Index of drugs

Table. 20 mg: Adults and adolescents aged ≥12 years. Symptomatic form of gastroesophageal reflux disease. Long-term treatment and prevention of recurrent reflux oesophagitis. Adults. Prevention of gastric and duodenal ulcer caused by the use of NSAIDs in patients at increased risk who require long-term use of NSAIDs.Table. 40 mg: Adults and adolescents aged ≥12 years. Reflux oesophagitis. Adults. eradicationHelicobacter pylori in combination with appropriate antibiotics in patients with peptic ulcer diseaseH. pylori. Peptic ulcer of the stomach and duodenum. Zollinger-Ellison syndrome and other conditions associated with excessive secretion of hydrochloric acid.

1 tabl enteric contains 20 mg or 40 mg pantoprazole. The drug contains maltitol and soybean oil.

Pantoprazole is a substituted benzoimidazole that inhibits the secretion of hydrochloric acid by specifically affecting the parietal cells of the gastric mucosa. It is transformed into the active form in the acid environment of the intracellular channels of the gastric parietal cells, where it inhibits the activity of the enzyme H⁺/ K⁺- dependent ATPase, which is responsible for the final stage of production of hydrochloric acid in the stomach. The degree of inhibition of hydrochloric acid depends on the dose and applies to both the basic and stimulated secretion of hydrochloric acid. In most patients, this leads to relief of symptoms within 2 weeks of pantoprazole. Treatment with Pantoprazole leads to a decrease in gastric acidity and a secondary increase in gastrin concentration in proportion to the decrease in acidity. The increase in gastrin level is transient. Pantoprazole is rapidly absorbed from the gastrointestinal tract, reaching the maximum plasma concentration after about 2-2.5 hours. Total pantoprazole bioavailability is about 77%. Binding to serum proteins is about 98%. Pantoprazole is almost completely metabolised in the liver. The major metabolic pathway is demethylation by CYP2C19 with subsequent sulphate coupling, and other metabolic pathways include oxidation by CYP3A4. The drug is excreted mainly via the kidneys (in about 80%) in the form of metabolites; the remainder is excreted with faeces. T_0,5 the final phase of elimination is about 1.5 hours.

Hypersensitivity to Pantoprazole, substituted benzoimidazole, soy or any of the excipients or drugs used in combination therapy.

In patients with severe hepatic impairment, during treatment with pantoprazole, especially in the case of long-term use, liver enzymes should be monitored regularly; if the liver enzymes are increased, treatment should be discontinued. In the event of alarm symptoms (significant unintentional weight loss, recurrent vomiting, dysphagia, bloody vomiting, anemia, tar-like stools) and if there is suspicion or evidence of gastric ulcer, their cancerous background should be excluded, as treatment with pantoprazole may reduce the symptoms of cancer and delay its diagnosis . Further studies should be considered for patients whose disease symptoms persist despite adequate treatment. The concomitant use of proton pump inhibitors with atazanavir is not recommended. In patients with Zollinger-Ellison syndrome and other disorders of increased gastric acid secretion requiring long-term treatment, pantoprazole may reduce the absorption of vitamin B₁₂. In addition, this should be taken into account during long-term treatment of patients with vitamin B deficiency₁₂ and risk factors for its malabsorption or clinical symptoms. With long-term therapy, especially when the treatment lasts for more than a year, patients should be covered by regular medical supervision. It should be noted that proton pump inhibitors can increase the overall risk of fractures by 10-40%. This increase may partly depend on other risk factors. Patients at risk for osteoporosis should be treated in accordance with current clinical practice guidelines and should take adequate amounts of vitamin D and calcium.In patients who are planning longer-term treatment with proton pump inhibitors or patients taking these medicines concomitantly with Digoxin or drugs that can cause hypomagnesaemia (eg with diuretics), physicians should consider the determination of Magnesium levels prior to initiation of proton pump inhibitor therapy, and periodically thereafter time of treatment. The use of the drug may lead to a slight increase in the risk of gastrointestinal infections with bacteriaSalmonella andCampylobacter. The drug contains soya oil - do not use in patients with hypersensitivity to peanut or soya. In addition, the drug contains maltitol - do not use in patients with rare hereditary metabolic disorders with intolerance to fructose. Table. 20 mg - Administration of pantoprazole 20 mg in the prevention of gastric and duodenal ulcer caused by NSAIDs should be limited to patients who need to continue treatment with NSAIDs and those at increased risk of gastrointestinal disorders. The increased risk of these complications should be assessed taking into account individual risk factors such as older age (> 65 years), gastric or duodenal ulceration or history of GI bleeding. Table. 40 mg - The drug should not be used as a combined treatment for eradicationH. pylori in patients with moderate and severe hepatic impairment and in patients with impaired renal function (no data on efficacy and safety of use).

