Pantoprazole canon tablet p/o intestinal dissolved film 40 mg 28 pcs

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.

Reviews

This drug, like any other, has two sides to the coin. Some vied with each other in praising it, while others, on the contrary, wrote that the remedy did not help.

Reviews from doctors about this remedy indicate that the medicine is able to normalize the functioning of the gastrointestinal tract in a short time.

Patient reviews of this product are positive, because... As a result of taking the drug, adverse reactions occur extremely rarely. Some of the patients who took it note that they did not experience lethargy or drowsiness as a result of taking it, which allowed them to immediately drive after taking the pill.

The disadvantages of this drug include the fact that the drug has contraindications, as well as adverse reactions. In addition, many pregnant women consider the inability to take the drug in this position as a disadvantage.

If you have experience using the product, then please be so kind as to leave your review about it. Your opinion is extremely important to us.

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.

What side effects are observed?

Sometimes a person may experience a negative reaction, which manifests itself in the form of symptoms such as:

• Head pain, dizziness;
• Vomiting, bloating, diarrhea, constipation, abdominal pain, dry mouth;
• Exanthema, skin rash, itching;
• Increased fatigue, asthenia, malaise;
• Sleep disturbance;
• Agranulocytosis;
• Anaphylactic shock;
• Hyperlipidemia;
• Changes in taste, as well as sudden changes in weight;
• Depression that is severe;
• Blurred vision, as well as visual disturbances;
• Angioedema, urticaria;
• Myalgia, arthralgia;
• Gynecomastia;
• Peripheral edema, increased temperature;
• Pancytopenia, thrombocytopenia, leukopenia;
• Disorientation in space;
• Hypomagnesemia, hyponatremia;
• Nephritis;
• Confusion, hallucinations;
• Photosensitivity, Lyell's syndrome, Steven-Johnson syndrome;
• Jaundice, hepatocellular damage.

If suddenly during treatment you begin to experience these symptoms, then stop taking the drug immediately. The patient should then go to the hospital for further advice.

What to do if an overdose occurs?

No overdose phenomena were observed as a result of the use of the drug.

To date, an overdose of the drug has not been observed. A dosage of 240 mg was administered intravenously over two minutes and was very well tolerated.

However, doctors do not exclude the possibility of its occurrence. If suddenly this happens, then you need to rinse your stomach and also take the necessary medicine.

There is no special antidote.

Contraindications for use

This drug is not recommended for use if you have the following conditions:

• Allergic reaction to individual components of the product;
• Children's age up to 3 years.

Taking the drug during pregnancy

Being in an interesting position, a girl should, if possible, completely eliminate any use of funds. The same applies to the drug Pantap.

This medication should also not be taken during breastfeeding.

Instructions for use of Pantoprazole (Method and dosage)

Pantoprazole tablets must not be chewed or broken; they must be swallowed whole, taken before meals and washed down with water.

Pantoprazole tablets, instructions for use

For the treatment of mild reflux disease and associated symptoms (sour belching, heartburn , pain when swallowing), the recommended initial dose is 20 mg per day. Improvement is achieved after about 2-4 weeks; treatment of esophagitis that appears as a result of the disease usually requires monthly therapy. If the specified time period is not enough, recovery occurs within the next month. Relapses of the disease are controlled by taking 20 mg of Pantoprazole once daily as needed. If acceptable symptom control cannot be maintained in this manner, consideration may be given to switching to continuous therapy.

For long-term treatment of reflux esophagitis, a maintenance dosage of 20 mg per day is recommended. In case of frequent relapses, the dosage is increased to 40 mg per day. After relief of relapse symptoms, the dosage can be reduced again to 20 mg per day.

To prevent peptic ulcer disease induced by nonsteroidal anti-inflammatory drugs in individuals with risk factors, the recommended dosage is 20 mg of the drug per day.

In elderly people and patients with renal failure, the daily dosage of Pantoprazole should not exceed 40 mg.

Patients with severe liver failure should not exceed the dosage of Pantoprazole 20 mg per day. These patients should have their liver enzymes measured during therapy. If their concentration begins to increase, therapy with Pantoprazole must be discontinued.

Pantoprazole-LF tablets po enteric soluble 20 mg No. 10x3

Name

Pantoprazole-LF.

Release form

Enteric-coated tablets.

