LANZOPTOL
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)
Pharmaceutical form, composition and packaging
Capsules white; capsule contents – pellets from white to white with Valium or yellowish tint.
| 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. – blisters (2) – packs cardboard.
* – international non-proprietary name, recommended by the WHO – lansoprazole.
Pharmacological action
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.
Pharmacokinetics
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
Extensively metabolized in the “first pass” through the liver.
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.
Testimony
- 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.
Dosage regimen
The drug is taken orally.
At duodenal ulcer in the acute phase appoint 30 mg / day for 2-4 weeks, in resistant cases – to 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 goal of Helicobacter pylori eradication – 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 protyvoretsydyvnoho of treatment of reflux esophagitis – 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.
Side effect
From the digestive system: increased or decreased appetite, nausea, abdominal pain; rarely – diarrhea or constipation; in some cases – yazvennыy colitis, gastrointestinal candidiasis, increase in liver enzymes, elevated levels of bilirubin in the blood.
CNS: headache; rarely – malaise, dizziness, drowsiness, depression, alarm.
The respiratory system: rarely – cough, pharyngitis, rhinitis, infections of the upper respiratory tract, flu-like symptoms.
From the hematopoietic system: rarely – thrombocytopenia (with hemorrhagic manifestations); in some cases – anemia.
Allergic reactions: skin rash; in some cases – erythema multiforme.
Dermatological reactions: rarely – alopecia; in some cases – photosensitivity.
Other: rarely – myalgia.
Contraindications
- 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.
Pregnancy and lactation
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).
Cautions
Before treatment to rule out malignancy in the upper gastrointestinal tract, tk. the drug may mask simptomamiku and complicate diagnosis.
Drug Interactions
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).
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
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.
