Esomeprazolum

Description

Esomeprazole, the S-isomer of omeprazole, specifically inhibits the acid pump of parietal cells, thereby inhibiting both basal and stimulated gastric acid secretion.

Indications

• For adults and children over 12 years old:
  • Gastroesophageal reflux disease (GERD): treatment of erosive reflux esophagitis, long-term prevention of esophagitis recurrence after healing, and symptomatic treatment of GERD.
• For adults:
  • Eradication of Helicobacter pylori: healing of Helicobacter pylori-associated duodenal ulcers, and prevention of recurrence of Helicobacter pylori-associated peptic ulcers.
  • Healing of NSAID-associated gastric ulcers in patients who need to continue NSAIDs, and prevention of NSAID-associated gastric and duodenal ulcers in high-risk patients.
  • Prevention of recurrent bleeding from stomach or duodenal ulcers (for long-term use after intravenous infusion).
  • Treatment of Zollinger-Ellison syndrome.

Contraindications

• Hypersensitivity to the active substance, any auxiliary substance, any modified benzimidazole, or any auxiliary substance.
• Concurrent use with atazanavir and nelfinavir.

Dosage

• For adults (oral administration):

  • Erosive reflux esophagitis: 40 mg once daily for 4 weeks; if the esophagus does not heal or symptoms persist, continue for another 4 weeks. For long-term prevention after esophageal healing: 20 mg once daily.
  • Symptomatic treatment of GERD: 20 mg once daily, adjust to 20 mg as needed after symptoms disappear.
  • Eradication of Helicobacter pylori: 20 mg of esomeprazole, 1 g of amoxicillin, and 500 mg of clarithromycin twice daily for 7 days.
  • Healing of NSAID-associated gastric ulcers: 20 mg once daily for 4-8 weeks.
  • Prevention of NSAID-associated gastric and duodenal ulcers in high-risk patients: 20 mg once daily.
  • Treatment of Zollinger-Ellison syndrome: Initially, 40 mg twice daily; later, adjust the dose individually based on the clinical situation (most patients are controlled with 80-160 mg per day, doses greater than 80 mg per day are taken in 2 doses).

• For children:

  • Refer to the registered drug information.

• For elderly patients:

  • No need to adjust the dose.

• In renal impairment:

  • Use with caution, but no need to adjust the dose.

• In hepatic impairment:

  • Mild or moderate hepatic impairment: No need to adjust the dose.
  • Severe hepatic impairment: Do not exceed a daily dose of 20 mg.

Adverse Reactions

• Most common: Headache, abdominal pain, constipation, diarrhea, flatulence, nausea, or vomiting.
• Others: Dermatitis, itching, urticaria; dry mouth; paresthesia, drowsiness, insomnia, dizziness, temporary confusion, agitation, aggression, depression, hallucinations (especially in severe cases); gynecomastia; stomatitis, gastrointestinal candidiasis; leukopenia, thrombocytopenia, agranulocytosis, pancytopenia; increased liver enzyme concentration, encephalopathy (in patients with pre-existing liver disease), hepatitis with or without jaundice, renal function impairment; arthralgia, muscle weakness, myalgia; rash, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia; weakness; increased sensitivity (angioedema, fever, bronchospasm, interstitial nephritis, anaphylactic shock); increased sweating, peripheral edema, blurred vision, altered taste, hyponatremia.

Pregnancy

Epidemiological data from studies on the racemic mixture (omeprazole) do not show teratogenic or fetotoxic effects when used by a large number of pregnant women. Clinical data on the effects of esomeprazole during pregnancy are insufficient. Use with caution.

Breastfeeding

It is unknown whether esomeprazole is excreted in breast milk, and no studies have been conducted in lactating women. Do not use.

Warnings

Use with caution in cases of hepatic impairment. Esomeprazole may mask the symptoms of stomach cancer, so it is particularly important to investigate any changes in symptoms, especially in middle-aged or older patients.

Source | Drug Guide | Lithuanian University of Health Sciences | Institute of Physiology and Pharmacology | Doctor of Medical Sciences Rimas Jankūnas, Doctor of Medical Sciences Arvydas Milašius | Clinic of Internal Diseases | Doctor of Medical Sciences Palmira Leišytė