OMEPRAZOLE SODIUM FOR INJECTION 40MG 10ML

OMEPRAZOLE SODIUM FOR INJECTION 40MG 10ML

  • Documents: GMP,COPP,CTD

OMEPRAZOLE SODIUM FOR INJECTION 40MG 10ML

Indications:

Omeprazole for intravenous use is indicated as an alternative to oral therapy for the following indications i.e.

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:

In patients where the use of oral medicinal products is inappropriate, Omeprazole IV 40 mg once daily is recommended. In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily.

Omeprazole is to be administered in an intravenous infusion for 20-30 minutes.

Precautions & Warning:

In the presence of any alarm symptoms (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.

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.

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.

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

For patients expected to be on prolonged treatment or who take proton pump inhibitors with digoxin or medicinal products that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting proton pump inhibitor treatment and periodically during treatment.

Contra-indications:

Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients.

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

Drug interactions:

Active substances with pH dependent absorption:

Nelfinavir, Atazanavir,Digoxin,Clopidogrel

Other active substances:

The absorption of posaconazole, erlotinib, ketoconazol and itraconazol is significantly reduced and thus clinical efficacy may be impaired. For posaconazol and erlotinib concomitant use should be avoided.

Active substances metabolised by CYP2C19:

Omeprazole is a moderate inhibitor of CYP2C19, the major omeprazole metabolising enzyme. Thus, the metabolism of concomitant active substances also metabolised by CYP2C19, may be decreased and the systemic exposure to these substances increased. Examples of such medicinal products are R-warfarin and other vitamin K antagonists, cilostazol, diazepam and phenytoin.

Unknown mechanism: Saquinavir,Tacrolimus

Effects of other active substances on the pharmacokinetics of omeprazole:

Inhibitors of CYP2C19 and/or CYP3A4

Inducers of CYP2C19 and/or CYP3A4

Storage instructions:

Do not store above 25°C. Keep vials in the outer carton in order to protect from light.