Table. enteric-coated 20 mg. Adults and adolescents aged 12 years and above: treatment of the symptoms of gastroesophageal reflux disease; long-term treatment and prevention of recurrent reflux oesophagitis. Adults: prevention of gastrointestinal ulcers caused by the use of non-selective NSAIDs in at-risk patients who require continuous treatment with NSAIDs.Table. enteric 40 mg. Adults and adolescents aged 12 years and older: reflux oesophagitis. Adults: eradicationHelicobacter pylori in combination with appropriate antibiotics in infected patientsH. pyloriwith accompanying ulceration; peptic ulcer of the stomach and duodenum; Zollinger-Ellison syndrome and other conditions associated with excessive secretion of hydrochloric acid.
Composition:
1 tabl enterally contains 20 mg or 40 mg Pantoprazole in the form of sodium Pantoprazole, semi-professional.
Action:
Proton pump inhibitor. Pantoprazole is a substituted benzimidazole which, by specifically influencing proton pumps in parietal cells of the gastric mucosa, inhibits the secretion of hydrochloric acid. It is converted to the active form in an acidic environment in the light of the cells of the parietal cells, where it inhibits the activity of the enzyme H+/ K+- dependent ATPase, which is responsible for the final stage of production of hydrochloric acid in the stomach. The degree of inhibition of hydrochloric acid secretion depends on the dose and applies to both basal and stimulated secretion of hydrochloric acid. In most patients, this leads to relief of symptoms within 2 weeks of pantoprazole. Treatment with pantoprazole leads to a decrease in gastric acidity and a secondary increase in gastrin concentration in proportion to the decrease in acidity. The increase in gastrin level is reversible. Pantoprazole is rapidly absorbed from the gastrointestinal tract, reaching Cmax on average after 2.5 hours. Total bioavailability is about 77%. Plasma protein binding is around 98%. Pantoprazole is almost exclusively metabolised in the liver. Metabolites are excreted mainly via the kidneys (approximately 80%); the remainder is excreted with faeces. T0,5 the final phase of elimination is about 1.5 hours.
Contraindications:
Hypersensitivity to pantoprazole, substituted benzoimidazole or any of the excipients of the drug.
Precautions:
The preparation should not be used in children under 12 years of age (no experience). Administration of pantoprazole 20 mg to prevent recurrent gastrointestinal ulceration in patients treated with NSAIDs should be limited to patients requiring continuous NSAIDs and those at increased risk of developing gastrointestinal complications. Risk assessment with increased risk should be based on individual risk factors, such as advanced age (> 65 years), gastric or duodenal ulceration, or bleeding from the upper digestive tract. Pantoprazole may reduce the absorption of vitamin B12 as a result of a decrease in gastric acidity or acid-freeness - this should be taken into account during long-term treatment with patients with vitamin B deficiency in pantoprazole12 or burdened with risk factors for its malabsorption. Do not use the drug in combination therapy for eradicationH. pylori in patients with impaired renal function and moderate or severe hepatic impairment, as there is currently no data on the efficacy and safety of the medicine. The use of IPP, especially in high doses and in long-term therapy (over 1 year), may slightly increase (by 10-40%) the risk of hip fractures, carpal or spinal bones, especially in older people or people with other factors risk. Patients at risk for osteoporosis should be treated in accordance with current clinical guidelines to ensure that adequate doses of vitamin D and Calcium are taken. Patients who have been treated for at least 3 months and in most cases have severe hypomagnesaemia for one year. You should therefore discontinue the drug and top up the level of magnesium.Consideration should also be given to determining Magnesium levels prior to and periodically during treatment in patients on long-term therapy or concomitantly taking IPP with Digoxin or other drugs that may cause hypomagnesaemia (e.g., diuretics).
Pregnancy and lactation:
The drug should not be used during pregnancy unless it is absolutely necessary. There are insufficient data on the use of pantoprazole in pregnant women, and animal studies indicate a toxic effect on reproduction. Breast-feeding of pantoprazole has been reported in breast milk. Therefore, when deciding to continue / terminate breastfeeding or continue / discontinue pantoprazole treatment, the benefits of breastfeeding for the child and the benefits of pantoprazole treatment for the mother should be considered.
