The Pharmaceutical Journal
Vol 272 No 7290 p305
13 March 2004

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Omeprazole goes over-the-counter as Zanprol

Omeprazole 10mg has been launched by GlaxoSmithKline Consumer Healthcare as a pharmacy-only medicine. Zanprol will be available in pharmacies for the treatment of reflux-like symptoms (eg, heartburn) in adults from 16 March.

GSK says the product will enable pharmacists to take a central role in the management of this condition.

In a GSK press release, Robert Walt, consultant gastroenterologist, Birmingham Heartlands Hospital, said: “Years of experience with omeprazole and its ubiquitous use in general practice makes it a good candidate for non-prescription use. It is one of the most effective treatments for heartburn and is well tolerated. In addition, a pharmacist should be perfectly able to identify potential alarm symptoms so as to ensure certain patients get to their GPs when necessary.”

Speaking to The Journal, Kenneth McColl, professor of gastroenterology, University of Glasgow, said he was confident in the rigorous procedure required for POM to P switches. He believes that pharmacists can provide short-term omeprazole treatment for heartburn as long as patients show no sinister symptoms.

Richard Stevens, GP and chairman of the Primary Care Society for Gastroenterology, said that about 10 per cent of GP consultations are for gastrointestinal disease. About half of these are loosely classed as dyspepsia including heartburn — a large burden for general practice. He believes that proton pump inhibitors (PPIs) are safe and effective drugs and that their over-the-counter availability provides a great opportunity to empower patients.

Dr Stevens highlighted draft guidelines on dyspepsia from the National Institute for Clinical Excellence, which encourage dyspepsia patients to manage their own symptoms and emphasise the importance of community pharmacists in providing initial and ongoing help for this condition.

Heartburn is largely benign, he said, adding that GPs use PPIs long term, usually without reservation. He thought concerns over masking more serious conditions with PPIs were unwarranted. “We don’t worry about masking the symptoms of brain tumours by treating headaches or lung cancer by treating cough,” he commented.

Brian Curwain, head of medicines management at New Forest Primary Care Trust, welcomed OTC proton pump inhibitors as safe drugs with few side effects. He said: “Doctors often choose a PPI over an H2 antagonist and the new product might replace some of the existing market rather than generating a new one.” He added that omeprazole might be included in some minor ailment pharmacy prescribing projects.

GSK is recommending that Zanprol is used in short courses, saying that a course can give weeks of remission from recurrent attacks of heartburn (twice a week or more). Patients obtaining no symptom relief within two weeks or those requiring continuous treatment for more than four weeks to relieve symptoms, must be referred to a GP. The number of courses of Zanprol a patient can take is not specified.

The starting dose is two 10mg tablets once daily for three to four days to obtain symptom relief. When symptoms improve the dose can then be reduced to one 10mg tablet daily, returning to two tablets if symptoms return. GSK says that the lowest effective dose should always be used. The tablets should be swallowed whole with plenty of liquid before a meal. It is important they are not crushed or chewed.

GSK has produced a package of educational materials including a treatment algorithm for Zanprol use (see Panel). Training materials will be sent to pharmacies shortly.