Nolpaza enteric tablets 40mg №14×2

Name:
Nolpaza tab. intestinal sol. 40mg per blister. in pack. No. 14×2
Description:
Oval-shaped tablets, enteric-coated, light yellowish-brown, slightly biconvex The main active ingredient pantoprazole sodium sesquihydrate 22.55 mg or 45.10 mg Form release tablets Dosage 40 mg Special instructions Liver failure In patients with severe impaired liver function during treatment with pantoprazole, especially with prolonged use, the level of liver enzymes should be regularly monitored. In the event of an increase in liver enzymes, treatment should be discontinued. Simultaneous use of NSAIDs The use of a dosage of 20 mg should be limited for the prevention of gastroduodenal ulcers in patients requiring long-term treatment with non-specific non-steroidal anti-inflammatory drugs (NSAIDs) and who are at increased risk of developing gastrointestinal complications. The increased risk should be assessed according to individual risk factors, for example: advanced age (> 65 years), gastric or duodenal ulcer, or history of upper gastrointestinal bleeding. Combination treatment In combination therapy for H. pylori eradication, the summary of the characteristics of the respective medicinal products should be taken into account. If there are warning signs If there are any warning signs (eg, significant unintentional weight loss, repeated bouts of vomiting, dysphagia, hematemesis, anemia, or melena), or if a stomach ulcer is present or suspected, malignancy must be ruled out because pantoprazole is taken may relieve symptoms and delay diagnosis. Before starting treatment, the possibility of malignancy should be excluded. Co-treatment with atazanavir Co-administration of atazanavir with proton pump inhibitors is contraindicated. Influence on absorption of vitamin B12 Pantoprazole, like all drugs that block the production of hydrochloric acid, can reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- and achlorhydria. This should be taken into account during long-term therapy in patients with low body weight or with an increased risk of reduced absorption of vitamin B12, or if relevant clinical symptoms are observed. Long-term treatment In long-term treatment, especially when treated for more than 1 year, patients should be monitored regularly. Gastrointestinal infections caused by bacteria Pantoprazole, like all proton pump inhibitors, increases the number of bacteria normally present in the upper gastrointestinal tract. Treatment with Nolpaza may lead to an increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter. Hypomagnesemia Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) such as pantoprazole for at least three months and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia may occur, but may be asymptomatic and insidious. In most patients, hypomagnesaemia resolves after replacement of magnesium deficiency and discontinuation of PPI treatment. In patients undergoing long-term treatment, or patients taking PPIs with digoxin or other drugs that can cause hypomagnesaemia (eg, diuretics), magnesium levels should be measured before initiating PPI treatment and periodically during treatment. Fracture of hip, wrist, and spine Proton pump inhibitors, especially at high doses and for long periods (>1 year), may slightly increase the risk of hip, wrist, and spine fractures, predominantly in older age or in the presence of other recognized risk factors . Observational studies show that proton pump inhibitors can increase the overall risk of fractures by 10-40%. Some of this increase may be due to other risk factors. Patients at risk of developing osteoporosis should receive care in accordance with current clinical guidelines and should receive sufficient vitamin D and calcium. Excipients Nolpaza® contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Pediatric use Due to insufficient data on safety and efficacy, the use of pantoprazole in children under 12 years of age with reflux esophagitis, symptomatic gastroesophageal reflux disease, is not recommended. Data on the use of pantoprazole in children and adolescents under 18 years of age with gastric and duodenal ulcers, Helicobacter pylori eradication, Zollinger-Ellison syndrome, for the prevention of erosive and ulcerative lesions of the stomach and duodenum caused by non-selective NSAIDs are not available. Pregnancy and lactation Animal studies indicate the reproductive toxicity of pantoprazole. Nolpazu should not be used during pregnancy unless clearly necessary. Pantoprazole is excreted in breast milk. For the period of drug treatment, breastfeeding should be stopped. Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms During treatment, adverse reactions such as dizziness and visual disturbances may occur. In such cases, patients should not drive vehicles or operate machinery. Pharmacological propertiesPharmacodynamicsNolpaza® is a substituted benzimidazole that inhibits the secretion of hydrochloric acid in the stomach through a specific effect on the proton pumps of parietal cells. Pantoprazole is converted to its active form in the acidic environment of the parietal cells, where it inhibits the enzyme H+/K+ATPase and blocks the final step of hydrochloric acid synthesis in the stomach. The inhibition is dose dependent and affects both basal and stimulated acid secretion. In gastric and duodenal ulcers associated with Helicobacter pylori, such a decrease in gastric secretion increases the sensitivity of the microorganism to antibiotics. After oral administration of Nolpaza®, the antisecretory effect occurs after 1 hour and reaches a maximum after 2 to 4 hours. Does not affect the motility of the gastrointestinal tract. Secretory activity returns to baseline 3 to 4 days after the end of the intake. In most patients, cessation of symptoms is achieved within 2 weeks. Like other proton pump inhibitors and H2 receptor inhibitors, pantoprazole therapy reduces gastric acidity and thus a reversible increase in gastrin. Pantoprazole can affect the secretion of hydrochloric acid, regardless of stimulation by other substances (acetylcholine, histamine, gastrin). Pharmacokinetics Pantoprazole is rapidly absorbed, maximum concentrations (for a dosage of 20 mg: 1-1.5 mcg / ml, for a dosage of 40 mg: 2-3 mcg / ml) in blood plasma are reached approximately 2-2.5 hours after taking the drug orally and remain constant after repeated doses. Absolute bioavailability is 77%, food intake does not affect AUC (area under the concentration-time curve), maximum serum concentrations and bioavailability. In the dose range from 10 mg to 80 mg, the kinetics of pantoprazole in blood plasma is linear. 