Loenzar-sanovel (Loenzar-sanovel)

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: & nbspcapsules
    Composition:

    Each capsule contains:

    Dosage of 15 mg

    active substance: lansoprazole 15 mg;

    Excipients: magnesium carbonate 11.2 mg, sugar grits (sucrose, starch syrup) 55 mg, sucrose 29.9 mg, starch 18.2 mg, giprolose 21.3 mg;

    enteric coating composition: methacrylic acid and ethyl acrylate copolymer [1: 1] (Eudragit L-30 D-55) 22.3 mg, talc 7 mg, titanium dioxide 2.2 mg, macrogol 6000 2.2 mg, polysorbate 80 1 mg, silicon dioxide colloidal 0,3 mg; composition of the capsule shell: capsule body -indigocarmine 0.17%, titanium dioxide 1.32%, gelatin up to 100%; lid capsule - dye azorubin 0.0328%, dye sunset yellow 0.219%, titanium dioxide 2%, gelatin to 100%.

    Dosage of 30 mg

    active substance: lansoprazole 30 mg;

    Excipients: magnesium carbonate 22.4 mg, sugar grits (sucrose, starch syrup) 110 mg, sucrose 59.8 mg, starch 36.4 mg, giprolose 42.6 mg;

    enteric coating composition: methacrylic acid and ethyl acrylate copolymer [1: 1] (Eudragit L-30 D-55) 44.6 mg, talc 14 mg, titanium dioxide 4.4 mg, macrogol 6000 4.4 mg, polysorbate 80 2 mg, silicon dioxide colloid 0.6 mg; composition of the capsule shell: capsule body -titanium dioxide 2%, gelatin up to 100%; lid capsule - dye azorubin 0.06%, iron dye oxide yellow 0,8%, titanium dioxide 2,3333%, gelatin up to 100%.

    Description:

    Capsules 15 mg: Hard gelatin capsules consisting of a blue body and a lid of a dark orange color. Capsules contain pellets of white or almost white color, covered with enteric coating.

    Capsules 30 mg: Hard gelatin capsules, consisting of a white body and an orange lid. Capsules contain pellets of white or almost white color, covered with enteric coating.

    Pharmacotherapeutic group:Gastric secretion reducing agent - proton pump inhibitor
    ATX: & nbsp

    A.02.B.C   Proton pump inhibitors

    A.02.B.C.03   Lansoprazole

    Pharmacodynamics:

    Specific proton pump inhibitor (H+/TO+-ATPase); is metabolized in parietal cells of the stomach to active sulfonamide derivatives that inactivate the sulfhydryl groups of H+/TO+-AT Phases. It blocks the final stage of synthesis of hydrochloric acid, 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 and concentrates in them.

    The rate and degree of inhibition of basal and stimulated secretion of hydrochloric acid are dose-dependent; The pH begins to grow after 1-2 hours and 2-3 hours after taking 15 and 30 mg, respectively; inhibition of production of hydrochloric acid at a dose of 30 mg is 80-97%. Does not affect the 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.

    In patients with Zollinger-Ellison syndrome, it is more prolonged. Increases the concentration of pepsinogen in the blood serum and reduces the activity of pepsin.Reduces the blood flow in the antral part of the stomach, pylorus and bulb of the duodenum by an average of 17%, inhibits the motor-evacuation function of the stomach. Oppression of secretion is accompanied by an increase in the number of bacteria that restore nitrates, and an increase in the concentration of nitrites in the gastric secretion.

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

    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). The frequency of recurrence of peptic ulcers after treatment is 55-62%. With reflux esophagitis, complete cure of patients is noted at the end of week 8 (30 mg / day) in 88.7%.

    In the experiment with the administration of high doses lansoprazole causes hyperplasia of enterochromaffin-like (ECL) cells, increases the frequency of metaplasia of the epithelium of the gastric mucosa and the formation of adenoma in the interstitial tissue of the testes.

