Lanzabel - instructions for use, dose, side effects, contraindications

Composition:Per one capsule:
active substance: lansoprazole 30 mg;
Excipients: magnesium carbonate 22.5 mg, pellets - sugar grits [sucrose, molasses starch] 102.0 mg, mannitol 90.0 mg, sodium carboxymethyl starch 9.00 mg, povidone K 30 9.24 mg, sucrose 7.74 mg, poloxamer 9.39 mg, hypromellose 22.5 mg,
methacrylic acid and ethyl acrylate copolymer [1: 1] 45.0 mg, talc 23.07 mg, triethyl citrate 6.75 mg, emetic simethicone 0.2025 mg.
Hard gelatine capsules: Capsule casing - iron oxide dye red oxide 0.085%, titanium dioxide 2%, iron dye oxide yellow 0.755%, gelatin up to 100%; cap capsule - dye blue patented 0,026%, titanium dioxide 1,41%, iron oxide dye yellow 0.99%, gelatin up to 100%.

Description:Hard gelatin capsules No. 1, consisting of a light orange opaque body and a dark green opaque cap containing white or nearly white round micropellets.

Pharmacotherapeutic group:An agent that reduces the secretion of the glands of the stomach is a proton pump inhibitor.

ATX: & nbsp

A.02.B.C Proton pump inhibitors

A.02.B.C.03 Lansoprazole

Pharmacodynamics: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 extent of inhibition of basal and stimulated hydrochloric acid secretion are dose-dependent: the pH begins to grow after 1-2 hours and 2-3 hours after administration of 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 4 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 normalized 3-4 days after the end of the drug intake. In patients with Zollinger-Ellison syndrome, it is more prolonged. 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. Increases the concentration of pepsinogen in the blood serum and inhibits the production of pepsin. Oppression of secretion is accompanied by an increase in the number of nitro-zobacteria and an increase in the concentration of nitrates in the gastric secretion. Effective in the treatment of gastric ulcer and duodenal ulcer resistant to H2-histamine receptor blockers. 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).

Pharmacokinetics:Absorption of lansoprazole begins as soon as the drug leaves the stomach.The rate of absorption is high and the maximum plasma concentration in the plasma is achieved after 1.7 hours, which is combined with a high degree of bioavailability of more than 80%. With cirrhosis of the liver, absorption may be delayed.
Eating lowers absorption and bioavailability (by 50%), but the inhibitory effect on gastric secretion remains the same, regardless of food intake. Such indicators of pharmacokinetics of lansoprazole as the maximum concentration in plasma (C_max) and the area under the "concentration-time" curve in the plasma are approximately proportional. If the drug is taken 30 minutes after eating, both pharmacokinetic indicators are reduced by 50%. Food does not have any significant effect if the drug is taken before meals. The connection with plasma proteins is 97.7-99.4%, in patients with impaired renal function, binding can be reduced by 1-1.5%. Lansoprazole well penetrates into the tissue, incl. in the lining of the stomach. The volume of distribution is 0.5 l / kg.
Lansoprazole is metabolized in the liver. In significant amounts in the plasma, two metabolites (sulfinyl hydroxide and sulfone derivative) are found which are inactive. In the acidic environment of the tubules of parietal cells lansoprazole is transformed into 2 active substances, but not detectable in the systemic blood stream.
The beginning of the action. After the first dose of lansoprazole at a dose of 30 mg, the pH of the gastric juice increases after 1-2 hours. When taking the drug several times a day (30 mg each), the pH of the gastric juice is increased in the first hour after administration.
Duration of action. More than 24 hours. The half-life of lansoprazole is less than 2 hours, which does not affect the duration of suppression of gastric secretion.
Restoration of the level of secretion of hydrochloric acid to normal occurs gradually in the period from 2 to 4 days after taking several doses of the drug.
It is excreted from the body in the form of lansoprazole sulfone and hydroxylansoprazole with bile (2/3), kidneys -14-23% (renal failure for speed and clearance value does not significantly affect).

Indications:- Stomach ulcer and duodenal ulcer (in the phase of exacerbation);
- erosive-ulcerative esophagitis;
- reflux esophagitis;
- Zollinger-Ellison syndrome;
- erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori (as part of complex therapy);
- eradication of Helicobacter pylori;
- stress ulcers of the gastrointestinal tract;
- non-ulcer dyspepsia.

