Pantoloc

Pantoloc Special Precautions

pantoprazole

Manufacturer:

Takeda

Distributor:

Zuellig
Full Prescribing Info
Special Precautions
In patients with severe liver impairment, the liver enzymes should be monitored regularly during treatment with pantoprazole, particularly on long-term use. In the case of a rise of the liver enzymes, the treatment should be discontinued.
Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis. 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.
Further investigation is to be considered if symptoms persist despite adequate treatment.
Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, due to significant reduction in their bioavailability.
Treatment with Pantoprazole (Pantoloc) may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. difficile.
Hypomagnesaemia: Severe hypomagnesaemia has been reported in patients treated with PPIs like pantoprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with digoxin or medicinal products that may cause hypomagnesaemia (e.g. diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
Bone fractures: Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in older people or in the presence of other recognized risk factors.
Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
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 healthcare professional should consider stopping Pantoprazole (Pantoloc) 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, pantoprazole treatment should be stopped for at least 5 days before CgA measurements (see Pharmacology: Pharmacodynamics under Actions). 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.
20 mg: The use of Pantoprazole (Pantoloc) 20 mg as a preventive of gastroduodenal ulcers induced by non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) should be restricted to patients who require continued NSAID treatment and have an increased risk to develop gastrointestinal complications.
The increased risk should be assessed according to individual risk factors, e.g. age (>65 years), history of gastric or duodenal ulcer or upper gastrointestinal bleeding.
Pantoprazole, as all acid blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.
In long term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.
Note: Prior to treatment the possibility of malignancy of gastric ulcer or a malignant disease of the esophagus should be excluded as the treatment with pantoprazole may alleviate the symptoms of malignant ulcers and can thus delay diagnosis. Patients who do not respond after 4 weeks should be investigated.
40 mg: Pantoprazole is not indicated for mild gastrointestinal complaints such as nervous dyspepsia. In the case of combination therapy, the summaries of product characteristics of the respective drugs should be observed.
In the presence of any alarm symptom (eg significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded.
In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment, pantoprazole, as all acid-blocking medicines may reduce the absorption of vit B12 (cyanocobalamin) due to hypo- or achlorydia. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.
In long-term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.
IV: Gastric malignancy: The intravenous administration of Pantoprazole (Pantoloc) IV is recommended only if oral application is not appropriate.
Pantoprazole (Pantoloc) IV is not indicated for mild gastrointestinal complaints such as nervous dyspepsia. Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis.
In the presence of any alarm symptom (eg significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded. Further investigation is to be considered if symptoms persist despite adequate treatment.
Hepatic impairment: The daily dose of 40 mg pantoprazole should not be exceeded in elderly patients or in those with impaired renal functions.
In patients with severe liver impairment the daily dose has to be reduced to 20 mg pantoprazole.
Furthermore, in these patients the liver enzymes should be monitored during Pantoprazole (Pantoloc) IV therapy. In case of a rise of the liver enzymes Pantoprazole (Pantoloc) IV should be discontinued.
Co-administration with HIV protease inhibitors: Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, due to significant reduction in their bioavailability (see Interactions).
Gastrointestinal infections caused by bacteria: Treatment with Pantoprazole (Pantoloc) may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C.difficile.
Sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. is essentially 'sodium-free'.
Effects on ability to drive and use of machines: Pantoprazole has no or negligible influence on the ability to drive and use machines.
Adverse drug reactions, such as dizziness and visual disturbances may occur (see Adverse Reactions). If affected, patients should not drive or operate machines.
Use in Children: To date there is insufficient experience with treatment in children under 5 to justify a general recommendation.
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