Index of drugs

Table. enteric-coated 20 mg. Adults and adolescents in many 12 years and older: symptomatic gastroesophageal reflux disease; long-term treatment and prevention of recurrent reflux oesophagitis. Adults: prevention of gastrointestinal ulceration caused by non-selective NSAIDs in at-risk patients requiring continuous NSAID treatment.Table. enteric 40 mg. Adults and adolescents aged 12 years and older: reflux oesophagitis. Adults: eradicationHelicobacter pylori in combination with appropriate antibiotic therapy in patients with peptic ulcer diseaseH. pylori; Zollinger-Ellison syndrome and other conditions associated with excessive acid secretion.

1 tabl enterally contains 20 mg or 40 mg of Pantoprazole in the form of a semi-professional sodium salt. The preparation contains sorbitol.

Proton pump inhibitor. Pantoprazole is a substituted benzoimidazole that inhibits the secretion of hydrochloric acid in the stomach by specifically blocking the proton pump of parietal cells. In an acidic environment, in the lumen of the parietal cells, pantoprazole is converted to the active form where it inhibits the H enzyme⁺, K⁺-ATPase, i.e. the last step in the production of hydrochloric acid in the stomach. This inhibition is dose-dependent and affects both basal and stimulated acid secretion. In the majority of patients, the symptoms disappear within 2 weeks. Treatment with pantoprazole increases the amount of gastrin in proportion to the decrease in gastric acidity. The increase in gastrin secretion is reversible. Pantoprazole can affect the secretion of hydrochloric acid independently of stimulation by other substances (acetylcholine, histamine, gastrin). The drug is quickly absorbed from the digestive tract. The maximum serum concentration is about 2-2.5 hours after administration. Absolute bioavailability is about 77%. Simultaneous food intake does not affect the bioavailability, but increases the variability of the drug's delay. Pantoprazole binds to plasma proteins in about 98%. Metabolized almost exclusively in the liver. The major metabolic pathway is demethylation by CYP2C19, followed by conjugation with sulfate; other metabolic pathways include CYP3A4-mediated oxidation. T_0,5 in the phase of elimination is about 1 hour. Metabolites of pantoprazole are mainly excreted by the kidneys (about 80%), the rest is excreted in the faeces. The main metabolite in both plasma and urine is demethyl Pantoprazole, which is conjugated to sulfate. T_0,5 the main metabolite is about 1.5 hours.

Hypersensitivity to the active substance, substituted benzimidazoles, sorbitol, to any of the excipients.

In patients with severe hepatic impairment, liver enzymes should be monitored regularly during treatment with pantoprazole, in particular during long-term use. If the liver enzymes are increased, treatment should be discontinued. Application of tabl. 20 mg as an anti-duodenal agent induced by NSAIDs should be limited to patients who require continuous NSAID treatment and are at greater risk of developing gastrointestinal complications. In the event of any disturbing symptoms (eg unintentional significant weight loss, recurrent vomiting, swallowing disorders, bloody vomiting, anemia or tarry stools) and when stomach ulcers are suspected or diagnosed, their cancerous background should be excluded, as treatment with pantoprazole may reduce the symptoms of the disease cancer and delay its diagnosis; if the symptoms persist despite proper treatment, further testing should be considered. Atazanavir is not recommended for concomitant use with proton pump inhibitors. If such combination therapy is necessary, careful clinical monitoring (eg viral load) is recommended with increasing dose of atazanavir to 400 mg administered with 100 mg ritonavir; do not exceed 20 mg pantoprazole daily.In patients with Zollinger-Ellison syndrome and other conditions associated with excessive acid secretion requiring long-term treatment, pantoprazole, like all drugs that inhibit acid production, may reduce the absorption of vitamin B₁₂ following hypo- or achlorhydria. This should be taken into account in patients with reduced body stores or risk factors for reducing the absorption of vitamin B₁₂ if you are on long-term treatment or if you get the right clinical symptoms. In the case of long-term treatment, in particular, longer than 1 year, patients should be covered by regular medical supervision. Treatment with the preparation may lead to a slightly higher risk of gastrointestinal infections caused by bacteria such asSalmonella Campylobacterand C. difficile. Due to the risk of hypomagnesaemia in patients prescribed for long-term therapy with a proton pump inhibitor or in patients who will take a medicine with Digoxin or medicines that can cause hypomagnesaemia (eg diuretics), consideration should be given to determining Magnesium before initiating therapy with an inhibitor proton pump and periodically during treatment. 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 risk factors. Proton pump inhibitors can increase the overall risk of fractures at 10-40%. Patients at risk for osteoporosis should receive care in accordance with current clinical guidelines and should take the appropriate dose of vitamin D and calcium. The preparation is not recommended for use in children under 12 years due to limited data on safety and efficacy in this age group. The preparation contains sorbitol - should not be used in patients with rare inherited disorders associated with fructose intolerance.

It should not be used during pregnancy unless clearly necessary. Pantoprazole is excreted in human breast milk - the decision to continue or stop breastfeeding or to continue or stop treatment should be taken taking into account the benefits of breastfeeding for the child and the benefits of treatment for the woman.

