Pantap enteric tablets 20mg №14×2

Name:
Pantap tab. intestinal sol. 20mg in bl. in pack. No. 14×2. The main active substance Pantoprazole Release form Tablets Composition 1 enteric tablet contains: active substance: pantoprazole (in the form of pantoprazole sodium sesquihydrate) 20 mg or 40 mg; excipients: anhydrous sodium phosphate, isomalt LM-PF, sodium carboxymethylcellulose – 7MXF, cross-linked polyvinylpyrrolidone (crospovidone), sodium stearyl fumarate; intermediate coating: hypromellose (pharmacoat 603), povidone (PVP K 250), film coating material No. 9 Sepispers AP 3232 yellow (30%)*, propylene glycol; enteric coating: copolymer of methacrylic acid and ethyl acrylate 1:1, dispersion 30% (Eudragit L 30 D-55 30%), triethyl citrate (Citroflex), simethicone emulsion 30%. * Film casing No. 9 Sepispers AP 3232 yellow (30%): purified water, hypromellose (hydroxypropyl methylcellulose), propylene glycol, titanium dioxide (E 171), iron oxide yellow (E 172).
Description:
Light yellow to yellow oval film-coated tablets Dosage 20 mg or 40 mg Indications for use Adults and children 12 years and older: – reflux esophagitis. Adults: – eradication of Helicobacter pylori as part of combination therapy with antibacterial agents; – gastric or duodenal ulcer; – Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion. Contraindications Hypersensitivity to the ingredients of the drug. With caution: liver failure. Pantoprazole, as well as other proton pump inhibitors, should not be taken with atazanavir. Use during pregnancy and lactationCategory B during pregnancy. It is not known whether pantoprazole is excreted in breast milk. A decision should be made to stop breastfeeding or stop taking the drug, taking into account the benefit of the drug to the mother. Controlled studies of pantoprazole in pregnant women have not been conducted. Animal studies have shown fetotoxicity with pantoprazole at doses greater than 5 mg/kg. The potential risk to humans is unknown. Pantoprazole should not be used during pregnancy unless absolutely necessary. Dosage and administration Tablets should be swallowed whole, they should not be chewed or broken. Take 1 hour before meals with a little water. Recommended doses: Adults and children 12 years of age and older: Reflux esophagitis 20-40 mg pantoprazole per day. In some cases, the dose may be doubled, especially when there was no response to other therapy. Usually a 4 week treatment period is required. If it is not sufficient, the therapeutic effect is usually achieved within the next 4 weeks. Adults: Eradication of Helicobacter pylori as part of combination therapy with antibacterial agents In Helicobacter pylori-positive patients with gastric and duodenal ulcers, eradication of the microorganism should be achieved using combination therapy. Reference should be made to official local guidelines (eg national guidelines) on bacterial resistance and the appropriate prescribing and use of antibacterial agents. Depending on the spectrum of resistance, the following combinations may be recommended: a) Pantoprazole 40 mg twice daily + amoxicillin 1000 mg twice daily + clarithromycin 500 mg twice daily b) Pantoprazole 40 mg twice daily + 400-500 mg metronidazole (or 500 mg tinidazole) 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 tinidazole) twice daily When conducting eradication therapy, the second dose 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. Further therapy with pantoprazole is then indicated to ensure healing of the ulcers, using doses recommended for duodenal and gastric ulcers. If combination therapy is not indicated (Helicobacter pylori-negative patient), the following dose regimens for PANTAPOM monotherapy should be followed. Treatment of gastric ulcer 40 mg pantoprazole per day. In some cases, the dose may be doubled, especially when there was no response to other therapy. A 4-week treatment period is usually required. If it is not sufficient, healing is usually achieved within the next 4 weeks. Treatment of duodenal ulcer 40 mg pantoprazole per day. In some cases, the dose may be doubled, especially when there was no response to other therapy. Healing of a duodenal ulcer usually occurs within 2 weeks. If this period is not sufficient, healing is achieved in almost all cases within the next 4 weeks. Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion For long-term treatment of Zollinger-Ellison syndrome and other pathological hypersecretory conditions, a daily dose of pantoprazole 80 mg should be started. The dose should then be titrated up or down based on measurements of gastric acid secretion. Daily doses exceeding 80 mg should be divided into 2 doses. A temporary increase in dosage above 160 mg is possible, but it should not be longer than required for adequate control of secretion. The duration of treatment for Zollinger-Ellison syndrome and other pathological hypersecretory conditions is not limited and should be consistent with clinical need. Special Patient Populations Children under 12 years of age PANTAP is not recommended for use in children under 12 years of age due to limited safety and efficacy data in this age group. Hepatic insufficiency In patients with severe hepatic insufficiency, the daily dose of pantoprazole 20 mg should not be exceeded. The drug should not be used as part of combination therapy for the eradication of Helicobacter pylori in patients with moderate or severe liver dysfunction, since there are currently no data on the efficacy and safety of pantoprazole as part of combination therapy in such patients (see section Precautions). Renal failure In patients with impaired renal function, dose adjustment is not required. The drug should not be used as part of combination therapy for the eradication of Helicobacter pylori in patients with impaired renal function, since there are currently no data on the efficacy and safety of pantoprazole as part of combination therapy in such patients. Elderly patients Elderly patients should not exceed a daily dose of 40 mg. Side effects Approximately 5% of cases may develop adverse reactions. The most common adverse reactions are diarrhea and headache; both of these reactions occur in approximately 1% of patients. Undesirable effects are evaluated according to the frequency of their occurrence: Very often (> 1/10); often (>1/100 to <1/10); infrequently (>1/1000 to <1/100); rarely (>1/10000 to <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data). Within each frequency group, adverse effects are presented in order of decreasing severity. Blood and lymphatic stolon disorders Rare: agranulocytosis; Very rare: thrombocytopenia, leukopenia, pancytopenia. Immune system stolon disorders Rare: hypersensitivity (including anaphylactic reactions and anaphylactic shock). Metabolic and nutritional disorders Rare: hyperlipidemia and elevated lipid levels (triglycerides, cholesterol); change in body weight; Frequency unknown: hyponatremia, hypomagnesemia (see Precautions), hypocalcemia associated with hypomagnesemia, hypokalemia. Psychiatric disorders Uncommon: sleep disorders; Rare: depression (and all its consequences); Very rare: disorientation (and all its consequences); Frequency unknown: hallucinations, confusion (especially in predisposed patients, as well as aggravation of pre-existing symptoms). Nervous system disorders Common: taste disturbances; Uncommon: headache, dizziness; Frequency unknown: parasthesia. On the part of the organ of vision Rarely: visual disturbances, blurred vision. Gastrointestinal disorders Uncommon: diarrhea, nausea, vomiting, flatulence and bloating, constipation, dry mouth, abdominal pain and discomfort. Liver and biliary tract disorders Uncommon: increased levels of liver enzymes (transaminases, β-GTP); Rarely: increased bilirubin levels; Frequency unknown: hepatocellular damage, jaundice, hepatocellular insufficiency. Skin and subcutaneous tissue disorders Uncommon: rash, exanthema, itching; Rare: urticaria, Quincke's edema; Frequency unknown: Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, photosensitivity, subacute cutaneous lupus erythematosus. Musculoskeletal and connective tissue disorders Uncommon: fracture of the hip, wrist or spine (see Precautions); Rare: arthralgia, myalgia; Frequency unknown: muscle spasm as a result of electrolyte imbalance. Renal and urinary tract disorders Not known: interstitial nephritis (with possible progression to renal failure). Reproductive system disorders Common: gynecomastia. General disorders Uncommon: asthenia, fatigue and malaise. Rare: fever, peripheral edema. Preclinical Studies Neuroendocrine neoplasms were found in a two-year carcinogenicity study of pantoprazole in rats. In addition, one study found squamous gastric papillomas in rats. After studying the mechanisms leading to the formation of gastric carcinomas, it was concluded that there was a secondary reaction to a pronounced increase in plasma gastrin levels in rats as a result of long-term administration of high doses of pantoprazole. In a two-year rodent study, an increase in liver tumors was observed in rats (in one study) and in female mice, which was explained by the high rate of metabolism of pantoprazole in the liver. A slight increase in thyroid tumors was observed in a group of rats treated with high doses of pantoprazole (200 mg/kg) in one two-year study. The occurrence of these neoplasms is associated with pantoprazole-induced changes in the metabolism of thyroxine in the liver of rats. Since the therapeutic doses used in humans are lower, the development of side effects from the thyroid gland is not expected. Animal studies have shown no evidence of impaired fertility or teratogenic effects. An increase in the penetration of pantoprazole through the placenta in rats with an increase in the duration of pregnancy was found. As a result, the concentration of pantoprazole in the fetus increases shortly before birth. Overdose So far, no overdose effects have been noted as a result of the use of PANTAP. Doses up to 240 mg were administered intravenously over 2 minutes and were well tolerated. However, in case of overdose and only in the presence of clinical manifestations, symptomatic and supportive treatment is carried out. Pantoprazole is not excreted by hemodialysis. Interactions with other drugs Drugs with gastric pH-dependent absorption Due to the pronounced and prolonged suppression of gastric secretion, pantoprazole may interfere with the absorption of drugs whose bioavailability depends on gastric pH, for example, some azole antifungals such as ketoconazole, itraconazole, posaconazole, as well as other drugs such as erlotinib. HIV protease inhibitors The combined use of pantoprazole with inhibitors of HIV protease, the absorption of which depends on the acidic intragastric pH, for example, with atazanavir, can lead to a significant decrease in their bioavailability (see section "Precautions"). If it is not possible to avoid the combination of HIV protease inhibitors with a proton pump inhibitor, careful monitoring (eg, viral load monitoring) is recommended. The dose of pantoprazole 20 mg per day should not be exceeded. Dose adjustment of HIV protease inhibitors may be required. Coumarin anticoagulants (phenprocoumon or warfarin) Co-administration of pantoprazole with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenprocoumon or international normalized ratio (INR). However, an increase in INR and prothrombin time has been reported in patients receiving other proton pump inhibitors and warfarin or phenprocoumon at the same time. An increase in INR and prothrombin time can lead to bleeding and even death. Patients receiving pantoprazole and warfarin or phenprocoumon may need to be monitored for increases in INR and prothrombin time. Methotrexate It has been reported that the combined use of a high dose of metrotrexate (eg, 300 mg) and proton pump inhibitors increases the levels of methotrexate in some patients. Thus, in the setting of high doses of methotrexate, such as cancer and psoriasis, temporary withdrawal of pantoprazole may be considered. Other Interaction Studies Pantoprazole is extensively metabolized in the liver via the cytochrome P450 enzyme system. The main metabolic pathway is demethylation by CYP2C19, other metabolic pathways include oxidation by CYP3A4. Interaction studies with drugs metabolized by these pathways, such as carbamazepine, diazepam, glibenclamide, nifedipine, an oral contraceptive containing levonorgestrel and ethinyl estradiol, did not reveal clinically significant interactions. An interaction of pantoprazole with other drugs or compounds that are metabolized by the same enzyme system cannot be ruled out. The results of a number of interaction studies indicate that pantoprazole does not affect the metabolism of active substances metabolized by CYP1A2 (such as caffeine, theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol) and does not change p-glycoprotein-dependent absorption of digoxin. There are no interactions with co-administered antacids. Interaction studies have also been conducted with antibiotics co-administered with pantoprazole (clarithromycin, metronidazole, amoxicillin). No clinically significant interactions were found. Medicinal products that inhibit or induce CYP2C19 CYP2C19 inhibitors such as fluvoxamine may increase the systemic exposure to pantoprazole. A dose reduction may be required in patients who receive high doses of pantoprazole for a long time, or in those who have hepatic insufficiency. Enzyme inducers that affect CYP2C19 and CYP3A4, such as rifampicin and St. John's wort (Hypericum perforatum), may reduce plasma concentrations of proton pump inhibitors metabolized by these enzyme systems. Precautions Hepatic insufficiency In patients with severe hepatic insufficiency during treatment with pantoprazole, regular