Famotidine (20mg)

Clinical Pharmacologist's Monograph

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

1. Clinical Overview

Famotidine is a competitive, reversible histamine H2-receptor antagonist. It is a potent antisecretory agent that significantly inhibits both basal and stimulated gastric acid secretion (including nocturnal and meal-stimulated secretion). It is widely used in the Indian market for the management of acid-peptic disorders due to its efficacy, safety profile, and cost-effectiveness.

OnsetDurationBioavailability
Within 1 hour for symptom relief; peak antisecretory effect occurs in 1-3 hours.10-12 hours for a single 20mg dose.40-45% (Oral administration). Reduced by food but not clinically significant.

2. Mechanism of Action

Famotidine competitively and reversibly inhibits the action of histamine at the histamine H2-receptors located primarily on the parietal cells of the gastric mucosa. This blockade prevents the activation of adenylate cyclase, leading to a decrease in intracellular cyclic AMP (cAMP). Reduced cAMP levels inhibit the activation of the proton pump (H+/K+ ATPase), resulting in a marked reduction in both the volume and hydrogen ion concentration of gastric acid secretion.

3. Indications & Uses

  • Active Duodenal Ulcer
  • Active Gastric Ulcer
  • Gastroesophageal Reflux Disease (GERD)
  • Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

4. Dosage & Administration

Adult Dosage: Duodenal/Gastric Ulcer: 20 mg twice daily or 40 mg at bedtime. Maintenance: 20 mg at bedtime. GERD: 20 mg twice daily for up to 6 weeks. Hypersecretory conditions: Start at 20 mg every 6 hours, adjust as needed.

Administration: Can be taken with or without food. Tablet should be swallowed whole with a glass of water. For once-daily dosing, take at bedtime. For twice-daily dosing, take in the morning and at bedtime.

5. Side Effects

Common side effects may include:

  • Headache
  • Dizziness
  • Constipation
  • Diarrhea

6. Drug Interactions

DrugEffectSeverity
Ketoconazole, Itraconazole, AtazanavirFamotidine increases gastric pH, which can significantly reduce the absorption of these drugs that require an acidic environment. Separate administration by at least 2 hours.Major
WarfarinTheoretical interaction due to altered absorption; however, clinically significant interaction is rare. Monitor INR periodically.Moderate
ProcainamideFamotidine may reduce renal clearance of procainamide, increasing its plasma levels and risk of toxicity.Moderate
AntacidsMay reduce the absorption of Famotidine. Administer Famotidine at least 1-2 hours before or after antacids.Minor

7. Patient Counselling

  • Do take the medication as prescribed, even if symptoms improve quickly.
  • Do inform your doctor about all other medications, including OTC antacids and supplements.
  • Don't crush or chew the tablet unless advised (some dispersible forms exist).
  • Don't take a double dose to make up for a missed one.

8. Toxicology & Storage

Overdose: Symptoms are extensions of side effects: CNS effects (confusion, agitation, seizures - especially in renal failure), hypotension, bradycardia, arrhythmias, vomiting, diarrhea, muscle cramps.

Storage: Store below 30°C, in a cool, dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date printed on the pack.