Лансобел®

General characteristics. Structure:

Active ingredient: 77,4 mg of a lansoprazol of micropellets that is equivalent to 30 mg of a lansoprazol.

Structure of the case of the capsule: titanium dioxide (Е 171), ferrous oxide red (Е 172), ferrous oxide yellow (Е 172), gelatin.

Capsule lid: titanium dioxide (Е 171), ferrous oxide yellow (Е 172), patent blue V (Е 131), gelatin.

Pharmacological properties:

Pharmacodynamics. Lansobel - anti-secretory drug, the replaced benzimidazole, specifically inhibits fermental system (N +-K+) ATP-ases on the secretory surface of covering cells of a stomach. Being inhibitor of the protonew pump, Lansobel® suppresses a final stage of secretion of hydrochloric acid. The developing dozozavisimy effect provides inhibition of basal and stimulated secretion. At treatment lansoprazoly the gipergastrinemiya coming to initial within 1-2 weeks after drug withdrawal is observed. After peroral purpose of a lansoprazol value рН a stomach between 3 and 4. ЛАНСОБЕЛ® considerably reduces development and volume of hydrochloric acid, stimulated both meal, and Pentagastrinum. Patients with the raised hypersecretion have acids, ЛАНСОБЕЛ® considerably reduces basal and stimulated Pentagastrinum secretion, slows down normal increase in volume of secretion of acidity and the production of acid induced by insulin.

Suppression of acidity can strengthen action of antimicrobic means at an eradikation of Helicobacter pylori (H. pylori).

Pharmacokinetics. Absorption of a lansoprazol happens in intestines. Лансобел® it is quickly soaked up and reaches average maximum concentration in plasma approximately in 1,7 hours, after intake, bioavailability higher than 80%. Peak plasma concentration and area under a curve of plasma concentration (AUC) of a lansoprazol is approximately proportional in doses from 15 mg to 60 mg after single oral administration. Лансобел® does not accumulate and its pharmacokinetics does not change at repeated use.

Time of semi-removal from a blood plasma makes 1,5 (±1.0) hours. The maximum concentration in plasma and area indicators under a curve "concentration - time" decreases to 50% if drug is accepted in 30 minutes after food unlike reception on an empty stomach. 97% of a lansoprazol contact proteins of plasma. Linkng with plasma proteins is invariable at concentration ranging from 0,05 to 5,0 mkg/ml., лансопразол it is extensively metabolized in a liver. In the measured quantities in plasma two metabolites were revealed (hydroxylated sulfinit also sulfonic derivatives of a lansoprazol). These metabolites have practically no anti-secretory activity. Lansoprazol is transformed to two active look which suppress acid secretion inhibiting (N + - K+) – ATP-ase in tubules of covering cells, but have no effect in a big circle of blood circulation. The elimination half-life of a lansoprazol makes about 2 hours and does not influence duration of suppression of hydrochloric acid in a stomach.

At elderly the clearance (clearing coefficient) of a lansoprazol with lengthening of an elimination half-life approximately decreases by 50% and 100%. The repeated single dose in days does not lead to cumulation at elderly people. Peak plasma concentration at elderly do not increase.

Indications to use:

- a peptic ulcer of a stomach and duodenum in an aggravation stage;

- gastroesophageal reflux disease (GERB);

- the gastropathies caused by non-steroidal anti-inflammatory drugs (NPVS - gastropathies) an eradikation of H. Pylori;

- Zollingera-Ellison's syndrome.

Route of administration and doses:

Inside. Capsules are swallowed, without chewing. Drug should be accepted before food.

Exacerbation of stomach ulcer and duodenum. The recommended peroral dose for adult 30 mg of drug (1 capsule) once a day to food within 4-8 weeks.

GERB. The recommended peroral dose for adult 30 mg of drug (1 capsule) once a day to food within 4 - 8 weeks. If necessary the course can be repeated.

NPVS-gastropathies. The recommended peroral dose for adult 30 mg of drug (1 capsule) once a day to food within 4-8 weeks.

Eradikation H. pylori. On 30 mg of drug (1 capsule) 2 times a day (in 12 hours) within 7-14 days.

Features of use:

At use of a combination therapy лансопразоламоксициллин кларитромицин and лансопразоламоксициллин no specific side reactions to this combination of drugs were observed.