monitoring of liver enzymes should be carried out, especially with prolonged use of the drug. In the event of an increase in their level, treatment should be discontinued (see section "Method of application and dosage"). Combination therapy When conducting combination therapy, the instructions for medical use of the respective medicinal products should be taken into account. Gastric malignancy If any warning sign is present (eg, significant involuntary weight loss, repeated vomiting, dysphagia, hematemesis, anemia, melena) and if a gastric ulcer is present or suspected, malignancy should be ruled out because treatment with pantoprazole may relieve symptoms and delay diagnosis. They have unintentional weight loss, anemia, gastrointestinal bleeding, dysphagia, persistent or bloody vomiting. These conditions can alleviate symptoms and delay diagnosis in severe conditions. In these cases, a malignant tumor must be excluded. Patients have a history of gastric ulcer or gastrointestinal surgery. They are on continuous symptomatic treatment for dyspepsia or heartburn for four or more weeks. They have jaundice, liver damage or disease. They have some other serious disease that affects the general condition of the body. They are over 55 years of age and have recently developed new or changed symptoms. Additional testing should be considered if symptoms persist despite adequate therapy. Co-administration with HIV protease inhibitors Co-administration of pantoprazole with HIV protease inhibitors, the absorption of which depends on the pH of the stomach, such as atazanavir, is not recommended due to a significant decrease in their bioavailability. Effect on vitamin B12 absorption 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 considered in patients with reduced stores of this vitamin or in the presence of risk factors for reducing its absorption during long-term therapy or in the presence of relevant clinical symptoms. Long-term treatment During long-term therapy, especially when it exceeds a period of one year, patients should be monitored regularly. Gastrointestinal infections of a bacterial nature Treatment with pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. difficile. Hypomagnesemia Severe hypomagnesemia has been reported in patients treated with proton pump inhibitors for at least three months (in most cases within a year). Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmias may occur, but they may begin insidiously and may go unnoticed. In the majority of patients, hypomagnesemia was cured by the administration of magnesium against the background of discontinuation of proton pump inhibitors. For patients who are expected to be on long-term treatment or who are taking proton pump inhibitors with digoxin or drugs that can cause hypomagnesaemia (eg, diuretics), healthcare professionals should consider measuring blood magnesium levels prior to initiating treatment and periodically during treatment. Bone fractures Proton pump inhibitors, especially when used at high doses and for a long time (greater than one year), may moderately increase the risk of hip, wrist and spine fractures, mainly in the elderly or in the presence of other recognized risk factors. Observational studies indicate that proton pump inhibitors may increase the overall risk of fractures by 10-40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive medical care in accordance with current clinical guidelines and consume adequate amounts of vitamin D and calcium. Subacute cutaneous lupus erythematosus (SCLE) The use of proton pump inhibitors has been associated with very rare cases of SCLE. In the event of the appearance of pathological changes, especially in areas of the skin exposed to the sun, and in the event of arthralgia, the patient should immediately seek medical help, and the medical professional should evaluate the advisability of discontinuing the drug. SCLE after prior treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. Laboratory Confounding Elevated CgA levels can confound test results for neuroendocrine tumors. To avoid interference, treatment with PANTAP should be discontinued at least 5 days before determining the level of CgA (see section "Pharmacodynamics"). If the levels of CgA and gastritis have not returned to the normal range after the initial determination, the measurement should be repeated 14 days after cessation of proton pump inhibitor therapy. Storage conditions Store at a temperature not exceeding +25 ° C in the original packaging to protect from light and moisture. Keep out of the reach of children. Buy Pantap enteric tablets 20mg No. 14x2