Description

Round tablets, yellowish-beige in color, biconvex, film-coated.

Compound

Each tablet contains: Active substance: pantoprazole (in the form of pantoprazole sodium sesquihydrate) – 20 mg or 40 mg; Excipients: sodium carbonate anhydrous, calcium stearate, crospovidone, povidone (K-17), mannitol. Shell composition: Aquarius Prefered® yellow (hypromellose, copovidone plasdon, polydextrose, polyethylene glycol, caprylic/capric acid triglyceride, titanium dioxide E-171, iron oxide yellow E-172); Acryl-IZ® colorless (copolymer of methacrylic acid and ethyl acrylate, talc, macrogol/PEG, colloidal anhydrous silicon dioxide, sodium bicarbonate, sodium lauryl sulfate), simethicone.

Pharmacotherapeutic group

Antiulcer drugs and drugs used for gastroesophageal reflux disease. Proton pump inhibitors. ATX code: A02BC02.

pharmachologic effect

Mechanism of Action Pantoprazole is a substituted benzimidazole that inhibits gastric acid secretion by specifically blocking the parietal cell proton pump. Pantoprazole is converted to its active form in the acidic environment of parietal cells, where it inhibits the enzyme H+, K+-ATPase, that is, the final stage of hydrochloric acid production in the stomach. Inhibition is dose dependent and affects both basal and stimulated acid secretion. Pantoprazole reduces acidity in the stomach, and thus increases gastrin levels in proportion to the decrease in acidity. The increase in gastrin is reversible. Since pantoprazole interacts with an enzyme distal to the receptor, it can inhibit the secretion of hydrochloric acid regardless of stimulation by other substances (acetylcholine, histamine, gastrin). The same effect is observed when the active substance is administered orally or intravenously. Fasting gastrin values ​​increase with pantoprazole. With short-term use, in most cases they do not exceed the upper limit of normal. During long-term treatment, gastrin levels double in most cases. Excessive increase, however, occurs only in isolated cases. As a result, in a small number of cases of long-term treatment, a mild to moderate increase in the number of specific endocrine cells (ECL) (from simple to adenomatoid hyperplasia) is observed in the stomach. However, according to studies conducted to date, the formation of carcinoid precursors (atypical hyperplasia) or gastric carcinoids, as found in animal experiments, has not been observed in humans. When treated with drugs that suppress secretion, serum gastrin levels increase in response to decreased secretion of hydrochloric acid. As gastric acidity decreases, chromogranin A (CgA) levels increase. Elevated CgA levels may interfere with tests for neuroendocrine tumors. Available published data suggest that proton pump inhibitors should be discontinued 5 days to 2 weeks before CgA measurements. This allows CgA levels to return to the normal range that may be falsely elevated after treatment with proton pump inhibitors. Clinical efficacy In a retrospective analysis of 17 studies of 5960 patients with gastroesophageal reflux disease (GERD) treated with pantoprazole 20 mg as monotherapy, symptoms associated with acid reflux, such as heartburn and sour regurgitation, were assessed according to a standardized procedure. Eligible studies were required to have at least one acid reflux symptom point at 2 weeks. The diagnosis of GERD in these studies was based on endoscopic evaluation, with the exception of one study in which patient inclusion was based on symptoms alone. In these studies, the percentage of patients who experienced complete resolution of heartburn after 7 days ranged from 54.0% to 80.6% in the pantoprazole group. After 14 and 28 days, complete disappearance of heartburn was observed in 62.9-88.6% and 68.1-92.3% of patients, respectively. For the complete disappearance of sour belching, results similar to those for heartburn were obtained. After 7 days, the percentage of patients whose sour belching completely disappeared ranged from 61.5% to 84.4%, after 14 days – from 67.7% to 90.4%, and after 28 days – from 75.2% up to 94.5%, respectively. Pantoprazole consistently performed better than placebo and H2 receptor antagonists, and was at least as good as other proton pump inhibitors. The resolution of acid reflux symptoms was largely independent of the initial stage of GERD.

