Lansoptol^® (Capsules) Instructions for Use

Marketing Authorization Holder

Krka, D.D. (Slovenia)

ATC Code

A02BC03 (Lansoprazole)

Active Substance

Lansoprazole (Rec.INN WHO registered)

Dosage Form

Lansoptol®

Capsules 30 mg: 14 pcs.

Dosage Form, Packaging, and Composition

Capsules are white; the capsule contents are pellets ranging from white to white with a creamy or yellowish tint.

Excipients: sugar spheres, hypromellose, magnesium carbonate, sucrose, corn starch, sodium lauryl sulfate, hydroxypropyl methylcellulose, methacrylic acid, talc, macrogol 600, titanium dioxide.

Capsule shell composition: titanium dioxide, gelatin.

7 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

H⁺-K⁺-ATPase inhibitor. Antiulcer drug

Pharmacotherapeutic Group

Proton pump inhibitor

Pharmacological Action

An antiulcer drug, a specific proton pump inhibitor (H⁺-K⁺-ATPase). It is metabolized in the gastric parietal cells to active sulfonamide derivatives that inactivate the sulfhydryl groups of H⁺-K⁺-ATPase. It 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 gastrointestinal motility. The inhibitory effect increases during the first 4 days of administration. After discontinuation of administration, acidity remains below 50% of the basal level for 30 hours, and no rebound increase in secretion is observed. Secretory activity is restored 3-4 days after the end of drug administration. In patients with Zollinger-Ellison syndrome, the effect is more prolonged.

Pharmacokinetics

Absorption

After oral administration, absorption is high. Food intake reduces absorption and bioavailability, but the inhibitory effect on gastric secretion remains the same, regardless of food intake. When taken orally at a dose of 30 mg, C_max in blood plasma is reached in 1.5-2.2 hours and is 0.75-1.15 mg/L.

Distribution

Plasma protein binding is 97.7-99.4%.

Metabolism

It is actively metabolized during the first pass through the liver.

Excretion

T_1/2 is 1.3-1.7 hours.

It is excreted by the kidneys as metabolites (14-23%) and through the intestines.

Pharmacokinetics in special clinical cases

Excretion is slowed in hepatic insufficiency and in elderly patients.

Indications

• Gastric and duodenal ulcer;
• Reflux esophagitis, erosive-ulcerative esophagitis;
• Erosive-ulcerative lesions of the stomach and duodenum associated with NSAID use, stress ulcers;
• Erosive-ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori (as part of combination therapy);
• Zollinger-Ellison syndrome.

ICD codes

Dosage Regimen

The drug is taken orally.

For duodenal ulcer in the acute phase, 30 mg/day is prescribed for 2-4 weeks; in resistant cases – up to 60 mg/day.

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

For erosive-ulcerative lesions of the gastrointestinal tract caused by NSAID use – 30 mg/day for 4-8 weeks.

For the purpose of Helicobacter pylori eradication – 30 mg twice a day for 10-14 days in combination with antibacterial agents.

For anti-relapse treatment of gastric and duodenal ulcer – 30 mg/day.

For anti-relapse treatment of reflux esophagitis – 30 mg/day for a long period (up to 6 months).

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

Capsules should be swallowed whole, without chewing.

Adverse Reactions

From the digestive system: increase or decrease in appetite, nausea, abdominal pain; rarely – diarrhea or constipation; in some cases – ulcerative colitis, gastrointestinal candidiasis, increased activity of liver enzymes, increased bilirubin levels in the blood.

From the central nervous system: headache; rarely – malaise, dizziness, drowsiness, depression, anxiety.

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

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 neoplasms in the gastrointestinal tract;
• First trimester of pregnancy;
• Lactation period;
• Age under 18 years;
• Hypersensitivity to the components of the drug.

With caution, the drug should be prescribed for hepatic and/or renal insufficiency, pregnancy (second and third trimesters), and elderly patients.

Use in Pregnancy and Lactation

The drug is contraindicated for use in the first trimester of pregnancy and during lactation (breastfeeding).

The drug should be prescribed with caution during pregnancy (second and third trimesters).

Use in Hepatic Impairment

With caution, the drug should be prescribed for hepatic insufficiency.

Use in Renal Impairment

With caution, the drug should be prescribed for renal insufficiency.

Pediatric Use

Contraindication: age under 18 years .

Geriatric Use

With caution, the drug should be prescribed for elderly patients.

Special Precautions

Before starting treatment, it is necessary to exclude the presence of a malignant process in the upper gastrointestinal tract, because taking the drug may mask symptoms and complicate diagnosis.

Drug Interactions

With simultaneous use, Lansoprazole 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%.

Lansoprazole changes the pH-dependent absorption of drugs belonging to the groups of weak acids (slowing down) and bases (acceleration).

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

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

Storage Conditions

The drug should be stored out of the reach of children, in a dry place at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.