Trade Names:Axid- Solution, oral 15 mg/mL
Trade Names:Axid AR- Tablets 75 mg
Trade Names:Axid Pulvules- Capsules 150 mg
Trade Names:Nizatidine- Capsules 300 mgApo-Nizatidine (Canada)Gen-Nizatidine (Canada)PMS-Nizatidine (Canada)
Reversibly and competitively blocks histamine at H 2 receptors, particularly those in gastric parietal cells, leading to inhibition of gastric acid secretion.
Absolute bioavailability is more than 70%, C max is 700 to 1,800 mcg/L (150 mg dose) and 1,400 to 3,600 mcg/L (300 mg dose), and T max is 0.5 to 3 h. Food increases nizatidine AUC and C max by approximately 10%.
Vd is 0.8 to 1.5 L/kg and the plasma protein binding is about 35%, mainly to alpha-1 acid glycoprotein.
Less than 7% of nizatidine is metabolized as N2-monodesmethylnizatidine (main metabolite). Other metabolites include N2-oxide (less than 5%) and S-oxide (less than 6%).
Eliminated in urine (90% excreted; 60% as unchanged) and feces (less than 6%). The t 1/ 2 is 1 to 2 h, plasma Cl is 40 to 60 L/h, and renal Cl is 500 mL/min.
Moderate to severe renal function impairment prolongs nizatidine t 1/ 2 and decreases Cl. Reduce amount and frequency of dose according to severity.
Treatment and maintenance of duodenal ulcer, gastroesophageal reflux disease (GERD) (including erosive or ulcerative disease), and benign gastric ulcer; prevention of heartburn, acid indigestion, and sour stomach brought on by consuming food and beverages.
Prevention of olanzapine-induced weight gain; prevention of NSAID-induced gastroduodenal ulcer, in combination with amoxicillin and clarithromycin for Helicobacter pylori infection.
Hypersensitivity to H 2 antagonists.
PO 300 mg at bedtime or 150 mg twice daily for up to 8 wk.Maintenance
PO 150 mg at bedtime.Benign Gastric Ulcer (Active)Adults
PO 300 mg at bedtime or 150 mg twice daily.Moderate to Severe Renal Function Impairment
CrCl 20 to 50 mL/min: 150 mg daily; maintenance dose 150 mg every other day. CrCl less than 20 mL/min: 150 mg every other day; maintenance dose 150 mg every 3 days.GERDAdults
PO 150 mg twice daily.Children 12 yr of age and older
PO (oral solution) 150 mg twice daily for up to 8 wk (max, 300 mg/day).Moderate to Severe Renal Function Impairment
CrCl 20 to 50 mL/min: 150 mg daily; maintenance dose 150 mg every other day. CrCl less than 20 mL/min: 150 mg every other day; maintenance dose 150 mg every 3 days.Acid ReductionAdults and Children 12 yr of age and older
PO 75 mg with water before eating or up to 1 h before consuming food and beverages that may cause symptoms. Can be used up to twice daily.
Oral solution: Store at 59° to 86°F. Protect from light. Capsules and tablets: Store at 68° to 77°F. Protect from light.
Increased salicylate levels in patients taking very high doses of aspirin (3.9 g/day).Ethanol
Peak plasma ethanol levels may be increased.Ketoconazole
Effects of ketoconazole may be reduced.
False-positive tests for urobilinogen with Multistix may occur.
Headache (17%); dizziness (5%); asthenia, insomnia (3%); abnormal dreams, anxiety, somnolence (2%); nervousness (1%). Children: irritability, pyrexia (greater than 5%).
Pruritus, rash (2%).
Rhinitis (10%); pharyngitis (3%); amblyopia (1%). Children: nasal congestion, nasopharyngitis (greater than 5%).
Abdominal pain (8%); diarrhea (7%); dyspepsia, flatulence, nausea (5%); vomiting (4%); constipation (2%); anorexia, dry mouth, GI disorder, nausea and vomiting, tooth disorder (1%). Children: diarrhea, vomiting (greater than 5%).
Eosinophilia, thrombocytopenia, thrombocytopenic purpura.
Elevated liver enzymes.
Back pain, myalgia (2%).
Increased cough, sinusitis (2%). Children: cough (greater than 5%).
Pain (4%); chest pain, fever, infection (2%); accidental injury (1%); anaphylaxis, serum sickness–like reaction.
Category B .
Excreted in breast milk.
Safety and efficacy not established (capsules and tablets). Safety and efficacy not established in children younger than 12 yr of age (oral solution).
Decreased Cl may occur in patients with renal function impairment; reduced dosage may be needed.
Use drug with caution in patients with hepatic function impairment; decreased Cl may occur. In patients with uncomplicated hepatic function impairment, nizatidine disposition is generally normal.
Abnormalities appear to be reversible after discontinuation of drug.
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