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Action/Kinetics:
Decreases gastric acid secretion by blocking the effect of histamine on histamine H
2 receptors. Does not affect the P-450 and P-448 drug metabolizing enzymes.
Onset: 30 min.
Peak plasma levels: 0.5-3 hr after a PO dose.
Time to peak effect: 0.5-3 hr.
Duration, nocturnal: Up to 12 hr;
basal: Up to 8 hr.
t
1/2: 1-2 hr. Approximately 60% of a PO dose is excreted unchanged in the urine. Clients with moderate to severe renal impairment manifest a significant prolongation of t
1/2 with decreased clearance.
Uses:
Treatment of acute duodenal ulcer and maintenance following healing of a duodenal ulcer. GERD, including erosive and ulcerative esophagitis. Short-term treatment of benign gastric ulcer. OTC use to prevent meal-induced heartburn.
Contraindications:
Hypersensitivity to H
2 receptor antagonists. Cirrhosis of the liver, impaired renal or hepatic function. Lactation.
Special Concerns:
Safety and efficacy have not been determined in children.
Side Effects:
CNS: Headache, fatigue, somnolence, insomnia, dizziness, abnormal dreams, anxiety, nervousness, confusion (rare).
GI: N&V;, diarrhea, pancreatitis, constipation, abdominal discomfort, flatulence, dyspepsia, anorexia, dry mouth.
Dermatologic: Exfoliative dermatitis, erythroderma, pruritus, urticaria, erythema multiforme.
CV: Asymptomatic VT;
rarely, cardiac arrhythmias or arrest following rapid IV use.
Respiratory: Rhinitis, pharyngitis, sinusitis, cough.
Body as a whole: Asthenia, back pain, chest pain, infection, fever, myalgia.
Miscellaneous: Impotence, loss of libido, thrombocytopenia, sweating, gynecomastia, hyperuricemia, eosinophilia, gout, and cholestatic or hepatocellular effects (resulting in increased AST, ALT, or alkaline phosphatase).
Laboratory Test Alterations:
False + test for urobilinogen.
Drug Interactions:
-
Antacids containing Al and Mg hydroxides /
Nizatidine absorption by about 10%
-
Aspirin, high doses /
Salicylate serum levels
-
Simethicone /
Nizatidine absorption by about 10%
How Supplied:
Capsule: 150 mg, 300 mg
; Tablet: 75 mg
Dosage
Axid
?Capsules
Active duodenal ulcer.
Adults: Either 300 mg once daily at bedtime or 150 mg b.i.d. If the C
CR is 20-50 mL/min: 150 mg/day; if C
CR is less than 20 mL/min: 150 mg every other day.
Prophylaxis following healing of duodenal ulcer.
Adults: 150 mg/day at bedtime. If C
CR is 20-50 mL/min: 150 mg every other day; if C
CR is less than 20 mL/min: 150 mg every 3 days.
Treatment of benign gastric ulcer.
Adults: 150 mg b.i.d. or 300 mg at bedtime
GERD, including erosive and ulcerative esophagitis.
Adults: 150 mg b.i.d.
Axid AR
?Tablets
Heartburn.
1 tablet b.i.d.