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Stadnex 40 CAP
Rx

Esomeprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production.

Pack size Box of 20 capsules, 28 capsules, 42 capsules, 56 capsules, 70 capsules
Shelf-life 36 months
Composition Esomeprazole (as esomeprazole (magnesium dihydrate) pellets 22%)
Dosage forms and strengths Hard gelatin capsule: 40 mg.
Product code :

PRESCRIBING INFORMATION

Indications

  • Gastro-oesophageal reflux disease (GORD).
  • Peptic ulcer disease caused by H. pylori.
  • Prophylaxis for NSAID-associated ulceration.
  • Zollinger-Ellison syndrome.

Dosage

Adults and adolescents from the age of 12 years:

  • Treatment of erosive reflux oesophagitis: 40 mg once daily in 4 weeks (if oesophagitis has not healed or persistent symptoms: 8 weeks).
  • Long-term management of patients with healed oesophagitis to prevent relapse: 20 mg once daily.
  • Symptomatic treatment of gastro-oesophageal reflux disease (GORD): 20 mg once daily in patients without oesophagitis. If symptom control has not been achieved after 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily. In adults, an on-demand regimen taking 20 mg once daily, when needed, can be used. In NSAID treated patients at risk of developing gastric and duodenal ulcers, subsequent symptom control using an on-demand regimen is not recommended.

Adults:

  • In combination with an appropriate antibacterial therapeutic regimen for the eradication of pylori and prevention of relapse of peptic ulcers in patients with H. pylori [20 mg Esomeprazole + 1 g Amoxicillin + 500 mg Clarithromycin] twice daily in 7 days.
  • Healing of gastric ulcers associated with NSAID therapy: 20 mg once daily in 4-8 weeks.
  • Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk: 20 mg once daily.
  • Zollinger-Ellison syndrome: Initial 40 mg twice daily, then individually adjust. Doses between 80 to 160 mg daily (doses > 80 mg daily should be divided and given twice).

Children younger than 12 years of age: Should not use.

Patients with severe liver impairment: The maximum dose is 20 mg.

Usage

  • The capsules should be swallowed whole with some water. They should not be chewed or crushed.
  • Known hypersensitivity to any of the active substance or excipients.
  • Pregnancy in the first trimester.
  • Headache, vertigo, skin rash;
  • Nausea, vomiting abdominal pain, diarrhea, constipation, flatulence, dry mouth;
  • Fatigue, insomnia, rash, pruritus, abnormal vision.
  • Patients with severe renal insufficiency.
  • Malignancy should be excluded before using esomeprazole.
  • Using esomeprazole in high doses and over long durations (> 1 year) may modestly increase the risk of hip, wrist and spine fracture.
  • Hypomagnesemia can occur because of using prolonged treatment or taking proton pump inhibitor with medications such as digoxin or drugs that may cause hypomagnesemia (e.g. diuretics).
  • Contraindications for clarithromycin should be considered in patients concurrently taking other drugs metabolised via CYP3A4 such as cisapride.
  • Decreased gastric acidity due to drugs may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.
  • Pregnancy (only use when clearly needed), lactation (should not use).
  • Patients who experience vertigo or hallucinations while taking esomeprazole should refrain from driving or using machines.