Nizatidine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing nizatidine
Drugs List
Therapeutic Indications
Uses
Benign gastric ulcer
Duodenal ulcer
Gastric and/or duodenal ulcer associated with NSAIDs
Gastro-oesophageal reflux disease - treatment
Prevention of duodenal or benign gastric ulcer recurrence
Dosage
Adults
Duodenal or benign gastric ulcers (including NSAID associated)
300 mg every evening or 150 mg in the morning and 150 mg in the evening for 4 weeks.
Treatment may be stopped earlier than 4 weeks if healing is confirmed by endoscopy
If ulcer has not healed continue treatment for another 4 weeks. Maximum duration of treatment is 8 weeks.
During treatment of NSAID associated gastric and/or duodenal ulcer, the use of NSAID may continue.
Duodenal or benign gastric ulcer prophylactic maintenance therapy
150 mg in the evening
Gastric oesophageal reflux disease
150 mg to 300 mg twice daily. Therapy for up to 12 weeks in indicated for erosions and ulcerations and associated heartburn.
Patients with Renal Impairment
Dosage reduction is required in patient with moderate (creatinine clearance less than 50 ml/minute) to severe (creatinine clearance less than 20 ml/minute) renal impairment.
Creatinine clearance less than 50 ml/minute
Duodenal ulcer: 150 mg in the evening
Benign gastric ulcer: 150 mg in the evening
Prevention of duodenal or benign gastric ulcer recurrence: 150 mg in the evening on alternate days
Gastric oesophageal reflux disease: from 150 mg daily, up to 150 mg twice daily
Gastric and/or duodenal ulcer associated with concomitant use of NSAIDs: 150 mg in the evening
Creatinine clearance less than 20 ml/minute
Duodenal ulcer: 150 mg on alternate days
Benign gastric ulcer: 150 mg on alternate days
Prevention of duodenal or benign gastric ulcer recurrence: 150 mg in the evening every third day
Gastric oesophageal reflux disease: from 150 mg on alternate days, up to 150 mg daily
Gastric and/or duodenal ulcer associated with concomitant use of NSAIDs: 150 mg on alternate days
The Renal Drug Handbook suggests:
Glomerular filtration rate of 20 to 50 ml/minute: 150 mg every 12 to 48 hours
Glomerular filtration rate of less than 20 ml/minute: 150 mg every 24 to 72 hours
Contraindications
Children under 18 years
Precautions and Warnings
Breastfeeding
Hepatic impairment
Pregnancy
Renal impairment - creatinine clearance below 50ml/minute
Exclude gastric cancer before commencing treatment
Symptomatic response to nizatidine therapy does not preclude the presence of gastric malignancy.
Pregnancy and Lactation
Pregnancy
Use nizatidine with caution during pregnancy.
Nizatidine should only be used in pregnant women if the expected benefits are likely to outweigh any potential risks to the foetus.
Schaefer (2015) suggests that H2 receptor antagonists may be used during pregnancy, with ranitidine being the drug of choice.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use nizatidine with caution during breastfeeding.
Nizatidine is excreted in breast milk, with 0.1% of the administered oral dose being secreted in milk in proportion to plasma concentration.
Schaefer (2015) indicates that famotidine is the H2 receptor blocker of choice whilst breastfeeding. The American Academy of Paediatrics classifies a similar H2 receptor blocker, cimetidine, as compatible with breastfeeding (Briggs, 2015).
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Agranulocytosis
Anaemia
Arthralgia
Cholestatic liver changes
Exfoliative dermatitis
Fever
Gynaecomastia
Hepatitis
Hyperuricaemia
Impotence
Increase in alkaline phosphatase
Increases in hepatic enzymes (reversible)
Jaundice
Leucopenia
Myalgia
Nausea
Reversible confusional states
Reversible liver damage
Somnolence
Sweating
Thrombocytopenia
Thrombocytopenic purpura
Urticaria
Vasculitis
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: May 2017
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Nizatidine Capsules. Flynn Pharma Ltd. Revised November 2015.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Nizatidine. Last revised: 10 March 2015
Last accessed: 12 May 2017
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