Active material: Lansoprazole
When ATH: A02BC03
CCF: Inhibitor N+-K+-ATPase. Anti-ulcer drug
ICD-10 codes (testimony): E16.8, K20, K21.0, K25, K26, K27
When CSF: 11.01.03
Manufacturer: KRKA d.d. (Slovenia)
Capsules white; содержимое капсулы – пеллеты от белого до белого с кремоватым или желтоватым оттенком цвета.
| 1 caps. | |
| * lansoprazole | 30 mg |
Excipients: Sugar Beads, hydroksypropyltsellyuloza, magnesium carbonate, sucrose, corn starch, sodium lauryl, hydroxypropyl, methacrylic acid, talc, macrogol 600, Titanium dioxide.
The composition of the shell capsules: Titanium dioxide, gelatin.
7 PC. – блистеры (2) – пачки картонные.
* – непатентованное международное наименование, рекомендованное ВОЗ – ланзопразол.
Anti-ulcer drug, a specific inhibitor of proton pump (H+-K+-ATPase). It is metabolized in the parietal cells of the stomach to the active sulfonamide derivatives, that inactivate the sulfhydryl group of H+-K+-ATPase. Blocking the final stage of the synthesis of hydrochloric acid, lowering both basal and stimulated secretion, regardless of the nature of the stimulus. Inhibition of production of hydrochloric acid at a dose of 30 mg - 80-97%. No effect on the motility of the gastrointestinal tract. The inhibitory effect of increases in the first 4 Day reception. After stopping for acidity 30 h remains below 50% the basal level, rebound increased secretion is not marked. The secretory activity is restored through 3-4 the day after taking the drug. In patients with Zollinger-Ellison effect more lasting.
Absorption
After oral administration, absorption is high. Food intake reduces the absorption and bioavailability, but an inhibitory effect on gastric secretion remains the same, regardless of the meal. When administered at a dose of 30 mg Cmax plasma levels achieved after 1.5-2.2. h and is 0.75-1.15 mg / l.
Distribution
Plasma protein binding - 97.7-99.4%.
Metabolism
Активно метаболизируется при “первом прохождении” через печень.
Deduction
T1/2 is 1.3-1.7 no.
Excreted by the kidneys as metabolites (14-23%) and through the intestine.
Pharmacokinetics in special clinical situations
In hepatic insufficiency and in the elderly is slowing down.
- Gastric ulcer and duodenal ulcer;
- Reflux esophagitis, erosive and ulcerative esophagitis;
- Erosive and ulcerative lesions of the stomach and duodenum, associated with taking NSAIDs, stress ulcers;
- Erosive and ulcerative lesions of the stomach and duodenum, associated with Helicobacter pylori (in the complex therapy);
- Zollinger-Ellison.
The drug is taken orally.
At duodenal ulcer in the acute phase appoint 30 mg / day for 2-4 weeks, в резистентных случаях – до 60 mg / day.
At stomach ulcer in the acute phase and erosive and ulcerative esophagitis - By 30-60 mg / day for 4-8 weeks.
At erosive and ulcerative lesions of the gastrointestinal tract, caused by NSAID - By 30 mg / day for 4-8 weeks.
FROM целью эрадикации Helicobacter pylori – by 30 mg 2 times / day for 10-14 days in combination with antibacterial agents.
To anti-treatment of gastric ulcer and duodenal ulcer - By 30 mg / day.
To противорецидивного лечения рефлюкс-эзофагита – 30 mg / day for a long time (to 6 Months).
At Zollinger-Ellison syndrome Dose set individually to achieve the level of basal secretion less 10 mmol / h.
The capsules should be swallowed whole, without chewing.
From the digestive system: increased or decreased appetite, nausea, abdominal pain; редко – диарея или запор; в отдельных случаях – язвенный колит, gastrointestinal candidiasis, increase in liver enzymes, elevated levels of bilirubin in the blood.
CNS: headache; редко – недомогание, dizziness, drowsiness, depression, alarm.
The respiratory system: редко – кашель, pharyngitis, rhinitis, infections of the upper respiratory tract, flu-like symptoms.
From the hematopoietic system: a rare - thrombocytopenia (with hemorrhagic manifestations); в отдельных случаях – анемия.
Allergic reactions: skin rash; в отдельных случаях – многоформная эритема.
Dermatological reactions: редко – алопеция; in some cases - photosensitivity.
Other: редко – миалгия.
- Malignant tumors in the digestive tract;
- I trimester of pregnancy;
- Lactation;
- Up to 18 years;
- Hypersensitivity to the drug.
FROM caution should be prescribed the drug for liver and / or kidney failure, pregnancy (II and III trimesters), elderly patients.
The drug is contraindicated for use in the I trimester of pregnancy and lactation (breast-feeding).
Precautions should be prescribed the drug during pregnancy (II and III trimesters).
Before treatment to rule out malignancy in the upper gastrointestinal tract, tk. the drug may mask simptomamiku and complicate diagnosis.
With simultaneous use of lansoprazole, slows excretion of drugs, metabolized in the liver by microsomal oxidation (incl. diazepama, phenytoin, anticoagulants).
Decreases theophylline clearance to 10%.
Lansoprazole alters pH-dependent absorption of drugs, belonging to the groups of weak acids (slowdown) and bases (acceleration).
Sucralfate reduces the bioavailability of lansoprazole on 30% (observe the interval between administration of these preparations 30-40 m).
Antacids slow down and reduce the absorption of lansoprazole (antacids should be given for 1 h or through 1-2 hours after administration of lansoprazole).
The drug is released under the prescription.
The drug should be stored out of reach of children, a dry place at a temperature no higher than 25 ° C. Shelf life - 3 year.
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