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Nizatidine (Axid)
(nye- ZAY-tih-deen)
Pregnancy Category: C Apo-Nizatidine Axid (Rx) Axid AR (OTC)

Classification: Histamine H 2 receptor antagonist

See Also: See also Histamine H 2 Antagonists .

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

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.

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