98% of pantoprazole binds to plasma proteins. The volume of distribution is about 0.15 l/kg. Pantoprazole is almost completely metabolized in the liver. The terminal half-life is about 1 hour and the clearance is about 0.1 l/h/kg. In some cases, the withdrawal time may increase. Due to the specific binding of pantoprazole to the proton pump of parietal cells, the half-life does not correlate with the duration of the therapeutic effect (suppression of hydrochloric acid secretion). The main route of excretion of pantoprazole metabolites (about 80%) is through the kidneys; the rest is excreted in the feces. The main metabolite, determined in plasma and urine, desmethylpantoprazole, conjugates with sulfate, the half-life of which is only slightly longer (about 1.5 hours) than that of pantoprazole. In patients with impaired renal function (including patients on dialysis), no dose reduction is required when using pantoprazole In patients with cirrhosis of the liver (Child class A and B), the elimination half-life is longer (from 3 to 6 hours) , AUC is 3-5 times higher, and the maximum plasma concentration is 1.3 times higher than in healthy people. In elderly patients – a slight increase in AUC and Cmax (have no clinical significance). Children After the use of a single oral dose of 20 or 40 mg of pantoprazole in children aged 5 to 16 years, the AUC and Cmax values were in the range of the corresponding values in adults. Indications for use For a dosage of 20 mg: Adults and adolescents from 12 years of age and older – symptomatic gastroesophageal reflux disease – for long-term treatment and prevention of relapse of reflux esophagitis. Adults – prevention of erosive and ulcerative lesions of the stomach and duodenum caused by the use of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at increased risk and in need of ongoing treatment with NSAIDs (See section “special instructions”) For a dosage of 40 mg Adults and adolescents from 12 years and older – reflux esophagitis Adults – eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with peptic ulcer associated with H. pylori – peptic ulcer of the stomach and duodenum – Zollinger-Ellison syndrome and other pathological hypersecretory conditions Dosage and administration Nolpaza® enteric tablets should not be chewed or crushed, they should be swallowed whole before meals with a small amount of liquid. Adults and adolescents 12 years of age and older Symptomatic gastroesophageal reflux disease: The recommended oral dose is one 20 mg tablet daily. Relief of symptoms usually occurs within 2-4 weeks. If this time is not enough, recovery usually occurs in the next additional 4 weeks of therapy. After relief of symptoms when they reappear, it is enough to take a dose of 20 mg once a day in the “on demand” mode. Long-term maintenance therapy is indicated if on-demand administration fails to achieve the desired symptom relief. Reflux esophagitis: The recommended oral dose is one 40 mg tablet daily. In some cases, the dose can be doubled (increased to 2 tablets of 40 mg per day), especially when there is no clinical improvement in response to other treatment. For the treatment of reflux esophagitis, a 4-week course of treatment is necessary, if necessary, therapy is continued for another 4 weeks. Long-term treatment and prevention of relapse of reflux esophagitis: For long-term treatment, a maintenance dose of 20 mg per day is recommended, increased to 40 mg per day for exacerbations. After the symptoms of exacerbation disappear, the dose can be reduced again to 20 mg of pantoprazole. Prevention of erosive and ulcerative lesions of the stomach and duodenum caused by the use of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at increased risk and requiring ongoing treatment with NSAIDs: the recommended oral dose is 20 mg of pantoprazole per day. Eradication of H. pylori in combination with two appropriate antibiotics: In patients with gastric and duodenal ulcers associated with H. pylori, eradication of the bacterium should be carried out by combination therapy. The review should take into account official local guidelines (eg national guidelines) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents. Depending on resistance, the following combinations can be recommended for eradication of H. pylori: a) Nolpaza® 40 mg 2 times a day + amoxicillin 1000 mg 2 times a day + clarithromycin 500 mg 2 times a day b) Nolpaza® 40 mg 2 times a day + metronidazole 400-500 mg 2 times a day (or 500 mg tinidazole) + clarithromycin 250–500 mg 2 times a day c) Nolpaza® 40 mg 2 times a day + amoxicillin 1000 mg 2 times a day + metronidazole 400-500 mg 2 times a day (or 500 mg tinidazole). In combination therapy for H. pylori eradication, the second Nolpaza® tablet should be taken 1 hour before dinner. Combination therapy is carried out for 7 days and can be extended for another 7 days (total duration – up to 2 weeks). To ensure the