Universal reference book for medicines
Name of the preparation: LANSOPRAZOL-STADA (LANSOPRAZOL-STADA)

Active substance: lansoprazole

Type: H + -K + -ATPase inhibitor.
Antiulcer drug
Manufacturer: NIZHFARM (Russia) manufactured by HETERO DRUGS Limited (India) packed with SKOPINSKY FARM PLANT (Russia)
Composition, form of production and packaging
Capsules
hard gelatinous, size 1, with a body and a lid of a red color;
the contents of the capsules are spherical pellets coated with an enteric-soluble white coating.
1 caps.

lansoprazole 30 mg

Excipients: mannitol, magnesium carbonate, lactose, sucrose, potato starch, carmellose, povidone (K-30), hypromellose, methacrylic acid, polysorbate, sodium hydroxide, diethyl phthalate, ethanol, propylene glycol.

The composition of the capsule: gelatin, water, karmazin.

10 pieces.
- packings without cell contour (1) - packs cardboard.
10 pieces.
- Packings without glue contour (2) - packs cardboard.
10 pieces.
- Packings without glue contour (3) - packs cardboard.
10 pieces.
- packings of cellular contour (1) - packs cardboard.
10 pieces.
- packings cellular planimetric (2) - packs cardboard.
10 pieces.
- packings cellular planimetric (3) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

Protozoa ulcer.
Specific proton pump inhibitor (H + -K + -ATPase); is metabolized in parietal cells of the stomach to active sulfonamide derivatives that inactivate the sulfhydryl groups of H + -K + -ATPase. It blocks the final stage of synthesis of hydrochloric acid, reducing basal and stimulated secretion, regardless of the nature of the stimulus. The inhibition of production of hydrochloric acid at a dose of 30 mg - 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, there is no ricochetial increase in secretion.
Secretory activity is restored 3-4 days after the end of the drug.
In patients with Zollinger-Ellison syndrome, it is more prolonged.
PHARMACOKINETICS

Suction

After ingestion, absorption is high.
Eating lowers absorption and bioavailability, but the inhibitory effect on gastric secretion remains the same, regardless of food intake. After oral administration in a dose of 30 mg C max is achieved through 1.5-2.2 hours and is 0.75-1.15 mg / l.
Distribution and Metabolism

The binding with plasma proteins is 97.7-99.4%.

It is actively metabolized by the "first pass" through the liver.

Excretion

T 1/2 is 1.3-1.7 hours. It is excreted by the kidneys in the form of metabolites - 14-23% and through the intestine.

Pharmacokinetics in special clinical cases

With hepatic insufficiency and in elderly patients, excretion slows down.

INDICATIONS

- Stomach ulcer and duodenal ulcer;

- reflux-esophagitis, erosive-ulcerative esophagitis;

- erosive and ulcerative lesions of the stomach and duodenum associated with the administration of NSAIDs, stress ulcers;

- erosive and ulcerative lesions of the stomach and duodenum, associated with Helicobacter pylori (as part of complex therapy);

- Zollinger-Ellison syndrome.

DOSING MODE

Assign inside.
Capsules should be swallowed whole, not liquid.
Peptic ulcer of the duodenum in the phase of exacerbation - 30 mg / day for 2-4 weeks (in resistant cases - up to 60 mg / day).

Stomach ulcer in the phase of exacerbation and erosive-ulcerative esophagitis - 30-60 mg / day for 4-8 weeks.

Erosive-ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs - 30 mg / day for 4-8 weeks.

Eradication Helicobacter pylori - 30 mg 2 times / day for 10-14 days in combination with antibacterial agents.

Antrepid treatment of peptic ulcer of the stomach and duodenum - 30 mg / day.

Antrepid treatment of reflux esophagitis - 30 mg / day for a long time (up to 6 months).

In Zollinger-Ellison syndrome, the dose is individually selected to achieve a basal secretion level of less than 10 mmol / h.

SIDE EFFECT

On the part of the digestive system: increased or decreased appetite, nausea, abdominal pain;
rarely diarrhea or constipation; in some cases - ulcerative colitis, candidiasis of the gastrointestinal tract, an increase in the activity of hepatic enzymes, an increase in the level of bilirubin in the blood.
From the side of the central nervous system: headache;
rarely - malaise, dizziness, drowsiness, depression, anxiety.
On the part of the respiratory system: rarely - cough, pharyngitis, rhinitis, infection of the upper respiratory tract, influenza-like syndrome.

From the hemopoietic system: rarely - thrombocytopenia (with hemorrhagic manifestations);
in some cases - anemia.
Allergic reactions: skin rash;
in some cases - photosensitivity, erythema multiforme.
Other: rarely - myalgia, alopecia.

CONTRAINDICATIONS

- malignant neoplasms of the gastrointestinal tract;

- I trimester of pregnancy;

- lactation;

- age up to 18 years;

- Hypersensitivity to the components of the drug.

With caution should prescribe the drug for hepatic and / or renal failure, in the II-III trimester of pregnancy, elderly patients.

PREGNANCY AND LACTATION

The drug is contraindicated in the first trimester of pregnancy.
With caution appoint in the II-III trimester of pregnancy.
If you need to use the drug during lactation, breastfeeding should be discontinued.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should prescribe the drug for kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should prescribe the drug for liver failure.

SPECIAL INSTRUCTIONS

Before the beginning of treatment it is necessary to exclude the presence of malignant process in the upper GI tract, tk.
The drug may mask symptoms and make diagnosis difficult.
OVERDOSE

Data on an overdose of Lansoprazole is not available.

DRUG INTERACTION

Lanzoprazole 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%.

Changes the pH-dependent absorption of drugs belonging to weak acid groups (deceleration) and bases (acceleration).

Sucralfate reduces the bioavailability of lansoprazole by 30% (the interval between taking these drugs should be 30-40 min).

Antacids slow down and reduce the absorption of lansoprazole (they should be prescribed for 1 hour or 1-2 hours after taking lansoproazole).

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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