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Pronunciation:

(ni ZA ti deen)

U.S. Brand Names:

Axid®; Axid® AR [OTC]

Generic Available:

Yes: Capsule

Canadian Brand Names:

Apo-Nizatidine®; Axid®; Gen-Nizatidine; Novo-Nizatidine; Nu-Nizatidine; PMS-Nizatidine

Use:

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

Use - Unlabeled/Investigational:

Part of a multidrug regimen for H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Pregnancy Risk Factor:

Pregnancy Implications:

Teratogenic effects were not observed in animal studies.

Lactation:

Enters breast milk/may be compatible

Contraindications:

Hypersensitivity to nizatidine or any component of the formulation; hypersensitivity to other H2 antagonists (cross-sensitivity has been observed)

Warnings/Precautions:

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

Adverse Reactions:

>10%: Central nervous system: Headache (16%)

1% to 10%:

Central nervous system: Anxiety, dizziness, fever (reported in children), insomnia, irritability (reported in children), somnolence, nervousness

Dermatologic: Pruritus, rash

Gastrointestinal: Abdominal pain, anorexia, constipation, diarrhea, dry mouth, flatulence, heartburn, nausea, vomiting

Respiratory: Reported in children: Cough, nasal congestion, nasopharyngitis

<1% (Limited to important or life-threatening): Alkaline phosphatase increased, anaphylaxis, anemia, AST/ALT increased, bronchospasm, confusion, eosinophilia, exfoliative dermatitis, gynecomastia, hepatitis, jaundice, laryngeal edema, serum-sickness like reactions, thrombocytopenia, thrombocytopenic purpura, vasculitis, ventricular tachycardia

Overdosage/Toxicology:

Symptoms of overdose include muscular tremor, vomiting, and rapid respiration. LD50 ~80 mg/kg. Treatment is symptomatic and supportive.

Drug Interactions:

Inhibits 3A4 (weak)

Antifungal agents (imidazole): Nizatidine may decrease the absorption of itraconazole or ketoconazole.

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may cause gastric mucosal irritation).

Mechanism of Action:

Competitive inhibition of histamine at H2-receptors of the gastric parietal cells resulting in reduced gastric acid secretion, gastric volume and hydrogen ion concentration reduced. In healthy volunteers, nizatidine suppresses gastric acid secretion induced by pentagastrin infusion or food.

Pharmacodynamics/Kinetics:

Distribution: Vd: 0.8-1.5 L/kg

Protein binding: 35% to 1-acid glycoprotein

Metabolism: Partially hepatic; forms metabolites

Bioavailability: >70%

Half-life elimination: 1-2 hours; prolonged with renal impairment

Time to peak, plasma: 0.5-3.0 hours

Excretion: Urine (90%; ~60% as unchanged drug); feces (<6%)

Dosage:

Oral:

Children:

<12 years: GERD (unlabeled use): 10 mg/kg/day in divided doses given twice daily; may not be as effective in children <12 years

12 years:

GERD: Refer to Adults dosing

Meal-induced heartburn, acid indigestion and sour stomach: Refer to Adults dosing

Adults:

Duodenal ulcer:

Treatment of active ulcer: 300 mg at bedtime or 150 mg twice daily

Maintenance of healed ulcer: 150 mg/day at bedtime

Gastric ulcer: 150 mg twice daily or 300 mg at bedtime

GERD: 150 mg twice daily

Meal-induced heartburn, acid indigestion, and sour stomach: 75 mg tablet [OTC] twice daily, 30 to 60 minutes prior to consuming food or beverages

Helicobacter pylori eradication (unlabeled use): 150 mg twice daily; requires combination therapy

Dosing adjustment in renal impairment:

Active treatment:

Clcr 20-50 mL/minute: 150 mg/day

Clcr<20 mL/minute: 150 mg every other day

Maintenance treatment:

Clcr 20-50 mL/minute: 150 mg every other day

Clcr<20 mL/minute: 150 mg every 3 days

Test Interactions:

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

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take as directed; do not change dose or discontinue without consulting prescriber. Do not take within 1 hour of any antacids. Follow diet instructions of prescriber. 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, CNS changes, or muscle or joint pain. Pregnancy precaution: Inform prescriber if you are or intend to become pregnant.

Additional Information:

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

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause dizziness or drowsiness; may rarely cause insomnia

Mental Health: Effects on Psychiatric Treatment:

May rarely cause agranulocytosis; use caution with clozapine and carbamazepine

Dosage Forms:

Capsule (Axid®): 150 mg, 300 mg

Solution, oral (Axid®): 15 mg/mL (480 mL) [bubble gum flavor]

Tablet (Axid® AR): 75 mg

International Brand Names:

Acinon® (JP); Antizid® (ZA); Apo-Nizatidine® (CA); Axid® (BR, CA, CZ, GB, HK, HR, ID, IE, MX, NL, RO, RU, TH, TR); Calmaxid® (CH); Cronizat® (IT); Distaxid® (ES); Galitidin® (YU); Gen-Nizatidine (CA); Izatax® (DK); Naxidine® (NL); Naxidin® (HU); Naxidin-S® (HU); Nizalap® (DO); Nizatidine® (GB); Nizax® (DE, DK, FI, IT, NO); Nizaxid® (FR, LU, PT); Novo-Nizatidine (CA); Nu-Nizatidine (CA); Panaxid® (BE, LU); PMS-Nizatidine (CA); Tazac® (AU); Ulcosal® (ES); Ulxit® (AT); Zanizal® (IT); Zinga® (GB)

References

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.

Fennerty MD and Higbee M, "Drug Therapy of Gastrointestinal Disease,"Geriatric Pharmacology, Bressler R and Katz MD, eds, New York, NY: McGraw-Hill, 1993, 585-608.

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.

Rudolph CD, Mazur LJ, Liptak GS, et al, "Guidelines for Evaluation and Treatment of Gastroesophageal Reflux in Infants and Children: Recommendations of the North American Society for Pediatric Gastroenterology and Nutrition,"J Pediatr Gastroenterol Nutr, 2001, 32(Suppl 2):1-31.

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.

Sullivan TJ, Reese JH, Buchmann KA, et al, "Bioavailability Study of Nizatidine When Administered in Food,"Am J Therapeut, 1995, 2:275-8.

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

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