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Pantoprazole Canon (tab.pl/vol. 20mg No. 28)

A country

Russia
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Pantoprazole

Compound

1 tablet contains: pantoprazole sodium sesquihydrate 22.57 mg.
Excipients: heavy magnesium hydroxycarbonate 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 composition: Opadry transparent 2.4 mg (including: hypromellose (hydroxypropyl methylcellulose) 1.920 mg, macrogol (polyethylene glycol) 0.48 mg), Acrylic-Iz green 8.6 mg (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, iron oxide yellow 0.06 mg, indigo carmine dye 0.069 mg, brilliant blue dye 0.026 mg, talc 1.419 mg, titanium dioxide 1.135 mg). Triethyl citrate 1 mg.

pharmachologic effect

Pharmacodynamics Proton pump inhibitor (H+/K+-ATPase).
Blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus. Antisecretory activity After oral administration of the drug Pantoprazole Canon, the antisecretory effect occurs after 1 hour and reaches a maximum after 2-4 hours. In case of duodenal ulcer associated with Helicobacter pylori, a decrease in gastric secretion increases the sensitivity of microorganisms to antibiotics. Does not affect gastrointestinal motility. Secretory activity returns to normal 3-4 days after the end of administration. Compared with other proton pump inhibitors, pantoprazole has greater chemical stability at neutral pH and a lower potential for interaction with the cytochrome P450-dependent hepatic oxidase system. Therefore, pantoprazole does not interact with many other common drugs. Pharmacokinetics Absorption Pantoprazole is rapidly absorbed after oral administration. The maximum concentration (Cmax) in blood plasma after oral administration is achieved after the first dose of 20 mg or 40 mg. On average, Cmax equal to 1.0 - 1.5 mcg/ml is achieved after 2-2.5 hours for a dosage of 20 mg, and equal to 2.0 -3.0 mcg/ml - after 2.5 hours for a dosage 40 mg. This indicator remains constant after repeated use of the drug. Absolute bioavailability is 77%. Concomitant use of pantoprazole with food does not affect the area under the concentration-time pharmacokinetic curve (AUC) and Cmax. Distribution: Plasma protein binding is 98%. The volume of distribution is 0.15 l/kg, clearance is 0.1 l/h/kg. Metabolism Metabolized in the liver. The main metabolite in blood plasma and urine is desmethylpantoprazole, which is conjugated with sulfate. Excretion The half-life (T½) of pantoprazole is 1 hour, that of the metabolite is 1.5 hours. The main route of elimination is through the kidneys (about 80%) in the form of pantoprazole metabolites, and a small amount is excreted through the intestines. Pharmacokinetics in different patient groups Age: A slight increase in AUC and Cmax in elderly people is not clinically significant. Renal failure: When using pantoprazole in patients with impaired renal function (including patients on hemodialysis), no dose reduction is required. As in healthy patients, excretion of the drug occurs fairly quickly and does not accumulate. Liver failure: In patients with liver cirrhosis (Child-Pugh classes A and B), the T½ value increases to 3-6 hours when using pantoprazole at a dosage of 20 mg and to 7-9 hours when using pantoprazole at a dosage of 40 mg. The AUC indicator increases by 3-5 times (for a dosage of 20 mg) and by 5-7 times (for a dosage of 40 mg). Cmax increases by 1.3 times (for a dosage of 20 mg) and 1.5 times (for a dosage of 40 mg) compared to healthy patients.

Indications for use

— Peptic ulcer of the stomach and duodenum (in the acute phase), erosive gastritis (including those associated with taking non-steroidal anti-inflammatory drugs (NSAIDs)); - treatment of symptoms of mild gastroesophageal reflux disease (such as heartburn, nausea, sour belching); - Zollinger-Ellison syndrome; eradication of Helicobacter pylori in combination with antibacterial agents.

