acid suppression persists ~24 hours despite a short plasma half-life).

Half-Life

1-1.5 hours.

Bioavailability

Approximately 50% after a single 20mg oral dose; increases to approximately 68% with repeated once-daily dosing.

Metabolism

Extensively metabolized in the liver primarily by CYP2C19 and to a lesser extent by CYP3A4.

Excretion

Approximately 80% of a dose is excreted in urine as inactive metabolites and approximately 20% in feces; negligible unchanged drug is excreted renally.

Protein Binding

Approximately 97% protein bound.

Product Information

Available Dosage Forms

Esomeprazole is available (depending on market/manufacturer) as gastro‑resistant/delayed‑release capsules, gastro‑resistant/delayed‑release tablets, granules/powder for oral suspension, and parenteral powder for solution for injection/infusion.

Generic Availability

Yes

Gi Condition

Acid Reflux/GERD, Ulcer

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