Index of drugs

Table. 20 mg. Adults and adolescents aged 12 and above: Symptomatic form of esophageal reflux disease. Long-term treatment and prevention of recurrent reflux oesophagitis.Adults. Prevention of gastric and duodenal ulcers caused by the use of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at increased risk who require long-term use of NSAIDs.Table. 40 mg. Adults and adolescents aged 12 and above: Reflux oesophagitis.Adults: Duodenal ulcer. Peptic ulcer disease. Zollinger-Ellison syndrome and other disease states with increased secretion of hydrochloric acid. eradicationHelicobacter pylori in combination with two antibiotics in patients with duodenal ulcer or stomach ulcer.

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

Pantoprazole inhibits the secretion of hydrochloric acid in the stomach through a specific effect on parietal mucosal cells. 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 the synthesis 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. Treatment with pantoprazole reduces the acidity of gastric acid and thus leads to a secondary increase in gastrin concentration in proportion to the reduction in acidity. The increase in gastrin level is transient. Pantoprazole is rapidly absorbed from the gastrointestinal tract, reaching a maximum plasma concentration after about 2-2.5 h. Serum protein binding 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 hour.

Hypersensitivity to the components of the preparation.

The administration of 20 mg pantoprazole for the prevention of duodenal ulcer caused by NSAIDs should be limited to patients who require continuous NSAIDs and are 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 upper GI bleeding. In patients with Zollinger-Ellison syndrome and other diseases with increased gastric acid secretion, requiring long-term treatment, pantoprazole may reduce the absorption of vitamin B₁₂ due to deficiency or lack of hydrochloric acid in gastric juice. Proton pump inhibitors, especially those used at high doses and in long-term therapy (over 1 year), may slightly increase the risk of hip fractures, carpal bones and spine, especially in the elderly or in patients with other known risk factors. Patients at risk for osteoporosis should receive care in accordance with current clinical guidelines and take the appropriate dose of vitamin D and calcium. For patients who are presumed to be long-term or taking IPP including Digoxin or other agents that may cause hypomagnesaemia (eg diuretics), consideration should be given to measuring Magnesium in the blood prior to treatment with IPP and periodic measurements during treatment. In patients with severe hepatic impairment, especially during long-term use of Pantoprazole, liver enzymes should be monitored regularly - if treatment is increased, treatment should be discontinued.In the case of alarm symptoms (such as significant unintentional weight loss, recurrent vomiting, dysphagia, bloody vomiting, anemia, tarry stools) and when suspected or confirmed gastric ulcers, their cancerous background should be excluded, as treatment with pantoprazole may relieve the symptoms of cancer and delay her diagnosis. Further studies should be considered for patients whose disease symptoms persist despite adequate treatment. The medicinal product contains soya lecithin. Do not use in patients with hypersensitivity to peanut or soya. Do not use in children under 12 years of age.

The preparation can be given during pregnancy and breastfeeding only when the benefits of therapy for the mother outweigh the possible risk to the fetus and infant.

Uncommon: sleep disturbances, headache and dizziness, epigastric pain and discomfort, diarrhea, constipation, abdominal fullness and flatulence, nausea, vomiting, dry mouth, increased liver enzymes (aminotransferases, γ-glutamyl transpeptidases), rash, eczema, eruptions, pruritus, hip fracture, wrist or spine, weakness, tiredness and malaise. Rare: hypersensitivity reactions (including anaphylactic shock), hyperlipidemia, increased lipids (triglycerides, cholesterol), changes in body weight, depression (and worsening of symptoms), blurred vision (blurred vision), increased bilirubin, urticaria, angioneurotic edema, joint and muscle pain, gynecomastia, increased body temperature, peripheral edema. Very rare: thrombocytopenia, leukopenia, confusion (and worsening of symptoms). In addition: hyponatraemia, hypomagnesemia, hallucinations, convulsion (especially in predisposed individuals, worsening of these symptoms in the event of their previous occurrence), liver cell damage, jaundice, hepatic failure, Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, photosensitivity, interstitial nephritis. Administration of drugs that reduce gastric acid secretion may be associated with a slight increase in the risk of gastrointestinal infections, e.g.Salmonella andCampylobacter.

Orally.Table. 20 mg. Symptomatic form of reflux oesophagitis: 20 mg once daily for 2-4 weeks, if necessary continue for another 4 weeks. After the symptoms have resolved, recurrent symptoms can be controlled with 20 mg once a day if necessary, if you can not control symptoms when overdosed if necessary re-use 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. Long-term therapy, carried out for more than one year, requires careful consideration of the benefit / risk ratio.Prevention of gastric and duodenal ulcer caused by the use of NSAIDs in high-risk patients requiring long-term intake of NSAIDs20 mg daily.
In patients with severe hepatic impairment, a dose of more than 20 mg per day should not be used. No dosage adjustment is necessary for patients with impaired renal function and in the elderly.
Table. 40 mg. Reflux oesophagitis and peptic ulcer: 40 mg daily for 4-8 weeks. In individual cases, a doubling of the dose (2 tablets per day) may be considered, especially when there is no response to other treatments.Duodenal ulcer:40 mg daily for 2-4 weeks. In individual cases, a doubling of the dose (2 tablets per day) may be considered.Zollinger-Ellison syndrome and other diseases associated with increased secretion of gastric juice: treatment should start with a daily dose of 80 mg (2 tables 40 mg). Then, if necessary, the dose can be increased or decreased depending on the results of gastric acid secretion. Daily doses greater than 80 mg should be divided and administered twice a day. A periodic increase in the dose above 160 mg per day is allowed, but it should only be used until adequate inhibition of gastric acid secretion is achieved. The duration of treatment is not limited and should be adapted to clinical symptoms.eradicationHelicobacter pylori: in combination therapy 40 mg 2 times a day. Depending on the type of resistance, the following combination regimens are recommended: regimen 1 - 2 times daily 40 mg + 2 times daily 1000 mg Amoxicillin + 2 times daily 500 mg of clarithromycin; diagram 2 - 2 times a day 40 mg + 2 times a day 400-500 mg of Metronidazole (or 500 mg of tididazole) + 2 times a day 250-500 mg of clarithromycin; 3 - 2 times daily regimen 40 mg + 2 times daily 1000 mg amoxicillin + 2 times daily 400-500 mg metronidazole (or 500 mg tnidazole).
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. Combination therapy is usually carried out for 7 days and can be extended up to a maximum of 2 weeks. If further treatment with pantoprazole is indicated to ensure full healing of the ulcer, doses recommended for the treatment of gastric and duodenal ulcers should be considered. With the exception of patients with Zollinger-Ellison syndrome and other diseases with excessive gastric acid secretion, treatment should not be longer than 8 weeks
In elderly patients, a daily dose of more than 40 mg pantoprazole should not be used, with the exception of combination therapy for eradicationH. pyloriduring which patients should take the recommended dose of pantoprazole (twice daily for 40 mg) for 7 days.
In patients with impaired renal function should not use a daily dose of more than 40 mg, therefore, it is not recommended in these patients combination therapy with the three drugs to eradicateH. pylori. In patients with severe hepatic impairment, the dose should be reduced to 40 mg every other day. In patients with severe hepatic impairment, combination therapy for eradication is not recommendedH. pylori.