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Pharmacologic class: Histamine2 (H2)-receptor antagonist
Therapeutic class: Antiulcer drug
Pregnancy risk category B
Inhibits histamine action at H2-receptor sites in gastric parietal cells, reducing gastric acid secretion and pepsin production
Capsules: 150 mg, 300 mg
Oral solution: 15 mg/ml
Tablets: 75 mg
Indications and dosages
➣ Active duodenal ulcer Adults: 300 mg P.O. daily at bedtime or 150 mg b.i.d. for up to 8 weeks
➣ Maintenance of healed duodenal ulcers
Adults and children ages 12 and older: 150 mg P.O. daily at bedtime for up to 1 year
➣ Esophagitis and associated heartburn caused by gastroesophageal reflux disease (GERD)
Adults: 150 mg P.O. b.i.d. for up to 12 weeks
➣ Active benign gastric ulcer Adults: 150 mg P.O. b.i.d. or 300 mg P.O. once daily at bedtime
➣ Erosive esophagitis; GERD
Children ages 12 and older: 150 mg P.O. b.i.d. for up to 8 weeks
• Moderate to severe renal impairment
• Elderly patients
• Hypersensitivity to drug or other H2-receptor antagonists
Use cautiously in:
• mild renal impairment
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 12 (safety and efficacy not established).
• Give with or without food.
• If patient is to take drug twice daily, give one dose in morning and one at bedtime.
CNS: dizziness, drowsiness, headache, anxiety, nervousness, insomnia, abnormal dreams, asthenia
CV: chest pain
EENT: amblyopia, sinusitis, rhinitis, pharyngitis
GI: nausea, vomiting, diarrhea, constipation, dyspepsia, abdominal pain, flatulence, anorexia, dry mouth
Musculoskeletal: back pain, myalgia
Skin: rash, pruritus
Other: tooth disorder, infection, fever, pain
Drug-drug. Salicylates (high doses): increased salicylate blood level
Drug-diagnostic tests. Alanine amino-transferase, alkaline phosphatase, aspartate aminotransferase: elevated levels
Urobilinogen tests using Multistix: false-positive result
Drug-herbs. Pennyroyal: altered rate of herbal metabolite formation
• Monitor liver and renal function tests.
• Check temperature; watch for fever and other signs and symptoms of infection.
• Advise patient to take once-daily dose at bedtime with or without food, or twice-daily doses in morning and at bedtime.
• Instruct patient to take exactly as prescribed. Caution him not to take other OTC drugs (especially aspirin).
• Tell patient to report signs and symptoms of infection.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.