Active substancePantoprazolePantoprazole
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  • Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration
    Composition:

    Composition of lyophilizate:

    One bottle contains:

    Active substance: Sodium pantoprazole sesquihydrate 45.1 mg (equivalent to pantoprazole) 40.0 mg

    Solvent composition:

    In 1 ml of solution contains:

    Sodium chloride 9.00 mg

    Water for injection - up to 1 ml

    Description:

    Description of lyophilizate: White or almost white lyophilizate.

    Description of solvent: Clear colorless solution

    Pharmacotherapeutic group:glands of the stomach secretion-lowering agent - proton pump inhibitor
    ATX: & nbsp

    A.02.B.C   Proton pump inhibitors

    A.02.B.C.02   Pantoprazole

    Pharmacodynamics:

    Proton pump inhibitor (H + K + ATPase). It blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus. With IV administration, 80 mg antisecretory effect reaches a maximum within 1 hour and lasts 24 hours. With duodenal ulcer associated with Helicobacter pylori, decrease in gastric secretion increases the sensitivity of the microorganism to antibiotics. Does not affect the motility of the gastrointestinal tract. Secretory activity is restored 3-4 days after the end of admission.

    Pharmacokinetics:

    In the dose range of 10 to 80 mg, the pharmacokinetic parameters of pantoprazole have a linear relationship after intravenous administration. The drug is not cumulated. Values ​​of pharmacokinetic parameters of pantoprazole for multiple and single administrations are comparable.

    Distribution

    The volume of distribution is 0.15 l / kg.Basically, the drug is distributed in the extracellular fluid. Binding to plasma proteins is 98%.

    Metabolism

    Intensively metabolized in the liver, mainly with the participation of the enzyme system CYP2C19. The main metabolite in blood plasma and urine is desmethylpentoprazole, conjugated with sulfate.

    Excretion

    Half-life after intravenous administration is an average of 1 hour. Most of the drug is excreted by the kidneys in the form of inactive metabolites. In small quantities is excreted through the intestine.

    Pharmacokinetics in special clinical cases

    In patients with renal insufficiency, the pharmacokinetics do not change significantly.

    When liver failure duration half-life period is increased to 7 - 9 hours area under the curve values. "Concentration - time" in the above 5-7 times, and the maximum concentration is 1.5 times higher in patients with liver failure compared to volunteers.

    Indications:

    - Peptic ulcer and duodenum 12 (exacerbation), erosive gastritis (including related nonsteroidal anti-inflammatory drugs (NSAIDs)..;

    - gastroesophageal reflux disease (GERD): erosive reflux-esophagitis (treatment), symptomatic treatment of GERD (ie NERB - non-erosive reflux disease);

    - Zollinger-Ellison syndrome;

    - eradication Helicobacter pylori in combination with antibacterial agents.

    - Treatment and prevention of stress ulcers, as well as their complications (bleeding, perforation, penetration).

    Contraindications:

    Hypersensitivity, dyspepsia of neurotic genesis, lactation period, children's age till 18 years.

    Carefully:Pregnancy; liver failure.
    Pregnancy and lactation:During pregnancy and breastfeeding: experience in the use of the drug in this period is limited. In studies of reproductive function in animals, little embryotoxicity was noted in doses exceeding 5 mg / kg. The drug may be used only if the benefit to the mother from the application exceeds the possible risk to the fetus. There are no data on the release of pantoprazole with breast milk. You should stop breastfeeding while taking the drug.
    Dosing and Administration:

    This dosage form of Sunprase is indicated only for intravenous administration.The drug is recommended only in cases where oral administration of pantoprazole is not indicated. As soon as oral therapy becomes available, intravenous administration should be discontinued.

    The recommended dose for intravenous administration is the administration of the contents of one vial (40 mg pantoprazole) once a day. Data on intravenous administration can be used for 7-10 days, prolongation of the course of treatment depends on the clinical need.

    With prolonged treatment of Zollinger-Ellison syndrome and other pathological hypersecretory states, the recommended daily dose at the beginning of treatment is 80 mg of Sanpras. After this dose may be increased or decreased. If the drug is used in a daily dose of more than 80 mg, the dose should be divided and administered twice a day. Perhaps a temporary increase in the daily dose to 160 mg of Sanpras.

    With eradication Helicobacter pylori in combination with antibacterial agents, the recommended daily dose is 80 mg of Sanprasse for 7-10 days, the dose should be divided and administered twice a day.

    Patients with impaired hepatic function: with severe violations of liver function, the daily dose should be reduced to 20 mg of pantoprazole. In addition, during treatment with the drug, such patients need regular monitoring of the activity of liver enzymes. In the case of increased activity of hepatic enzymes, treatment should be discontinued.

    To elderly patients: there is no need to increase the daily dose of pantoprazole 40 mg, as well as to patients with impaired renal function (including patients on hemodialysis).

