Pantoprazole contains the active substance pantoprazole. Pantoprazole is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine. Pantoprazole is used to treat adults and adolescents 12 years of age and above for
• Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.
• An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning.
• Stomach and duodenal ulcers.
• Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.
Pantoprazole is a proton pump inhibitor (PPI). It inhibits specifically and dose proportionately H+/K+-ATPase, the enzyme which is responsible for gastric acid secretion in the parietal cells of the stomach. It effectively inhibits normal acid secretion and stimulated acid secretion.
• Significant hepatic disease.
• Investigate and rule out malignancies, such as gastric carcinoma.
• PPI therapy may be associated with an increased risk for osteoporosis related fractures of the hip, wrist, or spine. The risk of fracture is increased in patients who receive high doses; defined as multiple daily doses, and long-term PPI therapy.
• Acute interstitial nephritis may occur at any point during PPI therapy and is generally associated to an idiopathic hypersensitivity reaction. Discontinue pantoprazole if acute interstitial nephritis develops.
• Hepatic impairment – risk of accumulation in high dose therapy.
• Avoid use in pregnancy, safe in breastfeeding.
Concomitant administration of pantoprazole and warfarin can cause increased INR and prothrombin time. Monitoring of prothrombin time/INR is recommended during treatment. As with all acid suppressant medications, the absorption of drugs whose bioavailability is pH dependent (e.g. ketoconazole, itraconazole, posaconazole, erlotinib), might be altered due to the decrease in gastric acidity.
Pantoprazole, should not be coadministered with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH, such as atazanavir.
• Dry mouth, metallic taste, increased sweating.
• Diarrhoea, constipation or flatulence
• Headache, dizziness.
Pregnancy Category B Reproduction studies have been performed in rats at oral doses up to 88 times the recommended human dose and in rabbits at oral doses up to 16 times the recommended human dose and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed
Pantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known. Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants.
Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.
Driving and using machines
Pantoprazole has no or negligible influence on the ability to drive and use machines.
Dosage and method of administration
Pantoprazole 40 mg (one tablet) should be given once a day. In most patients, freedom from symptoms is achieved rapidly and healing generally occurs within two weeks. If a two week period of treatment is not sufficient, healing will be achieved in almost all cases within a further two weeks.
Pantoprazole 40 mg (one tablet) should be given once a day. In most patients, freedom from symptoms is achieved rapidly and healing usually takes four weeks. If a four week period of treatment is not sufficient, healing will usually be achieved in a further four weeks.
Lesions Refractory to H2-Receptor Antagonists
Pantoprazole 40 mg (one tablet) should be given once a day. In most patients, freedom from symptoms is achieved rapidly and healing usually takes four weeks. If a four week period of treatment is not sufficient, healing is achieved in the majority of patients in a further four weeks. In a small group of patients, there may be benefit in extending pantoprazole therapy to a total of 12 weeks.
The number of pantoprazole 40 mg tablets should be individually adjusted, so that the acid output remains below 10 mmol/L. No fixed period of time is proposed for treatment of Zollinger-Ellison syndrome.
Symptomatic Gastroesophageal Reflux Disease (Treatment of Symptomatic Reflux)
The recommended dosage is one pantoprazole 20 mg tablet/day. If symptom control has not been achieved after four weeks treatment with pantoprazole 20 mg tablets daily, further investigation is recommended, for example, endoscopy.
Treatment of Reflux Oesophagitis
The recommended oral dosage is one pantoprazole 20 or 40 mg tablet/day. A four week period is usually required for healing, however, if this is not sufficient, healing will usually be achieved within a further four weeks. This dosage may be increased up to pantoprazole 80 mg/day. Maintenance of Healed Reflux Oesophagitis in Patients Previously Treated for Moderate to Severe
For long-term management, a maintenance dose of one pantoprazole 20 or 40 mg tablet/day is recommended, dependent upon patient response.