Zomep

Zomep Special Precautions

omeprazole

Manufacturer:

Drug International

Distributor:

ECE Pharma

Marketer:

Jazmark
Full Prescribing Info
Special Precautions
Before giving Omeprazole or other proton pump inhibitors to patients with gastric ulcers the possibility of malignancy should be excluded since these drugs may mask symptoms and delay diagnosis. Omeprazole and other proton pump inhibitors should be used with caution in hepatic impairment and dose adjustment maybe required.
Gastric carcinoma: Proton pump inhibitors relieve dyspeptic symptoms associated with gastric carcinoma and can therefore delay its diagnosis. In addition, there is some evidence that they may also endoscopically "heal" early gastric carcinoma so that the diagnosis is missed. Consequently, some commentators recommend that proton pump inhibitors, should not be prescribed for symptom control before endoscopy in patients at risk for gastric carcinoma.
Helicobacter infection: Treatment with proton pump inhibitors may cause false-negative results in the urea breath test for Helicobacter pylori infection. In one study in patients with H. pylori infection, 4 weeks of treatment with Lanzoprazole 30 mg daily caused 33% of patients to have negative urea breath tests. The breath test became positive again in all patients within 2 weeks of stopping lanzoprazole therapy. In a similar study, 52% of patients had negative urea breathe tests for H. pylori while receiving Omeprazole 20 mg daily, and the breath test became positive again in all patients within 2 to 5 days of stopping treatment. The manufacturers of the urea breath test for H. pylori recommend that it should not be performed for at least 2 weeks after stopping treatment with an antisecretory drug.
Hepatic impairment: In patients with cirrhosis, an increase in omeprazole bioavailability and elimination half-life has been reported.
Pregnancy: Proton-pump inhibitors are not generally licensed for use during pregnancy, but a meta-analysis of 1 of 5 studies of exposure to proton pump inhibitors during the first trimester, involving 593 exposed infants found the relative risks of major abnormalities associated with such exposure to be only 1.18 with a 95% confidence interval ranging from 0.72 to 1.94. Metanalysis of exposure to Omeprazole (from 4 studies only) gave a relative risk of 1.05 (95% confidence interval 0.59 to 1.85). It was concluded that exposure to proton pump inhibitors and Omeprazole in particular, did not pose an important teratogenic risk.
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