Pantoprazole Canon 20mg Coated Tablets N28
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Active ingredients
Pantoprazole
Release form
Pills
Composition
1 enteric-coated tablet, film-coated, 20 mg contains: active ingredient: pantoprazole sodium sesquihydrate 22.57 mg, in terms of pantoprazole 20 mg; excipients: magnesium hydroxycarbonate heavy 7.53 mg, macrogol (polyethylene glycol) 1.2 mg, mannitol 63 mg, calcium stearate 1.2 mg, colloidal silicon dioxide 1 mg, crospovidone 20 mg, povidone K-30 3.5 mg; film coating composition: Opadry transparent 2.4 mg (including: hypromellose (hydroxypropylmethylcellulose) 1,920 mg, macrogol (polyethylene glycol) 0.48 mg), Acryl-Of green 8.6 mg (in including: methacrylic acid and ethyl acrylate copolymer [1: 1] 5.676 mg, colloidal silicon dioxide 0.086 mg, sodium bicarbonate 0.086 mg, sodium lauryl sulfate 0.043 mg, ferric oxide yellow 0.06 mg, dye indigo carmine 0.069 mg, dye blue diamond 0.026 mg , talc 1.419 mg, titanium dioxide 1.135 mg). Triethyl citrate 1 mg.
Pharmacological effect
Proton pump inhibitor (H + / K + -ATP-ase). Blocks the final stage of secretion of hydrochloric acid, reducing basal and stimulated secretion, regardless of the nature of the stimulus. Antisecretory activityAfter oral administration of the drug Pantoprazole Canon, the antisecretory effect occurs after 1 h and reaches a maximum after 2-4 h. reduction of gastric secretion increases the sensitivity of microorganisms to antibiotics. Does not affect the motility of the gastrointestinal tract. Secretory activity is normalized 3-4 days after the end of administration. Compared with other proton pump inhibitors, pantoprazole has greater chemical stability at neutral pH and less potential for interaction with the liver oxidase system, dependent on cytochrome P450. Therefore, pantoprazole does not interact with many other common drugs.
Pharmacokinetics
Absorption Pantoprazole is rapidly absorbed after oral administration. The maximum concentration (Cmax) in the blood plasma when administered orally is achieved already after the first dose of 20 mg or 40 mg. On average, Cmax, equal to 1.0-1.5 μg / ml, is achieved in 2-2.5 hours for a dosage of 20 mg, and equal to 2.0-3.0 mg / ml - after 2.5 hours for a dosage 40 mg.This indicator remains constant after repeated use of the drug. Absolute bioavailability is 77%. Simultaneous use of pantoprazole with food does not affect the area under the concentration-time pharmacokinetic curve (AUC) and Cmax. Distribution Binding to plasma proteins is 98%. The volume of distribution is 0.15 l / kg, clearance - 0.1 l / h / kg. Metabolism Metabolized in the liver. The main metabolite in blood plasma and urine is desmethylpanthoprazole conjugating with sulfate. ExcretionThe half-life (T1 / 2) of pantoprazole is 1 hour, the metabolite is 1.5 hours. The main route of excretion is through the kidneys (about 80%) as pantoprazole metabolites, in a small amount is excreted through the intestines. The pharmacokinetics in different groups of patients. Age: A slight increase in the AUC and Cmax of the elderly is not clinically significant. Renal failure: When using pantoprazole in patients with impaired function a check (including patients on hemodialysis) dose reduction is not required. As in healthy patients, the excretion of the drug occurs fairly quickly and cumulation does not occur. Hepatic insufficiency: In patients with cirrhosis of the liver (classes A and B according to Child-Pugh), the T1 / 2 value increases to 3-6 h with the use of pantoprazole in the dosage 20 mg and up to 7-9 hours with the use of pantoprazole at a dosage of 40 mg. The AUC is increased by 3-5 times (for a dosage of 20 mg) and by 5-7 times (for a dosage of 40 mg). Cmax increases 1.3 times (for a dosage of 20 mg) and 1.5 times (for a dosage of 40 mg) compared with healthy patients.
Indications
peptic ulcer of the stomach and duodenum (in the acute phase), erosive gastritis (including those associated with nonsteroidal anti-inflammatory drugs (NSAIDs)), treatment of mild gastroesophageal reflux disease (such as heartburn, nausea, sour regurgitation); Zollinger-Ellison; Helicobacter pylori eradication in combination with antibacterial agents.
