NEXIUM 20/MG TAB 14/TAB

Indications

Approved Uses

OTC: short-term treatment of frequent heartburn (≥2 days/week) as a 14-day course. Prescription/medical indications for esomeprazole include GERD (symptomatic), healing and maintenance of erosive esophagitis, H. pylori eradication (with antibiotics) to reduce duodenal ulcer recurrence, risk reduction of NSAID-associated gastric ulcers, and pathologic hypersecretory conditions (e.g., Zollinger-Ellison syndrome).

Dosage & Administration

Initial Dose

20 mg once daily.

Maintenance Dose

20 mg once daily.

Children's Dosage

Not applicable for this OTC 20 mg gastro-resistant tablet; pediatric dosing requires physician-directed use and may require different strengths/formulations.

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. Uncommon (≥0.1% to <1%): dizziness, insomnia, peripheral edema, rash/pruritus/urticaria, dry mouth, increased liver enzymes. Rare/very rare (<0.1%): hypersensitivity reactions, severe cutaneous reactions, hepatitis/jaundice, hypomagnesemia (esp. long-term), acute interstitial nephritis, subacute cutaneous lupus erythematosus, C. difficile-associated diarrhea, and increased fracture risk with long-term/high-dose use.

Safety & Warnings

Age Restriction

OTC self-treatment for frequent heartburn is for adults ≥18 years; not for children <18 years unless directed by a doctor.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions include: clopidogrel (reduced activation/antiplatelet effect), warfarin (INR changes-monitor), high-dose methotrexate (increased levels-consider holding PPI), digoxin (increased exposure), tacrolimus (increased levels), cilostazol (increased exposure), drugs needing acidic pH (e.g., ketoconazole/itraconazole, iron salts-reduced absorption), and antiretrovirals affected by gastric pH/CYP (atazanavir reduced; nelfinavir/rilpivirine contraindicated). Enzyme inducers such as rifampin and St. John’s wort may reduce PPI exposure.

Food Interaction

Take on an empty stomach, ideally 30-60 minutes before a meal; food can reduce/delay absorption and may lessen acid-suppression onset.

Special Populations

Children

Not applicable for this OTC 20 mg gastro-resistant tablet; pediatric dosing requires physician-directed use and may require different strengths/formulations.

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): do not exceed 20 mg per day.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not take two doses at once.

Overdose

Symptoms may include confusion, drowsiness, blurred vision, tachycardia, nausea, sweating/flushing, headache and dry mouth; management is supportive/symptomatic, seek urgent medical attention, and hemodialysis is not expected to be effective.

Pharmacology

Mechanism of Action

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

Duration of Effect

Persists longer than 24 hours due to irreversible binding to H+/K+-ATPase; duration of antisecretory effect extends beyond 24 hours.

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 and CYP3A4 (CYP2C19 is the major pathway; CYP3A4 contributes).

Product Information

Available Dosage Forms

For this SFDA-registered product: gastro-resistant tablet (oral). Esomeprazole is also available in other markets as delayed-release capsules/granules for oral suspension and as IV injection/infusion formulations.

Generic Availability

Yes

Gi Condition

Acid Reflux/GERD

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