Active substanceLansoprazoleLansoprazole
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  • Dosage form: & nbspTOthe apsules.
    Composition:

    Pellets of lansoprazole - 0.37 g; in terms of 100% of the substance - 0.03 g.

    Description:

    Capsules of green color number 1. The contents of capsules are spherical microgranules of white or almost white color.

    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.03   Lansoprazole

    Pharmacodynamics:

    Antiulcer. Specific proton pump inhibitor (H + K + ATPase); metabolized in parietal cells of the stomach to active sulfonamide derivatives, which inactivate the sulfhydryl groups of H + K + ATPase. It blocks the final stage of synthesis of hydrochloric acid, reducing basal and stimulated secretion,irrespective of the nature of the stimulus. Deceleration of hydrochloric acid production at dose 30 mg - 80-97%. Does not affect motility of the gastrointestinal tract. Inhibitory effect increases in the first four days of admission. After stopping the intake, the acidity for 39 hours remains below 50% basal level, "ricochet" increase in secretion is not noted. Secretory activity is restored 3-4 days after the end of the drug. Have patients with Zollinger-Ellison syndrome are more effective.

    Pharmacokinetics:

    Absorption - high, bioavailability - 80% (eating reduces absorption and bioavailability by 50%, but the inhibitory effect on gastric secretion remains the same, regardless of food intake).

    The time of the maximum concentration (Cmax) after oral administration 30 mg - 1,5-2,2 h, CmOh - 0,75-1,15 mg / l. The connection with plasma proteins is 97.7-99.4%. It is actively metabolized by primary passage through the liver. The half-life is 1.3-1.7 hours. Excretion by the kidneys (in the form of metabolites) - 14-23% and through the intestines. With hepatic failure and in elderly patients excretion slows down.

    Indications:

    - Stomach ulcer and duodenal ulcer.

    - Reflux-esophagitis, erosive-ulcerative esophagitis.

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

    - Erosive-ulcerative lesions of the stomach and duodenum, associated with Helicobacter pylori (as part of complex therapy).

    - Zollinger-Ellison Syndrome.

    Contraindications:

    Hypersensitivity to the components of the drug, malignant neoplasms of the gastrointestinal tract, pregnancy (I trimester), lactation period, age to 18 years.

    Carefully:Hepatic and / or renal failure, pregnancy (II-III term), the elderly.
    Dosing and Administration:

    Inside. Capsules should be swallowed whole, not liquid.

    Peptic ulcer of duodenum in the phase of exacerbation - at 30 mg per day for 2-4 weeks (in resistant cases up to 60 mg per day).

    Stomach ulcer in the phase of exacerbation and erosive-ulcerative esophagitis - 30 to 60 mg per day for 4 to 8 weeks.

    Erosive-ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs - 30 mg per day for 4-8 weeks.

    Eradication Helicobacter pylori - 30 mg twice a day for 10-14 days in combination with antibacterial agents.

    Anti-relapse treatment of peptic ulcer of stomach and duodenum - 30 mg per day.

    Anti-relapse treatment of reflux esophagitis - 30 mg per day for a long time (up to 6 months).

    Zollinger-Ellison Syndrome - the dose is selected individually until the level of basal secretion is less than 10 mmol / h.

    Side effects:

    From the digestive system: increased or decreased appetite, nausea, abdominal pain; rarely diarrhea or constipation; in some cases - ulcerative colitis, candidiasis of the gastrointestinal tract, increased activity of "liver" enzymes, increased levels of bilirubin in the blood.

    From the nervous system: headache; rarely - malaise, dizziness, drowsiness, depression, anxiety.

    From the respiratory system: rarely - cough, pharyngitis, rhinitis, upper respiratory tract infection, flu-like syndrome.

    On the part of the organs of hematopoiesis: rarely - thrombocytopenia (from hemorrhagic manifestations); in some cases - anemia.

    Allergic reactions: skin rash; in some cases - photosensitivity, erythema multiforme.

    Other: rarely - myalgia, alopecia.
    Interaction:

    Slows down the elimination of drugs metabolized in the liver by microsomal oxidation (incl.diazepam, phenytoin, indirect anticoagulants).

    Reduces the clearance of theophylline by 10%.

    Changes pH-dependent absorption of drugs belonging to weak acid groups (deceleration) and bases (acceleration).

    Sucralfate reduces the bioavailability of lansoprazole by 30% (the interval between taking these drugs should be 30-40 minutes)

    Antacids slow down and reduce the absorption of lansoprazole (they should be prescribed for 1 hour or 1-2 hours after taking lansopazole).

    Special instructions:

    Before the beginning of treatment, it is necessary to exclude the presence of malignant process in the upper GI tract, because taking the drug can "mask" the symptoms and make diagnosis more difficult.

    Form release / dosage:Capsules, 30 mg.
    Packaging:

    For 7 or 10 capsules in a contour mesh package.

    For 2, 3 contour packs of 10 capsules or 1, 2, 4 contour packs of 7 capsules together with the instructions for use are placed in a pack.

    Storage conditions:

    In a dry place, protected from light and out of reach of children, at a temperature not exceeding 25 ° C.

    Shelf life:

    2 years.

    Do not use the product after the expiry date indicated on the package

    Terms of leave from pharmacies:On prescription
    Registration number:P N002932 / 01
    Date of registration:22.10.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia
    Information update date: & nbsp22.10.2016
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