Contraindications
hypersensitivity to the components of the drug, dyspepsia neurotic genesis, children under 18 years of age (safety and efficacy in pediatrics have not been established), malignant diseases of the gastrointestinal tract, simultaneous use with atazanavir, eradication of Helicobacter pylori in patients with severe renal insufficiency (clearance of creatinine 20 ml / min); breastfeeding period.
Precautionary measures
With caution, hepatic insufficiency, pregnancy, old age, in patients with an increased risk of developing complications of the gastrointestinal tract and receiving nonsteroidal anti-inflammatory drugs for a long time as a anti-relapse treatment of gastric ulcer or duodenal ulcer at a dose of 20 mg.
Use during pregnancy and lactation
Pantoprazole canon can be used during pregnancy only if the benefit to the mother outweighs the potential potential risk to the fetus. Experimental studies have shown that pantoprazole is excreted in breast milk, so if necessary, use of the drug Pantoprazole canon breastfeeding should be stopped.
Dosage and administration
Inside The tablet should be swallowed whole, not chewed or cracked, washed down with a small amount of liquid, before eating, usually before breakfast. When taking a second dose of the drug twice, it is recommended to take before dinner. Peptic ulcer and duodenal ulcer, erosive gastritis (including those associated with the intake of NSAIDs) The recommended dose of 40-80 mg per day. The treatment course is 2 weeks for exacerbation of duodenal ulcer and 4-8 weeks for exacerbation of gastric ulcer. Anti-relapse treatment of gastric ulcer and duodenal ulcer is 20 mg per day. Eradication of Helicobacterpylori As a triple therapy, the following combinations are used: 1. Pantoprazole Kanonpo 20-40 mg 2 times a day + amoxicillin 1000 mg 2 times a day + clarithromycin 500 mg 2 times a day. The course of treatment is 7-14 days.2. Pantoprazole Kanonpo 20-40 mg 2 times a day + metronidazole 500 mg 2 times a day + clarithromycin 500 mg 2 times a day. The course of treatment is 7-14 days.3. Pantoprazole Kanonpo 20-40 mg 2 times a day + amoxicillin 1000 mg 2 times a day + metronidazole 500 mg 2 times a day. The course of treatment is 7-14 days. After the end of combination therapy, the use of Pantoprazole Canon can be continued in order to heal the ulcer. In case of duodenal ulcer, taking Pantoprazole Canon can be prolonged from 1 to 3 weeks. For patients with severe renal dysfunction (creatinine clearance less than 20 ml / min), or on hemodialysis, Helicobacter pylori eradication therapy is not prescribed for such patients. diseases of mild severity (such as heartburn, nausea, sour belching) The recommended dose of the drug is 20 mg per day.To achieve positive dynamics in the elimination of symptoms, it may be necessary to take the drug for 2-3 days, but to completely eliminate the symptoms, it may be necessary to take the drug for 7 days. If the condition worsens during the first 3 days of treatment, it is recommended to consult a specialist. The drug should be stopped immediately after the symptoms disappear. Zollinger-Ellison syndrome A recommended dose of 40-80 mg per day. In patients with severely impaired liver function, the dose should be reduced to 40 mg 1 time in 2 days. In this case, it is necessary to monitor blood biochemical parameters. With an increase in liver enzyme activity, discontinue use of the drug. Older patients Dose adjustment is not required. However, elderly patients should not exceed a daily dose of 40 mg. An exception is the use of combination antimicrobial therapy for Helicobacter pylori, when elderly patients should also use Pantoprazole Canon 40 mg 2 times a day. hemodialysis should not exceed the daily dose of 40 mg. For this reason, eradication therapy for Helicobacter pylori is not prescribed for such patients. Pantoprazole Canon should not be taken for prophylaxis.
