Epicurus
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: FP Obolensky Company (Russia)
Pharmaceutical form, composition and packaging
Capsules green color, №1; contents of capsules – spherical micro-granules of white or nearly white.
| 1 caps. | |
| lansoprazole | 30 mg |
7 PC. – packings Valium planimetric (1) – packs.
7 PC. – packings Valium planimetric (2) – packs.
7 PC. – packings Valium planimetric (4) – packs.
10 PC. – packings Valium planimetric (2) – packs.
10 PC. – packings Valium planimetric (3) – packs.
Pharmacological action
Anti-ulcer drug. A specific inhibitor of proton pump (N+-K+-ATPase).
It is metabolized in the parietal cells of the gastric mucosa to active sulfonamide derivatives, which inhibit the sulfhydryl groups 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.
Use of the drug in a dose of 30 mg causes a decrease in gastric acid secretion on 80-97%. The inhibitory effect increases for 4 days. After stopping treatment, the acidity is maintained below 50% basal level during 39 no, “Ricochet” increase the secretion is not marked.
The secretory activity is restored through 3-4 the day after taking the drug.
The drug has no effect on the motility of the gastrointestinal tract.
In patients with Zollinger-Ellison syndrome the drug acts more lasting.
Pharmacokinetics
Absorption and distribution
After taking the drug inside lansoprazole is well absorbed from the gastrointestinal tract. Bioavailability is 80%. Taking the drug with food at the same time reduces the absorption and bioavailability 50%, but an inhibitory effect on gastric secretion remains the same. After oral dose 30 mg Cmax achieved through 1.5-2 h and is 0.75-1.15 mg / l.
Plasma protein binding – 97.7-99.4%.
Metabolism and excretion
Actively biotransformiroetsa at “first pass” through the liver. T1/2 is 1.3-1.7 no. Kidneys (as metabolites) output 14-23% of the dose, rest – through the intestine.
Pharmacokinetics in special clinical situations
In hepatic insufficiency and in the elderly is slowing down the excretion of lansoprazole.
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;
- Zollinger-Ellison.
Dosage regimen
The capsules should be taken orally, swallowing whole, without chewing.
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 appoint 30-60 mg / day for 4-8 weeks.
At erosive and ulcerative lesions of the gastrointestinal tract, caused by NSAIDs, – by 30 mg / day for 4-8 weeks.
To eradication of Helicobacter pylori – by 30 mg 2 times / day for 10-14 days in combination with antibiotic therapy.
To anti-treatment of gastric ulcer and duodenal ulcer – by 30 mg / day.
To protyvoretsydyvnoho of treatment of reflux esophagitis – by 30 mg / day for a long time (to 6 Months).
At Zollinger-Ellison syndrome the dose is adjusted individually to achieve the level of basal secretion <10 mmol / h.
Side effect
CNS: headache; rarely – malaise, dizziness, drowsiness, depression, alarm.
From the digestive system: decreased or increased appetite, nausea, stomach ache; rarely – diarrhea, constipation; in a few cases – yazvennыy colitis, gastrointestinal candidiasis, increased activity of liver transaminases, giperʙiliruʙinemija.
The respiratory system: rarely – cough, pharyngitis, rhinitis, infection 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 – photosensitivity, erythema multiforme.
Other: rarely – myalgia, alopecia.
Contraindications
- Malignant neoplasms of the gastrointestinal tract;
- I trimester of pregnancy;
- Lactation (breast-feeding);
- Childhood and adolescence up 18 years;
- Hypersensitivity to the drug.
FROM caution use in patients with hepatic / renal failure, II and III trimester of pregnancy, in elderly patients.
Pregnancy and lactation
The drug is contraindicated for use in the I trimester of pregnancy and lactation (breast-feeding). In II and III trimester of pregnancy, the drug is prescribed with caution.
Cautions
Before starting treatment with Epicurus should exclude the possibility of cancer in the upper digestive tract, because the drug may mask the symptoms and delay the correct diagnosis.
Overdose
Data on overdose are not provided.
Drug Interactions
Lansoprazole medicines slows down, metabolized in the liver by microsomal oxidation (incl. diazepam, phenytoin, indirect anticoagulants).
Lansoprazole reduces the clearance of theophylline on 10%.
Lansoprazole slow pH-dependent absorption of drugs, belonging to the groups of weak acids, and accelerates the pH-dependent absorption of drugs, belonging to groups bases.
With simultaneous application of sucralfate reduces the bioavailability of lansoprazole on 30%, so the interval between administration of these medications must be 30-40 m.
Antacids slow down and reduce absorption of lansoprazole, so they should be used for 1 hours before or after 1-2 hours after administration of lansoprazole.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
List B. The drug should be stored out of reach of children, dry, dark place at a temperature no higher than 25 ° C. Shelf life – 2 year.