Side effects

WHO classification of the incidence of side effects: very often - >1/10 prescriptions (>10%) often - from >1/100 to 1% and infrequently - from >1/1000 to 0.1% and rarely - from >1/10000 to 0.01% and very rare - frequency unknown - cannot be estimated from available data. Disorders of the blood and lymphatic system: - rarely - agranulocytosis; very rarely - leukopenia, thrombocytopenia, pancytopenia. Immune system disorders: very rarely - anaphylactic reactions, including anaphylactic shock. Mental disorders: - infrequently - sleep disorders; rarely - depression, hallucinations, disorientation, clouding of consciousness, especially in patients predisposed to this, as well as an increase in these symptoms if they were previously observed in patients. Nervous system disorders: - often - headache; - infrequently - dizziness; rarely – dysgeusia. Visual impairment: uncommon – visual impairment (blurred vision). Gastrointestinal disorders: - often - pain in the upper abdomen, diarrhea, constipation, flatulence; - infrequently - nausea/vomiting; rarely – dry mouth. Liver and biliary tract disorders: very rarely - severe damage to the liver parenchyma, leading to jaundice with or without liver failure. Disorders of the skin and subcutaneous tissues: - uncommon - itching and skin rash; very rarely - urticaria, angioedema, malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, Lyell's syndrome, photosensitivity. Musculoskeletal and connective tissue disorders: - rarely - arthralgia; very rarely - myalgia. Metabolic disorders: - rarely - hyperlipidemia, changes in body weight; frequency unknown - hyponatremia, hypomagnesemia. Disorders of the urinary system: very rarely - interstitial nephritis. Disorders of the genital organs and breast: rarely - gynecomastia. General disorders: - infrequently - weakness, fatigue and malaise; very rarely - peripheral edema, increased body temperature. Laboratory and instrumental data: - rarely - increased bilirubin levels; very rarely - increased activity of liver enzymes (aspartate aminotransaminase, gamma-glutamyltransferase), increased triglyceride content.

Contraindications

- Hypersensitivity to the components of the drug; — dyspepsia of neurotic origin; - children under 18 years of age (safety and effectiveness 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 failure (creatinine clearance during breastfeeding. With caution - liver failure; - pregnancy; - elderly age; - in patients who have an increased risk of developing complications from the gastrointestinal tract and are receiving non-steroidal drugs for a long time anti-inflammatory drugs as an anti-relapse treatment for gastric or duodenal ulcers in a dose of 20 mg Use during pregnancy and breastfeeding The drug Pantoprazole Canon can be used during pregnancy only if the benefit to the mother outweighs the possible potential risk to the fetus. Experimental studies have shown that pantoprazole is excreted in breast milk, therefore, if it is necessary to use the drug Pantoprazole Canon, breastfeeding should be discontinued.

Mode of application

Inside. The tablet should be swallowed whole, without chewing or breaking, with a small amount of liquid, before meals, usually before breakfast. When taken twice, the second dose of the drug is recommended to be taken before dinner. Peptic ulcer of the stomach and duodenum, erosive gastritis (including those associated with taking NSAIDs) The recommended dose is 40-80 mg per day. The course of treatment is 2 weeks for exacerbation of duodenal ulcer and 4-8 weeks for exacerbation of gastric ulcer. Anti-relapse treatment of gastric and duodenal ulcers – 20 mg per day. Eradication of Helicobacter pylori The following combinations are used as triple therapy: 1. Pantoprazole Canonpo 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 Canonpo 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 Canonpo 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, taking Pantoprazole Canon can be continued for the purpose of healing the ulcer. For duodenal ulcers, taking Pantoprazole Canon can be extended from 1 to 3 weeks. Patients with severe renal impairment (creatinine clearance) Treatment of symptoms of mild gastroesophageal reflux disease (such as heartburn, nausea, sour belching) The recommended dose of the drug is 20 mg per day. To achieve positive dynamics in eliminating symptoms, it may be necessary to take the drug in within 2-3 days, however, 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, consultation with a specialist is recommended. The drug should be stopped immediately after the symptoms disappear. Zollinger-Ellison syndrome Recommended dose 40- 80 mg per day. In patients with severe liver dysfunction, the dose should be reduced to 40 mg 1 time every 2 days. In this case, it is necessary to monitor biochemical blood parameters. If the activity of liver enzymes increases, the drug should be discontinued. Elderly patients No dose adjustment is required. However, elderly patients should not exceed a daily dose of 40 mg. An exception is the use of combination antimicrobial therapy against Helicobacter pylori, when elderly patients should also use the drug Pantoprazole Canon 40 mg 2 times a day. Patients with renal failure Patients with severe renal impairment (creatinine clearance) should not take Pantoprazole Canon for prophylactic purposes.

special instructions

The activity of liver enzymes in the blood plasma should be regularly monitored when using the drug Pantoprazole Canon in patients with severe liver failure, especially with long-term use. If the activity of transaminases in the blood plasma increases, treatment with the drug should be discontinued. In patients who have an increased risk of developing complications from the gastrointestinal tract and are receiving non-steroidal anti-inflammatory drugs for a long time, the drug Pantoprazole Canon at a dose of 20 mg for the prevention of gastric and duodenal ulcers should be used with caution. Pantoprazole Canon should be used with caution in elderly patients (over 65 years of age) with a history of gastric or duodenal ulcers, as well as bleeding from the upper gastrointestinal tract. Before and after treatment, endoscopic monitoring is required to exclude the possibility of malignant diseases of the stomach and esophagus, since treatment with Pantoprazole Canon can mask symptoms and complicate correct diagnosis. A decrease in the acidity of gastric juice increases the number of bacteria in 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 vitamin 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 reduced absorption of vitamin B12. Patients in whom treatment has not resulted in an effect within 4 weeks need to be examined. When taking Pantoprazole Canon for a long time, patients need regular medical supervision. Impact on the ability to drive vehicles and engage in other potentially hazardous activities Please note that dizziness may develop during treatment, and therefore care must be taken when driving and engaging in other potentially hazardous activities that require increased concentration and attention. speed of psychomotor reactions Overdose To date, no overdose phenomena have been observed as a result of the use of pantoprazole. Doses greater than 240 mg IV were administered 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. Hemodialysis is ineffective.