    Pharmacokinetics:

    Absorption is high, bioavailability is 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 of maximum concentration (TCmax) after oral administration of 30 mg - 1.7 hours, the maximum concentration (Cmax) - 0,75-1,15 mg / l. The maximum plasma concentrations and the area under the curve (AUC) are approximately proportional to the single dose taken. 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%. 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 period (T1 / 2) is about 1.3-1.7 hours, in elderly patients it is 1.9-2.9 hours, with a violation of liver function - 3.2-7.2 hours. It is excreted in the form of lansoprazolesulfone and hydroxylansoprazole with bile (2/3), kidneys -14-23% (renal failure for speed and clearance value does not significantly affect).

    Indications:

    - Treatment and prevention of exacerbations of peptic ulcer of the stomach and duodenum;

    - Treatment and prevention of erosive and ulcerative lesions of the stomach and duodenum associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAIDs-gastropathy);

    - Gastroesophageal reflux disease (GERD), including erosive-ulcerative reflux esophagitis and non-erosive forms of reflux disease (NERD);

    - Eradication of Helicobacter pylori (as part of combination therapy);

    - Zollinger-Ellison syndrome and other pathological conditions, accompanied by increased acid secretion in the stomach.

    Contraindications:Hypersensitivity to the components of the drug, pregnancy (I trimester), lactation period, children under 18 years of age (due to the lack of data on use in children), sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
    Carefully:Hepatic insufficiency, pregnancy (II-III trimesters), advanced age, diabetes, malignant neoplasms of the gastrointestinal tract.
    Pregnancy and lactation:

    The use of the drug in the first trimester of pregnancy is contraindicated. Use in the II and III trimesters is permissible only in cases where the expected benefit of using the drug for the mother justifies the possible risk to the fetus.

    If it is necessary to use the drug during lactation, breastfeeding should be stopped, since lansoprazole penetrates into breast milk.

    Dosing and Administration:

    Inside. Capsules should be swallowed whole, not liquid.

    Preferably with a single admission per day, the drug should be taken in the morning, before breakfast, but perhaps in the evening, before supper. If necessary, twice taken before breakfast and dinner. If you can not swallow the whole capsule, its contents can be mixed with a small amount of apple juice (about 1 full tablespoon) and immediately swallowed without chewing. You can also enter through the probe.

    The maximum daily dose - 60 mg, in the case of Zollinger-Ellison syndrome - may be higher.

    Peptic ulcer of the duodenum in the phase of exacerbation - 30 mg per day for 1 reception, for 2-4 weeks (in resistant cases, up to 60 mg per day);

    Stomach ulcer in the phase of exacerbation - 30 mg once a day for 4-8 weeks;

    Erosive-ulcerative lesions of the stomach and duodenum associated with the administration of NSAIDs (NSAIDs-gastropathy) - 30 mg per day for 4-8 weeks;

    GERD, including reflux esophagitis and NERB - 30 mg per day for 4-8 weeks. In cases of erosive esophagitis, if necessary, the duration of therapy can be doubled.

    Eradication Helicobacter pylori - 30 mg twice a day, in combination with antibiotics (clarithromycin and amoxicillin), for 7-14 days;

    Prevention of exacerbations of peptic ulcer of the stomach and duodenum - 15 mg per day. The efficacy and safety of 12-month therapy with lansoprazole has been proven.

    Preventive maintenance of relapses of erosive esophagitis - on 15 mg a day. The efficacy and safety of 12-month therapy with lansoprazole has been proven.

    Prevention of erosive and ulcerative lesions of the stomach and duodenum, as well as dyspeptic symptoms when taking NSAIDs - 30 mg per day.

    Zollinger-Ellison syndrome - the dose is selected individually before basal acid production is less than 10 mmol / h. The recommended starting dose is 60 mg once a day. If you need a daily dose of 120 mg, it is recommended to use in two divided doses. The duration of therapy is determined by the doctor.

    With liver failure and in elderly patients, treatment starts with half the doses, gradually increasing them to the recommended, but not more than 30 mg per day.

    Side effects:

    The following are adverse reactions that may be associated with taking the drug. The frequency is defined as "infrequently" (more than 1/1000 and less than 1/100) and "rarely" (more than 1/10000 and less than 1/1000).

    From the digestive system: often - constipation; infrequently - abdominal pain, nausea, diarrhea, dry mouth, dyspepsia, taste perversion, flatulence; rarely - jaundice, hepatitis; in some cases - ulcerative colitis, candidiasis of the gastrointestinal tract, increased activity of "hepatic" enzymes (alanine aminotransferase, aspartate aminotransferase, gamma-glutamintransferase, alkaline phosphatase and lactate dehydrogenase), hyperbilirubinemia ..

