Lancid, 15mg capsules, 30pcs

Composition

of 1 capsule:

– lansoprazole 15 mg

Auxiliary substances:

mannitol – 129.7 mg,

lactose monohydrate-13 mg,

sucrose-16.6 mg,

povidone-3.5 mg,

hypromellose phthalate-18.2 mg,

cetyl alcohol-2 mg.

Capsule body composition:

gelatin – 24.7626 mg, sodium lauryl sulfate-0.024 mg, propyl parahydroxybenzoate-0.24 mg, methyl parahydroxybenzoate-0.06 mg, titanium dioxide-0.5557 mg, diamond blue dye-0.0034 mg, quinoline yellow dye-0.0042 mg, water-4.35 mg.

Capsule cap composition:

gelatin-16.5084 mg, sodium lauryl sulfate-0.016 mg, propyl parahydroxybenzoate-0.04 mg, methyl parahydroxybenzoate-0.16 mg, titanium dioxide-0.3705 mg, diamond blue dye-0.0022 mg, quinoline yellow dye-0.0028 mg, water-2.9 mg

Pharmacological action

Lancide is a specific proton pump inhibitor (H+-K+-ATPASE); it is metabolized in the parietal cells of the stomach to active sulfonamide derivatives that inactivate H+-K+-ATPASE. Blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus. Having high lipophilicity, it easily penetrates 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 hydrochloric acid secretion are dose-dependent: pH begins to increase 1-2 hours and 2-3 hours after taking 15 and 30 mg, respectively; inhibition of hydrochloric acid production when taken at a dose of 30 mg is 80-97%. It does not affect the motility of the gastrointestinal tract. The inhibitory effect increases in the first 4 days of use. After stopping the intake, the acidity remains below 50% of the basal level for 39 hours, and there is no” rebound ” increase in secretion. Secretory activity normalizes in 3-4 days after the end of taking the drug.

In patients with Zollinger-Ellison syndrome, it acts for a longer time. 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. Inhibition 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 peptic ulcer of the stomach and duodenum, resistant to histamine H2-receptor blockers. Provides faster healing of duodenal ulcers (85% of duodenal ulcers heal after 4 weeks of treatment at a dose of 30 mg / day).

After the first use of lansoprazole at a dose of 30 mg, the pH of gastric juice increases in 1-2 hours. When taking the drug several times a day (30 mg each), an increase in the pH of gastric juice is noted in the first hour after ingestion. The duration of action is more than 24 hours. No risk of increased gastric acidity was observed after discontinuation of lansoprazole. Recovery of the level of hydrochloric acid secretion to normal occurs gradually in the period from 2 to 4 days after taking several doses of the drug.

Pharmacokinetics:  

Absorption The absorption of lansoprazole begins as soon as the drug leaves the stomach. The rate of absorption is high and Cmax in plasma is reached in 1.7 hours, which is combined with a high degree of bioavailability of more than 80%. Food intake reduces absorption and bioavailability (by 50%), but the inhibitory effect on gastric secretion remains the same, regardless of food intake. The pharmacokinetics of lansoprazole, such as Cmax and AUC, 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.

Distribution Binding to plasma proteins is 97.7-99.4%. Lansoprazole penetrates well into the tissues, including the lining cells of the stomach. Vd – 0.5 l / kg.

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

The elimination of 1/2 of lansoprazole is less than 2 hours, which does not affect the duration of suppression of gastric secretion. It is excreted from the body in the form of lansoprazole sulfone and hydroxylansoprazole with bile (2/3), with urine-14-23%.

Pharmacokinetics in special clinical cases

With cirrhosis of the liver, absorption may be delayed.

Renal failure does not significantly affect the rate and magnitude of elimination. In patients with impaired renal function, protein binding may be reduced by 1-1.5%.

Indications

-peptic ulcer of the stomach and duodenum (in the acute phase);— erosive and ulcerative esophagitis; – reflux esophagitis— – Zollinger-Ellison syndrome;- stress ulcers of the gastrointestinal tract;- non-ulcer dyspepsia.

Contraindications

– malignant neoplasms of the gastrointestinal tract— – I trimester of pregnancy— – lactation period;- hypersensitivity to the components of the drug Lancid. Caution should be exercised when prescribing the drug in patients with hepatic insufficiency, in the II-III trimesters of pregnancy, elderly patients and patients under the age of 18 years.

Side effects

 From the digestive system: less often-increased or decreased appetite, nausea, abdominal pain; rarely-diarrhea or constipation; in some cases-ulcerative colitis, gastrointestinal candidiasis, increased activity of hepatic transaminases (ALT, AST), GGT, alkaline phosphatase and LDH, hyperbilirubinemia.

Nervous system disorders: headache; rarely-malaise, dizziness, drowsiness, depression, anxiety.

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

Hematopoietic disorders: rarely-thrombocytopenia (with hemorrhagic manifestations); in some cases – anemia.

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

Other: rarely-myalgia, alopecia.

Interaction

When used concomitantly, lansoprazole slows down the elimination of drugs that are metabolized in the liver by microsomal oxidation (including diazepam, phenytoin, indirect anticoagulants). Lansoprazole reduces theophylline clearance by 10%. Lansoprazole, when used concomitantly, slows down the pH-dependent absorption of drugs belonging to the weak acid groups and accelerates the absorption of drugs belonging to the base groups. Prevents the absorption of ketoconazole, ampicillin, iron salts, digoxin. Lansoprazole is compatible with ibuprofen, Indometacin, diazepam, propranolol, warfarin, oral contraceptives, phenytoin, prednisone. Sucralfate reduces the bioavailability of lansoprazole by 30%, so it is necessary to observe the interval between taking medications of 30-40 minutes. Antacids should be given 1 hour before or 1-2 hours after taking lansoprazole, as they slow down and reduce their absorption.

How to take, course of use and dosage

They are taken orally. Lancid capsules should be swallowed without chewing.

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

In case of gastric ulcer and erosive-ulcerative esophagitis-30 mg/day. for 4-8 weeks; if necessary-60 mg / day. For reflux esophagitis – 30 mg / day. within 4 weeks.

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

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

For non-ulcer dyspepsia: 15-30 mg / day. within 2-4 weeks.

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

Special instructions

Before and after treatment, endoscopic monitoring is required to exclude malignancy, as treatment may mask symptoms and delay proper diagnosis.

Form of production

Capsules.

Active ingredient

Lansoprazole

Conditions of release from pharmacies

By prescription

Dosage form

Capsules