Uncommon: sleep disturbances, headache and dizziness, diarrhea, nausea, vomiting, abdominal fullness, bloating, constipation, dry mouth, abdominal pain and discomfort, increased liver enzymes (transaminases, γ-GT) , rash, skin eruptions, pruritus, hip fracture, wrist or spine, weakness, fatigue, malaise. Rare: agranulocytosis, hypersensitivity (including anaphylactic reactions and anaphylactic shock), hyperlipidemia (increased triglycerides and cholesterol), change in body weight, depression (and its exacerbations), dysgeusia, visual disturbances, blurred vision, increased bilirubin, urticaria, angioneurotic edema, joint pain, muscle pain, gynecomastia; increased body temperature, peripheral edema. Very rare: thrombocytopenia, leukopenia, pancytopenia, confusion (and its exacerbations). Not known: hyponatraemia, hypomagnesaemia, hypomagnesaemia, hypokalemia, hallucinations, confusion (especially in sensitive patients, as well as worsening of these symptoms in the case of earlier occurrence), paresthesias, hepatocyte damage, jaundice, hepatic failure, Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, hypersensitivity to light, muscle cramps associated with electrolyte disturbances, interstitial nephritis (with possible progression to renal failure).

Orally.Table. enteric-coated 20 mg. Adults and adolescents ≥12 years. Symptomatic gastroesophageal reflux disease: the recommended dose is 20 mg once a day, the symptoms usually disappear within 2-4 weeks. If the treatment is not sufficient, the symptoms usually disappear within the Next 4 weeks. After the symptoms have resolved, the recurrent symptoms can be controlled using the drug regimen. 20 mg once a day, if necessary ("on demand"). Replacement for permanent therapy can be considered if there is not enough symptom control for on-demand treatment.Long-term treatment and prevention of recurrent reflux oesophagitisThe recommended maintenance dose is 20 mg once a day. If the disease recurs, the dose may be increased to 40 mg daily (in this case, 40 mg gastrointestinal tables are recommended). After curing the relapse the dose can be reduced again to 20 mg a day.Adults. Prevention of gastric and duodenal ulcer caused by NSAIDs in at-risk patients requiring continuous NSAID treatmentThe recommended dose is 20 mg once a day.Table. enteric 40 mg. Adults and adolescents ≥12 years. Reflux oesophagitis: 40 mg once a day. In individual cases the dose can be doubled up to 80 mg a day, especially when there is no response to another treatment. Treatment of reflux oesophagitis usually requires a 4-week period. If it is not enough, cure usually takes 4 weeks.Adults. eradicationHelicobacter pylori in combination with the appropriate antibiotics. In patients with gastric or duodenal ulcer disease with a positive result testH. pyloribacterial eradication should be performed using combination therapy. Official local guidelines on bacterial resistance and the prescription of antibacterial agents should be taken into account. Depending on the type of resistance, the following combination regimens are recommended for eradicationH. pylori: a) 40 mg pantoprazole twice daily + 1000 mg Amoxicillin twice daily + 500 mg Clarithromycin twice daily; b) 40 mg pantoprazole twice daily + 400-500 mg Metronidazole (or 500 mg tjidazole) twice daily + 250-500 mg clarithromycin twice daily; c) 40 mg pantoprazole twice daily + 1000 mg amoxicillin twice daily + 400-500 mg metronidazole (or 500 mg tnidazole) twice daily. In combination treatment for eradicationH. pylori, the second tablet of the preparation should be taken 1 hour before the evening meal. Combination therapy is usually used for 7 days and may be prolonged for a further 7 days, up to a total duration of treatment for up to 2 weeks. If further treatment with pantoprazole is indicated to ensure that the ulcer is healed, recommendations on the dosage for the disease should be taken into account ulcer stomach and duodenal ulcer.
If combination therapy is not necessary, for example when in the testH. pylori a negative result was obtained, the following dosage of the preparation is recommended in monotherapy.Peptic ulcer disease40 mg daily. In individual cases, the dose may be doubled (increased to 80 mg / day), especially when there is no response to another treatment. Treatment of stomach ulcers usually requires a 4-week period. If it is not enough, cure usually takes 4 weeks.Duodenal ulcer40 mg daily. In individual cases, the dose may be doubled (increased to 80 mg / day), especially when there is no response to other treatments. Cure of duodenal ulcers usually takes place within 2 weeks. If there is not enough, 2 weeks. period, recovery is achieved, in almost all cases, within the next 2 weeks.Zollinger-Ellison syndrome and other diseases with excessive acid secretion: the starting dose is 80 mg per day. Subsequently, the dosage may be increased or decreased as required, using measurements of gastric acid secretion as an indicator. For doses greater than 80 mg per day, the dose should be divided and administered twice daily. A periodic dose increase of more than 160 mg pantoprazole is possible, but should not be used for longer than is necessary to achieve adequate control of acid secretion. The duration of treatment for Zollinger-Ellison syndrome and other conditions with excessive acid secretion is not limited and should be adjusted to clinical needs.
No dose adjustment is required in patients with impaired renal function or elderly patients. In patients with severe hepatic impairment, a dose greater than 20 mg should not be used. The preparation must not be used as a combined treatment for eradicationH. pylori in patients with moderate to severe hepatic impairment and in patients with impaired renal function, due to the lack of data on the safety and efficacy of combination therapy in this group of patients.
The tablets should be taken 1 hour before a meal, swallowed whole and washed down with water.The tablets should not be chewed or crushed.