Pantokem/Pantokem IV Special Precautions

Pantokem: Symptomatic response does not preclude gastric malignancy; not indicated for maintenance therapy. Safety and efficacy for use beyond 16 weeks have not been established.
Use in Pregnancy: See Use in Pregnancy & Lactation section for further information.
Use in Children: Pantoprazole is not recommended for use in children <12 years. Safety and efficacy in pediatric patients have not been established.
Pantokem IV: In presence of alarm symptoms: In the presence of any alarm symptom (e. g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with pantoprazole may alleviate symptoms and delay diagnosis.
Further investigation is to be considered if symptoms persist despite adequate treatment.
Hepatic impairment: In patients with severe liver impairment, the liver enzymes should be monitored during therapy. In the case of a rise in the liver enzymes, the treatment should be discontinued.
Co-administration with atazanavir: Co-administration of atazanavir with proton pump inhibitors is not recommended. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir.
A pantoprazole dose of 20 mg per day should not be exceeded.
Gastrointestinal infections caused by bacteria: Pantoprazole, like all proton pump inhibitors (PPIs), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. Treatment with pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria (e.g. Salmonella and Campylobacter and C. difficile).
Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Pantoprazole.
SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, treatment should best topped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
Sodium: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially "sodium-free".
Before giving Pantoprazole or other proton pump inhibitors to patients with gastric ulcers the possibility of malignancy should be considered since these drugs may mask symptoms and delay diagnosis. Pantoprazole and other proton pump inhibitors should be used with caution in hepatic impairment.