Lansoprazole (30mg)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

Lansoprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. It is a substituted benzimidazole prodrug that is activated in the acidic environment of the parietal cell canaliculus. It is widely used in the management of acid-peptic disorders and is available in India as capsules, orally disintegrating tablets (ODTs), and sachets.

OnsetDurationBioavailability
Within 1-2 hours after oral administration.The antisecretory effect persists for more than 24 hours. Full therapeutic effect for healing of erosive esophagitis may take up to 4-8 weeks.Approximately 80-85% after oral administration. Bioavailability may be decreased if taken with food.

2. Mechanism of Action

Lansoprazole is a prodrug. In the acidic environment of the parietal cell canaliculus (pH < 4), it is converted to its active form, sulfenamide. This active metabolite forms covalent disulfide bonds with cysteine residues (specifically Cys813 and Cys321) on the extracellular domain of the H+/K+ ATPase (proton pump), irreversibly inhibiting the enzyme's function.

3. Indications & Uses

  • Healing of Erosive Reflux Esophagitis (GERD)
  • Maintenance of Healed Erosive Esophagitis
  • Healing of Duodenal Ulcers
  • Healing of Gastric Ulcers
  • Eradication of Helicobacter pylori (in combination with antibiotics)

4. Dosage & Administration

Adult Dosage: Erosive Esophagitis: 30mg once daily for 4-8 weeks. Maintenance: 15mg once daily. Duodenal/Gastric Ulcer: 30mg once daily for 4-8 weeks. H. pylori Eradication: 30mg twice daily + amoxicillin 1g twice daily + clarithromycin 500mg twice daily for 10-14 days (or other regimen as per local guidelines). Hypersecretory Conditions: Starting dose 60mg once daily, adjust individually (max 120mg/day in divided doses).

Administration: Take on an empty stomach, at least 30-60 minutes before the first meal of the day (typically breakfast). Swallow capsule whole; do not crush, chew, or split. For patients with swallowing difficulties: Capsule can be opened and granules sprinkled on 1 tablespoon of applesauce, yogurt, or acidic fruit juice (e.g., apple, orange) and swallowed immediately without chewing. ODT: Place on tongue, allow to disintegrate with or without water, and swallow. Do not split ODT.

5. Side Effects

Common side effects may include:

  • Headache
  • Diarrhea
  • Nausea
  • Abdominal pain
  • Constipation
  • Flatulence

6. Drug Interactions

DrugEffectSeverity
Atazanavir, RilpivirineDecreased absorption and plasma concentration of these HIV drugs due to increased gastric pH, leading to loss of virologic response.Major - Contraindicated.
ClopidogrelLansoprazole (a moderate CYP2C19 inhibitor) may reduce the antiplatelet effect of clopidogrel (a prodrug activated by CYP2C19), potentially increasing cardiovascular risk. Consider pantoprazole or H2 blockers.Moderate
MethotrexateMay decrease renal clearance of methotrexate, potentially increasing toxicity. Monitor closely with high-dose methotrexate.Moderate
WarfarinPotential for increased INR and risk of bleeding due to possible interaction. Monitor INR closely when starting or stopping lansoprazole.Moderate
Ketoconazole, Itraconazole, ErlotinibDecreased absorption of these drugs due to increased gastric pH, reducing their efficacy.Moderate
TacrolimusMay increase tacrolimus blood levels. Monitor tacrolimus concentrations.Moderate
DigoxinIncreased bioavailability of digoxin due to elevated gastric pH. Monitor digoxin levels.Minor

7. Patient Counselling

  • DO take the medication on an empty stomach, 30-60 minutes before breakfast.
  • DO swallow the capsule whole with a glass of water. Do not crush or chew.
  • DO inform your doctor if you are pregnant, planning pregnancy, or breastfeeding.
  • DO inform your doctor about all other medications, vitamins, and herbal supplements you are taking.
  • DONT take the medication with food as it reduces effectiveness.
  • DONT open the capsule and mix with liquids other than those recommended (e.g., applesauce). Do not mix with milk, water, or carbonated drinks in the sprinkle method.
  • DONT stop taking the medication abruptly if used long-term; consult your doctor for a tapering plan to avoid rebound acidity.

8. Toxicology & Storage

Overdose: Overdose experience is limited. Expected symptoms would be an extension of the pharmacologic effect: hypochlorhydria, and possibly the known adverse effects like confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, and dry mouth.

Storage: Store below 30°C, in a cool, dry place. Protect from moisture and light. Keep out of reach of children. Do not use after the expiry date printed on the pack. For ODTs: Keep in the original blister pack until use to protect from moisture.