Pharmacokinetics

Absorption Pantoprazole is rapidly absorbed and the maximum plasma concentration (Cmax) after oral administration is achieved after the first dose of 40 mg. On average, Cmax equal to 2.0-3.0 μg/ml is achieved after 2.5 hours. This indicator remains constant after repeated use of the drug. Pharmacokinetics after single or repeated administration do not differ. Over the dose range of 10 to 80 mg, the plasma kinetics of pantoprazole are virtually linear after both oral and intravenous administration. The absolute bioavailability of pantoprazole tablets is about 77%. Their simultaneous use with food does not affect AUC and Cmax and thus bioavailability. When coadministered with food, only latency variability was increased. Distribution The binding of pantoprazole to plasma proteins is 98%. The volume of distribution is 0.15 l/kg. Metabolism. Metabolized almost exclusively in the liver. Elimination The terminal half-life is about 1 hour and the clearance is 0.1 l/h/kg. Several cases of delayed elimination have been described. Due to the specific binding of pantoprazole to the parietal cell proton pump, the half-life does not correlate with a significantly longer period of action (suppression of acid secretion). The main route of elimination is through the kidneys (about 80%) in the form of pantoprazole metabolites, the rest is excreted in feces. The main metabolite in blood plasma and urine is desmethylpantoprazole, conjugated with sulfate. The half-life of the main metabolite (about 1.5 hours) significantly exceeds that of pantoprazole. Characteristics in special patient populations Approximately 3% of the European population do not have a functional CYP2C19 enzyme and are designated as poor metabolizers. In these individuals, the metabolism of pantoprazole is likely catalyzed by CYP3A4. After a single dose of 40 mg pantoprazole, the mean AUC was approximately 6 times greater in poor metabolizers than in subjects with a functional CYP2C19 enzyme (extensive metabolizers). Average Cmax increased by approximately 60%. These data do not affect pantoprazole dosing regimens. Patients with impaired renal function When using pantoprazole in patients with impaired renal function (including patients on hemodialysis, which removes only a small amount of pantoprazole), no dose reduction is required. As in healthy patients, the half-life of pantoprazole is short. Although the half-life of the main metabolite is slightly longer (2-3 hours), excretion remains rapid and accumulation does not occur. Patients with hepatic impairment: After administration of pantoprazole to patients with hepatic impairment (Child-Pugh classes A, B and C), the half-life increased to 3-7 hours and AUC values ​​increased 3-6 times, while Cmax increased only slightly (1.3 times) compared to healthy subjects. Children: After a single oral dose of 20 or 40 mg of pantoprazole to children from 5 to 16 years of age, AUC and Cmax were within the range of those in adults. Following a single intravenous dose of 0.8 or 1.6 mg/kg pantoprazole to children 2 to 16 years of age, there was no significant association between pantoprazole clearance and age or weight. AUC and volume of distribution were consistent with data obtained in adults. Elderly Patients The slight increase in AUC and Cmax in elderly volunteers compared with younger subjects was not clinically significant.

Indications for use

The drug Pantoprazole-LF 20 mg is used for the short-term treatment of reflux symptoms (for example, heartburn, sour belching) in adults. The drug Pantoprazole-LF 40 mg is used for the following indications: Adults and children 12 years of age and older: - reflux esophagitis. Adults: - eradication of Helicobacter pylori as part of combination therapy with antibacterial agents; - stomach or duodenal ulcer; - Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion.

Contraindications

- hypersensitivity to the active substance, benzimidazoles derivatives or any component of the drug; The combined use of pantoprazole with HIV protease inhibitors, such as atazanavir, nelfinavir, the absorption of which depends on the acidity of the intragastric pH, is not recommended due to a significant decrease in their bioavailability.

