Lancid capsule 30mg, No. 30

• peptic ulcer and 12 duodenal ulcer (in the acute phase);

• erosive and ulcerative esophagitis;

• reflux esophagitis;

• Zollinger-Ellison syndrome;

• stress ulcers of the gastrointestinal tract;

• non-ulcer dyspepsia.

Inside. The capsules are swallowed without chewing.

For duodenal ulcer and stress ulcers - 30 mg / day per 1 dose, preferably in the morning, before meals for 2-4 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.

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

For the eradication of Helicobacter pylori - 30 mg 2 times a day, in combination with antibiotics (clarithromycin and amoxicillin), for at least 7 days.

Non-ulcer dyspepsia: 15-30 mg / day for 2-4 weeks.

In hepatic insufficiency and in elderly patients, treatment begins with half doses, gradually increasing them to the recommended ones, but not more than 30 mg / day.

The composition of the capsule containing lansoprazole - 30 mg (body): Gelatin - 38.9575 mg, sodium lauryl sulfate - 0.0376 mg, propyl parahydroxybenzoate - 0.37 (30 mg.methyl parahydroxybenzoate - 0.0940 mg, titanium dioxide - 0.7120 mg , crimson dye [Ponso 4R] - 0.0078 mg, water - 6.8150 mg.

Composition of a capsule containing lansoprazole - 30 mg (cap): Gelatin - 24.0376 mg. sodium lauryl sulfate - 0.0232 mg, propyl parahydroxybenzoate - 0.0580 mg, methyl parahydroxybenzoate - 0.2320 mg, titanium dioxide - 0.4393 mg, crimson dye [Ponso 4R] - 0.0048 mg. water - 4.2050 mg.

Composition of black ink: ethanol - 29-33%, isopropanol - 9-12%, butanol - 4-7%, shellac - 24-28%, iron oxide black dye - 24-28%. aqueous ammonia - 1-3%, propylene glycol 0.5-2%.

• Hypersensitivity

• pregnancy (I trimester),

• lactation period;

• malignant neoplasms of the gastrointestinal tract.

With care: Liver failure, pregnancy (II-III trimesters), advanced age, age up to 18 years.

Trade name: Lancid

International non-proprietary name: lansoprazole

Chemical rational name: 2 - [[[3-methyl-4-2- (2,2,2-trifluoroethoxy) -2-pyridyl] methyl] sulfinyl] benzimidazole.

Active substance: lansoprazole

Dosage form: Enteric capsules.

Composition:

1 capsule contains:

Active ingredient: Lansoprazole - 15 mg or 30 mg.

Auxiliary components for capsules containing 15 mg of lapsonrazole: Mannitol - 22.72 mg, sucrose - 68.69 mg, povidone - 0.61 mg, sucrose microspheres 21.7l mg, sodium hydrogen phosphate - 1.15 mg, calcium carmellose - 5.75 mg, magnesium hydroxycarbonate 2.93 mg, polysorbate 80 - 0.55 mg, hypromellose - 14.13 mg, titanium dioxide - 2.02 mg, methyl acrylic acid copolymer (type A) - 36.34 mg, talc - 4.85 mg, diethyl phthalate 4.48, sodium hydroxide 0.24 mg.

The composition of the capsule containing lansoprazole - 15 mg (body): Gelatin - 24.7626 mg. sodium lauryl sulfate - 0.0240 mg. propyl parahydroxybenzoate - 0.2400 mg, methyl parahydroxybenzoate - 0.0600 mg, titanium dioxide - 0.5557 mg, brilliant blue dye - 0.0034 mg, quinoline yellow dye - 0.0042 mg, water 4.3500 mg.

The composition of the capsule containing lansoprazole - 15 mg (cap): Gelatin - 16.5084 mg, sodium lauryl sulfate - 0.0160 mg, propyl parahydroxybenzoate - 0.0400 mg, methyl parahydroxybenzoate - 0.1600 mg, titanium dioxide - 0.3705 mg. brilliant blue dye - 0.0022 mg, quinoline yellow dye - 0.0028 mg, iodine - 2.900 mg.

