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Indications and Dosage
Oral
Benign gastric and duodenal ulceration, NSAID-associated ulceration Adult: 300 mg at bedtime or in 2 divided doses for 4-8 weeks. Maintenance: 150 mg at bedtime. Oral Dyspepsia Adult: 75 mg daily, repeated if needed, up to a max of 150 mg daily for up to 2 wk. Oral Gastro-oesophageal reflux disease Adult: 150-300 mg bid for up to 12 weeks.
Child: ≥12 yr 150 mg bid for up to 8 wk. |
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Renal Impairment
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Administration
May be taken with or without food.
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Special Precautions
Possibility of malignancy should be excluded prior to therapy as the drug may mask symptoms and delay diagnosis of gastric malignancy. Increased risk of community-acquired pneumonia. Renal impairment. Pregnancy and lactation.
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Adverse Reactions
Headache, dizziness, insomnia, abnormal dreams, somnolence, asthenia, anxiety, excessive sweating, diarrhoea, nausea and/or vomiting, abdominal pain/discomfort, constipation, flatulence, dyspepsia, dry mouth, anorexia, tooth disorder, urticaria, rash, pruritus, exfoliative dermatitis, anaemia, rhinitis, pharyngitis, sinusitis, reversible hepatocellular injury, diaphoresis, myalgia, fever. Rarely, asymptomatic ventricular tachycardia, thrombocytopenic purpura, decreased libido, gynaecomastia, reversible cholestatic or mixed cholestatic-hepatocellular injury w/ jaundice.
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Patient Counseling Information
May impair ability to drive, operate machinery and perform hazardous tasks.
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Overdosage
Symptoms: Lacrimation, salivation, emesis, miosis, and diarrhoea. Management: Symptomatic and supportive treatment. Activated charcoal, emesis or lavage may reduce absorption.
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Drug Interactions
May increase absorption of aspirin when used in high-doses. May decrease bioavailability w/ antacids.
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Food Interaction
Food slightly enhance the bioavailability of nizatidine. May cause gastric mucosal irritation w/ alcohol. Apple juice may reduce absorption.
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Lab Interference
May cause false-positive tests for urobilinogen w/ Multistix.
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Action
Description: Nizatidine is a histamine H2-receptor antagonist. It blocks histamine H2-receptors on gastric parietal cells resulting in decreased gastric acid secretion, gastric volume and hydrogen ion concentration.
Pharmacokinetics: Absorption: Readily absorbed from the GI tract. Bioavailability: >70%; slightly increased by food. Time to peak plasma concentration: Approx 0.5-3 hr. Distribution: Widely distributed; enters breast milk. Volume of distribution: 0.8-1.5 L/kg. Plasma protein binding: Approx 35%. Metabolism: Partly hepatic. Converted to nizatidine N-2-oxide, nizatidine S-oxide, and N-2-monodesmethylnizatidine (60% of the activity). Excretion: Via urine (>90%), in part by active tubular secretion, w/in 12 hr, approx 60% as unchanged drug; faeces (<6%). Elimination half-life: 1-2 hr. |
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Storage
Store at 25°C.
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MIMS Class
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References
Anon. Nizatidine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/01/2014. Axid (Braintree Laboratories, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 10/01/2014. Buckingham R (ed). Nizatidine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/01/2014. McEvoy GK, Snow EK, Miller J et al (eds). Nizatidine. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 10/01/2014.
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