Zantac Special Precautions





Zuellig Pharma
Full Prescribing Info
Special Precautions
The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer and patients of middle age and over with new or recently changed dyspeptic symptoms, as treatment with ZANTAC may mask symptoms of gastric carcinoma.
Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with renal impairment.
The dosage should be adjusted as previously mentioned in Renal Impairment under Dosage & Administration.
Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks. ZANTAC should therefore be avoided in patients with a history of acute porphyria.
Regular supervision of patients who are taking non-steroidal anti-inflammatory drugs concomitantly with oral ZANTAC is recommended, especially in the elderly and in those with a history of peptic ulcer.
In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia. A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of H2-receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk increase of 1.63 (95% CI, 1.07 - 2.48).
Bradycardia in association with rapid administration of ZANTAC injection has been reported rarely, usually in patients with factors predisposing to cardiac rhythm disturbances. Recommended rates of administration should not be exceeded.
The use of higher than recommended doses of i.v. H2- antagonists has been associated with rises in liver enzymes when treatment has been extended beyond five days.
Syrup: ZANTAC syrup contains approximately 7.5% w/v ethanol (alcohol), i.e. up to 405 mg per 5ml spoonful (approximately a teaspoonful) which is equivalent to about 11ml of beer or 5ml of wine. This should be taken into account in children, pregnant or lactating women, or high risk groups (alcoholism, liver disease, epilepsy, brain injury or disease). It may modify or increase the effect of other medicines.
Effects on Ability to Drive and Use Machines: None reported.
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