Lansoprazol (Capsules) Instructions for Use

Marketing Authorization Holder

Medisorb, JSC (Russia)

ATC Code

A02BC03 (Lansoprazole)

Active Substance

Lansoprazole (Rec.INN registered by WHO)

Dosage Forms

	Lansoprazole	Enteric-coated capsules 15 mg: 7, 14, 20, 28, 30, 50 or 100 pcs.
		Enteric-coated capsules 30 mg: 7, 14, 20, 28, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules No. 3, with a white body and a blue cap; the contents of the capsules are white or almost white spherical pellets.

Excipients: sugar pellets – 14.94 mg, sugar syrup – 35.6 mg, mannitol – 44.82 mg, calcium carboxymethylcellulose – 7.47 mg, magnesium carbonate – 2.39 mg, disodium phosphate – 1.05 mg, sodium lauryl sulfate – 0.04 mg, povidone (K-30) – 0.18 mg, polysorbate 80 – 0.57 mg, hypromellose – 10.99 mg, macrogol – 4.3 mg, titanium dioxide – 1.41 mg, sodium hydroxide – 0.22 mg.

hard gelatin capsules “Coni Snap” No. 3 titanium dioxide – 1.44 mg, indigo carmine – 0.06 mg, gelatin up to 48 mg.

7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Enteric-coated capsules No. 1, with a white body and a green cap; the contents of the capsules are white or almost white spherical pellets.

Excipients: sugar pellets – 29.88 mg, sugar syrup – 71.2 mg, mannitol – 89.64 mg, calcium carboxymethylcellulose – 14.94 mg, magnesium carbonate – 4.78 mg, disodium phosphate – 2.1 mg, sodium lauryl sulfate – 0.08 mg, povidone (K-30) – 0.36 mg, polysorbate 80 – 1.14 mg, hypromellose – 21.98 mg, macrogol – 8.6 mg, titanium dioxide – 2.82 mg, sodium hydroxide – 0.44 mg.

hard gelatin capsules “Coni Snap” No. 1 titanium dioxide – 2.88 mg, iron oxide yellow dye – 1.3 mg, indigo carmine – 0.23 mg, gelatin up to 48 mg.

7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

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 parietal cells of the stomach, 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 the formation of hydrochloric acid 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 in the form of metabolites – Lansoprazole-sulfone and hydroxylansoprazole); while 14-23% is excreted in the urine per day. T_1/2 is 1.3-1.7 hours in healthy volunteers.

T_1/2 increases in patients with severe liver dysfunction and in patients over 69 years of age. In patients with impaired renal function, the absorption of lansoprazole practically does not change.

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

Take orally once daily, in the morning, before eating. Swallow the capsule whole; do not chew or crush.

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

For Helicobacter pylori eradication, use as part of combination therapy. A common regimen is 30 mg lansoprazole, 500 mg clarithromycin, and 1 g amoxicillin, all taken twice daily for 14 days.

For patients with severe hepatic impairment, the maximum daily dose should not exceed 30 mg.

If oral administration is impossible, administer 30 mg intravenously by infusion over 30 minutes, twice daily. Limit intravenous use to a short-term alternative for up to 7 days.

Do not use in children or adolescents under 18 years of age.

Adverse Reactions

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

From the central nervous system headaches; 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 dysfunction.

Pediatric Use

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

Special Precautions

Use with caution in patients with severe liver dysfunction.

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 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 with warfarin.

There is evidence that with simultaneous use, Lansoprazole increases the duration of action of vecuronium.

With simultaneous use with carbamazepine, a decrease in the concentration of carbamazepine in the blood plasma 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.