Cardiovascular As with other H2-blockers, rare reports of arrhythmias such as tachycardia , bradycardia , asystole , atrioventricular block, and premature ventricular beats. Hepatic In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving mg intravenously 4 times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously 4 times daily for 5 days.
There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, ranitidine should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred.
Rare cases of hepatic failure have also been reported. Musculoskeletal Rare reports of arthralgias and myalgias. Hematologic Blood count changes leukopenia , granulocytopenia , and thrombocytopenia have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis , pancytopenia , sometimes with marrow hypoplasia , and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.
Endocrine Controlled studies in animals and humans have shown no stimulation of any pituitary hormone by ZANTAC and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when ZANTAC has been substituted. However, occasional cases of gynecomastia, impotence, and loss of libido have been reported in male patients receiving ZANTAC, but the incidence did not differ from that in the general population.
Integumentary Rash , including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis. Respiratory A large epidemiological study suggested an increased risk of developing pneumonia in current users of histaminereceptor antagonists H2RAs compared to patients who had stopped H2RA treatment, with an observed adjusted relative risk of 1.
However, a causal relationship between use of H2RAs and pneumonia has not been established. Other Rare cases of hypersensitivity reactions e. Procainamide Ranitidine, a substrate of the renal organic cation transport system, may affect the clearance of other drugs eliminated by this route. High doses of ranitidine e. Although this interaction is unlikely to be clinically relevant at usual ranitidine doses, it may be prudent to monitor for procainamide toxicity when administered with oral ranitidine at a dose exceeding mg per day.
Warfarin There have been reports of altered prothrombin time among patients on concomitant warfarin and ranitidine therapy. Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine. Ranitidine may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability.
This can result in either an increase in absorption e. Appropriate clinical monitoring is recommended. Atazanavir Atazanavir absorption may be impaired based on known interactions with other agents that increase gastric pH. See atazanavir label for specific recommendations. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.
Patients considered to be still at risk may then be treated orally with Ranitidine tablets mg twice daily. In the prophylaxis of upper gastro-intestinal haemorrhage from stress ulceration in seriously ill patients a priming dose of 50 mg as a slow intravenous injection followed by a continuous intravenous infusion of 0.
Prophylaxis of Mendelson's syndrome: In patients considered at risk of developing acid aspiration Mendelson's syndrome, Ranitidine Solution for Injection 50 mg may be given intramuscularly or by slow intravenous injection, 45 to 60 minutes before induction of general anaesthesia.
Peptic Ulcer Acute Treatment and Gastro-Oesophageal Reflux Intravenous therapy in children with peptic ulcer disease is indicated only when oral therapy is not possible. For acute treatment of peptic ulcer disease and gastro-oesophageal reflux in paediatric patients, Ranitidine injection may be administered at doses that have been shown to be effective for these diseases in adults and effective for acid suppression in critically ill children.
The initial dose 2. Alternatively treatment can be continuous, administering a loading dose of 0. Neonates under 1 month Patients over 50 years of age See Section 5. It is recommended in such patients that ranitidine be administered in doses of 25mg. Method of Administration For instructions on dilution of the medicinal product before administration, see section 6.
Renal Disease 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 detailed in Section 4. Recommended rates of administration should not be exceeded. 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 ranitidine alone versus those who had stopped treatment, with an observed adjusted relative risk increase of 1. Post-marketing data indicate reversible mental confusion, depression, and hallucinations have been reported most frequently in severely ill and elderly patients see section 4.
The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment Interactions occur by several mechanisms including: Ranitidine at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by this enzyme system such as diazepam, lidocaine, phenytoin, propanolol and theophylline.
There have been reports of altered prothrombin time with coumarin anticoagulants e. Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.
Since ranitidine is partially eliminated by the cationic system, it may affect the clearance of other drugs eliminated by this route. High doses of ranitidine e. The bioavailability of certain drugs may be affected. This can result in either an increase in absorption e. Like other drugs, ranitidine should only be used during pregnancy if considered essential.
Breast-feeding Zantac is also excreted in human breast milk. Like other drugs, ranitidine should only be used during breast-feeding if considered essential. Fertility There are no data on the effects of ranitidine on human fertility.
There were no effects on male and female fertility in animal studies see section 5.
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© Copyright 2017 Zantac 50mg iv - IV Push Dilute to a maximum of mg/ml (50 mg/20 ml) using non-preserved NS or other compatible IV solution. Inject at a rate no greater than 4 ml/minute (i.e., 50 mg/20 ml dose should be pushed over 5 minutes). Intermittent IV infusion Dilute to a maximum of mg/ml using D5W, NS, or other compatible IV solution..