Do not use this medicine during pregnancy unless clearly necessary. There are no adequate studies on the use of pantoprazole in pregnant women; the potential danger to humans is unknown. The decision on whether to continue breastfeeding or treatment should be made taking into account the benefits for the baby resulting from breastfeeding and the benefits for the woman resulting from treatment with pantoprazole.

Uncommon: sleep disorders; headache, dizziness; diarrhea, nausea, vomiting, abdominal bloating and gas, constipation, dry mouth, epigastric pain and discomfort; increased activity of liver enzymes (transaminases, γ-glutamyl transpeptidases); skin rash, eczema, eruptions, pruritus; fracture of the hip, wrist or spine; weakness, tiredness and malaise. Rare: agranulocytosis, hypersensitivity (including anaphylactic reactions and anaphylactic shock); hyperlipidemias and increased lipid levels (triglycerides, cholesterol), weight changes; depression (and all agitations); taste disorders; blurred vision, blurred vision; increase in bilirubin; urticaria, angioneurotic edema; arthralgia, muscle pain, gynecomastia; increase in body temperature, peripheral edema. Very rare: leukopenia, thrombocytopenia, pancytopenia; confusion (and all agitations). Frequency unknown: hyponatraemia, hypomagnesemia; hallucinations, confusion (especially in predisposed patients, as well as the severity of these symptoms in the event of their previous occurrence); liver cell damage, jaundice, hepatic cell failure; Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, hypersensitivity to light; interstitial nephritis.

Orally.Table. 20 mg. Adults and adolescents aged ≥12 years. Symptomatic form of gastroesophageal reflux disease: 20 mg once daily for 2-4 weeks, and if the effect is not sufficient, use the product for another 4 weeks. After the symptoms have resolved, recurrent symptoms can be controlled with 20 mg once a day if necessary, in case of inability to control symptoms. dosage, if necessary, re-application of the preparation may be considered on a continuous basis.Long-term treatment and prevention of recurrent reflux oesophagitis: the maintenance dose is 20 mg per day, in case of relapse, it can be increased to 40 mg per day; after curing the relapse the dose can be reduced again to 20 mg a day.Adults. Prevention of gastric and duodenal ulcer caused by the use of NSAIDs in patients at increased risk requiring long-term use of NSAIDs20 mg once a day.
Table. 40 mg. Adults and adolescents aged ≥12 years. Reflux oesophagitis: 40 mg once daily for 4-8 weeks, in individual cases, the dose may be increased to 80 mg daily (2 tables 40 mg).Adults: eradicationHelicobacter pylori in combination with two appropriate antibiotics: 40 mg twice daily in combination with one of the three following regimens: regimen 1 - 2 times a day for 1000 mg Amoxicillin + twice daily for 500 mg clarithromycin; 2 - 2 times daily regimen of 400-500 mg of Metronidazole (or 500 mg of tididazole) + 2 times daily for 250-500 mg of clarithromycin; 3 - 2 times daily regimen of 1000 mg amoxicillin + 2 times daily after 400-500 mg of metronidazole (or 500 mg of tididazole). The duration of treatment is usually 1-2 weeks. If further treatment with pantoprazole is indicated to ensure complete healing of ulcers, the recommended dosage for the treatment of gastric and duodenal ulcers should be considered.Treatment of duodenal ulcer and stomach: 40 mg once a day, in individual cases the dose may be increased to 80 mg daily. Duration of treatment: duodenal ulcer: 2-4 weeks, gastric ulcer: 4-8 weeksTreatment of Zollinger-Ellison syndrome and other conditions associated with excessive secretion of hydrochloric acid: an initial dose of 80 mg per day, then, if necessary, the dose can be increased or decreased, depending on the results of gastric acid secretion tests. Daily doses greater than 80 mg should be divided and administered twice a day. It is possible to periodically increase the dose above 160 mg per day, but it should not be used longer than necessary to achieve adequate inhibition of gastric acid secretion. The duration of treatment is not limited and should be adapted to clinical symptoms.
Table. should be taken 1 hour before a meal swallowing whole and washed down with water. In the case of combination therapy, the second table should be taken in the evening, before dinner. In patients with severe hepatic impairment, a daily dose of more than 20 mg pantoprazole should not be used. There is no need to modify the dosage in elderly patients.