Directions for use and doses

The tablets should be swallowed whole and should not be chewed or broken. Take 1 hour before meals with plenty of water. Short-term treatment of reflux symptoms The recommended dose for adults is 20 mg of the drug Pantaza-LF (1 tablet) per day. To relieve symptoms, it may be necessary to take the medicine for 2-3 days. Once the symptoms have disappeared, treatment can be stopped. Treatment should not exceed 4 weeks without consulting a doctor. If no improvement in symptoms is obtained within 2 weeks of continuous treatment, the patient should be informed of the need to consult a physician. Reflux esophagitis The recommended dose for adults and children 12 years of age and older is 40 mg of Pantaza-LF (1 tablet) per day. In some cases, the dose may be doubled (increased to 2 tablets per day), especially when there has been no response to other therapy. A 4-week treatment period is usually required. If it is not sufficient, the therapeutic effect is usually achieved within the next 4 weeks. Eradication of Helicobacter pylori as part of combination therapy with antibacterial agents In Helicobacter pylori-positive adult patients with gastric and duodenal ulcers, eradication of the microorganism should be achieved using combination therapy. Official local guidelines (eg national recommendations) should be consulted regarding bacterial resistance and appropriate prescribing and use of antibacterial agents. Depending on the spectrum of resistance, the following combinations may be recommended: a) one tablet (40 mg) of the drug Pantaza-LF twice a day + 1000 mg of amoxicillin twice a day + 500 mg of clarithromycin twice a day. b) one tablet (40 mg) of the drug Pantaza-LF twice a day + 400-500 mg of metronidazole (or 500 mg of tinidazole) twice a day + 250-500 mg of clarithromycin twice a day. c) one tablet (40 mg) of the drug Pantaza-LF twice a day + 1000 mg of amoxicillin twice a day + 400-500 mg of metronidazole (or 500 mg of tinidazole) twice a day. When carrying out eradication therapy, the second tablet of the drug Pantaza-LF should be taken 1 hour before the evening meal. Combination therapy is usually given for 7 days and can be continued for another 7 days for a total duration of 14 days. To ensure healing of the ulcers, further therapy with pantoprazole is then indicated, using doses recommended for duodenal and gastric ulcers. If combination therapy is not indicated (Helicobacter pylori is a negative patient), the following dosage regimens for monotherapy with the drug Pantaza-LF should be followed: Treatment of stomach ulcers 1 tablet (40 mg) of the drug Pantaza-LF per day. In some cases, the dose may be doubled (increased to 2 tablets per day), especially when there has been no response to other therapy. A 4-week treatment period is usually required. If this is not sufficient, healing is usually achieved within the next 4 weeks. Treatment of duodenal ulcers: 1 tablet (40 mg) of the drug Pantaza-LF per day. In some cases, the dose may be doubled (increased to 2 tablets per day), especially when there has been no response to other therapy. Healing of a duodenal ulcer usually occurs within 2 weeks. If this period is not sufficient, healing in almost all cases is achieved 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, start with a daily dose of 80 mg (2 tablets of the drug Pantaza-LF 40 mg). 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 correspond to clinical need. Special groups of patients Patients with impaired liver function In patients with severe hepatic impairment, the daily dose of pantoprazole should not exceed 20 mg. 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 effectiveness and safety of pantoprazole as part of combination therapy in such patients. Patients with impaired renal function No dose adjustment is required in patients with impaired renal function. 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 effectiveness and safety of pantoprazole as part of combination therapy in such patients. Children under 12 years of age: Prescription is not recommended due to limited data on safety and effectiveness in this age group. Elderly patients: No dose adjustment is required.

Side effect

In approximately 5% of cases, adverse reactions may occur. The most common adverse reactions are diarrhea and headache. Both of these reactions occur in approximately 1% of patients. Adverse reactions are rated according to the frequency of their occurrence. When using pantoprazole, undesirable effects were recorded with the following frequency: very often - 1/10 or more; often - from 1/100 to 1/10; infrequently – from 1/1000 to 1/100; rarely - from 1/10,000 to 1/1000; very rare - less than 1/10000, frequency unknown - cannot be determined based on available data. Within each frequency category, adverse reactions are listed in descending order of severity. Disorders of the blood and lymphatic system: rarely - agranulocytosis; very rarely - thrombocytopenia, leukopenia, pancytopenia. Immune system disorders: rarely - hypersensitivity (including anaphylactic reactions and anaphylactic shock). Metabolic and nutritional disorders: rarely - hyperlipidemia and increased levels of lipids (triglycerides, cholesterol); changes in body weight; frequency unknown - hyponatremia, hypomagnesemia, hypocalcemia1, hypokalemia. Mental disorders: infrequently – sleep disorders; rarely – depression (and deterioration); very rarely - disorientation (and deterioration); frequency unknown - hallucinations, confusion (especially in predisposed patients, as well as worsening of pre-existing symptoms). Nervous system disorders: uncommon – headache, dizziness; rarely - taste disturbances. Visual disturbances: rarely – visual disturbances/blurred vision. Gastrointestinal tract disorders: often – stomach polyps (benign); uncommon – diarrhea, nausea/vomiting, flatulence and bloating, constipation, dry mouth, abdominal pain and discomfort. Disorders of the liver and biliary tract: infrequently - increased levels of liver enzymes (transaminases, γGTP); rarely – increased bilirubin levels; frequency unknown - hepatocyte damage, jaundice, hepatocellular failure. Disorders of the skin and subcutaneous tissues: uncommon – rash/exanthema/rash, itching; rarely – urticaria, angioedema; 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, spine; rarely – arthralgia, myalgia; frequency unknown – muscle spasm2. Renal and urinary tract disorders: frequency unknown - interstitial nephritis (with possible progression to renal failure). Disorders of the genital organs and breast: rarely - gynecomastia. General disorders: infrequently - asthenia, fatigue and malaise; rarely – increased body temperature, peripheral edema. 1Hypocalcemia associated with hypomagnesemia. 2Muscle spasm as a consequence of electrolyte imbalance. Overdose To date, no overdose phenomena have been observed as a result of the use of pantoprazole. 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. Since pantoprazole has a high affinity for proteins, it is difficult to undergo hemodialysis.

