Description
Trade name:
Antopral
Compound:
Each tablet contains:
Pantoprazole 40 mg
Auxiliary components:
Calcium stearate, microcrystalline cellulose, crospividone, sodium carbonate, anhydrous silica, anhydrous collodion.
Properties:
It has antibacterial activity against Helicobacter pylori and promotes the anti-Helicobacter effect of other drugs. The MIC is 128 mg/l. The therapeutic effect after a single dose occurs quickly and lasts for 24 hours. Provides rapid symptom relief and healing of duodenal ulcers. When taken at a dose of 40 mg, pH values> 3 are maintained for more than 19 hours. After 2 weeks of treatment (40 mg daily), complete healing of duodenal ulcers is observed in 89% of patients. After 4 weeks of treatment (40 mg), complete healing of gastric ulcers is observed in 88% of patients. The recurrence rate of peptic ulcers after treatment is 55%. Within 4 weeks of treatment at a dose of 40 mg/day provides complete remission in 82% of patients with gastroesophageal reflux disease stage II-III (according to Savary – Miller), after 8 weeks – in 92%. Complete endoscopic remission in 57% of children aged 6-13 years with gastroesophageal reflux disease stage Ic/II (according to Vandeplas) is achieved after 4 weeks of therapy at a dose of 20 mg/day. Over 4-8 weeks of treatment, the level of gastrin in the plasma increases by 1.5 times. Maintenance therapy (40-80 mg daily for more than 3 years) in patients with peptic ulcer disease was accompanied by a slight increase in the number of enterochromaffin-like (ECL-) cells.
Experimental studies of carcinogenicity indicate that long-term use of pantoprazole is associated with an increased risk of ECL cell hyperplasia and the development of gastric carcinoid, liver adenoma and carcinoma, and neoplastic processes in the thyroid gland.
Indications:
Ulcer of the duodenum or stomach in the acute phase, including those associated with the use of NSAIDs, or refractory to therapy with histamine H2-receptor blockers; gastroesophageal reflux disease (moderate and severe forms); Zollinger-Ellison syndrome; combined anti-Helicobacter eradication therapy in patients with peptic ulcer in order to reduce the frequency of relapses.
Method of administration and dosage:
Orally, before meals (usually before breakfast), with the required amount of water. Tablets should be swallowed whole, without chewing.
Adults and adolescents aged 12 years and over:
Treatment of gastroesophageal reflux disease, reflux esophagitis:
1 tablet of pantoprazole daily. In individual cases, the dose can be increased to 2 tablets of pantoprazole daily. Usually, 4 weeks are required to treat reflux inflammation of the esophagus. If necessary, the duration of treatment is increased to 8 weeks.
Adults:
Eradication of Helicobacter pylori (in combination therapy):
In Helicobacter pylori-positive patients with gastric and duodenal ulcers, eradication of the microorganism should be achieved using combination therapy.
Official local guidelines (e.g. national recommendations) should be consulted for bacterial resistance and appropriate prescribing and use of antibacterial agents. Depending on the resistance spectrum, the following combinations may be recommended:
a. One pantoprozole tablet twice daily
– 1000 mg amoxicillin twice daily
– 500 mg clarithromycin twice daily
b. One tablet of pantoprazole twice daily
– 400-500 mg metronidazole (or 500 mg tinidazole) twice daily
– 250-500 mg clarithromycin twice daily
c. One tablet of pantoprazole twice daily
– 1000 mg amoxicillin twice daily
– 400-500 mg metronidazole (or 500 mg tinidazole) twice a day.
When carrying out eradication therapy, the second tablet of pantoprazole should be taken 1 hour before the evening meal. Combination therapy is usually carried out for 7 days and can be continued for another 7 days for a total duration of 14 days. To ensure ulcer healing, further pantoprazole therapy is then indicated using the doses recommended for duodenal and gastric ulcers.
If combination therapy is not indicated (Helicobacter pylori-negative patient), the following dosage regimens for pantoprazole monotherapy should be followed.
Treatment of stomach ulcers:
1 pantoprazole tablet per day. In some cases, the dose can be increased to 2 pantoprazole tablets per day. Usually, 4 weeks are required to treat a stomach ulcer. If necessary, the duration of treatment is increased to 8 weeks.
Treatment of duodenal ulcer:
1 pantoprazole tablet per day. In some cases, the dose can be increased to 2 pantoprazole tablets per day. Usually, 2 weeks are required to treat a duodenal ulcer. If necessary, the duration of treatment is increased to 4 weeks.
Zollinger-Ellison syndrome and other pathological hypersecretory diseases:
For long-term treatment of Zollinger-Ellison syndrome and other pathological hypersecretory diseases, treatment is started with a daily dose of 80 mg (2 pantoprazole tablets of 40 mg). The dose can then be increased or decreased as needed, based on gastric acid secretion indices. At daily doses above 80 mg, the dose should be divided and administered twice daily. A temporary increase in the dose above 160 mg is possible, but only for the time required to adequately suppress hydrochloric acid secretion. The duration of treatment of Zollinger-Ellison syndrome and other pathological hypersecretory diseases is not limited and can be carried out in accordance with clinical need.
