Monolitum (Lansoprazole)

Lansoprazole is a proton pump inhibitor used to manage conditions caused by excess gastric acid.

• Gastro‑esophageal reflux disease (GERD): reduces reflux symptoms and promotes healing of esophageal irritation.
• Duodenal ulcer: accelerates ulcer healing and prevents recurrence.
• Gastric ulcer: decreases acid secretion to allow mucosal repair.
• Zollinger‑Ellison syndrome: controls hyper‑gastrinemia and associated ulceration.
• NSAID‑induced ulcer prophylaxis: protects the stomach lining in patients taking non‑steroidal anti‑inflammatory drugs.
• Helicobacter pylori eradication (as part of combination therapy): enhances eradication rates when combined with antibiotics.

• Lansoprazole irreversibly binds to the H+/K+ ATPase enzyme (gastric proton pump) located on the secretory surface of gastric parietal cells. By inhibiting this final step of acid production, it markedly reduces basal and stimulated gastric acid secretion, thereby increasing gastric pH and allowing ulcer healing and symptom relief in acid‑related disorders.

Common side effects are generally mild and transient.

Common Side Effects

• Headache: mild to moderate intensity.
• Diarrhea: loose stools occurring during early therapy.
• Nausea: occasional feeling of queasiness.
• Abdominal pain: discomfort in the upper abdomen.
• Flatulence: increased gas formation.
• Constipation: reduced bowel movements.

Serious or Rare Side Effects

• Clostridioides difficile infection: severe colitis risk with prolonged use.
• Severe allergic reaction (anaphylaxis): rash, swelling, difficulty breathing.
• Hepatic enzyme elevation: increased ALT/AST levels.
• Hypomagnesemia: low magnesium leading to muscle cramps or arrhythmia.
• Stevens‑Johnson syndrome: rare skin blistering disorder.
• Interstitial nephritis: inflammation of kidney tissue.

Before initiating therapy, consider the following safety measures.

• Renal function assessment: adjust use in patients with severe renal impairment.
• Hepatic impairment caution: monitor liver function tests during treatment.
• Long‑term use monitoring: evaluate risk of bone fractures and vitamin B12 deficiency.
• Drug interaction review: check for concomitant medications that may alter acid levels.
• Hypersensitivity avoidance: discontinue if allergic reactions occur.
• Store at room temperature: keep in the original packaging, protect from moisture and heat.

Lansoprazole can affect the absorption and metabolism of several drugs.

Major Interactions (Avoid)

• Clopidogrel: reduced antiplatelet effectiveness.
• Atazanavir: decreased antiviral plasma concentrations.
• Methotrexate: increased toxicity risk.
• HIV protease inhibitors (e.g., ritonavir): lowered antiviral activity.
• Warfarin: potential alteration of INR values.

Moderate Interactions (Monitor Closely)

• Digoxin: possible increased serum levels.
• Phenytoin: reduced anticonvulsant concentrations.
• Fluconazole: elevated lansoprazole exposure.
• Ketoconazole: decreased antifungal efficacy.
• Rifampin: reduced lansoprazole plasma levels.