Precautionary measures

Liver failure In patients with severe liver failure, liver enzymes should be regularly monitored during treatment with pantoprazole, especially with long-term use of the drug. If their level increases, treatment should be discontinued. Combination therapy When carrying out combination therapy, the instructions for medical use of the relevant drugs should be taken into account. Gastric malignancy If any warning sign is present (eg, significant involuntary weight loss, recurrent vomiting, dysphagia, hematemesis, anemia, melena) and if gastric ulcer is present or suspected, malignancy should be excluded as treatment with pantoprazole may reduce symptoms and delay making a diagnosis. The need for additional examination should be considered if symptoms persist despite adequate therapy. Co-administration with HIV protease inhibitors Co-administration of pantoprazole with HIV protease inhibitors whose absorption is dependent on gastric pH, such as atazanavir, is not recommended due to a significant reduction in their bioavailability. Effect on the absorption of vitamin B12 In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term therapy, pantoprazole, like all antisecretory agents, can 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 reducing its absorption during long-term therapy or in the presence of corresponding clinical symptoms. Long-term treatment During long-term therapy, especially when it exceeds a period of one year, patients should be monitored regularly. Bacterial gastrointestinal infections Treatment with pantoprazole may result in 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 for a year). Severe manifestations of hypomagnesemia, such as fatigue, tetany, delirium, seizures, dizziness, and ventricular arrhythmia, may occur, but may begin insidiously and may go undetected. In most patients, hypomagnesemia was relieved by magnesium administration while proton pump inhibitors were discontinued. For patients undergoing long-term treatment or taking proton pump inhibitors concomitantly with digoxin or drugs that can cause hypomagnesemia (eg, diuretics), healthcare providers should consider measuring blood magnesium levels before starting treatment and periodically during treatment. Bone fractures Proton pump inhibitors, especially when used in high doses and for long periods of time (more than one year), may moderately increase the risk of hip, wrist and spine fractures, mainly in the elderly or with other recognized risk factors. Observational studies indicate that proton pump inhibitors may increase the overall risk of fracture by 10% to 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 is associated with very rare cases of SCLE. If pathological changes occur, especially in areas of the skin exposed to sun, and in the event of arthralgia, the patient should immediately seek medical help, and a medical professional should evaluate the advisability of discontinuing the drug. PPCI following prior treatment with a proton pump inhibitor may increase the risk of PPCI with other proton pump inhibitors. Laboratory Interference Elevated CgA levels may interfere with tests for neuroendocrine tumors. To avoid interference, treatment with Pantaza-LF should be discontinued at least 5 days before CgA levels are determined. If CgA and gastrin levels have not returned to the normal range after the initial determination, measurement should be repeated 14 days after discontinuation of proton pump inhibitor therapy.

Pregnancy and breastfeeding period

Pregnancy The small amount of data on the use of pantoprazole in pregnant women (300-1000 cases) indicates no toxicity causing malformations or fetal/newborn toxicity associated with Pantaza-LF. Animal studies have demonstrated reproductive toxicity. As a precautionary measure, it is advisable to avoid the use of the drug Pantaza-LF during pregnancy. Lactation Animal studies have demonstrated that pantoprazole passes into breast milk. Exclusion into human breast milk has been reported. A risk to the nursing infant cannot be excluded. Therefore, the decision to continue / stop breastfeeding or continue / stop therapy with pantoprazole should be made taking into account the benefits of breastfeeding for the child and the benefits of therapy using the drug Pantaza-LF for the woman. Fertility Animal studies have shown no evidence of impaired fertility following the use of pantoprazole.

