Table. enteric-coated 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 gastroduodenal ulcerations induced by non-selective NSAIDs in patients at increased risk requiring long-term NSAID treatment.Table. enteric 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 / or duodenum; Zollinger-Ellison syndrome and other diseases associated with excessive secretion of hydrochloric acid.
Composition:
1 tabl enteric contains 20 mg or 40 mg pantoprazole. The product contains maltitol and soya lecithin.
Action:
A drug that inhibits the secretion of hydrochloric acid in the parietal cells of the stomach as a result of selective blocking of H activity+/ K+-ATP-azy (the so-called proton pump). The effect of the drug depends on the dose and leads to the inhibition of both basal secretion and stimulated secretion. It reduces the acidity of gastric contents and secondarily (in a reversible way) increases gastrin secretion to an extent proportional to the decrease in acidity. After oral administration, Pantoprazole is rapidly absorbed from the gastrointestinal tract, reaching a maximum concentration in the blood after 2.5 hours. The bioavailability is about 77%, the food does not reduce bioavailability, it can only delay the absorption of the drug. About 98% is bound to plasma proteins. It is metabolized in the liver, excreted in about 80% by the kidneys in the form of metabolites, the remaining part is excreted in the faeces. T0,5 is about 1.5 hours.
Contraindications:
Hypersensitivity to the active substance, substituted benzimidazole, soybean lecithin or to any of the excipients or preparations used in combination therapy.
Precautions:
Do not use in children under 12 years of age due to insufficient data on the safety and efficacy of therapy in this age group. In patients with severe hepatic impairment, especially during long-term use of Pantoprazole, liver enzymes should be monitored regularly; if their activity increases, treatment should be discontinued. Further studies should be considered in patients whose disease symptoms persist despite adequate treatment. Co-administration with atazanavir is not recommended. There is an increased risk of gastrointestinal disorders in elderly patients (over 65 years of age), gastric or duodenal ulceration, and gastrointestinal bleeding. In patients with Zollinger-Ellison syndrome and other diseases associated with excessive secretion of hydrochloric acid for long-term treatment with pantoprazole, a reduced absorption of vitamin VI may occur. B12what is caused by hypochlorhydria or achlorhydria (this should be taken into account during long-term treatment of patients with vitamin B deficiency)12 and risk factors for impaired absorption if there are clinical symptoms). Due to the content of maltitol, the preparation should not be used in patients with hereditary fructose intolerance.
Pregnancy and lactation:
Do not use during pregnancy unless clearly necessary. Pantoprazole is excreted in human milk; during breastfeeding, the benefits of breastfeeding and the benefits for the mother due to the use of pantoprazole should be considered.
Side effects:
Uncommon: sleep disorders; pain and dizziness; diarrhea, nausea, vomiting, feeling of fullness in the abdomen, bloating, constipation, dry mouth, pain and discomfort in the epigastrium; increased activity of liver enzymes (aminotransferases, γ-GT); skin rash, eczema, eruptions, pruritus; weakness, fatigue, bad mood.Rare: hypersensitivity (including anaphylactic reactions and anaphylactic shock); hyperlipidemia (increased triglycerides and cholesterol), weight change; depression (and all agitations); blurred vision, blurred vision; increase in bilirubin; urticaria, angioneurotic edema; pain in the joints and muscles; gynecomastia; increase in body temperature, peripheral edema. Very rare: thrombocytopenia, leukopenia; confusion. Frequency unknown: hyponatremia; hallucinations, confusion (especially in predisposed individuals, 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, hypersensitivity to light, interstitial nephritis. Treatment with pantoprazole may slightly increase the risk of gastrointestinal infections caused by microorganisms such as:Salmonella andCampylobacter.
Dosage:
Orally.Table. enteric-coated 20 mg. Adults and adolescents ≥12 years. Symptomatic form of gastroesophageal reflux disease: 20 mg once a day, the symptoms usually disappear after 2-4 weeks; if treatment is not sufficient, the medicine should be used for 4 weeks. After the symptoms have resolved, recurrent disease symptoms can be monitored with 20 mg once a day if needed ("on demand"); in the absence of improvement, re-use may be considered continuously.Long-term treatment and prevention of recurrent reflux oesophagitis: The maintenance dose is 20 mg once a day. If the disease recurs, the dose can 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 ulcers caused by the use of non-selective NSAIDs in high-risk patients requiring long-term NSAID treatment20 mg once a day.Table. enteric 40 mg. Adults and adolescents aged ≥12 years. Reflux oesophagitis: 40 mg once a day. In individual cases the dose can be doubled up to 80 mg daily, especially when there is no response to other treatments. The period of application is 4 weeks, if it is not sufficient to cure it, it should be extended for another 4 weeks.Adults.eradicationHelicobacter pylori in combination with two appropriate antibiotics: 40 mg twice daily (second tablet of pantoprazole should be taken 1 hour before supper) for 7 days simultaneously with antimicrobial treatment (amoxicillin 1 g 2 times daily and Clarithromycin 500 mg twice daily or clarithromycin 250-500 mg 2 times per day) daily and Metronidazole 400-500 mg twice daily or Amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily); if necessary, you can continue treatment for the Next 7 days. If further treatment with pantoprazole is indicated to completely cure the ulcer, consideration should be given to the dosage recommended for the treatment of gastric and duodenal ulcer.Treatment of peptic ulcer: 40 mg daily; in individual cases when there is no response to 80 mg treatment per day. Usually healing occurs within 4 weeks; if this period is insufficient, the treatment should be prolonged for another 4 weeks.Treatment of duodenal ulcer: 40 mg daily; in individual cases when there is no response to 80 mg treatment per day. Usually healing occurs within 2 weeks; if this period is insufficient, the treatment should be prolonged for another 2 weeks.Zollinger-Ellison syndrome and other diseases associated with excessive secretion of hydrochloric acid: initially 80 mg per day, then the dose can be increased or decreased based on the results of gastric acid secretion tests. Daily doses greater than 80 mg daily administered in two doses. It is possible to periodically use a dose of more than 160 mg, but it should not be used longer than necessary to achieve adequate suppression of gastric acid secretion. The duration of treatment is not limited and should be adapted to clinical symptoms. 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. Do not use in combination therapy in eradicationH. pylori in patients with moderate and severe hepatic impairment and in patients with impaired renal function due to a lack of data on safety and efficacy. The tablets should be taken 1 hour before a meal, swallowed whole and washed down with water. The tablets should not be chewed, chewed or crushed.