Indications

Treatment of duodenal ulcers; Prevention of relapse of duodenal ulcers; Treatment of gastric ulcers; Prevention of relapse of gastric ulcers; In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease; Treatment of NSAID-associated gastric and duodenal ulcers; Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk; Treatment of reflux oesophagitis; Long-term management of patients with healed reflux oesophagitis; Treatment of symptomatic gastro-oesophageal reflux disease; Treatment of Zollinger-Ellison syndrome

Dosage and Administration

Usage: Oral

1.Treatment of duodenal ulcers: The recommended dose in patients with an active duodenal ulcer is Omeprazole 20 mg once daily.

2.Prevention of relapse of duodenal ulcers: For the prevention of relapse of duodenal ulcer in H. pylori negative patients or when H. Pylori eradication is not possible the recommended dose is Omeprazole 20 mg once daily.

3.Treatment of gastric ulcers

The recommended dose is Omeprazole 20 mg once daily. In most patients healing occurs within four weeks.

Precautions & Warning:

1. In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.

2. Co-administration of atazanavir with proton pump inhibitors is not recommended. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; omeprazole 20 mg should not be exceeded.

3. Omeprazole, as all acid-blocking medicinal products, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy.

4. Omeprazole is a CYP2C19 inhibitor. When starting or ending treatment with omeprazole, the potential for interactions with medicinal products metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and omeprazole. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged.

Contraindications:

1.Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients.

2.Omeprazole like other proton pump inhibitors (PPIs) must not be used concomitantly with nelfinavir

Adverse Reactions:

The most common adverse reactions (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.

Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with omeprazole treatment

Drug interactions:

Effects of omeprazole on the pharmacokinetics of other active substances

Active substances with pH dependent absorption

The decreased intragastric acidity during treatment with omeprazole might increase or decrease the absorption of active substances with a gastric pH dependent absorption.

Nelfinavir, atazanavir

The plasma levels of nelfinavir and atazanavir are decreased in case of co-administration with omeprazole.

Concomitant administration of omeprazole with nelfinavir is contraindicated.

Co-administration of omeprazole (40 mg once daily) reduced mean nelfinavir exposure by ca. 40% and the mean exposure of the pharmacologically active metabolite M8 was reduced by ca. 75 –90%. The interaction may also involve CYP2C19 inhibition.

Storage instructions:

Do not store above 25°C.