Lanzap^® (Capsules) Instructions for Use

Marketing Authorization Holder

Dr. Reddy’s Laboratories Ltd. (India)

ATC Code

A02BC03 (Lansoprazole)

Active Substance

Lansoprazole

Dosage Form

Lanzap®

Enteric-coated capsules 30 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules hard gelatin, size No. 1, white or almost white with a creamy tint, marked “LANZAP” on the body and cap; the capsule contents are granules of white or almost white color.

Excipients: mannitol 155.705 mg, magnesium carbonate 21.126 mg, lactose 16.057 mg, carmellose calcium 10.564 mg, sucrose 61.267 mg, povidone 1.254 mg, sodium methylparaben 0.023 mg, sodium propylparaben 0.002 mg.

Capsule shell composition: propylparaben, methylparaben, sodium lauryl sulfate, water, titanium dioxide, gelatin.

10 pcs. – blisters (2) – cardboard boxes.

Clinical-Pharmacological Group

H⁺-K⁺-ATPase inhibitor. Antiulcer drug

Pharmacotherapeutic Group

Proton pump inhibitor

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 has 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 meals.

Plasma protein binding is 97.7-99.4%.

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

T_1/2 is increased 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

Administer orally 30 mg once or twice daily. The duration of therapy is indication-dependent.

For duodenal ulcer, use 30 mg once daily for 4 weeks.

For gastric ulcer, use 30 mg once daily for 8 weeks.

For erosive reflux esophagitis, use 30 mg once daily for up to 8 weeks. For maintenance therapy of healed esophagitis, use 15 mg once daily.

For Helicobacter pylori eradication, use a triple therapy regimen. Administer Lansoprazole 30 mg twice daily with amoxicillin 1 g twice daily and clarithromycin 500 mg twice daily for 10 to 14 days.

For Zollinger-Ellison syndrome, the initial dose is 60 mg once daily. Adjust the dose individually based on patient response; doses above 120 mg daily should be divided.

When oral administration is not possible, administer 30 mg intravenously by infusion over 30 minutes, twice daily. Limit intravenous use to a maximum of 7 days.

Swallow the capsule whole in the morning before eating. Do not crush or chew the enteric-coated granules.

For patients with severe hepatic impairment, consider a dose reduction.

No dose adjustment is required for patients with renal impairment or elderly patients.

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 rashes; 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 down.

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 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, when used simultaneously, may reduce the bioavailability of ketoconazole 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.