Index of drugs

Table. enteric-coated 20 mg. A benign form of reflux oesophagitis, prevention of relapse and long-term treatment of reflux oesophagitis, protection of gastric and duodenal mucosa before ulceration in patients at increased risk, using long-term non-selective non-steroidal anti-inflammatory drugs (NSAIDs).Table. enteric 40 mg. eradicationHelicobacter pylori in combination with two appropriate antibiotics, gastric ulcer, duodenal ulcer disease, moderate and severe reflux oesophagitis, Zollinger-Ellison syndrome and other hyper-hydrochloric acid states.

1 tabl enteric contains 20 mg or 40 mg pantoprazole.

Proton pump inhibitor (H⁺/ K⁺ATP-ases) in the parietal cells of the stomach. It inhibits the secretion of hydrochloric acid, both basic and stimulated (regardless of the stimulating factor of this secretion). Pantoprazole quickly absorbs from the gastrointestinal tract, reaching C_max in 2-2.5 hours. Bioavailability is about 77%; binding to plasma proteins - 98%. It is metabolized in the liver. The major metabolic pathway is demethylation by CYP2C19 followed by conjugation with sulfate, other metabolic pathways include oxidation by CYP3A4. The metabolites of pantoprazole are mainly excreted via the kidneys (approximately 80%); the rest is excreted with faeces. T_0,5 pantoprazole in the final phase of elimination is about 1 hour; T_0,5 the main metabolite - about 1.5 h. In patients with renal insufficiency_0,5 the main metabolite is prolonged to 2-3 hours, however, excretion of pantoprazole in this group of patients is rapid and there is no accumulation. In patients with cirrhosis (Child-Pugh A and B), T_0,5 it extends to 3-6 h, AUC increases 3-5 times, and the maximum concentration in the blood increases 1.3 times.

Hypersensitivity to Pantoprazole, substituted benzoimidazoles or to any of the excipients.

Do not use in mild gastrointestinal disorders (eg nervous dyspepsia). Patients with severe hepatic insufficiency should not exceed 40 mg pantoprazole every other day, liver enzymes should be monitored regularly, especially if pantoprazole is used for a long time (if increased levels of liver enzymes occur, pantoprazole should be discontinued). For combination therapy, please refer to the appropriate SmPC for both medicines. In patients with suspected or diagnosed peptic ulcer disease, as well as any disturbing symptoms (eg, significant unintentional weight loss, recurrent vomiting, swallowing difficulties, bloody vomiting or tarry stools, anemia), the cancerous background of the disease should be excluded, as treatment pantoprazole can relieve the symptoms of cancer and delay its diagnosis. Further studies should be considered for patients whose disease symptoms persist despite adequate treatment. Patients who have been on treatment for a long time (especially if the treatment lasts for more than a year) should remain under regular medical supervision. Lack of treatment efficacy after 4 weeks of pantoprazole requires re-diagnosis. Treatment with pantoprazole may slightly increase the risk of gastrointestinal infections with such bacteria asSalmonella spp., Campylobacter spp.and C. difficile.Pantoprazole may reduce the absorption of vitamin B₁₂ (cyanocobalamin) due to hypo or achlorhydria; this should be taken into account during long-term treatment of patients with reduced vitamin B stores₁₂ or risk factors favoring the reduction of its absorption, during long-term therapy or in case of clinical symptoms. Patients treated with pantoprazole for at least 3 months (in most cases for a year) have experienced severe hypomagnesaemia; patients who are prescribed long-term treatment or who take proton pump inhibitors at the same time as Digoxin or hypomagnesaemic agents (e.g.diuretics), consideration should be given to determining Magnesium levels before starting treatment with pantoprazole and then periodically during treatment. Proton pump inhibitors can increase the overall risk of fractures by 10-40%; Patients at risk of osteoporosis should receive care in accordance with current clinical guidelines, and provide adequate amounts of vitamin D and calcium. In case of skin lesions, especially in places exposed to sunlight, with joint pain, consideration should be given to discontinuation of pantoprazole (possibility of subacute cutaneous form of SCLE Lupus Erythematosus, SCLE as a result of earlier IPP treatment may increase the risk of SCLE as a result of treatment with other IPP) . The use of pantoprazole with atazanavir is not recommended (reduction of atazanavir exposure).