Impact on the ability to drive vehicles and operate machinery

Pantoprazole has no or negligible effect on the ability to drive a vehicle or use machinery. Adverse reactions such as dizziness or visual disturbances may occur. If they occur, patients should not drive or operate machinery.

Interaction with other drugs

Drugs with absorption dependent on gastric pH Due to the pronounced and prolonged suppression of gastric secretions, pantoprazole may interfere with the absorption of drugs whose bioavailability depends on gastric pH, for example, some azole antifungals such as ketoconazole, itraconazole, posaconazole, and others drugs such as erlotinib. HIV protease inhibitors Concomitant use of pantoprazole with HIV protease inhibitors whose absorption is dependent on acidic intragastric pH, such as atazanavir, may lead to a significant decrease in their bioavailability. If the combination of an HIV protease inhibitor with a proton pump inhibitor cannot be avoided, close monitoring (eg, viral load monitoring) is recommended. The dose of pantoprazole should not exceed 20 mg per day. Dosage adjustment of HIV protease inhibitors may be required. Coumarin anticoagulants (phenprocoumon or warfarin) Concomitant use of pantoprazole with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenprocoumon or the international normalized ratio (INR). However, increases in INR and prothrombin time have been reported in patients receiving other proton pump inhibitors and warfarin or phenprocoumon concomitantly. 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 Concomitant use of high dose methotrexate (eg, 300 mg) and proton pump inhibitors has been reported to increase methotrexate levels in some patients. Therefore, in settings where high doses of methotrexate are used, 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 through these pathways, such as carbamazepine, diazepam, glibenclamide, nifedipine, oral contraceptives containing levonorgestrel and ethinyl estradiol, did not reveal clinically significant interactions. Interaction of pantoprazole with other drugs or compounds that are metabolized through the same enzyme system cannot be excluded. 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 alter p-glycoprotein-dependent absorption of digoxin. There are no interactions with co-prescribed antacids. Interaction studies were also conducted with antibiotics prescribed together with pantoprazole (clarithromycin, metronidazole, amoxicillin). No clinically significant interactions were found. Medicines that inhibit or induce CYP2C19 CYP2C19 inhibitors, such as fluvoxamine, may increase the systemic exposure of pantoprazole. A dose reduction may be necessary in patients receiving high doses of pantoprazole for a long time or in those with hepatic impairment. Enzyme inducers affecting 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.

Storage conditions

In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Best before date

2 years. Do not use after the expiration date stated on the packaging.

Package

10 tablets each in a blister pack made of polymer film and aluminum foil. Three blister packs each along with instructions for medical use in a cardboard pack.

Buy Pantoprazole-LF tablets po enteric soluble 20 mg No. 10x3 in the pharmacy

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Instructions for use for Pantoprazol-LF tablets po enteric soluble 20 mg No. 10x3

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.

special instructions

Individuals with severe liver failure treated with Pantoprazole are advised to regularly measure liver enzyme levels. If liver enzyme levels increase, therapy should be discontinued. The use of Pantoprazole 20 mg tablets to prevent the appearance of gastric and duodenal ulcers induced by non-steroidal anti-inflammatory drugs is indicated for patients who require long-term use of NSAIDs and have an increased risk of developing complications from the digestive system.

With decreased acidity, the number of bacteria present in the gastrointestinal tract tends to increase. Therefore, therapy with acid-lowering drugs can lead to a slight increase in the risk of gastrointestinal infections.

Pantoprazole can reduce the absorption of vitamin B12 as a result of hypochlorhydria or achlorhydria.

Before starting treatment, it is necessary to exclude the presence of malignant tumors of the esophagus or stomach, since treatment with Pantoprazole can mask the symptoms of such diseases and lead to their delayed diagnosis.

What instructions does this product have?

This medicinal product has instructions, which you should carefully read. It contains information regarding conditions of administration, indications, combination with other drugs, pharmacology, release form/composition, side effects, contraindications, actions in case of overdose, taking the drug during pregnancy, as well as storage conditions. If all this information is not enough for you, then on our website you can find data on the possible price range, possible analogues, as well as deducing the positive/negative aspects of the product based on reviews. If you ignore the data from the article, then negative consequences may occur in the future.