Interaction with other drugs

The simultaneous use of pantoprazole may reduce the absorption of drugs whose bioavailability depends on the pH of the stomach (for example, iron salts, ketoconazole, atazanavir). It is known that the absorption of ritonavir is also pH dependent. Therefore, the use of pantoprazole together with ritonavir should be done with caution, due to a possible decrease in the bioavailability of ritonavir. Pantoprazole, unlike other proton pump inhibitors, can be prescribed without the risk of drug interactions: - patients with cardiovascular diseases taking cardiac glycosides (digoxin), slow calcium channel blockers (nifedipine), beta-blockers (metoprolol) ; - patients with diseases of the gastrointestinal tract taking antibiotics (amoxicillin, clarithromycin); - patients taking oral contraceptives; - patients taking non-steroidal anti-inflammatory drugs (diclofenac, phenazone, naproxen, piroxicam); - patients with diseases of the endocrine system taking glibenclamide, levothyroxine sodium; - patients with anxiety and sleep disorders taking diazepam; - patients with epilepsy taking carbamazepine and phenytoin; - patients who have undergone transplantation and are taking cyclosporine, tacrolimus. There is no data on the simultaneous interaction of pantoprazole with antacids. When used simultaneously with warfarin, the international normalized ratio (INR) may increase; monitoring of this indicator is necessary. There is also no drug interaction with theophylline, caffeine and ethanol.

Dispensing conditions in pharmacies

On prescription

How to properly store this product?

This product should be kept away from small children or pets.

The product should be stored at a temperature that will not exceed 30 degrees. The medicine must be in its original packaging, which must be protected from moisture and light.

This product should be stored for no more than three years. After the expiration of this period, its further use is under no circumstances allowed.

If you take medications regularly, it is better to stock up.

Interaction

The drug may reduce the absorption of agents whose bioavailability is correlated depending on pH (for example, Itraconazole, Ketoconazole, atazanavir ).

The use of proton pump blockers is prohibited during treatment with Atazanavir.

The drug is metabolized in the liver under the influence of cytochrome P450 , however, significant interactions with Diazepam, Carbamazepine, caffeine, Diclofenac, ethanol, Digoxin, Glibenclamide, Naproxen, Metoprolol, Nifedipine, Piroxicam, Theophylline, phenytoin or oral contraceptives have not been identified.

If the patient uses coumarin anticoagulants , it is recommended to measure the prothrombin period and INR value during and after treatment with Pantoprazole.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Suppresses the production of hydrochloric acid in the stomach through the action of a proton pump on gastric cells. The active substance is transformed into an active form in the channels of the walls of parietal cells and blocks the enzyme HK-ATPase , that is, at the final stage of hydrochloric acid synthesis. In most patients, symptom relief occurs after 2 weeks of therapy.

Like other proton pump and H2 , drug therapy causes a decrease in acidity and an increase in gastrin content.

Pharmacokinetics

Pantoprazole is actively absorbed, the highest concentration in the blood is achieved after a single dose. On average, the highest concentration in the blood occurs 2.5 hours after application.

The half-life is approximately an hour. There have been a number of cases of delayed withdrawal.

Reaction with plasma proteins approaches 98%. The original drug is almost completely transformed in the liver.

The kidneys excrete about 80% of the metabolites , the rest is excreted in the feces. The main metabolite is desmethylpantoprazole , its half-life is approximately 1.5 hours.

Side effects

Digestive reactions: nausea, diarrhea , increased appetite , dry mouth, vomiting, belching, flatulence, constipation, gastrointestinal carcinoma , abdominal pain, increased transaminases.
Reactions from nervous activity and sensory organs: drowsiness, headache, dizziness, asthenia, insomnia , depression , nervousness, tremor, photophobia, paresthesia, tinnitus, visual impairment.
Reactions from the genitourinary area: edema , hematuria, impotence.
Skin reactions: alopecia, exfoliative dermatitis, acne.
Allergic reactions: rash, urticaria , angioedema , itching .
Other reactions: eosinophilia, hyperglycemia, myalgia, hyperlipoproteinemia, fever, hypercholesterolemia.