Auxiliary components for capsules containing lansoprazole - 30 mg: Mannitol - 41.11 mg. sucrose - 123.22 mg, povidone -1.09 mg, sucrose microspheres 38.19 mg, sodium hydrogen phosphate - 2.08 mg, calcium carmellose - 10.41 mg, magnesium hydroxycarbonate - 5.30 mg, polysorbate 80 - 0 , 99 mg. hypromellose -25.58 mg, titanium dioxide -2.19 mg, methylcrylic acid copolymer (type A) - 65.78 mg, talc - 8.77 mg. diethyl phthalate - 8.11 mg, sodium hydroxide - 0.44 mg.

The composition of the capsule containing lansoprazole - 30 mg (body): Gelatin - 38.9575 mg, sodium lauryl sulfate - 0.0376 mg, propyl parahydroxybenzoate - 0.37 (30 mg.methyl parahydroxybenzoate - 0.0940 mg, titanium dioxide - 0.7120 mg , crimson dye [Ponso 4R] - 0.0078 mg, water - 6.8150 mg.

Composition of a capsule containing lansoprazole - 30 mg (cap): Gelatin - 24.0376 mg. sodium lauryl sulfate - 0.0232 mg, propyl parahydroxybenzoate - 0.0580 mg, methyl parahydroxybenzoate - 0.2320 mg, titanium dioxide - 0.4393 mg, crimson dye [Ponso 4R] - 0.0048 mg. water - 4.2050 mg.

Composition of black ink: ethanol - 29-33%, isopropanol - 9-12%, butanol - 4-7%, shellac - 24-28%, iron oxide black dye - 24-28%. aqueous ammonia - 1-3%, propylene glycol 0.5-2%.

Description:

Capsules containing 15 mg of lansoprazole: hard gelatin capsules No. 3 with a turquoise (bluish-green) body and cap and black MICRO / MICRO inscription.

Capsules containing lansoprazole 30 mg: hard gelatin capsules No. 1 with a pink body and cap and a black inscription MICRO / MICRO.

The contents of the capsules are granules (pellets) of white or almost white color.

Pharmacotherapeutic group : An agent that lowers the secretion of gastric glands - a proton pump inhibitor.

ATC:
A.02.BC Proton pump inhibitors
A.02.BC03 Lansoprazole

Pharmacodynamics:

Specific proton pump inhibitor (H + / K + ATPase); metabolized in parietal cells of the stomach to active sulfonamide derivatives that inactivate H + / K + ATP-ase. 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 the 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: pH begins to rise in 1-2 hours and 2-3 hours after taking 15 and 30 mg, respectively; inhibition of hydrochloric acid production at a dose of 30 mg is 80-97%.Does not affect the motility of the gastrointestinal tract. The inhibitory effect increases in the first 4 days of administration. After stopping the intake, the acidity remains below 50% of the basal level for 39 hours, there is no 'rebound' increase in secretion. Secretory activity is normalized 3-4 days after the end of the drug intake. In patients with Zollinger-Ellison syndrome, the effect is longer. Promotes the formation of specific IgA to Helicobacter pylori in the gastric mucosa, suppressing their growth, increases the anti-Helicobacter activity of other drugs. Increases the concentration of pepsinogen in the blood serum and inhibits the production of pepsin. The suppression of secretion is accompanied by an increase in the number of nitrosobacteria and an increase in the concentration of nitrates in gastric secretions.It is 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:

The absorption of lansoprazole begins as soon as the drug leaves the stomach. The absorption rate is high and the maximum concentration of the drug in the plasma is reached 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.