Side effects
WHO classification of the incidence of side effects: very often - ≥1 / 10 prescriptions (more than 10%) often - from ≥1 / 100 to less than 1/10 prescriptions (more than 1% and less than 10%) infrequently - from ≥1 / 1000 to less than 1/100 appointments (more than 0.1% and less than 1%) are rare - from ≥1 / 10,000 to less than 1/1000 appointments (more than 0.01% and less than 0.1%) very rarely - less than 1 / 10,000 appointments (less than 0.01%) the frequency is not known - impossible to assess on the basis of available dataDisturbations of the blood and lymphatic system: rarely - agranulocytosis; very rarely - leukopenia, thrombocytopenia, pancytopenia. Violations of the immune Noah systems: very rarely - anaphylactic reactions, including anaphylactic shock. Psychiatric disorders: infrequent - sleep disturbances; rarely - depression, hallucinations, disorientation, clouding of consciousness, especially in patients prone to this, as well as increased symptoms in patients they are earlierObserved. Violations of the nervous system: often - headache; infrequently - dizziness; rarely - dysgeusia. Disruption of the organ of vision: infrequently - blurred vision (blurred vision). Violations of the gastrointestinal tract: often - pain in the upper part abdomen, diarrhea, constipation, flatulence; rarely - nausea / vomiting; rarely - dry mouth. Disorders of the liver and biliary tract: very rare - severe damage to the liver parenchyma, leading to jaundice with or without liver failure. Disorders from one hundred They are skin and subcutaneous tissues: rarely - itching and skin rash, very rarely - urticaria, angioedema, malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, Lyell's syndrome, photosensitization. rarely - arthralgia; very rarely - myalgia. Disruption of metabolism: rarely - hyperlipidemia, changes in body weight; frequency is unknown - hyponatremia, hypomagnesemia. Disorders from the urinary system: very rare co - interstitial nephritis. Violations of the genitals and breast: rarely - gynecomastia. General disorders: infrequently - weakness, fatigue and malaise; very rarely - peripheral edema, fever. Laboratory and instrumental data: rarely - increased bilirubin; very rarely, an increase in the activity of liver enzymes (aspartate aminotransaminase, gamma-glutamyltransferase), an increase in the content of triglycerides.
Overdose
So far, no overdose events have been noted as a result of the use of pantoprazole. Doses exceeding 240 mg intravenously were administered within 2 minutes and were well tolerated. However, in the case of overdose and only in the presence of clinical manifestations, symptomatic and supportive treatment is carried out. Hemodialysis is ineffective.
Interaction with other drugs
The simultaneous use of pantoprazole can reduce the absorption of drugs, the bioavailability of which depends on the pH of the stomach (for example, iron salts, ketoconazole, atazanavir). It is known that the absorption of ritonavir also depends on pH.Therefore, pantoprazole should be used with ritonavir with caution, because of the possible decrease in the bioavailability of ritonavir. Pantoprazole, unlike other proton pump inhibitors, can be administered without the risk of drug interaction: - in patients with cardiovascular diseases receiving cardiac glycosides (digoxin ), “slow” calcium channel blockers (nifedipine), beta-blockers (metoprolol); - patients with diseases of the gastrointestinal tract, taking antibiotics (amoxicillin, to Larythromycin); - patients taking oral contraceptives; - patients taking nonsteroidal anti-inflammatory drugs (diclofenac, phenazone, naproxen, piroxicam); - patients with endocrine system diseases, taking glibenclamide, levothyroxine sodium; diazepam; - patients with epilepsy, taking carbamazepine and phenytoin; - patients undergoing transplantation, taking cyclosporine, tacrolimus. There are no data of simultaneous interaction Via antacid sredstvami.Pri pantoprazole with the simultaneous use of warfarin may increase international normalized ratio (INR), requires control of pokazatelya.Otmecheno also lack drug interactions with theophylline, caffeine and ethanol.
special instructions
It should regularly monitor the activity of liver enzymes in the blood plasma when using the drug Pantoprazole Canon in patients with severe liver failure, especially with prolonged use. With increased activity of transaminases in the blood plasma, treatment with the drug should be discontinued. In patients with an increased risk of developing complications of the gastrointestinal tract and receiving nonsteroidal anti-inflammatory drugs for a long time, Pantoprazole Canon in a dose of 20 mg should be used to prevent gastric ulcer and duodenal ulcer. with caution. It is necessary to use the drug Pantoprazole Canon with caution in elderly patients (over 65 years) with a history of peptic ulcer order or duodenal ulcer,as well as bleeding from the upper gastrointestinal tract. Before and after treatment, endoscopic control is necessary to rule out the possibility of malignant diseases of the stomach and esophagus, since Pantoprazole canon treatment can mask symptoms and make it difficult to diagnose. the stomach, leading to the development of infectious diseases of the gastrointestinal tract caused by Salmonella spp. and Campylobacter spp. Pantoprazole reduces the absorption of vitamine amine B12 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 reducing the absorption of vitamin B12. Patients in whom treatment did not lead to an effect for 4 weeks need to be examined. With long-term use of Pantoprazole Canon, patients need regular medical attention. observation.