Lancid - instructions for use, doses, side effects, contraindications

Mannitol - 22.72 mg, sucrose - 68.69 mg, povidone - 0.61 mg, microspheres of sucrose 21.7l mg, sodium hydrophosphate - 1.15 mg, carmellose calcium-5.75 mg, magnesium hydroxycarbonate 2.93 mg, polysorbate 80-0.55 mg, hypromellose 14.13 mg, titanium dioxide 2.02 mg, methylacrylic acid copolymer (type A) 36.34 mg, talc 4.85 mg, diethyl phthalate 4.48, sodium hydroxide-0.24 mg.

Composition of capsule with lansoprazole 15 mg (body):

Gelatin - 24.7626 mg. sodium lauryl sulfate - 0.0240 mg.propyl parahydroxybenzoate 0.200 mg, methyl parahydroxybenzoate 0.0600 mg, titanium dioxide 0.5557 mg, diamond brilliant blue 0.0034 mg, quinoline yellow color 0.0042 mg, water 4.3500 mg.

Composition of the capsule with lansoprazole 15 mg (lid):

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. the color of the brilliant blue is 0.0022 mg, the quinoline yellow colorant is 0.0028 mg, the iodine is 2.900 mg.

Auxiliary components for capsules containing lansoprazole - 30 mg:

Mannitol - 41.11 mg. sucrose - 123.22 mg, povidone -1.09 mg, microspheres from sucrose 38.19 mg, sodium hydrogen phosphate 2.08 mg, carmellose calcium 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. diethylphthalate 8.11 mg, sodium hydroxide 0.44 mg.

The composition of the capsule containing lansoprazole is 30 mg (body):

Gelatine 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, pencil dye [Ponso 4R] 0.0078 mg water 6.850 mg.

The composition of the capsule with lansoprazole - 30 mg (lid):

Gelatin - 24,0376 mg.sodium lauryl sulfate 0.0232 mg, propyl parahydroxybenzoate 0.0580 mg, methyl parahydroxybenzoate 0.22320 mg, titanium dioxide 0.4393 mg, pencil 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 oxide 24-28%. Ammonia water - 1-3%, propylene glycol 0.5-2%.

Description:

Capsules containing lansoprazole 15 mg: Hard gelatin capsules №3 with a case and a cover of turquoise (bluish-green) color and an inscription of black color MICRO / MICRO.

Capsules containing lansoprazole 30 mg: Hard gelatin capsules №1 with a case and a cover of pink color and an inscription of black color MICRO / MICRO.

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

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 + / K + ATPase); 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 nitrosobacteria 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. There was no risk of gastric acidity after stopping the use of lansoprazole.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 is not significantly affected).

Indications:

- Peptic ulcer of stomach and duodenum (in the phase of exacerbation);

- erosive-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.

Carefully:Hepatic insufficiency, pregnancy (II-III trimesters), advanced age, age 18 years.

Pregnancy and lactation:

Group B. Adequate and controlled studies in pregnant women have not been conducted.

The use of the drug during lactation is contraindicated.

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 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.

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: 15-30 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:

- 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 "liver" transaminases (ALT, ACT, GGT, APF 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 hematopoiesis: rarely - thrombocytopenia (with hemorrhagic manifestations); in some cases - anemia.

- Allergic reactions: skin rash; in some cases - 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, since they slow down and reduce their 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.

Form release / dosage:Capsules intestinal soluble 15 mg and 30 mg.

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

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014267 / 01

Date of registration:07.10.2008 / 12.05.2012

Expiration Date:Unlimited

The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India

Manufacturer: & nbsp

MICRO LABS, Limited India

Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India

Information update date: & nbsp15.02.2018

Illustrated instructions

Instructions

Lanzid (Lancid)