    From the central and peripheral nervous system: often - headache; infrequently - malaise, dizziness, agitation, fear, confusion, depression, drowsiness, anxiety.

    From the sense organs: often - pain in the eyes, impaired vision; in some cases - noise in the ears.

    From the skin and subcutaneous tissue: rarely - skin itching, purpura, petechiae and hair loss; in some cases - toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme.

    From the side of skeletal-muscular and connective tissues: rarely - pain in the joints, muscles and bones.

    From the genitourinary system: rarely - interstitial nephritis, renal insufficiency, creatininemia; in some cases - urogenital disorders, impotence, enlargement of the mammary glands or gynecomastia.

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

    On the part of the hematopoiesis system: rarely - leukopenia, thrombocytopenia (with hemorrhagic manifestations), eosinophilia, pancytopenia, agranulocytosis; in some cases - anemia.

    Allergic reactions: rarely - hives, angioedema, photosensitization, skin rash; in some cases - anaphylactic reactions, multiform exudative erythema.

    Metabolic and nutritional disorders: rarely - anorexia, increased appetite.

    Other: alopecia, weakness.

    Overdose:Loenzar-sanovel was not reported about cases of overdose. In case of taking high doses of the drug, observation and, if necessary, symptomatic therapy, in which the patient should be under medical supervision, is shown. Hemodialysis is ineffective.
    Interaction:

    Lansoprazole reduces the acidity of gastric juice, which can affect the absorption of certain drugs. For example, it decreases the bioavailability of ketoconazole, ampicillin esters and iron salts.

    The bioavailability of digoxin is increased by 10%, which is clinically insignificant for most patients.

    Slows down the elimination of drugs metabolized by microsomal enzymes of the liver (including diazepam, ibuprofen, indomethacin, clarithromycin, prednisolone, propranolol, terfenadine or warfarin, phenytoin).

    Reduces the clearance of theophylline by 10%. The effect is clinically insignificant.

    Changes the 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 1 hour before or 1-2 hours after taking lansoprazole).

    Special instructions:

    Before and after treatment, endoscopic control is necessary to exclude malignant neoplasm (especially with gastric ulcer), as treatment can mask symptoms and delay correct diagnosis.

    With caution, it is necessary to take Loenzar-sanovel in patients with severe liver disease and in the elderly. The maximum daily dose is 30 mg.

    Dose changes for patients with kidney disease are not required.

    Loenzar-sanovel contains sucrose, so the drug is not recommended for patients with hereditary intolerance to fructose, glucose malabsorption syndrome and / or galactose, or a deficiency of sucrose isomaltase.

    Indication for patients with diabetes mellitus

    The digestible carbohydrates contained in one capsule of 15 mg are less than 0.01 "bread unit" (XE).

    The digestible carbohydrates contained in one capsule of 30 mg are less than 0.02 "bread units" (XE).

    Effect on the ability to drive transp. cf. and fur:Taking the drug in some cases can affect the ability to concentrate and the speed of psychomotor reactions, which can affect the ability to manage vehicles and mechanisms. Therefore, its use immediately before driving and working with mechanisms is not recommended.
    Form release / dosage:Capsules 15 mg, 30 mg.
    Packaging:

    Capsules 15 mg: For 30 capsules in a polyethylene bottle with a screw cap providing control of the opening and containing silica gel. A label is attached to the vial. 1 bottle is placed in a cardboard box together with instructions for use.

    Capsules 30 mg: For 14, 28 capsules in a polyethylene bottle with a screw cap providing control of the opening and containing silica gel. A label is attached to the vial. 1 bottle is placed in a cardboard box together 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:3 years. Do not use after the expiry date shown on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-006002/10
    Date of registration:25.06.2010 / 18.10.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Sanovel Pharmaco-industrial trading companySanovel Pharmaco-industrial trading company Turkey
    Manufacturer: & nbsp
    Representation: & nbspSANOVEL branch of the company pharmaco-industrial trading companySANOVEL branch of the company pharmaco-industrial trading companyRussia
    Information update date: & nbsp20.03.2018
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