Active substancePantoprazolePantoprazole
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  • Dosage form: & nbspenteric coated tablets
    Composition:

    Each tablet, coated with an enteric coating, contains:

    Active substance - Pantoprazole (in the form of pantoprazole sodium sesquihydrate) - 20 mg and 40 mg.

    Excipients: calcium stearate, povidone, crospovidone, sodium carbonate, mannitol, Opadri dye OY-B-28920 white (polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum), dye Sureretik Y-AE-6- 18107 white (polyvinyl acetate phthalate / titanium dioxide, talc, macrogol (polyethylene glycol 4000), sodium hydrogen carbonate, triethyl citrate, stearic acid purified, silicon dioxide colloid); dimethicone.

    Description:

    Tablets of 20 mg and 40 mg:

    Round biconvex tablets from white to almost white, covered with enteric coating.

    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:

    The proton pump inhibitor (selectively inhibits H+-TO+-ATPase). Dose-dependent blocks the final stage of the secretion of hydrochloric acid, reducing basal and stimulated secretion, regardless of the nature of the stimulus. With duodenal ulcer associated with Helicobacter pylori, due to the decrease in gastric secretion, the action of antibiotics, whose activity depends on pH values, is enhanced. Does not affect the motility of the gastrointestinal tract. Secretory activity is normalized 3-4 days after the end of admission.

    Pantoprazole is unstable in an acidic environment, to improve bioavailability is used in the form of tablets with an enteric coating.

    Pharmacokinetics:Quickly and completely absorbed after ingestion. Absolute bioavailability of pantoprazole is 77%, binding to plasma proteins reaches 98%, T1/2 - 1 hour Metabolized in the liver with the participation of the P450 system.

    The half-life of pantoprazole does not correlate with the duration of its inhibitory effect on NS secretionlBecause it accumulates in parietal cells. Pantoprazole does not accumulate in the body, is excreted as metabolites, mainly by the kidneys (80%) and with feces (20%). The main metabolite is demethylpentoprazole sulfate, the half-life of which is 1.5 h.

    Indications:

    - Stomach ulcer and duodenal ulcer in the phase of exacerbation;

    - Erosive gastritis;

    - Erosive-ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs);

    - Zolinger-Ellison syndrome;

    - Gastroesophageal reflux disease (reflux-esophagitis);

    - In the complex anti-Helicobacter therapy, gastric ulcers and duodenal ulcers.

    Contraindications:

    Hypersensitivity, dyspepsia of neurotic genesis, malignant diseases of the gastrointestinal tract.

    The efficacy and safety of the drug in children has not been established.

    Carefully:

    Pregnancy, lactation, liver failure (with increasing levels of liver enzymes should stop using the drug).

    Dosing and Administration:

    Inside, not liquid, squeezed liquid, preferably in the morning before or during breakfast. When applying Pepazol twice a day, the second dose is recommended to be applied 1 hour before dinner.

    The dose should be recommended by the doctor according to the patient's condition.

    With peptic ulcer of the stomach and duodenum, erosive gastritis - 40-80 mg / day. The course of treatment - 2 weeks with exacerbation of duodenal ulcer and 4-8 weeks with peptic ulcer exacerbation.

    Erosive-ulcerative lesions of the stomach and duodenum associated with the intake of NSAIDs - 40-80 mg per day. The course of treatment is 4-8 weeks.

    Reflux-esophagitis - for mild forms of gastroesophageal disease (heartburn, acidic eructation) take 20 mg / day, in the morning before breakfast,if necessary, the dose can be increased to 40 mg / day in a single dose. The course of treatment is 2 weeks, in individual cases it can be extended up to 4-8 weeks.

    With medium and severe forms of reflux esophagitis - 40-80 mg per day, the course of treatment - 4-8 weeks.

    As part of combined eradication anti-Helicobacter therapy in patients with peptic ulcer of the stomach or duodenum - 40 mg 2 once a day (before breakfast and before dinner), the duration of the course is 7-14 days (depending on the treatment regimen used).

    With liver failure - 40 mg once every 2 days under the control of the level of liver enzymes.

    Elderly patients, as well as patients with impaired renal function, can not exceed a daily dose of 40 mg. An exception is the use of Pepazol in combination antimicrobial therapy in relation to Helicobacter pylori, when elderly patients should take 40 mg pantoprazole 2 times a day.

    Experience with prolonged use of pantoprazole is not available, the duration of the drug should not exceed 8 weeks.

    Side effects:

    In usual dosages pantoprazole usually well tolerated.

    Rarely occur: headache, dizziness, nausea,swelling and abdominal pain, diarrhea, painful tension of the mammary glands, hyperthermia; allergic reactions (skin rash, skin hyperemia, anaphylactic reactions, including anaphylactic shock); very rarely - fever, depression, impaired vision.

    Overdose:

    Symptoms are not described.

    Interaction:

    Pantoprazole is metabolized with the participation of the enzymatic system of cytochrome P450 However, no clinically significant interaction with drugs metabolized by the same systemdiazepam, warfarin, theophylline, digoxin, phenytoin, carbamazepine, diclofenac, glibenclamide, nifedipine, metoprolol). Pantoprazole can affect the effectiveness of drugs, absorption of which depends on the pH (in particular, it is necessary to monitor the concentration of ketoconazole).

    Interactions with antacids have not been identified.

    Special instructions:

    Before and after treatment, endoscopic control is necessary to exclude malignant neoplasms of the stomach and esophagus, since symptomatic improvement with taking the drug may delay correct diagnosis and treatment.

    Form release / dosage:Intestine-soluble film coated tablets, 20 mg and 40 mg
    Packaging:For 15 tablets in a blister of aluminum foil, 1 or 2 blisters are packed in a cardboard box with instructions for use.
    Storage conditions:

    List B. In dry sheltered from light and inaccessible to children at a temperature of no higher than 25 ° C.

    Shelf life:

    2 years. Do not use after the expiration date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002131/08
    Date of registration:27.03.2008
    The owner of the registration certificate:Kimika Montpellier, SA, Bago Group CompanyKimika Montpellier, SA, Bago Group Company Argentina
    Manufacturer: & nbsp
    Representation: & nbspBBC FARMA BV BBC FARMA BV Netherlands
    Information update date: & nbsp08.09.2015
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