healing of ulcers, further treatment is indicated after considering the recommendations for dosing the drug for gastric and duodenal ulcers. In patients with a negative result for H. pylori with Nolpaza monotherapy, the following dosing principles can be followed: Treatment of gastric ulcer: the recommended dose is 1 tablet of 40 mg. In some cases, the dose can be doubled (increased to 2 tablets of Nolpaza® 40 mg per day), especially when there is no clinical improvement in response to other treatment. For the treatment of stomach ulcers, a 4-week course of treatment is usually necessary, in some cases, within the next 4 weeks. Treatment of duodenal ulcer: the recommended dose is 1 tablet of 40 mg. If ineffective, the dose can be doubled to 80 mg (2 Nolpaza® 40 mg tablets) per day. Healing of a duodenal ulcer usually occurs within 2 weeks, in some cases, within the next 4 weeks. Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion: for long-term treatment of patients with Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion, treatment should be started with a daily dose of 80 mg (2 tablets of 40 mg) . Thereafter, the dose may be increased or decreased as needed, depending on the level of hydrochloric acid secretion. At doses above 80 mg per day, the dose should be divided into two doses per day. Perhaps a temporary increase in the daily dose of pantoprazole above 160 mg, but should not be used longer than necessary for a period of adequate control of gastric secretion. The duration of treatment for Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion is not limited and should be adapted depending on the clinical need. Special category of patients In patients with severe hepatic insufficiency, the daily dose of pantoprazole should not exceed 20 mg. Nolpaza® should not be used in combination therapy with antibiotics for the eradication of H. pylori bacteria in patients with moderate to severe hepatic dysfunction and in patients with impaired renal function Dose adjustment is not required in elderly patients and patients with impaired renal function Interaction with other drugs Due to the deep and long-term inhibition of gastric acid secretion, pantoprazole may reduce the absorption of drugs whose bioavailability depends on the gastric pH, for example, some azole antifungals such as ketoconazole, itraconazole, posaconazole and other drugs such as erlotinib. Co-administration of atazanavir and other pH-dependent HIV drugs with proton pump inhibitors may result in a significant decrease in the bioavailability of HIV drugs and may reduce the effectiveness of these drugs. Co-administration of proton pump inhibitors with atazanavir is contraindicated. In patients taking coumarin anticoagulants (for example, phenprocoumon or warfarin), it is recommended to monitor prothrombin time/INR at the beginning of treatment, at the end of treatment, or during the occasional use of pantoprazole. Carbamazepine, diazepam, glibenclamide, nifedipine and oral contraceptives containing levonorgestrel and ethinyl estradiol, which have the same metabolic pathway as pantoprazole, did not show clinically significant interactions when used simultaneously. Pantoprazole does not affect active substances metabolized by CYP1A2 (such as caffeine, theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol) or does not participate in the absorption of digoxin, associated with p-glycoprotein. Pantoprazole does not interact with antacids when used simultaneously. Co-administration of pantoprazole with antibiotics such as clarithromycin, metronidazole, amoxicillin does not cause clinically significant interactions. Contraindications – hypersensitivity to pantoprazole, substituted benzimidazoles or auxiliary components of the drug – combined use with atazanavir Composition Active substance – pantoprazole sodium sesquihydrate 22.55 mg or 45.10 mg (equivalent to pantoprazole 20 mg or 40 mg, respectively), excipients: mannitol, crospovidone (type B), anhydrous sodium carbonate, sorbitol (E420), calcium stearate, enteric coating composition: hypromellose (2.4-3.6 mPas), povidone (K25), titanium dioxide (E171), iron oxide yellow (E172) , propylene glycol, *methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, macrogol 6000, talc Overdose Symptoms: increased side effects. Treatment: symptomatic, it is necessary to carry out the usual detoxification measures. Side effects Uncommon (≥ 1/1,000 to <1/100) sleep disturbances headache, dizziness diarrhea, nausea, vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain, discomfort increased levels of liver enzymes (transaminases , γ-GT) rash, exanthema, skin rash, itching fractures of the bones of the spine, hip and wrist asthenia, malaise and fatigue Rarely (from ≥ 1/10,000 to <1/1,000) agranulocytosis hypersensitivity reactions (including anaphylactic reactions and anaphylactic shock) hyperlipidemia, increased levels of triglycerides, cholesterol, changes in body weight, taste disturbance depression (and all exacerbations) visual disturbances, blurred vision increased bilirubin levels urticaria, angioedema arthralgia, myalgia gynecomastia fever, peripheral edema Very rare (<1 /10,000) thrombocytopenia, leukopenia, disorientation (and all associated exacerbations) Not known (cannot be estimated from the available data): hyponatremia, hypo hallucinations, confusion (especially in genetically predisposed patients, and exacerbation of these symptoms if they existed before treatment) hepatocellular damage, jaundice, hepatocellular insufficiency Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, photosensitivity interstitial nephritis packaging, at a temperature not exceeding 30 ºС, in a place protected from moisture. Store out of the reach of children! Buy Nolpaza enteric tablets 40 mg No. 14x2