Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.
Somac (Pharmacia)
40 mg tablets
Indication: peptic ulcers, reflux oesophagitis
This drug increases the prescriber's choice of proton pump inhibitors. Short courses of pantoprazole can be used to treat gastrointestinal lesions which have not responded to H2
receptor antagonists.
Pantoprazole is highly protein bound and rapidly cleared from the serum by liver metabolism. The half life is 1-2 hours with most of the metabolites being excreted in the urine. Some patients eliminate pantoprazole more slowly so that the half life extends to 10 hours. The drug is contraindicated for patients with severe liver disease.
The effect of pantoprazole on acid secretion is prolonged and the minimum effective dose may be less than the recommended daily dose. Treatment is usually given for up to 4 weeks, but some conditions such as reflux oesophagitis may take longer to heal. Safety data to support prolonged use of pantoprazole are not available. Its efficacy is similar to that of omeprazole.
The most common adverse effects reported in clinical trials were headache and diarrhoea. Some serious adverse reactions, such as hepatocellular tumours, thyroid adenomas and ocular toxicity, occurred in animal studies.
