Lanson-AF (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Alpharma, LLC (Russia)

Manufactured By

Deko Company, LLC (Russia)

ATC Code

A02BC03 (Lansoprazole)

Active Substance

Lansoprazole (Rec.INN WHO registered)

Dosage Form

Lanson-AF

Lyophilisate for preparation of solution for infusion 30 mg

Dosage Form, Packaging, and Composition

Lyophilisate for the preparation of a concentrate for the preparation of a solution for infusion

1 pc. – bottles – cardboard packs (1 pc.) – Prescription only
1 pc. – bottles (10 pcs.) – cardboard boxes (10 pcs.) – Prescription only

Pharmacotherapeutic Group

Acid-related disorder treatment agents; antiulcer agents and agents for the treatment of gastroesophageal reflux disease (GERD); proton pump inhibitors

Pharmacological Action

Antiulcer agent. A specific inhibitor of H⁺-K⁺-ATPase. Acting in the final phase of hydrochloric acid secretion in the stomach, Lansoprazole reduces acid production, regardless of the nature of the stimulating factor.

Having high lipophilicity, it easily penetrates into the gastric parietal cells, concentrates in them, and exerts a cytoprotective effect, increasing the oxygenation of the gastric mucosa and increasing secretion.

Pharmacokinetics

After oral administration, Lansoprazole is absorbed from the gastrointestinal tract. It is largely subject to the first-pass effect through the liver. Although food reduces the absorption and bioavailability of lansoprazole, the inhibitory effect on hydrochloric acid formation remains the same before and after food intake.

Plasma protein binding is 97.7-99.4%.

It is eliminated from the body with bile and urine (only as metabolites – Lansoprazole sulfone and hydroxylansoprazole); with 14-23% excreted in the urine over 24 hours. The T_1/2 is 1.3-1.7 hours in healthy volunteers.

T_1/2 increases in patients with severe liver function impairment and in patients over 69 years of age. In patients with impaired renal function, the absorption of lansoprazole is practically unchanged.

Indications

Duodenal ulcer in the acute phase, gastric ulcer in the acute phase, reflux esophagitis, Zollinger-Ellison syndrome; eradication of Helicobacter pylori in the gastric mucosa in infected patients with gastric and duodenal ulcers.

ICD codes

Dosage Regimen

For oral administration, administer 30 mg once or twice daily. The duration of therapy is determined by the specific indication and treatment protocol.

When oral administration is not possible, administer the drug intravenously. Use the lyophilisate for solution for infusion. Administer 30 mg as an intravenous infusion over 30 minutes, twice daily.

Reserve intravenous administration for short-term therapy, not exceeding 7 days. Transition to oral therapy as soon as clinically feasible.

For Helicobacter pylori eradication, use lansoprazole as part of a combination therapy regimen with appropriate antibiotics. Adhere strictly to the prescribed combination and duration.

In patients with severe hepatic impairment, exercise caution. Consider a dose adjustment or increased monitoring intervals due to a potential increase in elimination half-life.

For patients with Zollinger-Ellison syndrome, individualize the dosage. Initiate therapy with 60 mg once daily. Adjust the dose based on the patient’s response; doses exceeding 120 mg per day may be required and should be administered in divided doses.

Administer intravenous infusions using the prepared solution. Do not mix with other medications in the same infusion set. Use the solution immediately after reconstitution and dilution.

Do not administer via intravenous bolus injection. The infusion rate must be controlled over the specified 30-minute period to ensure safety and efficacy.

Adverse Reactions

From the digestive system diarrhea, abdominal pain; rarely – constipation.

From the central nervous system headache; rarely – dizziness, drowsiness; in some cases – depression.

From the respiratory system rarely – pharyngitis, rhinitis.

Other skin rash; in some cases – myalgia.

Contraindications

Pregnancy, lactation (breastfeeding), children and adolescents under 18 years of age, hypersensitivity to lansoprazole.

Use in Pregnancy and Lactation

Lansoprazole is contraindicated for use during pregnancy and during lactation (breastfeeding).

Use in Hepatic Impairment

Use with caution in patients with severe liver function impairment.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Use with caution in patients with severe liver function impairment.

Lansoprazole should be used with caution and under strict medical supervision in patients receiving theophylline.

Antacids containing aluminum and magnesium hydroxides should be taken 2 hours after taking lansoprazole. In patients with liver cirrhosis, the elimination of lansoprazole is slowed.

The efficacy and safety of lansoprazole use in children have not been studied.

Drug Interactions

With simultaneous use with antacids, the bioavailability of lansoprazole is moderately reduced.

With simultaneous use with amoxicillin, clarithromycin, metronidazole, glossitis, stomatitis and/or the appearance of dark discoloration of the tongue are possible.

Cases of enhanced anticoagulant effect of warfarin have been described with simultaneous use.

There is evidence that Lansoprazole increases the duration of action of vecuronium when used simultaneously.

With simultaneous use with carbamazepine, a decrease in the plasma concentration of carbamazepine is not excluded due to a decrease in its absorption from the gastrointestinal tract due to a decrease in the pH of the gastric contents under the influence of lansoprazole. This may lead to a decrease in the clinical efficacy of carbamazepine.

It is believed that Lansoprazole may reduce the bioavailability of ketoconazole when used simultaneously due to a decrease in the acidity of the gastric contents under the influence of proton pump inhibitors.

It is believed that with simultaneous use with lansoprazole, an increase in the toxicity of methotrexate is possible.

With simultaneous use, a slight increase in the clearance of theophylline is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.