OP-20

Anasec is indicated for the treatment of-
Gastric and duodenal ulcer
NSAID-associated duodenal and gastric ulcer
As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
Gastro-esophageal reflux disease
Long-term management of acid reflux disease
Acid-related dyspepsia
Severe ulcerating reflux esophagitis
Prophylaxis of acid aspiration during general anesthesia
Zollinger-Ellison syndrome
Helicobacter pylori-induced peptic ulcer.

Anasec is well tolerated and adverse reactions have generally been mild and reversible. Skin rash, urticaria and pruritus have been reported. Usually resolving after discontinuation of treatment. In addition photosensitivity, bullous eruption, erythema multiforme, angioedema and alopecia have been reported in isolated cases. Diarrhoea and headache have been reported and may be severe enough to require discontinuation of therapy in a small number of patients. In the majority of cases the symptoms resolved after discontinuation of therapy. Other gastrointestinal reactions have included constipation, nausea/vomiting, flatulence and abdominal pain. Dry mouth, stomatitis and candidiasis have been reported as isolated cases. Paraesthesia has been reported. Dizziness, light headedness and feeling faint have been associated with treatment, but all usually resolve on cessation of therapy. Also reported are somnolence, insomnia and vertigo. Reversible mental confusion, agitation, depression and hallucinations have occurred predominantly in severely ill patients. Arthritic and myalgic symptoms have been reported and have usually resolved when therapy is stopped. In isolated cases, the following have been reported: blurred vision, taste disturbance, peripheral oedema, increased sweating, gynaecomastia, leucopenia, thrombocytopenia, agranulocytosis, pancytopenia, anaphylactic shock, malaise, fever, bronchospasm, encephalopathy in patients with pre-existing severe liver disease, hepatitis with or without jaundice, rarely interstitial nephritis and hepatic failure. Increases in liver enzymes have been observed.

Avoid concomitant use of clopidogrel and Anasec as the pharmacological activity of clopidogrel is reduced if given concomitantly. Observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis- related fractures of the hip, wrist, or spine. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with Anasec. Concomitant use of PPIs with methotrexate may lead to methotrexate toxicities.

Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H
+
/K
+
ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.