    During pregnancy and breastfeeding: experience in the use of the drug in this period is limited. In studies of reproductive function in animals, little embryotoxicity was noted in doses exceeding 5 mg / kg. The drug may be used only if the benefit to the mother from the application exceeds the possible risk to the fetus. There are no data on the release of pantoprazole with breast milk. You should stop breastfeeding while taking the drug.

    Childhood. There is insufficient data on the use of the drug in children under 18 years of age.

    Before the injection, the contents of the vial must be reconstituted with 10 ml of 0.9% sodium chloride solution.

    This solution is injected or infused after mixing with 100 ml of 0.9% sodium chloride solution, 5% glucose solution or 10% glucose solution. The pH of the ready-to-use solution should be within 9-10. The duration of administration should be 2-15 minutes. The prepared solution should be used within 3 hours after preparation.

    Side effects:

    When taking Sanpras according to the indications and in recommended doses, side effects occur extremely rarely.

    Appointment of pantoprazole can be accompanied by the following side effects: headache, pain in the upper abdomen, diarrhea, constipation, flatulence, rarely - nausea / vomiting.

    Rarely: dry mouth; arthralgia; depression, hallucinations (especially in predisposed patients), disorientation and confusion.

    Rarely: leukopenia, thrombocytopenia; peripheral edema; hepatocellular insufficiency, leading to jaundice with or without hepatic insufficiency; anaphylactic reactions, including anaphylactic shock; increased activity of liver enzymes (transaminase, glutamyltranspeptidase); increased triglycerides; interstitial nephritis; hives,angioedema; allergic reactions such as pruritus and skin rash, severe skin reactions (Stevens-Johnson syndrome, polymorphic erythema, photosensitivity Lyell's syndrome); local reactions (phlebitis, thrombophlebitis).,

    In isolated cases reported dizziness or visual impairment, peripheral edema, increased body temperature, myalgia.

    Overdose:

    Symptoms of an overdose in humans are not known. Doses up to 240 mg with iv introduction were well tolerated.

    In case of an overdose with signs of intoxication, general disintoxication measures, symptomatic therapy, hemodialysis are used.

    Interaction:

    Simultaneous application of Sanprasse can reduce the absorption of drugs, the bioavailability of which depends on the pH of the stomach (eg, ketoconazole, iron salts, ritonavir). With the joint application of Sanpraz with atazanavir, plasma concentrations of atazanavir decrease and its therapeutic effect decreases.

    When carrying out specific tests of SanPraz with such drugs as digoxin, nifedipine, metoprolol, amoxicillin, clarithromycin, oral contraceptives (levonorgestrel / ethinyl estradiol), diclofenac, phenazone, naproxen, piroxicam, glibenclamide, levothyroxine sodium, diazepam, carbamazepine, phenytoin, ciclosporin, tacrolimus, cisapride, midazolam, metronidazole, theophylline, caffeine, ethanol no clinically significant interaction was found.

    According to post-marketing data, when taking a drug with warfarin, prothrombin time increases, which can lead to bleeding, up to a lethal outcome. It is recommended to determine prothrombin time.

    Special instructions:

    The use of pantopresa with dyspepsia of neurogenic genesis is not effective.

    In the presence of any of the anxiety symptoms (for example, significant unintended weight loss, recurrent vomiting, dysphagia, anemia or melena) and in case of suspected or having a stomach ulcer, the possibility of malignant growth should be excluded, since treatment with pantoprazole may reduce symptoms and delay the correct diagnosis. If the symptoms persist despite adequate treatment, further examination should be carried out.

    Before and after treatment, endoscopic control is mandatory to exclude the possibility of having malignant diseases of the stomach or esophagus,treatment can mask the symptoms and delay correct diagnosis.

    Effect on the ability to drive transp. cf. and fur:Does not affect.
    Form release / dosage:

    Lyophilizate for the preparation of a solution for intravenous administration of 40 mg complete with a solvent - sodium chloride solution 0,9%.

    Packaging:

    40 mg of pantoprazole lyophilizate in a 10 ml vials of colorless glass sealed with a gray bromobutyl rubber stopper, with an aluminum cap and a red plastic cover, and 10 ml of solvent in a 10 ml plastic vial together with the instructions for use are placed in cardboard dacha.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    For lyophilizate - 2 years.

    For solvent - 3 years.

    The expiration date on the cardboard bundle is indicated by the least expiration date, i.e. by lyophilizate.

    Do not use, after the expiration date stated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-010916/09
    Date of registration:31.12.2009
    The owner of the registration certificate:San Pharmaceutical Industries Co., Ltd.San Pharmaceutical Industries Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSAN PHARMACEUTICAL INDUSTRIES LTD. SAN PHARMACEUTICAL INDUSTRIES LTD. India
    Information update date: & nbsp29.08.2015
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