Nizatidine


Generic Medicine Info
Indications and Dosage
Oral
Benign gastric and duodenal ulceration, NSAID-associated ulceration
Adult: Treatment: 300 mg daily as a single dose at bedtime or in 2 divided doses for 4-8 weeks. Maintenance: 150 mg daily at night.

Oral
Gastro-oesophageal reflux disease
Adult: For the treatment of endoscopically diagnosed oesophagitis, including erosive and ulcerative oesophagitis, and associated heartburn: 150-300 mg bid for up to 12 weeks. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: ≥12 years 150 mg bid for up to 8 weeks. Max: 300 mg daily. Treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Renal Impairment
CrCl (mL/min) Dosage
<20 Treatment: 150 mg every other day. Maintenance: 150 mg every 3 days.
20-50 Treatment: 150 mg daily. Maintenance: 150 mg every other day.
Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Administration
May be taken with or without food.
Special Precautions
Symptomatic relief does not preclude the presence of gastric malignancy. Hepatic impairment and moderate to severe renal impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Vitamin B12 malabsorption and deficiency (prolonged use).
Blood and lymphatic system disorders: Rarely, anaemia.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea.
General disorders and administration site conditions: Rarely, fever.
Hepatobiliary disorders: Hepatitis, jaundice. Rarely, mixed hepatocellular and cholestatic jaundice.
Immune system disorders: Rarely, serum sickness-like reaction.
Investigations: Increased serum alkaline phosphatase, AST or ALT.
Metabolism and nutrition disorders: Rarely, hyperuricaemia.
Musculoskeletal and connective tissue disorders: Myalgia.
Nervous system disorders: Headache, dizziness.
Psychiatric disorders: Rarely, reversible mental confusion.
Reproductive system and breast disorders: Rarely, impotence, decreased libido, gynaecomastia.
Skin and subcutaneous tissue disorders: Urticaria, sweating. Rarely, exfoliative dermatitis.
Potentially Fatal: Rarely, thrombocytopenia.
Overdosage
Symptoms: Diarrhoea, emesis, salivation, lacrimation and miosis. Management: Symptomatic and supportive treatment. Administer activated charcoal, perform gastric lavage or induce emesis to reduce absorption.
Drug Interactions
Decreased bioavailability with antacids. Concurrent administration with very high doses of aspirin increases serum salicylate levels. May decrease the gastric absorption of other drugs whose absorption depends on acidic gastric pH.
Lab Interference
May cause false-positive tests for urobilinogen with Multistix®.
Action
Description:
Mechanism of Action: Nizatidine competitively inhibits histamine at the H2-receptors of the gastric parietal cells. This results in decreased gastric acid secretion, gastric volume and hydrogen ion concentration.
Pharmacokinetics:
Absorption: Readily absorbed from the gastrointestinal tract. Bioavailability: >70%. Time to peak plasma concentration: 0.5-3 hours.
Distribution: Crosses the placenta and enters breast milk. Volume of distribution: 0.8-1.5 L/kg. Plasma protein binding: Approx 35%, mainly to α1-acid glycoprotein.
Metabolism: Partially metabolised in the liver into N-2-monodesmethylnizatidine, nizatidine S-oxide and nizatidine N-2-oxide.
Excretion: Via urine (>90%, approx 60% as unchanged drug); faeces (<6%). Elimination half-life: 1-2 hours.
Chemical Structure

Chemical Structure Image
Nizatidine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3033637, Nizatidine. https://pubchem.ncbi.nlm.nih.gov/compound/Nizatidine. Accessed Oct. 25, 2023.

Storage
Store between 20-25°C. Protect from light.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BA04 - nizatidine ; Belongs to the class of H2-receptor antagonists. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
References
Anon. Nizatidine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 08/05/2023.

Anon. Nizatidine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/05/2023.

Buckingham R (ed). Nizatidine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/05/2023.

Joint Formulary Committee. Nizatidine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/05/2023.

Nizatidine 300 mg Capsules (Relonchem Limited). MHRA. https://products.mhra.gov.uk. Accessed 08/05/2023.

Nizatidine Capsule (Dr Reddy’s Laboratories Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/05/2023.

Nizatidine Solution (Amneal Pharmaceuticals LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/05/2023.

Disclaimer: This information is independently developed by MIMS based on Nizatidine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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