Lanpaz® (Lanzap)

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: & nbspenteric-coated capsules
    Composition:

    Each capsule contains:

    active substance: lansoprazole, 30 mg;

    Excipients: the contents of the granules: mannitol 155,705 mg, magnesium carbonate 21,126 mg, lactose 16,057 mg, carmellose calcium 10.564 mg, sucrose 61.267 mg, povidone 1,254 mg, methylparahydroxybenzoate sodium 0.023 mg, sodium propyl parahydroxybenzoate 0.002 mg; coating: Povidone 13.339 mg; enteric coating: hypromellose phthalate 36.612 mg, cetyl alcohol 4.063 mg, titanium dioxide 2.615 mg;

    The composition of the gelatin capsule number 1: propyl parahydroxybenzoate, methyl parahydroxybenzoate, sodium lauryl sulfate, water, titanium dioxide, gelatin.

    Description:Hard gelatin capsules of white or almost white with a cream color shade of the size of "No. 1" with "LANZAP" marking on the body and lid. The contents of the capsule are granules of white or almost white color.
    Pharmacotherapeutic group:Iron 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); is metabolized in parietal cells of the stomach to active sulfonamide derivatives that inactivate H + / K + -ATPase. It blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus. Possessing high lipophilicity, it easily penetrates into the parietal cells of the stomach, concentrates in them and has a cytoprotective effect, increasing oxygenation of the gastric mucosa and increasing the secretion of bicarbonate.

    The rate and degree of inhibition of basal and stimulated secretion of hydrochloric acid are dose-dependent. After taking 30 mg of lansoprazole, the pH begins to rise after 2-3 hours. The inhibition of production of hydrochloric acid at a dose of 30 mg is 80-97%. Inhibitory effect increases in the first 4 days of admission. After stopping the intake, the acidity for 39 hours remains below 50% basal level, the "ricochet" increase in secretion is not noted.Secretory activity is normalized 3-4 days after the end of the drug intake.

    In patients with Zollinger-Ellison syndrome lansoprazole lasts longer. Increases the concentration of pepsinogen in the blood serum and inhibits the production of pepsin.

    It promotes the formation in the gastric mucosa of specific IgA to Helicobacter pylori, suppressing their growth, increases the anti-Helicobacter pylori activity of other drugs.

    Reduces blood flow in the antrum of the stomach, pylorus and bulb of the duodenum, on average, by 17%, inhibits the motor-evacuation function of the stomach.

    Increases the concentration of gastrin in serum by 50-100% (the level of gastrin reaches the plateau after 2 months of treatment and returns to the initial values ​​after the end of the course of treatment).

    Effective in the treatment of peptic ulcer of the stomach and duodenal, resistant to blockers H2-gistaminovyh receptors. Provides faster healing of ulcerative defects in the duodenum (85% of duodenal ulcers heal after 4 weeks of treatment at a dose of 30 mg / day). With reflux esophagitis, complete cure of patients is noted at the end of 8 weeks of admission (30 mg / day) in 88.7%.

    Pharmacokinetics:

    Absorption - high, bioavailability - 80%; food intake reduces absorption and bioavailability (by 50%), but the inhibitory effect on gastric secretion remains the same regardless of food intake. The time to reach the maximum concentration (TCmax ) after oral administration of 30 mg of lansoprazole 1.5-2.2 hours, the maximum concentration (Cmax) - 0,75-1,15 mg / l. In the dose range of 15 to 60 mg, the linear-concentration pharmacokinetics are proportional to the dose, the parameters are constant and no cumulation occurs. The connection with plasma proteins is 97.7-99.4%. It penetrates well into the tissues, including the lining of the stomach. The volume of distribution is -0.5 l / kg.

    It is actively metabolized at the "first passage" through the liver with the participation of the CYP2C19 isoenzyme with the formation of sulphinyl, sulphone and hydroxy derivatives. It is an inhibitor of CYP2C19. The half-life (T1/2) - about 1,5 h, in elderly patients - 1,9-2,9 h, with a violation of the liver - 3,2-7,2 h.

    It is excreted from the body in the form of lansoprazole sulfone and hydroxylansoprazole with bile (about 30%), kidneys - 14-23% (renal failure for speed and clearance value does not significantly affect).

    Indications:

    - Stomach ulcer and duodenal ulcer.

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

    - Reflux-esophagitis, erosive-ulcerative esophagitis.

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

    - Non-ulcer dyspepsia.

    - Zollinger-Ellison Syndrome.

    Contraindications:Hypersensitivity to the components of the drug, pregnancy (I trimester), lactation period, malignant neoplasms of the gastrointestinal tract.
    Carefully:Hepatic insufficiency, pregnancy (II-III trimesters), advanced age, age 18 years.
    Pregnancy and lactation:

    Inside. Capsules swallowed whole, not liquid.

    With peptic ulcer of stomach and duodenum and stress ulcers - 30 mg / day for 1 reception, in the morning, for 2-4 weeks. (in resistant cases - up to 60 mg per day).

    To eradicate Helicobacter pylori - 30 mg twice a day, in combination with antibiotics, for 10-14 days.

    With erosive-ulcerative esophagitis - 30 mg / day 2 times a day for 4-8 weeks. (in resistant cases - up to 60 mg per day).

    With Zollinger-Ellison syndrome, the dose is selected individually, until basal acid production is less than 10 mmol / h.

    Non-ulcer dyspepsia - 30 mg / day for 2-4 weeks.

    With hepatic insufficiency and in elderly patients, treatment starts with a dose of 30 mg / day.

    Dosing and Administration:

    Classification of the incidence of side effects: very frequent - 1/10, frequent -1/100, not frequent - 1/1000, rare - 1/10000, very rare - 1/100000 prescriptions.

    From the digestive system: not often - increased or decreased appetite, nausea, abdominal pain; rarely diarrhea or constipation; very rarely-ulcerative colitis, candidiasis of the gastrointestinal tract, increased activity of "liver" transaminases (ALT, ACT, GGT, APF and LDH), hyperbilirubinemia.

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

    From the hematopoiesis: rarely - thrombocytopenia (with hemorrhagic manifestations); very rarely anemia.

    From the nervous system: not often - headache; rarely - malaise, dizziness, drowsiness, depression, anxiety.

    Allergic reactions: rarely - skin rash; very rarely - photosensitization, multiforme exudative erythema.

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

    Compatible with ibuprofen, indomethacin, diazepam, propranolol, warfarin, oral contraceptives, phenytoin, prednisolone.

    Sucralfate reduces the bioavailability of lansoprazole by 30% (the interval between taking these medicines is 30-40 minutes).

    Antacids slow down and decrease the absorption of lansoprazole (they should be prescribed 1 hour before or 1-2 hours after lansoprazole administration).

    Special instructions:Before and after treatment, endoscopic control is necessary to exclude malignant neoplasm, as treatment can mask the symptoms and delay correct diagnosis.
    Form release / dosage:Capsules, enteric, soluble 30 mg.
    Packaging:For 10 capsules in PVC / PVDC / aluminum blister. 2 blisters per pack of cardboard along with instructions for use.
    Storage conditions:

    In a dry, protected from light 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 expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014769 / 01
    Date of registration:04.05.2008 / 28.02.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspDr. Reddy`c Laboratoris Ltd.Dr. Reddy`c Laboratoris Ltd.
    Information update date: & nbsp14.02.2018
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