Table. enteric-coated 20 mg. Treatment of mild gastroesophageal reflux disease and its symptoms (such as heartburn, regurgitation, pain during swallowing). Long-term treatment of reflux oesophagitis and prevention of its recurrence. Prevention of gastroduodenal duodenal ulcer caused by non-selective, non-steroidal anti-inflammatory drugs (NSAIDs) in high-risk patients in whom long-term NSAID treatment is necessary.Table. enteric 40 mg. eradicationHelicobacter pylori in combination with two antibiotics and prevention of recurrent ulcers of the stomach and duodenum in patients with ulcer caused byH. pylori. Duodenal ulcer. Peptic ulcer disease. Moderate and severe form of reflux oesophagitis. Long-term treatment of Zollinger-Ellison syndrome and other disorders associated with pathologically increased secretion of hydrochloric acid.
Composition:
1 tabl enterally contains 20 mg or 40 mg Pantoprazole (as sodium Pantoprazole, semi-professional). The drug contains maltitol.
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 inhibition of both basal secretion and stimulated secretion (regardless of the type of stimulus). It reduces the acidity of gastric contents and, secondarily, in a reversible manner, 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 blood concentration in 2-2.5 hours. The bioavailability is about 77%, the food does not reduce the bioavailability, it can only affect the delay of the drug. About 98% is bound to plasma proteins. Pantoprazole is metabolized in the liver, excreted in approximately 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 benzimidazoles, concomitantly used preparations or any of the excipients. In addition, tabl. 40 mg: do not use the preparation in combination therapy in eradicationH. pylori in patients with severe hepatic impairment due to the lack of clinical data on the efficacy and safety of combination therapy in these patients.
Precautions:
The use of pantoprazole (20 mg tablet) in the prevention of gastric and duodenal ulceration in patients treated with non-selective NSAIDs should be limited to patients who need to continue NSAID treatment and are at increased risk of developing gastrointestinal disorders. The increased risk of gastrointestinal disorders should be determined in accordance with individual risk factors, including elderly (over 65 years old), gastric or duodenal ulceration, history of gastrointestinal bleeding. In patients with severe hepatic impairment, especially during long-term treatment, liver enzymes should be monitored regularly; if their activity increases, treatment should be discontinued. If there are signs of alarm (such as significant unintended weight loss, recurrent vomiting, dysphagia, bloody vomiting, anemia, tar-like stools) and if there is suspicion or evidence of stomach ulceration, their cancerous background should be excluded. Treatment with pantoprazole may relieve the symptoms of cancer and delay its diagnosis. Additional studies should be considered in patients whose disease symptoms persist despite adequate treatment. Co-administration of atazanavir with proton pump inhibitors is not recommended; if it is necessary to administer atazanavir with a proton pump inhibitor, careful clinical monitoring (e.g.viral load) in combination with an increase of atazanavir to 400 mg and administration of 100 mg ritonavir; do not take a daily dose of more than 20 mg pantoprazole. Pantoprazole may reduce the absorption of vitamin B12 (Cyanocobalamin). This is due to a deficiency of hydrochloric acid in gastric juice or acid-free gastric juice. This should be taken into account during long-term treatment of patients with vitamin B deficiency12 and with risk factors for impaired absorption, or if clinical symptoms occur. With long-term therapy, especially when treatment lasts for more than a year, patients should undergo regular medical check-ups. If, despite treatment with pantoprazole, the symptoms last longer than 4 weeks, further tests should be considered. Treatment with pantoprazole may lead to a slightly higher risk of food-borne infections caused by, e.g.SalmonellaCampylobacter and C. difficile. Patients treated with proton pump inhibitors such as pantoprazole have experienced severe hypomagnesaemia for at least 3 months, and in most cases more than one year. For patients who are prescribed for long-term treatment or who use proton pump inhibitors concomitantly with Digoxin or preparations that may cause hypomagnesaemia (eg diuretics), Magnesium measurement should be considered prior to initiating treatment with proton pump inhibitors and periodically during treatment. The use of proton pump inhibitors, especially those taken at high doses and in long-term therapy (over 1 year), may slightly increase the risk of hip fractures, carpal or spinal bones, especially in older people or people with other risk factors. Patients with risk factors for osteoporosis should be treated in accordance with current clinical guidelines to ensure that adequate doses of vitamin D and Calcium are taken. 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. The drug contains maltitol - should not be used in patients with hereditary fructose intolerance.
Pregnancy and lactation:
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.
Side effects:
Common: headache, epigastric problems, diarrhea, constipation, flatulence and wind blows. Uncommon: sleep disturbances, dizziness, blurred vision (blurred vision); nausea or vomiting, dry mouth, epigastric pain and discomfort; increased activity of liver enzymes (aminotransferases, GGT); allergic reactions (pruritus, eczema, skin eruptions and skin rash), hip fracture, carpal or spinal bones, weakness, tiredness and malaise. Rare: agranulocytosis, hypersensitivity (including anaphylactic reactions and anaphylactic shock), hyperlipidemias and increased lipids (triglycerides, cholesterol), changes in body weight; depression, hallucinations, confusion and confusion, especially in predisposed patients, as well as the severity of these symptoms, if they occurred earlier; taste disorders, increased bilirubin, urticaria, angioneurotic edema, arthralgia, myalgia, gynecomastia, increased body temperature, peripheral edema. Very rare: leukopenia, thrombocytopenia, pancytopenia, severe liver cell damage leading to jaundice with or without hepatic impairment; severe skin reactions, e.g. Stevens-Johnson syndrome, erythema multiforme, Lyell's syndrome, hypersensitivity reactions to light; interstitial nephritis (with possible progression to renal failure); hypernatremia in elderly patients. Frequency unknown: hyponatremia, hypomagnesemia, hypocalcemia due to hypomagnesemia, hypokalemia, paresthesia, muscle cramps due to electrolyte disturbances.
Dosage:
Orally.Adults and adolescents from 12 years.A mild form of gastroesophageal reflux disease and accompanying symptoms (eg heartburn, regurgitation of stomach contents, pain during swallowing)20 mg daily for 2-4 weeks; if necessary, continue for another 4 weeks; Recurrent symptoms can be controlled with 20 mg daily if necessary ("on demand" tablet).Long-term treatment and prevention of recurrent reflux oesophagitis20 mg daily; in case of relapse, the dose can be increased to 40 mg daily, after the recurrence of symptoms disappears, the dose can be reduced again to 20 mg daily; long-term treatment may last for more than a year only after thorough risk-benefit assessment.Moderate and severe form of reflux oesophagitis: 40 mg daily; in individual cases, especially in patients not responding to other treatment, the dose can be increased 2-fold.Adults.Prevention of gastroduodenal ulcers caused by the use of non-selective NSAIDs in patients at increased risk who need long-term NSAID treatment20 mg daily.eradicationHelicobacter pylori: 40 mg twice daily for 7 days in combination with antimicrobial therapy (amoxicillin 1 g twice daily and Clarithromycin 500 mg twice daily or clarithromycin 250-500 mg twice daily and Metronidazole 400-500 mg 2 times per day) daily or Amoxicillin 1g twice daily and metronidazole 400-500 mg twice daily); take the second dose before dinner; treatment lasts usually 7 days, can be extended up to a maximum of 2 weeks.Peptic ulcer of the stomach and duodenum: 40 mg daily for 2-4 weeks, and if necessary for another 4 weeks; in individual cases, especially in patients not responding to other treatment, the dose can be increased 2-fold.Zollinger-Ellison syndrome: initially 80 mg per day, the dose can be increased above 160 mg per day, doses above 80 mg per day administered in two doses; the maximum duration of use is not specified.Special groups of patients. Elderly patients should not receive a dose higher than 40 mg daily (with the exception of combination therapy for eradicationH. pylori). In patients with severe hepatic impairment, a dose greater than 20 mg daily or 40 mg every other day should not be used. No dose adjustment is necessary for patients with renal impairment.Way of giving. Table. should be taken whole with water. Table. do not chew or chew.