No

Histamine H₂ Antagonist

Treatment and maintenance of duodenal ulcer; treatment of gastroesophageal reflux disease (GERD); OTC tablet used for the prevention of meal-induced heartburn, acid indigestion, and sour stomach

C

Hypersensitivity to nizatidine or any component of the preparation; hypersensitivity to other H₂-antagonists since a cross-sensitivity has been observed with this class of drugs

Use with caution in children <12 years of age; use with caution in patients with liver and renal impairment; dosage modification required in patients with renal impairment

1% to 10%:

Central nervous system: Dizziness, headache

Gastrointestinal: Constipation, diarrhea

<1%: Bradycardia, tachycardia, palpitations, hypertension, fever, fatigue, seizures, insomnia, drowsiness, acne, pruritus, urticaria, dry skin, abdominal discomfort, flatulence, belching, anorexia, agranulocytosis, neutropenia, thrombocytopenia, increased AST/ALT, paresthesia, weakness, increased BUN/creatinine, proteinuria, bronchospasm, allergic reaction

Symptoms of overdose include muscular tremors, vomiting, rapid respiration

LD₅₀~80 mg/kg; treatment is primarily symptomatic and supportive

No data reported

Nizatidine is an H₂-receptor antagonist. In healthy volunteers, nizatidine has been effective in suppressing gastric acid secretion induced by pentagastrin infusion or food. Nizatidine reduces gastric acid secretion by 29.4% to 78.4%. This compares with a 60.3% reduction by cimetidine. Nizatidine 100 mg is reported to provide equivalent acid suppression as cimetidine 300 mg.

Adults: Oral:

Treatment: 300 mg at bedtime or 150 mg twice daily

Maintenance: 150 mg/day

Meal-induced heartburn, acid indigestion, and sour stomach:

75 mg tablet [OTC] twice daily, 30 to 60 minutes prior to consuming food or beverages

Dosing adjustment in renal impairment:

Cl_cr 50-80 mL/minute: Administer 75% of normal dose

Cl_cr 10-50 mL/minute: Administer 50% of normal dose or 150 mg/day for active treatment and 150 mg every other day for maintenance treatment

Cl_cr <10 mL/minute: Administer 25% of normal dose or 150 mg every other day for treatment and 150 mg every 3 days for maintenance treatment

False-positive urine protein using Multistix®, gastric acid secretion test, skin tests allergen extracts, serum creatinine and serum transaminase concentrations, urine protein test

May cause dizziness or drowsiness; may rarely cause insomnia

May rarely cause agranulocytosis; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Take as directed; do not increase dose. It may take several days before you notice relief. If antacids approved by prescriber, take 1 hour between antacid and nizatidine. Avoid OTC medications, especially cold or cough medication and aspirin or anything containing aspirin. Follow ulcer diet as prescriber recommends. May cause drowsiness; use caution when driving or engaging in tasks that require alertness until response to drug is known. Report fever, sore throat, tarry stools, changes in CNS, or muscle or joint pain. Pregnancy precautions: Inform prescriber if you are or intend to be pregnant.

Giving dose at 6 PM may better suppress nocturnal acid secretion than 10 PM

Capsule: 150 mg, 300 mg

Tablet [OTC]: 75 mg

Callaghan JT, Bergstrom RF, Rubin A, et al, "A Pharmacokinetic Profile of Nizatidine in Man," Scand J Gastroenterol Suppl, 1987, 136:9-17.

Chey WD, Kochman ML, Traber PG, et al, "Possible Nizatidine-Induced Subfulminant Hepatic Failure," J Clin Gastroenterol, 1995, 20(2):164-7.

Knadler MP, Bergstrom RF, Callaghan JT, et al, "Nizatidine, An H₂-Blocker. Its Metabolism and Disposition in Man," Drug Metab Dispos Biol Fate Chem, 1986, 14(2):175-82.

Mikawa K, Nishina K, Maekawa N, et al, "Effects of Oral Nizatidine on Preoperative Gastric Fluid pH and Volume in Children," Br J Anaesth, 1994, 73(5):600-4.

Simeone D, Caria MC, Miele E, et al, "Treatment of Childhood Peptic Esophagitis: A Double-Blind Placebo-Controlled Trial of Nizatidine," J Pediatr Gastroenterol Nur, 1997, 25(1):51-5.

Vargas R, Ryan J, McMahon G, et al, "Pharmacokinetics and Pharmacodynamics of Oral Nizatidine," J Clin Pharmacol, 1988, 28(1):71-5.