Food intake reduces absorption and bioavailability (by 50%), but the inhibitory effect on gastric secretion remains the same, regardless of food intake. Such indicators of the pharmacokinetics of lansoprazole such as the maximum plasma concentration (Cmax) and the area under the plasma concentration-time curve are approximately proportional. If the drug is taken 30 minutes after a meal, both pharmacokinetic parameters are reduced by 50%. Food does not have any pronounced 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 penetrates well into tissues, incl. into the lining cells of the stomach. The volume of distribution is 0.5 l / kg.

Lansoprazole is metabolized in the liver. Two metabolites (sulfinyl hydroxylate and sulfone derivative), which are inactive, are found in significant amounts in plasma. In the acidic environment of the parietal cell tubules, lansoprazole is transformed into 2 active substances, but not detected in the systemic circulation.

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), there is an increase in the pH of gastric juice in the first hour after ingestion.

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. No risk of gastric acidity was noted after discontinuation of lansoprazole. The 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 does not significantly affect the rate and amount of excretion).

Indications:

• peptic ulcer and 12 duodenal ulcer (in the acute phase);

• erosive and ulcerative esophagitis;

• reflux esophagitis;

• Zollinger-Ellison syndrome;

• stress ulcers of the gastrointestinal tract;

• non-ulcer dyspepsia.

Contraindications:

• Hypersensitivity

• pregnancy (I trimester),

• lactation period;

• malignant neoplasms of the gastrointestinal tract.

With care: Liver failure, pregnancy (II-III trimesters), advanced age, age up to 18 years.

Pregnancy and lactation:

Group B. Adequate and well-controlled studies on pregnant women have not been conducted.
The use of the drug during lactation is contraindicated.

Method of administration and dosage:

Inside. The capsules are swallowed without chewing.

For duodenal ulcer and stress ulcers - 30 mg / day per 1 dose, preferably in the morning, before meals for 2-4 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.

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

For the eradication of Helicobacter pylori - 30 mg 2 times a day, in combination with antibiotics (clarithromycin and amoxicillin), for at least 7 days.

Non-ulcer dyspepsia: 15-30 mg / day for 2-4 weeks.

In hepatic insufficiency and in elderly patients, treatment begins with half doses, gradually increasing them to the recommended ones, but not more than 30 mg / day.

Side effects:

- From the digestive system: less often - increased or decreased appetite, nausea, abdominal pain; rarely, diarrhea or constipation; in some cases, ulcerative colitis, candidiasis of the gastrointestinal tract, increased activity of hepatic transaminases (ALT, ACT, GGT, alkaline phosphatase and LDH), 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 side of hematopoiesis: rarely - thrombocytopenia (with hemorrhagic manifestations); in some cases - anemia.

- Allergic reactions: skin rash; in some cases - photosensitization, exudative erythema multiforme.

- Others: rarely - myalgia, alopecia.

Interaction:

Slows down the elimination of drugs metabolized in the liver by microsomal oxidation (including diazepam, phenytoin, indirect anticoagulants). Reduces theophylline clearance by 10%.

It slows down the pH-dependent absorption of drugs belonging to weak acid groups and accelerates the absorption of drugs belonging to base groups. Interferes with the absorption of ketoconazole, ampicillin, iron salts, digoxin.

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

Sucralfate reduces bioavailability by 30%, therefore it is necessary to observe the interval between taking medications of 30-40 minutes.

Antacids should be prescribed 1 hour before or 1 to 2 hours after taking lansoprazole, as they slow down and reduce their absorption.

Special instructions:

Before and after treatment, endoscopic control is required to exclude malignant neoplasm, since treatment can mask symptoms and delay correct diagnosis.

Release form / dosage:

Enteric capsules 15 mg and 30 mg.

Packaging:

10 capsules in A1 / A1 blister. 3 blisters with instructions for use in a cardboard box.

Storage conditions:

In a dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life:

3 years.
Do not use the drug after the expiration date printed on the package.

Terms of dispensing from pharmacies:

On prescription