Dudencer

Rx

Indications:

• Relief of acid-related dyspepsia.
• Treatment of gastro-oesophageal reflux disease (GORD).
• Management of peptic ulcer disease.
• Treatment of NSAID-associated ulceration.
• Zollinger-Ellison syndrome.
• Prophylaxis of acid aspiration during general anaesthesia.

Dosage:

Relief of acid-related dyspepsia: 10 or 20 mg daily for 2 to 4 weeks.

Gastro-oesophageal reflux disease (GORD):

+ The usual dose: 20 mg once daily for 4 weeks, followed by a further 4 to 8 weeks if not fully healed. In refractory oesophagitis, a dose of 40 mg daily may be used.

+ Maintenance therapy after healing of oesophagitis is 20 mg once daily, and for acid reflux is 10 mg daily.

Peptic ulcer disease:

+ A single daily dose of 20 mg, or 40 mg in severe cases. Treatment is continued for 4 weeks for duodenal ulcer and 8 weeks for gastric ulcer. Maintenance therapy: 10 to 20 mg once daily.

+ For the eradication of H. pylori in peptic ulceration: Omeprazole may be combined with antibacterials in dual or triple therapy. Dual therapy: Omeprazole 20 mg twice daily for two weeks. Triple therapy: Omeprazole 20 mg twice daily for one week.

NSAID-associated ulceration: 20 mg daily;

Zollinger-Ellison syndrome: 60 mg once daily, adjusted as required.

Prophylaxis of acid aspiration during general anaesthesia: 40 mg in the evening before surgery and a further 40 mg two to six hours before the procedure.

Administration:

Dudencer is administered orally. It should be swallowed whole and not crushed or chewed.

Known hypersensitivity to any of the active substance or excipients.

Common: Headache, somnolence, dizziness; nausea, vomit, abdominal pain, diarrhoea, constipation, flatulence.

Less common: Insomnia, confusion, vertigo, fatigue; urticaria, itch, skin eruption; rise in values of transaminase (reversible).

Malignancy should be excluded before using omeprazole.

Co-administration of atazanavir or clopidogrel with proton pump inhibitors (PPIs) is not recommended.

Omeprazole may reduce the absorption of vitamin B₁₂ (cyanocobalamin).

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).

Using omeprazole in high doses and over long durations (> 1 year) may modestly increase the risk of hip, wrist and spine fracture;

It is not recommended to use Dudencer during the pregnancy (particularly during the first trimester) and breastfeeding.

Patients who experience vertigo or visual disturbances while taking omeprazole should refrain from driving or using machines.