NIZATIDINE

Method of administration For oral administration. Posology Adults: 1. For treatment of duodenal ulcer, the recommended daily dose is 300mg in the evening. Treatment should continue for four weeks, although this period may be reduced if healing is confirmed earlier by endoscopy.

Most ulcers will heal within four weeks, but if complete ulcer healing has not occurred after four weeks therapy, patients should continue therapy for a further four weeks. 2. For the treatment of benign gastric ulcer, the recommended daily dose is 300mg in the evening for four or, if necessary, eight weeks.

Prior to treatment with nizatidine, care should be taken to exclude the possibility of gastric cancer. If preferred, the 300mg daily dose for the treatment of duodenal or benign gastric ulcer may be given as two divided doses of 150mg in the morning and evening.

3. For the prevention of duodenal or benign gastric ulcer recurrence (prophylactic maintenance therapy), the recommended daily dose is 150mg in the evening. 4. For the treatment of gastric oesophageal reflux disease, the recommended dosage is from 150mg twice daily, up to 300mg twice daily.

Therapy for up to 12 weeks is indicated for erosions and ulcerations, and associated heartburn. 5. For the treatment of gastric and/or duodenal ulcer associated with concomitant use of non-steroidal anti-inflammatory drugs, the recommended daily dose is 300mg daily (either 300mg at bedtime or 150mg twice daily, in the morning and in the evening) for up to 8 weeks.

In most patients, the ulcers will heal within 4 weeks. During treatment, the use of non-steroidal anti-inflammatory drugs may continue.

The elderly:

Age does not significantly influence efficacy or safety. Normally dosage modification is not required, except in patients who have moderate to severe renal impairment (creatinine clearance less than 50ml/min).

Paediatric population:

The safety and efficacy of nizatidine in children has not been established. No data are available.

Patients with impaired renal function:

For patients who have moderate renal impairment (creatinine clearance less than 50ml/min) or patients who have severe renal impairment (creatinine clearance less than 20ml/min), the dosage should be reduced as follows. DOSAGE RECOMMENDED Indications Moderate Renasl Impairment Severe Renal Impairment Duodenal ulcer 150mg in the evening 150mg on alternate days Benign gastric ulcer 150mg in the evening 150mg on alternate days Prevention of duodenal or benign gastric ulcer recurrence 150mg in the evening on alternate days 150mg in the evening every third day Gastric oesophageal reflux disease From 150mg daily, up to 150mg twice daily From 150mg on alternate days, up to 150 mg daily Gastric and/or duodenal ulcer associated with concomitant use of non- steroidal anti-inflammatory drugs 150mg in the evening 150mg on alternate days

In large scale clinical trials, sweating and urticaria were significantly more common in patients treated with oral nizatidine when compared with placebo. 6% of placebo patients (non-significant). In the same trials, patients treated with both nizatidine and placebo had mild, transient, asymptomatic elevations of transaminases or alkaline phosphatase; rare instances of marked elevations (>500iu/l) occurred in nizatidine-treated patients.

The overall rate of occurrences of elevated liver enzymes and elevations to 3 times the upper limit of normal, however, did not differ significantly from placebo. All abnormalities were reversible after discontinuation of nizatidine.

Since introduction, hepatitis and jaundice have been reported. Rare cases of cholestatic or mixed hepatocellular and cholestatic injury with jaundice have been reported, with reversal of the abnormalities after discontinuation. The following effects have also been rarely reported, thrombocytopenic purpura, fatal thrombocytopenia, leucopenia, agranulocytosis, anaemia, exfoliative dermatitis, vasculitis, arthralgia, myalgia, gynaecomastia, impotence, hyperuricaemia, fever, nausea and reversible mental confusion.

Rare episodes of hypersensitivity reactions (eg, bronchospasm, laryngeal oedema, rash, pruritus and eosinophilia), serum sickness and anaphylaxis have been reported. Very rarely headache and diarrhoea have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

As nizatidine is partially metabolised by the liver and principally excreted by the kidneys, patients with impaired liver or kidney function should be treated with caution. (See 'Posology and method of administration' section). Symptomatic response to nizatidine therapy does not preclude the presence of gastric malignancy.

96 mg/kg/day.

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