Chemical formula: C₁₂H₂₁N₅O₂S₂ Molecular mass: 331.45 g/mol PubChem compound: 3033637
Nizatidine interacts in the following cases:
Nizatidine does not inhibit the hepatic cytochrome P450-linked drug metabolising enzyme system, but may increase absorption of salicylates when they are used in very high dosage.
For patients who have moderate renal impairment (creatinine clearance less than 50 ml/min) or patients who have severe renal impairment (creatinine clearance less than 20 ml/min), the dosage should be reduced as follows:
| Dosage recommended | ||
|---|---|---|
| Indications | Moderate Renal Impairment | Severe Renal Impairment |
| Duodenal ulcer | 150 mg in the evening | 150 mg on alternate days |
| Benign gastric ulcer | 150 mg in the evening | 150 mg on alternate days |
| Prevention of duodenal or benign gastric ulcer recurrence | 150 mg in the evening on alternate days | 150 mg in the evening every third day |
| Gastric oesophageal reflux disease | From 150 mg daily, up to 150 mg twice daily | From 150 mg on alternate days, up to 150 mg daily |
| Gastric and/or duodenal ulcer associated with concomitant use of non-steroidal anti-inflammatory drugs | 150 mg in the evening | 150 mg on alternate days |
The safety of nizatidine for use during pregnancy has not been established. Animal studies have shown no evidence of impaired fertility or teratogenicity attributable to nizatidine. Nizatidine should only be used in pregnant women, or in those planning pregnancy, if considered absolutely necessary, and then with caution.
Studies conducted in lactating women have shown that 0.1% of the administered oral dose of nizatidine is secreted in human milk in proportion to plasma concentrations. Because of the growth depression in pups reared by lactating rats treated with nizatidine, it should be administered to nursing mothers only if considered absolutely necessary.
There is no influence of nizatidine on the ability to drive or use machines.
In large scale clinical trials, sweating and urticaria were significantly more common in nizatidine-treated patients when compared with placebo. In these trials, 1.9% of treated patients experienced somnolence, compared to 1.6% 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 (>500 iu/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. Hepatitis and jaundice have been reported. Rare cases of cholestatic or mixed hepatocellular and cholestatic injury with jaundice have also 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.
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