Pseudomembranous colitis can be observed at use of a klaritromitsin and amoxicillin. Before an initiation of treatment any penicillin, it is necessary to conduct attentive survey of rather previous reactions of hypersensitivity to penicillin, cephalosporins and other allergens. Heavy anaphylactic reactions demand immediate and urgent use of adrenaline. It is also necessary to appoint oxygen, intravenously steroids and control of breath, including an intubation.

Side reactions of a vremenna also do not demand the treatment termination. At patients with a heavy renal failure, linkng with plasma proteins decreases by 1,0% - 1,5%.

At patients with different degrees of a liver failure the average plasma elimination half-life of medicine is extended from 1,5 to 3,2 - 7,2 o'clock. Increase in average AUC (the area under a concentration curve) to 500% was observed with steady constancy, at patients with the broken function of a liver in comparison with healthy faces. At patients with a serious illness of a liver it is necessary to consider reduction of a dosage.

In the presence of any alarming symptoms (for example, a considerable spontaneous degrowth of a body, frequent vomiting, a dysphagy, vomiting with impurity of blood or a melena), and also in the presence of stomach ulcer (or suspicion of stomach ulcer) it is necessary to exclude a possibility of a malignant new growth therefore in these cases before an initiation of treatment endoscopic control since treatment lansoprazoly can "disguise" symptomatology is obligatory and delay the correct diagnosis.

At use at advanced age correction of a dosage is not required.

Features of influence of medicine on ability to manage the vehicle or potentially dangerous mechanisms. Drug does not influence ability to manage the vehicle and work with potentially dangerous mechanisms.

Side effects:

- diarrhea;

- headache.

Not often:

- increase or loss of appetite, nausea, abdominal pains.

Seldom:

- feeling of an indisposition, dizziness, drowsiness, depression, alarm;

- lock;

- severe cough, pharyngitis, rhinitis, inflammation or upper respiratory tract infection;

- thrombocytopenia (with hemorrhagic manifestations).

 In some cases:

- nonspecific ulcer colitis, GIT candidiasis, increase in activity of liver enzymes (ALT, nuclear heating plant, ShchF, gamma глутамилтрансфераза, lactate dehydrogenase) and bilirubin;

- anemia;

- photosensitization, mnogoformny erythema, alopecia, skin rash;

Others:

- grippopodobny syndrome, mialgiya;

- alopecia.

Interaction with other medicines:

Лансобел® P450 cytochrome, especially through CYP3A and CYP2C19 isoenzymes is metabolized through fermental system.

Лансобел® has no considerable clinical interactions with other drugs which are metabolized by means of system P450 cytochrome, such as warfarin, antipyrine, indometacin, an ibuprofen, Phenytoinum, propranolol, Prednisonum, diazepam, кларитромицин or терфенадин.

At combined use of a lansoprazol with theophylline (CYP1A2, CYP3A), slight increase (10%) of clearance of theophylline was observed. At joint reception of these drugs it is necessary to modify a theophylline dose.

Лансобел® it is necessary to accept in 30 minutes prior to reception of a sukralfat.

Due to the suppression of secretion of hydrochloric acid bioavailability of drugs for which рН a stomach is important can be reduced (кетоканазол, ampicillin, iron salts, digoxin).

Contraindications:

- hypersensitivity to a lansoprazol or any of drug components;

- malignant new growths of digestive tract;

- heavy renal failure (clearance of creatinine <30 ml/min.);

- liver failure;

- children's and teenage age up to 18 years;

- pregnancy and period of a lactation.

Overdose:

Symptoms: are not described. The overdose case without side reactions is known.

Treatment: drug has no known antidote. In case of overdose it is necessary to carry out a symptomatic and maintenance therapy. The gastric lavage and use of absorbent carbon is effective. Drug is not removed from an organism by means of dialysis.

Storage conditions:

To store at a temperature not over 25 ºС, in the dry, protected from light place. To store in the place, unavailable to children! Period of storage 3 years. Not to apply after a period of validity.

Issue conditions:

According to the recipe

Packaging:

On 7 capsules place in a blister strip packaging from a film of polyvinyl chloride and printing aluminum foil.

On 2 or 4 planimetric packagings together with the instruction on a medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer.