Epicurus, capsules 30mg, 14pcs

Composition

1 capsule contains:

Active ingredients:

pellets of lansoprazole-353 mg, containing lansoprazole-30 mg,

Auxiliary substances:

pellets of sugar (sucrose),

sugar syrup (sucrose),

mannitol,

calcium carboxymethylcellulose (carmellose calcium),

magnesium carbonate,

sodium phosphate disodium (sodium hydrogen phosphate),

sodium lauryl sulfate,

polyvinylpyrrolidone K-30 (povidone),

tween 80 (Polysorbate 80),

hydroxypropyl methylcellulose (hypromellose),

acrylic coating L30DA (methacrylic acid),

talc,

polyethylene glycol 6000 (macrogol),

titanium dioxide,

sodium hydroxide.

Solid gelatin capsules (quinoline yellow [E 104], patent blue V, gelatin) methyl parahydroxybenzoate, propyl parahydroxybenzoate)

Pharmacological action

Epicurus is an anti-ulcer agent. A specific proton pump inhibitor (H+K+ATPASE); it is metabolized in the parietal cells of the stomach to active sulfonamide derivatives, which are inactivated by the sulfhydryl groups of H+K+ATPASE. Blocks the final stage of hydrochloric acid synthesis, reducing basal and stimulated secretion, regardless of the nature of the stimulus.

Inhibition of hydrochloric acid production at a dose of 30 mg is 80-97%. It does not affect the motility of the gastrointestinal tract. The inhibitory effect increases in the first four days of use. After stopping the intake, the acidity remains below 50% of the basal level for 39 hours, and there is no” rebound ” increase in secretion. Secretory activity is restored 3-4 days after the end of taking the drug. In patients with Zollinger-Ellison syndrome, it acts for a longer time.

Pharmacokinetics

Absorption-high, bioavailability-80% (food intake reduces absorption and bioavailability by 50%, but the inhibitory effect on gastric secretion remains the same, regardless of food intake).

The time of onset of the maximum concentration (cmax) after oral use of 30 mg is 1.5-2.2 hours, Cmax is 0.75-1.15 mg/l. Binding to plasma proteins is 97.7-99.4%. It is actively metabolized during the “primary passage” through the liver.

The elimination half-life is 1,3-1,7 h. Excretion by the kidneys (in the form of metabolites) is 14-23% and through the intestine. In hepatic insufficiency and in elderly patients, excretion slows down.

Indications

• Peptic ulcer of the stomach and duodenum.
• Reflux esophagitis, erosive and ulcerative esophagitis
• Erosive and ulcerative lesions of the stomach and duodenum associated with taking nonsteroidal anti-inflammatory drugs, stress ulcers.
• Erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori (as part of complex therapy).
• Zollinger-Ellison syndrome

Use during pregnancy and lactation

Contraindicated in the first trimester. In the second and third trimester, it is possible if the expected benefit of therapy exceeds the potential risk to the fetus. Breast-feeding should be discontinued for the duration of treatment.

Contraindications

• Hypersensitivity to the components of Epicurus,
• malignant neoplasms of the gastrointestinal tract,
• pregnancy (I trimester),
• lactation,
• age up to 12 years (safety and efficacy in patients under 12 years of age have not been sufficiently studied).

With caution: Hepatic and / or renal failure. Advanced age.

Side effects

From the digestive system: 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” enzymes, increased bilirubin levels in the blood.

Nervous system disorders: headache; rarely-malaise, dizziness, drowsiness, depression, anxiety.

From the respiratory system: rarely-cough, pharyngitis, rhinitis, upper respiratory tract infection, flu-like syndrome.

Hematopoietic disorders: rarely-thrombocytopenia (with hemorrhagic manifestations); in some cases – anemia.

Allergic reactions: skin rash; in some cases – photosensitization, erythema multiforme.

Other: rarely-myalgia, alopecia.

The interaction

slows down the elimination of drugs metabolized in the liver by microsomal oxidation (including diazepam, phenytoin, indirect anticoagulants). Reduces theophylline clearance by 10%.

Changes the pH-dependent absorption of drugs belonging to the groups of weak acids (slowing down) and bases (accelerating).

Sucralfate reduces the bioavailability of lansoprazole by 30% (it is necessary to observe the interval between taking these drugs for 30-40 minutes)

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

How to take, course of use and dosage

Inside. Capsules should be swallowed whole, without chewing.

Duodenal ulcer in the acute phase – 30 mg per day for 2-4 weeks (in resistant cases up to 60 mg per day).

Gastric ulcer in the acute phase and erosive-ulcerative esophagitis – 30-60 mg per day for 4-8 weeks.

Erosive and ulcerative lesions of the gastrointestinal tract caused by taking nonsteroidal anti-inflammatory drugs-30 mg per day for 4-8 weeks.

Eradication of Helicobacter Pylori– 30 mg 2 times a day for 7-14 days in combination with antibacterial agents. The recommended duration of treatment as part of various regimens of combined antihelicobacter therapy is 7 days.

Anti-relapse treatment of peptic ulcer of the stomach and duodenum 12-30 mg 1 time a day.

Anti-relapse treatment of reflux esophagitis – 30 mg once a day for a long time (up to 6 months).

Zollinger-Ellison syndrome-the dose is selected individually until the basal secretion level is less than 10 mmol/h.

Special instructions

Before starting treatment, it is necessary to exclude the presence of a malignant process in the upper gastrointestinal tract, since taking the drug can “mask” the symptoms and make diagnosis difficult.

Form of production

Capsules

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Lansoprazole

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Description

For adults as prescribed by a doctor, For pregnant women in the second and third trimester as prescribed by a doctor

Indications

Gastric and duodenal ulcers, Reflux Esophagitis, Gastrointestinal infections caused by Helicobacter Pylori