Drug Utilization Review (DUR) of Cimetidine

1. Justification for Use
  • Short-term management for active duodenal ulcer.
  • Long term prophylaxis
  • Benign gastric ulcer
  • Gastric hypersensitivity conditions
  • Acid indigestion
  • Soar stomach
  • To prevent upper gastrointestinal bleeding in acute ill patients

2. Process/Critical indicators

I. Adverse effects
  • 1-10 %
  • CNS: Dizziness, drowsiness, headache.
  • GIT: Nausea, vomiting, diarrhea.
  • Less than 1 %
  • Bradycardia, tachycardia, and hypotension.
II.  Contraindications: Hypersensitivity to cimetidine
III. Precautions/Warning: Adjust the dose in renal or hepatic impairment.
IV. Toxicity
  • Vomiting
  • Diarrhea
  • Hypotension
  • Respiratory failure
  • Restlessness
  • The toxic dose is 20 gm.


Management:
  • Gastric lavage
  • Induction of vomiting
  • Maintenance of supportive therapy.

V. Interactions
  1. Drug-drug interactions: Benzodiazepines, €-blockers, Ca-channel blockers and lidocaine increase the serum concentration of cimetidine.
  2. Drug-alcohol interaction: Avoid use with alcohol because alcohol causes gastric irritations.
  3. Drug-food interactions: Food decreases its absorption, therefore should be taken at least 30 min before meal. With coffee, it causes increased serum level of caffeine.

VI. Pharmacokinetics
  1. The onset of action: 1 hour
  2. Duration of action: 6 hours
  3. Protein binding: 20%
  4. Distribution: Can cross the placenta as well as enter breast milk.
  5. Metabolism: Partly hepatic
  6. Bioavailability: 40-60 %
  7. Elimination half-life :
  8. Neonates: 3.6 hrs
  9. Children: 1.4 hrs
  10. Adults: 2 hrs ( Ele: t⅟₂ is 1.4 hr in children because in children the rate of metabolism is high)
  11. Peak concentration time: 2 hrs after I.M / I.V / oral administration.
  12. Excretion: urine (primarily unchanged)


VII. Dose
  • Children: 20-40 mg/kg/day IM/IV/Oral
  • Adult: 300 mg 6 hourly IM/IV/Oral

VIII. Dosage form

As HCl salt.
  • Injection: 300 mg/ml
  • Suspension : 100 mg/5ml
  • Tablets: 200 mg, 400 mg.

IX. Drug-lab interactions
  • Raised ALT and AST

X. Monitoring test
  • Complete Blood Count (CBC)
  • Gastric PH
  • Liver function test

XI. Patient education
  • Smoking decreases the effectiveness of cimetidine.
  • Avoid use of ethanol
  • Inform prescriber of all prescriptions.

Conclusion
  • Take 30 min before meal.
  • Let your physician know about kidney or liver disease.
  • If dose is skipped, then follow the routine schedule, never double the dose.
  • Let your doctor know about the pregnancy.
  • Should not be used in immune-compromised individual because raised gastric PH may lead to an infection strong lodiasis.
  • Should not be used in child under 16 years of age.

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