Lanzol

Approved Indications:

• Gastroesophageal Reflux Disease (GERD):
• Short-term treatment of erosive esophagitis.
• Maintenance therapy after healing of erosive esophagitis.
• Relief of heartburn symptoms in non-erosive GERD.
• Peptic Ulcer Disease:
• Short-term treatment of active duodenal ulcers.
• Short-term treatment of active benign gastric ulcers.
• Maintenance to prevent recurrence of duodenal ulcers.
• Helicobacter pylori Eradication (as part of triple therapy):
• In combination with amoxicillin and clarithromycin for H. pylori eradication in patients with duodenal ulcer.
• Zollinger-Ellison Syndrome and Other Hypersecretory Conditions:
• Long-term management of pathological hypersecretory conditions.
• NSAID-Associated Gastric Ulcers:
• Healing of NSAID-associated gastric ulcers.
• Risk reduction of gastric ulcers in patients requiring NSAID therapy.

Clinically Accepted (Off-Label) Uses:

• Functional dyspepsia.
• Eosinophilic esophagitis.
• Laryngopharyngeal reflux (LPR).
• Stress ulcer prophylaxis in high-risk ICU patients.

Route of Administration: Oral (capsule, orally disintegrating tablet)

Adults:

• GERD (Erosive Esophagitis): 30 mg once daily for 8 weeks; may extend another 8 weeks if not healed.
• Maintenance of GERD Healing: 15 mg once daily.
• Non-Erosive GERD: 15 mg once daily for up to 4 weeks.
• Duodenal Ulcer: 15 mg once daily for 4 weeks.
• Gastric Ulcer: 30 mg once daily for 4–8 weeks.
• H. pylori Eradication (Triple Therapy):
• Lansoprazole 30 mg twice daily
• Amoxicillin 1000 mg twice daily
• Clarithromycin 500 mg twice daily
• Duration: 10–14 days
• Zollinger-Ellison Syndrome: Starting dose: 60 mg once daily; doses up to 90 mg twice daily may be required.
• NSAID-Induced Ulcers: 30 mg once daily for 8 weeks.
• NSAID Ulcer Prophylaxis: 15–30 mg once daily, during NSAID therapy.

Pediatrics (1–17 years):

• GERD (Erosive Esophagitis):
• ≤30 kg: 15 mg once daily for 8–12 weeks.
• 30 kg: 30 mg once daily for 8–12 weeks.
• Non-Erosive GERD (1–11 years): 15 mg once daily for up to 12 weeks.

Elderly:

• No routine dose adjustment required; monitor closely.

Renal Impairment:

• No adjustment required.

Hepatic Impairment:

• Mild to moderate: No adjustment needed.
• Severe: Use with caution; consider dose reduction.

Lansoprazole is a proton pump inhibitor that suppresses gastric acid secretion by selectively and irreversibly inhibiting the H⁺/K⁺-ATPase enzyme system (proton pump) on the secretory surface of gastric parietal cells. By blocking the final step in acid production, lansoprazole leads to a marked and long-lasting decrease in gastric acid secretion, providing relief from acid-related disorders and promoting mucosal healing.

• Absorption: Rapid; peak plasma concentration occurs within 1.5–2 hours.
• Bioavailability: 80–90% after repeated dosing.
• Protein Binding: Approximately 97%.
• Metabolism: Extensively metabolized in the liver by CYP2C19 and CYP3A4 enzymes.
• Elimination Half-Life: Approximately 1.5 hours; pharmacodynamic effects persist longer.
• Excretion: Primarily via feces (as metabolites); 15–30% via urine.
• Onset of Action: Within 1–3 hours.
• Duration of Action: Acid suppression lasts up to 24 hours.

• Pregnancy: Category B (FDA legacy classification). Animal studies show no harm; human data are limited. Use only if clearly needed.
• Lactation: Excretion in human milk is unknown. Due to potential suppression of gastric acid in the infant, caution is advised. Alternatives with more safety data may be preferred.

• Primary Class: Proton Pump Inhibitor (PPI)
• Subclass: Substituted benzimidazole derivative

• Known hypersensitivity to lansoprazole or any component of the formulation.
• Known hypersensitivity to other proton pump inhibitors.
• Concomitant use with rilpivirine-containing products.

• Clostridioides difficile–associated diarrhea: Especially with prolonged use.
• Bone fracture risk: Long-term use may increase risk of hip, spine, or wrist fractures.
• Hypomagnesemia: Risk increases with use >3 months; monitor magnesium levels.
• Vitamin B12 Deficiency: Risk with prolonged use (>3 years).
• Acute Interstitial Nephritis: Can occur at any time; consider if renal function declines.
• Lupus Erythematosus: Both cutaneous and systemic forms reported with PPIs.
• Gastric Malignancy: Symptom relief does not rule out malignancy; assess before initiating therapy.

Common:

• Gastrointestinal: Diarrhea, abdominal pain, nausea, constipation, flatulence
• Central Nervous System: Headache, dizziness
• Skin: Rash

Serious/Rare:

• Hypomagnesemia
• Acute interstitial nephritis
• Clostridioides difficile infection
• Hepatotoxicity
• Seizures (secondary to low magnesium)
• Bone fractures (hip, wrist, spine)
• Cutaneous/systemic lupus erythematosus

• Reduced Absorption of pH-Dependent Drugs: Decreased bioavailability of ketoconazole, atazanavir, itraconazole, erlotinib, and iron salts.
• Clopidogrel: May reduce antiplatelet effect due to CYP2C19 interaction.
• Digoxin: Increased serum levels; monitor closely.
• Methotrexate: High-dose methotrexate toxicity risk may be increased.
• Warfarin: Possible INR elevation; monitor closely.
• CYP Enzymes Involved: CYP2C19 (primary), CYP3A4 (secondary)

• Long-term PPI use has been increasingly linked to risks of kidney disease, fractures, and infections.
• Updated guidelines recommend PPIs like lansoprazole for shortest duration necessary.
• H. pylori treatment recommendations emphasize local antibiotic resistance patterns.
• Regulatory agencies (FDA, EMA) advise caution regarding long-term safety but continue to support appropriate PPI use.

• General Storage:
  Store at 20°C to 25°C (68°F to 77°F).
  Allowable excursions: 15°C to 30°C (59°F to 86°F).
• Protection:
  Keep away from moisture and light. Store in a tightly closed container.
• Orally Disintegrating Tablets:
  Use immediately after removal from blister; do not store outside the package.
• Do Not Refrigerate or Freeze.