Active substancePantoprazolePantoprazole
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  • Dosage form: & nbsptablets, coated with enteric film coating
    Composition:

    Each tablet contains:

    active substance: sodium pantoprazole sesquihydrate 45.10 mg (equivalent to pantoprazole 40 mg).

    Excipients: sodium carbonate 10.00 mg, mannitol 42.70 mg, crospovidone 50.00 mg, povidone K-90 4.00 mg, calcium stearate 3.20 mg.

    shell: opada yellow (hypromellose 79.96%, povidone K-25 1.52%, titanium dioxide 1.40%, iron dye oxide yellow0.12%, propylene glycol 17.00%) 20.00 mg.

    enteric membrane: methacrylic acid and ethyl acrylate copolymer [1: 1] (Eudragit L-30 D-55) 14.20 mg, triethyl citrate 1.48 mg.

    Description:Oval, biconvex tablets of light yellow or yellow color, on the fracture - white or almost white.
    Pharmacotherapeutic group:A drug that reduces the secretion of the glands of the stomach - the proton pump inhibitor
    ATX: & nbsp

    A.02.B.C   Proton pump inhibitors

    A.02.B.C.02   Pantoprazole

    Pharmacodynamics:

    Proton pump inhibitor (NTK-ATPase). It blocks the final stage of hydrochloric acid secretion, reducing the content of basal and stimulated secretion, regardless of the nature of the stimulus. The maximum effect manifests itself only in a highly acidic medium (pH <3), at higher pH values ​​it remains practically inactive, affects the motility of the gastrointestinal tract. Secretory activity normalized 3-4 days after the end of admission.

    Pharmacokinetics:Quickly absorbed from the gastrointestinal tract, the maximum concentration (Cmax) 2 - 3 mg / l in plasma is achieved after 2.5 hours. This value remains unchanged at repeated reception. Bioavailability is 65-77%. Reception of antacids or pisoup does not affect Сmах and bioavailability. Binding to plasma proteins is 98%.
    The volume of distribution is 11.0, - 23.6 liters, distributed mainly in extracellular fluid.
    Metabolized in the liver with the enzyme system CYP2C19. Main metabolite - desmethylpentoprazole, which is then subjected to sulfation.
    Clearance - 0.1 l / h / kg. It is excreted mainly by the kidneys (80%) in the form of metabolites in a small amount - the intestine. The half-life (T1 / 2) of pantoprazole-1 hour, metabolite-1.5 hours.
    When using pantoprazole in patients with limited renal function (including patients on hemodialysis) no dose reduction is required. As with healthy patients, half-life pantoprazole is short.
    Only a very small part of the drug is dialyzed. Not cumulated.
    With hepatic insufficiency (class A and B according to the Child-Pug classification), T1 / 2 for intake of 40 mg increases to 7-9 hours; area under the curve "concentration - time" (AUC) increases by a factor of 5-7, and the maximum concentration (Сmах) in 1,5 times.
    A small increase AUC and increase Сmах in elderly patients compared with the corresponding data in young patients are not clinically significant.
    Indications:

    Peptic ulcer of the stomach and duodenum (in the phase of exacerbation), erosive gastritis, erosive-ulcerative is affected by the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs); reflux-esophagitis; Zollinger-Ellison syndrome, eradication Helicobacter pylori in combination with antibacterial agents.

    Contraindications:

    Hypersensitivity, dyspepsia of neurotic genesis, malignant diseases gastrointestinal tract, children under 18 years of age, simultaneous use with atazanavir.

    Carefully:Hepatic insufficiency, old age.
    Pregnancy and lactation:

    If it is necessary to use the drug during pregnancy, it is necessary to estimate the prospective benefit for the mother and the potential risk to the fetus.

    If it is necessary to use during lactation, the question of stopping breastfeeding should be addressed. In experimental studies it was established that pantoprazole excreted in breast milk.

    Dosing and Administration:

    Inside, not liquid, squeezed liquid. The drug is recommended to take 1 hour before breakfast. When applying the drug 2 times a day, the second dose is recommended apply for 1 hour before dinner.

    Stomach ulcer and duodenal ulcer, erosive gastritis. To 40-80 mg per day. The course of treatment - 2 weeks with exacerbation of duodenal ulcer and 4-8 weeks with peptic ulcer exacerbation.

    Eradication Helicobacter pylori.

    As a triple therapy, the following combinations are used:

    Pantoprazole 40 mg twice a day in combination with amoxicillin 1000 mg 2 times at day, and clarithromycin 500 mg twice a day for 7-14 days.

    Pantoprazole 40 mg twice a day in combination with metronidazole 500 mg twice a day day, and clarithromycin 500 mg twice daily for 7-14 days.

    Erosive-ulcerative lesions of the stomach and duodenum associated with the intake of NSAIDs.

    At 40-80 mg per day for 4-8 weeks.

    Reflux esophagitis.

    At 40 mg per day for 4-8 weeks.

    Zollinger-Ellison syndrome.

    By 40 mg 2 times a day. Duration of admission is determined by the doctor.

    In patients with severe impairment of liver function, the dose should be reduced to 40 mg once every 2 days.In this case it is necessary to control the biochemical parameters of the blood. If the content of liver enzymes increases, the drug should be discontinued.

