Lansoprazole Stada (Lansoprazol Stada)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceLansoprazoleLansoprazole
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    • Dosage form: & nbspTOthe apes are enteric-soluble.
    Composition:

    The composition of pellets per one capsule:

    active substance - lansoprazole 30 mg;

    Excipients: mannitol, magnesium carbonate, lactose, sucrose, potato starch, carmellose, povidone (k-30), hypromellose, methacrylic acid, polysorbate, sodium hydroxide, diethyl phthalate, ethanol, propylene glycol.

    Capsule composition: gelatin, water, carmine.

    Description:

    Hard gelatin capsules No. 1, capsule body and cap of red color.

    The contents of capsules are pellets of spherical shape, covered with an enteric-soluble shell of 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, regardless of the nature of the stimulus. The inhibition of production of hydrochloric acid at a dose of 30 mg - 80-97%. Does not affect the motility of the gastrointestinal tract (GIT). 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. In patients with Zollinger-Ellison syndrome, it is more prolonged.

    Pharmacokinetics:

    Absorption is high (eating intake reduces absorption and bioavailability, but the inhibitory effect on gastric secretion remains the same, regardless of food intake). Time of maximum concentration (FROMmOh) after oral administration 30 mg - 1,5-2,2 h, Cmax - 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. Half-life is 1.3-1.7 hours Excretion by the kidneys (in the form of metabolites) - 14-23% and through the intestine. 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 before reaching a level of basal secretion of 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 (with 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 (including 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 decrease the absorption of lansoprazole (they should be prescribed for 1 hour or 1-2 hours after taking lansoprazole).

    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:

    10 capsules in a contour cell (blister) or a cell-free (strip) package; 1, 2 or 3 contour packs together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    Store in a dry place, protected from light and out of reach of children, at a temperature not exceeding 25 FROM.

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001579
    Date of registration:01.11.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSCNizhny Novgorod Chemical and Pharmaceutical Plant, OJSC
    Manufacturer: & nbsp
    Representation: & nbspMAKIZ-PHARMA, LLCMAKIZ-PHARMA, LLCRussia
    Information update date: & nbsp20.10.2016
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