Pharmacology

Pantap contains the active substance pantoprazole, which belongs to the group of substituted benzamidazole, which inhibits the final stage in the production of hydrochloric acid through the formation of a covalent bond with the (H+-K+) ATP enzyme system on the secretory surface of cells.

The duration of suppression of acid activity by pantoprazole is more than a day. Acid secretion normalizes within three to five days after taking the last dose. When taking the medicine, an increased level of serum gastritis is observed, which stabilizes after stopping treatment.

The active substance is absorbed into the gastrointestinal tract after a single or multiple doses. The bioavailability of the product is about 77%. The maximum concentration of the substance in the blood is 2.09 mcg/ml, the time to reach the maximum concentration in the blood is 2.8 hours.

The withdrawal period is 1.2-1.3 hours. The antisecretory activity of the drug persists throughout the day.

Indications

The drug is allowed to be taken in the presence of such conditions as:

• Zollinger-Ellison syndrome;
• Gastric or duodenal ulcer, including as a result of Helicobacter pylori infection;
• Gastroesophageal reflux disease;
• Treatment and prevention of erosive and ulcerative lesions of the gastrointestinal tract, which are associated with the use of NSAIDs.

An ulcer appears as a result of increased acidity, an increase in the content of hydrochloric acid in the stomach.

How exactly is the drug taken?

It is not recommended to chew or bite Pantap tablets: they should be swallowed whole and washed down with plenty of liquid. The drug is taken before the patient sits down to eat.

Symptoms begin to improve after a few days of treatment, however, complete recovery may take up to seven days.

For those patients who have had minor liver problems, the daily dose should in no case exceed 20 mg. If a person has a moderate or severe form of damage, then it is best to avoid taking this drug.

In old age. or for persons with impaired renal function, no dose adjustment is required.

Compound

After oral administration, the antisecretory effect occurs within 1 hour and reaches a maximum after 2 to 4 hours.

One tablet contains the main substance - pantoprazole. In addition, the composition contains elements such as talc, microcrystalline cellulose, magnesium carbonate, corn starch, Aerosil 200, magnesium stearate.

Talc and pharmacoat 603 are used as a preliminary coating. For enteric coating, talc, eydragit L 30D, macrogol 6000, simethicone emulsion, Selispers AP, triethyl citrate are used.

Combination with other means

The active substance of the drug Pantap can reduce or increase several times the absorption of drugs whose bioavailability depends on pH (for example, ketoconazole)

The studies did not reveal a particularly significant combination of this drug with drugs such as diclofenac, caffeine, nifediline, digoxin, phenprokomon, theophylline, phenytoin, warfarin, oral contraceptives, piroxicam, glibenclamide, naproxen, carbamazepine.

Analogues of Pantoprazole

Level 4 ATC code matches:
Khairabesol

Noflux

Lancid

Barol

Beret

Ontime

Gastrozol

Omeprazole

Proxium

Lansoprazole

Zulbex

Ultop

Epicurus

Pariet

Losek MAPS

Losek

Sanpraz

Emanera

Omez Insta

Omez

The most common analogues of Pantoprazole: Barol, Hasek, Geerdin, Dexilant, Lansoprazole, Lanzap, Loseprazole, Omez, Omeprazole, Oprazole, Pariet, Ultop, Emanera.

Differences between Pantoprazole and Omeprazole

Omeprazole and Pantoprazole belong to the same pharmacological group; the former has more effective indicators of therapeutic activity and a more affordable price.

Pantoprazole price, where to buy

The price of Pantoprazole Canon in Russia is 200-300 rubles.

• Online pharmacies in RussiaRussia

ZdravCity

• Pantoprazole Canon tablets p.p.o.
  enteric solution 20 mg 28 pcs. Canonpharma Production JSC RUB 239 order
• Pantoprazole Canon tablets p.p.o. enteric solution 40 mg 28 pcs. Canonpharma Production CJSC

  RUB 294 order

• Pantoprazole-Vertex tab. ksh/sol. p/o captivity. 0.04g 30pcs Vertex AO

  RUB 315 order

• Pantoprazole-Vertex tab. ksh/sol. p/o captivity. 0.02g 30pcs Vertex AO

  RUB 215 order