    Elderly patients, as well as patients with impaired renal function, can not

    exceed the daily dose of 40 mg. An exception is the use in combination therapy for eradication Helicobacter pylori, when elderly patients, should apply 40 mg pantoprazole 2 times a day.
    Side effects:

    The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - more than 1/10; often more than 1/100, but less than 1/10; infrequently - more than 1/1000, but less than 1/100; rarely - more than 1/10000, but less than 1/1000; very rarely, less than 1/10000.

    From the hematopoietic and lymphatic system: very rarely - leukopenia, thrombocytopenia.

    From the immune system: very rarely - anaphylactic reactions, including anaphylactic shock.

    From the nervous system: often - headache; infrequently - dizziness; very rarely - depression, hallucinations, disorientation, confusion, especially in predisposed patients, weighting of these symptoms, if they are present earlier.

    From the sense organs: infrequently - impaired vision.

    From the gastrointestinal tract: often - pain in the upper abdomen, diarrhea, constipation, flatulence; infrequently - nausea / vomiting; rarely dry mouth.

    From the liver and bile ducts: very rarely - severe damage to the liver parenchyma, leading to jaundice with or without liver failure.

    From the skin and subcutaneous fat: infrequently - itching and skin rash; very rarely - hives, angioedema, severe skin reactions such as Stevens-Johnson syndrome, erythema multiforme, Lyell's syndrome, photosensitivity.

    From the musculoskeletal system: rarely - arthralgia; less than 1 / 10,000 - myalgia.

    From the urinary system: very rarely - interstitial nephritis.

    On the part of the body as a whole: very rarely - peripheral edema, fever.

    From the laboratory indicators: very rarely - an increase in the activity of "liver" enzymes (transaminase, gamma-glutamyltransferase), increasing the concentration of triglycerides.

    Overdose:

    Information on symptoms of an overdose of pantoprazole is absent. Doses in excess of 240 mg intravenously were administered within 2 minutes and were well tolerated.

    Treatment: symptomatic therapy.Hemodialysis is not effective.
    Interaction:The simultaneous use of pantoprazole may reduce the absorption of drugs whose bioavailability depends on the pH of the stomach environment (incl. ketoconazole). Pantoprazole, like other proton pump inhibitors, can reduce or increase the absorption of drugs whose bioavailability depends on the pH of the stomach (ketoconazole, itraconazole, atazanavir). There were no significant interactions between pantoprazole and other drugs, such as diazepam, diclofenac, digoxin, glibenclamide, nifedipine, carbamazepine, caffeine, phenytoin, naproxen, piroxicam, theophylline, metoprolol, ethanol, oral contraceptives. Nevertheless, since pantoprazole is metabolized with the participation of the enzymatic system of cytochrome P450, it is impossible to completely exclude the possibility of interaction with other drugs that are metabolized with the participation of these enzymes. There is no interaction of pantoprazole with concomitant antacids. With simultaneous application with warfarin, an international normalized relationship (INR) can be increased and monitoring of this indicator is necessary.
    Special instructions:It is necessary to regularly monitor the activity of liver enzymes in blood plasma when pantoprazole is prescribed to patients with severe hepatic insufficiency, especially with prolonged use. When the activity of "hepatic" transaminases increases in the blood, the drug treatment should be stopped. In patients who have an increased risk of developing complications from the gastrointestinal tract and long-term receiving NSAIDs, pantoprazole in a dose of 20 mg for the prevention of peptic ulcer of the stomach and duodenum, should be taken with caution. It is necessary to use caution pantoprazole in elderly patients (over 65 years old) who have a history of gastric ulcer or duodenal ulcer, as well as bleeding from the upper sections of the gastrointestinal tract. Before and after treatment, endoscopic control is necessary to exclude the possibility of having malignant diseases of the stomach or esophagus. treatment can mask symptomatology and make it difficult to properly diagnose. Reduction of the acidity of gastric juice by means of reducing the secretion of the glands of the stomach, including proton pump inhibitors, can promote the reproduction of the natural microflora of the gastrointestinal tract,which may slightly increase the risk of developing gastrointestinal infections caused by Salmonella and Campylobacter. Pantoprazole, like all medicines, blocking the production of hydrochloric acid in the glands of the stomach, can reduce the absorption of vitamin B12 due to hypo- and achlorhydria. This should be taken into account in long-term therapy in patients with low body weight or at an increased risk of reducing absorption of vitamin B12. Patients who have symptoms of the disease after 4 weeks of treatment or have long-term pantoprazole (more than 1 year), require an additional examination.
    Effect on the ability to drive transp. cf. and fur:Taking the drug in some cases can affect the ability to concentrate and the speed of psychomotor reactions, which can affect the ability to manage vehicles and mechanisms. Therefore, its use immediately before driving and working with mechanisms is not recommended.
    Form release / dosage:Tablets coated with enteric film coating 40 mg.
    Packaging:By 14.28 tablets in a polyethylene bottle with a screw cap providing control of the opening and containingsilica gel. A label is attached to the vial. 1 bottle is placed in a cardboard box together with instructions for use.
    Storage conditions:

    In a dry place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:2 years. Do not use after the time specified on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-000849
    Date of registration:11.10.2011
    The owner of the registration certificate:Sanovel Pharmaco-industrial trading companySanovel Pharmaco-industrial trading company Turkey
    Manufacturer: & nbsp
    Representation: & nbspSANOVEL branch of the company pharmaco-industrial trading companySANOVEL branch of the company pharmaco-industrial trading companyRussia
    Information update date: & nbsp23.08.2015
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