Children under 12 years of age:
Pantoprazole is not recommended for use in children under 12 years of age due to limited safety and efficacy data in this age group.
Special patient groups:
Patients with impaired liver function:
In patients with severe hepatic impairment, the daily dose of pantoprazole 20 mg should not be exceeded (other medicinal products with a dosage of 20 mg should be used). During treatment with pantoprazole, it is necessary to monitor the level of liver enzymes in the blood plasma of such patients. In case of an increase in the activity of liver enzymes, it is necessary to discontinue pantoprazole. Pantoprazole should not be used in combination therapy for the eradication of Helicobacter pylori in patients with moderate or severe hepatic impairment, since there are currently no data on the efficacy and safety of pantoprazole in combination therapy in such patients.
Patients with impaired renal function:
In patients with renal impairment, no dose adjustment is required. The drug should not be used as part of combination therapy for Helicobacter pylori eradication in patients with renal impairment, since there are currently no data on the efficacy and safety of pantoprazole as part of combination therapy in such patients.
Elderly patients:
No dosage adjustment is required.
Contraindications:
Hypersensitivity to pantoprazole, benzimidazole derivatives or other components of the drug. Concomitant use of atazanavir. Due to insufficient data, the use of pantoprazole for the treatment of children under 12 years of age is not recommended.
With caution: pregnancy, lactation, liver failure.
Precautions:
In the presence of any alarming symptom (e.g. significant weight loss, recurrent vomiting, dysphagia, hematemesis, anaemia, melena) and in the presence or suspicion of gastric ulcer, malignancy should be excluded, since treatment with pantoprazole may alleviate symptoms and delay diagnosis.
The need for further investigation should be considered if symptoms persist despite adequate therapy.
Concomitant use of pantoprazole with HIV protease inhibitors whose absorption depends on gastric pH, such as atazanavir, is not recommended due to a significant reduction in their bioavailability.
In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term therapy, pantoprazole, like all antisecretory agents, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be taken into account in patients with reduced stores of this vitamin or in the presence of risk factors for reduced absorption during long-term therapy or in the presence of corresponding clinical symptoms.
During long-term therapy, especially when it exceeds one year, patients should be under regular supervision.
Treatment with pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. Difficile.
Severe hypomagnesemia has been reported in patients treated with proton pump inhibitors for at least three months (in most cases for a year). Serious manifestations of hypomagnesemia, such as fatigue, tetany, delirium, seizures, dizziness, and ventricular arrhythmia, may occur, but may have an insidious onset and may go unnoticed. In most patients, hypomagnesemia responds to magnesium replacement therapy after discontinuation of proton pump inhibitors.
For patients who are expected to receive long-term treatment or who are taking proton pump inhibitors concomitantly with digoxin or drugs that may cause hypomagnesemia (eg, diuretics), healthcare professionals should consider measuring blood magnesium levels before starting treatment and periodically thereafter.
Side effects:
Approximately 5% of patients may experience side effects from the drug.
The most common side effects are diarrhea and headache, occurring in approximately 1% of patients.
From the hematopoietic organs: rarely – agranulocytosis. Very rarely – thrombocytopenia, leukopenia, pancytopenia.
From the nervous system and sensory organs: uncommon – headache, dizziness, sleep disturbance. Rare – visual acuity impairment, depression (and aggravation). Very rare – disorientation, paresthesia. Frequency unknown – hallucinations, confusion (especially in predisposed patients, as well as exacerbation of these symptoms if they were present previously).
From the gastrointestinal tract: often – gastric polyps (benign). Uncommon – diarrhea, nausea/vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain and discomfort.
From the kidneys and urinary tract: frequency unknown – interstitial nephritis (with possible progression to renal failure).
From the skin and subcutaneous tissues: uncommon – rash/exanthema, itching. Rare – urticaria, Quincke’s edema. Frequency unknown: Stevens-Johnson syndrome, Lyell’s syndrome, erythema multiforme, photosensitivity, subacute cutaneous lupus erythematosus.
From the musculoskeletal and connective tissue: rarely – arthralgia, myalgia.
From the side of metabolism and water-electrolyte balance: rarely – hyperlipidemia and increased fat levels (triglycerides, cholesterol), change in body weight. Frequency unknown – hyponatremia, hypomagnesemia, hypocalcemia, hypokalemia.
From the immune system: rarely – hypersensitivity (including anaphylactic reactions and anaphylactic shock).
From the liver and biliary tract: uncommon – increased liver enzymes. Rare – increased bilirubin levels. Frequency unknown – hepatocyte damage, jaundice, hepatocellular insufficiency.
From the genitals and mammary gland: rarely – gynecomastia.
Others: uncommon – asthenia, dysphoria, fatigue. Rare – increased body temperature, peripheral edema.
Storage method:
Keep out of reach of children at a temperature not exceeding 25 degrees.
Package:
The cardboard box contains 2 blisters of 7 tablets and paper instructions.