Contraindications:Hypersensitivity, pregnancy (I trimester), the period of breastfeeding, childhood, malignant neoplasms of the gastrointestinal tract, sugar / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Carefully:Hepatic insufficiency, pregnancy (II-III trimesters), advanced age.

Pregnancy and lactation:The drug is contraindicated in the first trimester of pregnancy. With caution appoint in the II-III trimester of pregnancy, comparing the potential benefit to the mother and the possible risk to the fetus.
If Lanzabel® is needed during breastfeeding, breastfeeding should be discontinued.

Dosing and Administration:Inside. Capsules swallow without chewing ..
With duodenal ulcer and stress ulcers - 30 mg / day for 1 reception, preferably in the morning, before eating for 24 weeks.
With gastric ulcer and erosive-ulcerative esophagitis - 30 mg / day for 4-8 weeks; if necessary, 60 mg / day.
With reflux esophagitis - 30 mg / day for 4 weeks.
With Zollinger-Ellison syndrome, the dose is selected individually, until basal acid production is less than 10 mmol / h.
For eradication of Helicobacter pylori - 30 mg twice a day, in combination with antibiotics (clarithromycin and amoxicillin), for at least 7 days.
Non-ulcer dyspepsia: 30 mg / day for 2-4 weeks.
With hepatic insufficiency and in elderly patients, treatment starts with half doses, gradually increasing them to the recommended ones, but not more than 30 mg / day.

Side effects:Classification of the frequency of side effects: very often - more than 1/10, often - more than 1/100 and less than 1/10, infrequently - more than 1/1000 and less than 1/100, rarely - more than 1/10000 and less than 1/1000, very rarely, including individual cases - less than 1/10000.
- From the digestive system: infrequent - increased or decreased appetite, nausea, abdominal pain; rarely diarrhea or constipation; very rarely - nonspecific ulcerative colitis, candidiasis of the gastrointestinal tract, increased activity of hepatic transaminases (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase), alkaline phosphatase and lactate dehydrogenase, hyperbilirubinemia.
- 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.
- From the hematopoiesis: rarely - thrombocytopenia (with hemorrhagic manifestations); very rarely anemia.
- Allergic reactions: infrequent 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%.
Slows the pH-dependent absorption of drugs belonging to the weak acid groups and accelerates the absorption of drugs belonging to the groups of bases. Prevents the absorption of ketoconazole, ampicillin, iron salts, digoxin.
Compatible with ibuprofen, indomethacin, diazepam, propranolol, warfarin, oral contraceptives, phenytoin, prednisolone.
Sucralfate reduces bioavailability by 30%, so it is necessary to observe the interval between taking medicines 30-40 minutes.
Antacids should be prescribed 1 hour before or 1 -2 hours after taking lansoprazole, as they slow down and reduce its absorption.

Special instructions:Before and after treatment, endoscopic control is necessary to exclude malignant neoplasm, as treatment can mask the symptoms and delay correct diagnosis.

Effect on the ability to drive transp. cf. and fur:Not observed.

Form release / dosage:Capsules intestine soluble in 30 mg.

Packaging:There are 14 enteric capsules in a blister made of polyvinylchloride / thermoelastic / polyvinyl dichloride film and aluminum foil.
For 1 or 2 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:In the dark place at a temperature below 30 ° C. Keep out of the reach of children.

Shelf life:3 years.
Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001884/10

Date of registration:12.03.2010 / 29.06.2010

Expiration Date:Unlimited

The owner of the registration certificate:Nobel Ilach Sanayi Ve Tidjaret A.Sh.Nobel Ilach Sanayi Ve Tidjaret A.Sh. Turkey

Manufacturer: & nbsp

NOBEL ILAC SANAYII VE TICARET, A.S. Turkey

Representation: & nbspNobel Ilach Sanayi Ve Tidjaret A.Sh.Nobel Ilach Sanayi Ve Tidjaret A.Sh.Russia

Information update date: & nbsp2016-11-02

Illustrated instructions

Instructions

Lansabel® (Lanzabel)