Side effects:
Uncommon: sleep disorders; headache, dizziness; diarrhea; nausea / vomiting; feeling of fullness in the abdominal cavity and bloating; constipation; dry mouth; epigastric pain and discomfort; increased liver enzymes (aminotransferases, γ-glutamyl transpeptidases); rash / egzantema / bloom; itching; fracture of the hip, wrist or spine; weakness, fatigue, feeling unwell. Rare: agranulocytosis, hypersensitivity (including anaphylactic reactions and anaphylactic shock); hyperlipidemias and increased blood lipids (triglycerides, cholesterol); changes in body weight; depression (and all severity of symptoms); blurred vision / blurred vision; taste disorders; increase in bilirubin; urticaria, angioneurotic edema; joint pain, muscle pain; gynecomastia; increase in body temperature; peripheral edema. Very rare: thrombocytopenia; leukopenia, pancytopenia; disorientation (and all severity of symptoms). Not known: hyponatremia, hypomagnesemia, hypocalcaemia in connection with hypomagnesemia, hypokalaemia; hallucinations; confusion (especially in patients with predispositions, as well as all severity of these symptoms in the event of their previous occurrence); paresthesia; damage to liver cells; jaundice; liver cell failure; Stevens-Johnson syndrome; toxic epidermal necrolysis; erythema multiforme; hypersensitivity to light; muscle spasms as a result of electrolyte disturbances; interstitial nephritis (with possible deterioration to renal failure). The use of pantoprazole may slightly increase the risk of infection of the digestive system with bacteria such asSalmonellaCampylobacterandC. difficile.
Dosage:
Orally.Table. 20 mg. Adults and adolescents aged ≥12 years. Treatment of the symptoms of gastroesophageal reflux disease: 20 mg once daily for 2-4 weeks, if this is not sufficient, use the product for 4 weeks. After the symptoms have resolved, recurrence of the disease can be prevented by using 20 mg once a day "on demand", if you can not control the symptoms With the "on demand" dosage, you can consider re-applying the product continuously.Long-term treatment and prevention of relapse in reflux oesophagitis: the maintenance dose is 20 mg per day, in case of relapse, the dose can be increased to 40 mg daily. After curing the relapse the dose can be reduced again to 20 mg a day.Adults. Prevention of gastrointestinal ulcers caused by the use of NSAIDs in patients at risk who require continuous treatment with NSAIDs20 mg once a day. 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. Adults and adolescents aged ≥12 years. Treatment of reflux oesophagitis: 40 mg once a day for 4-8 weeks. In individual cases, the dose may be doubled.Adults. eradicationHelicobacter pylori in combination with two antibiotics: local official guidelines (eg national recommendations) regarding bacterial resistance and the proper use and prescription of antimicrobial agents should be considered. The following treatment regimens are recommended: 40 mg twice daily in combination with 1) Amoxicillin 1000 mg twice daily and Clarithromycin 500 mg twice daily or 2) Metronidazole 400 - 500 mg twice daily (or tididazole 500 mg) and clarithromycin 250-500 mg twice daily or 3) amoxicillin 1000 mg twice daily and metronidazole 400 mg500 mg twice daily (or tididazole 500 mg). The second tabl. 40 mg should be taken one hour before the evening meal. Treatment should last 1-2 weeks.Treatment of duodenal and gastric ulcer: 40 mg once a day. Duration of treatment: duodenal ulcer - 2 weeks, gastric ulcer - 4 weeks; in each case, the treatment time can be doubled if the disorder is not cured.Zollinger-Ellison syndrome and other conditions associated with excessive secretion of hydrochloric acid: initial dose 80 mg daily (2 tables 40 mg), then, if necessary, the dose can be increased or decreased, depending on the results of gastric acid secretion tests. Daily doses greater than 80 mg should be divided and administered twice a day. It is possible to periodically increase the dose to more than 160 mg per day, but it should not be used for longer than required to obtain adequate control of hydrochloric acid excretion. The duration of treatment is not limited and should be adapted to clinical symptoms. No dosage adjustment is necessary for patients with impaired renal function. Do not exceed the daily dose of 20 mg pantoprazole in patients with severe hepatic impairment.Way of giving. The tablets should be swallowed whole, for one hour before a meal, washed down with water.