Do not use during pregnancy unless clearly necessary. The penetration of pantoprazole into breast milk has been found. Therefore, the decision whether to continue / stop breast-feeding or to continue / stop taking the drug should be taken taking into account the benefits for the child resulting from breastfeeding and the benefits for a woman resulting from treatment with pantoprazole.

Uncommon: sleep disturbances, headache, dizziness, diarrhea, nausea, vomiting, abdominal fullness, bloating, constipation, dry mouth, epigastric pain and discomfort, increased liver enzymes (transaminases, GGT), rash dermal, erythema, skin eruptions, pruritus, hip bust, carpal bones, spine, weakness, fatigue, malaise. Rare: agranulocytosis, hypersensitivity (including anaphylactic reactions and anaphylactic shock), hyperlipidemias and increased lipids (triglycerides, cholesterol), changes in body weight, depression (and worsening of mental state), taste disturbances, blurred vision, blurred vision, increased bilirubin , urticaria, angioneurotic edema, joint pain, muscle pain, gynecomastia, elevated body temperature, peripheral edema. Very rare: thrombocytopenia, leukopenia, pancytopenia, confusion (and mental deterioration). Frequency unknown: hyponatremia, hypomagnesaemia, hypocalcemia in combination with hypomagnesaemia, hypokalaemia, hallucinations, confusion (especially in predisposed patients, as well as worsening of these symptoms in case of their previous occurrence), parasthesia, liver cell damage, jaundice, hepatic cell failure, Stevens syndrome -Johnson, toxic epidermal necrolysis, erythema multiforme, hypersensitivity to light, subacute cutaneous form of lupus erythematosus, muscular spasms (as a result of electrolyte disturbances), interstitial nephritis (with the possibility of developing renal failure).

Orally. A benign form of reflux oesophagitis: 20 mg once a day for 2-4 weeks; if necessary, continue for another 4 weeks. Long-term treatment and prevention of relapses of reflux oesophagitis: 20 mg once a day; if symptoms worsen, the dose may be increased to 40 mg once a day; after resolution of acute symptoms, it is recommended to reduce the dose to 20 mg once a day (the preparation can be used for more than a year only if the benefits of treatment outweigh the potential risk). Prevention of gastric and duodenal ulcers in patients at risk who require long-term NSAID treatment: 20 mg once a day. Peptic ulcer: 40 mg once daily for 4 weeks; if necessary, continue for another 4 weeks; when the patient is unresponsive to treatment, the dose can be increased to 80 mg daily. Duodenal ulcer: 40 mg once daily for 2 weeks; if necessary, continue for another 2 weeks. Moderate and severe reflux oesophagitis: 40 mg once daily for 4 weeks; if necessary, continue for another 4 weeks. Zollinger-Ellison syndrome and other hyper-hydrochloric acid states: individually, initially 80 mg per day, the dose can be increased> 160 mg per day, but should not be used longer than necessary; the maximum duration of use is not specified. eradicationHelicobacter pylori: 40 mg twice daily, in combination with antibacterial treatment: a) Amoxicillin 1 g 2 times daily and Clarithromycin 500 mg twice daily or b) clarithromycin 500 mg twice daily and Metronidazole 500 mg twice daily or c) amoxicillin 1 g twice daily and metronidazole 500 mg twice daily; treatment lasts 7 days, if necessary, you can continue treatment for the Next 7 days; in order to heal the peptic ulcer, it is recommended to continue using pantoprazole according to the dosage regimen used in the treatment of gastric and duodenal ulcer.Way of giving. The tablets should be taken 1 hour before a meal (preferably in the morning), washed down with water; in combination therapy with antibiotics, in eradicationH. pylori take the second dose before the evening meal. The tablets should not be chewed or chewed.