Stadnex 40 CAP

Rx

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.