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 high-risk patients requiring long-term use of NSAIDs.Table. 40 mg. Adults and adolescents aged> 12 years: Reflux oesophagitis. Adults: EradicationHelicobacter pyloriin combination with appropriate antibiotics in patients with peptic ulcer diseaseH. pylori. Peptic ulcer of the stomach and / or duodenum. Zollinger-Ellison syndrome and other conditions associated with excessive secretion of hydrochloric acid.

1 tabl enterally contains 20 mg or 40 mg of Pantoprazole in the form of a sodium salt.

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 a peak 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 drug is mainly excreted via the kidneys (approximately 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 benzoimidazoles or to any of the excipients.

It is not recommended for children under 12 years of age (insufficient data). The concomitant use of pantoprazole and atazanavir is not recommended; if combined treatment is required, close clinical monitoring (eg assessment of viral load) is recommended in combination with an increase of atazanavir to 400 mg with a dose of 100 mg ritonavir; do not use a dose of pantoprazole greater than 20 mg. The drug should not be used as a combined treatment for eradicationH. pyloriin patients with moderate and severe hepatic impairment and in patients with impaired renal function (no data on efficacy and safety of use). If the liver enzymes are increased, treatment should be discontinued. The use of pantoprazole (20 mg tablet) as a measure to prevent gastric and duodenal ulcers induced by NSAIDs should be limited to patients who require continuous NSAID treatment and are at risk of gastrointestinal complications. The risk should be assessed according to individual risk factors, eg older age (> 65 years), a positive history of gastric or duodenal ulceration or upper gastrointestinal bleeding. In patients with Zollinger-Ellison syndrome other conditions associated with excessive acid secretion, pantoprazole may reduce the absorption of vitamin B₁₂ following hypo- or achlorhydria. This should be taken into account in patients with reduced stocks or risk factors for decreased vitamin B absorption₁₂ in the case of long-term treatment or when specific clinical symptoms occur. Treatment with pantoprazole may lead to a slight increase in the risk of food-borne infections caused bySalmonella spp. andCampylobacter spp. Patients who are prescribed for long-term therapy with proton pump inhibitors (PPI) or patients who will take PPI with Digoxin or drugs that can cause hypomagnesaemia (eg diuretics) should be considered for Magnesium levels prior to initiation of PPI therapy and periodically during treatment. PPIs, especially when used in high doses and over a long period of time (> 1 year), may slightly increase the risk of fractures of the femoral neck, wrist or spine. This applies especially to elderly patients or when other recognized risk factors occur simultaneously. Research suggests that proton pump inhibitors can increase the overall risk of fractures by 10-40%. Patients at risk for osteoporosis should be under the proper care and take the appropriate dose of vitamin D and calcium.

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, feeling of fullness in the abdomen and bloating, constipation, dry mouth, pain and discomfort in the epigastrium; increased activity of liver enzymes (transaminases, γ-glutamyl transpeptidases); skin rash, eczema; skin eruptions, pruritus; fractures of the bones (hip, wrist or spine), weakness, tiredness and malaise. Rare: hypersensitivity (including anaphylactic reactions and anaphylactic shock); hyperlipidemias and increased lipid levels (triglycerides, cholesterol), weight changes; depression (and all agitations); blurred vision, blurred vision; increase in bilirubin; urticaria, angioneurotic edema; arthralgia, muscle pain, gynecomastia; increase in body temperature, peripheral edema. Very rare: leukopenia, thrombocytopenia; 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, toxic epidermal necrolysis, erythema multiforme, light-invasive; 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, if the symptoms can not be controlled. at dosing, if necessary, re-application of the preparation may be considered continuously.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; diagram 2 - 2 times on. 500 mg daily of Metronidazole + twice daily for 500 mg of clarithromycin; 3 - 2 times daily regimen of 1000 mg amoxicillin + 2 times daily for 500 mg metronidazole. The duration of treatment is usually 1-2 weeks.If further treatment with pantoprazole is indicated to ensure complete healing of ulcers, consideration should be given to the dosage recommended for the treatment of gastric and duodenal ulcer.Treatment of duodenal and gastric ulcer: 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, peptic ulcer and gastroesophageal reflux - 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 breakfast, 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.