LANSOPRAZLE DELAYED RELEASE CAPSULES USP 30 MG

Indications

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease
• Zollinger-Ellison syndrome
• Erosive esophagitis
• Prevention of gastric ulcers associated with NSAID use

Dosage

Children: Refer to the BNF for Children for appropriate dosing in pediatric patients.

Adults: Refer to prescribing information or relevant guidelines for specific dosing recommendations.

Mechanism of action

Lansoprazole inhibits the H+/K+ ATPase enzyme system (the proton pump) in the gastric parietal cells, leading to a decrease in gastric acid secretion. By binding to the cysteine residues of the ATPase enzyme, it effectively blocks the final step of acid production, resulting in prolonged suppression of gastric acidity.

Pharmacodynamics

The pharmacodynamic effects of lansoprazole include a reduction in gastric acidity, which helps to promote healing of acid-related gastrointestinal disorders. The onset of action typically occurs within 1-3 hours, with the maximum effect noted after several days of continued dosing. The acid suppression can last for up to 24 hours, facilitating symptom relief and mucosal healing.

Pharmacokinetics

Lansoprazole is well absorbed from the gastrointestinal tract, with peak plasma concentrations occurring approximately 1.5 to 2 hours after oral administration. It is extensively metabolized in the liver via cytochrome P450 enzymes, primarily CYP2C19 and CYP3A4. The elimination half-life is approximately 1 to 2 hours, but the effect on acid secretion can last much longer due to the irreversible binding to the proton pump. Lansoprazole is excreted mainly in the urine, with a minor fraction eliminated in feces.

Contra-indications

• Hypersensitivity to lansoprazole or any component of the formulation
• Concomitant use with nelfinavir

Adverse effects

• Headache
• Diarrhea
• Nausea
• Abdominal pain
• Constipation
• Dry mouth
• Fatigue
• Dizziness
• Rash
• Elevated liver enzymes

Interactions

• May reduce the efficacy of drugs requiring acidic pH for absorption (e.g., ketoconazole, atazanavir)
• May increase the concentration of drugs metabolized by CYP2C19 (e.g., warfarin, diazepam)
• Concomitant use with clopidogrel may reduce the antiplatelet effect

Precautions

• Use with caution in patients with hepatic impairment
• Monitor for signs of Clostridium difficile-associated diarrhea
• Long-term use may be associated with an increased risk of gastric cancer
• Consider vitamin B12 supplementation in long-term users

Pregnancy

Lansoprazole should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Lansoprazole is excreted in breast milk. Caution should be exercised when administered to breastfeeding women.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

• Capsules 15 mg
• Capsules 30 mg
• Oral suspension 3 mg/mL