Zantac

/ GSK

Adults: Ranitidine Injection may be given as: – a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; – an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals – an i.m. injection of 50 mg (2 ml) every six to eight hours.
PROPHYLAXIS OF MENDELSON’S SYNDROME
For prophylaxis of Mendelson’s syndrome 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.
PROPHYLAXIS OF HAEMORRHAGE FROM STRESS ULCERATION IN SERIOUSLY ILL PATIENTS In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients parenteral administration may be continued until oral feeding commences. Patients considered to be still at risk may then be treated with Ranitidine tablets 150 mg twice daily. In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patients A priming dose of 50 mg as a slow intravenous injection followed by continuous intravenous infusion of 0.125-0.250 mg/kg/hr may be preferred.
Children: The use of Ranitidine Injection in children has not been evaluated. Safety and efficacy in neonates has not been established.
Patients over 50 years of age: See Pharmacokinetics, Special Patient Populations, Patients over 50 years of age.
Renal Impairment: Accumulation of ranitidine with resulting elevated plasma concentrations will occur in patients with renal impairment (creatinine clearance less than 50 ml/min). It is recommended in such patients that ranitidine be administered in doses of 25 mg. Route of Administration- Intravenous or intramuscular injection.

Syrup
Adults: Zantac syrup is indicated for the treatment of duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents. Zantac syrup is also indicated for the treatment of post-operative ulcer, Zollinger-Ellison Syndrome and oesophageal reflux disease including long term management of healed oesophagitis. Zantac syrup is indicated for the following conditions where reduction of gastric secretion and acid output is desirable; the prophylaxis of gastro-intestinal haemorrhage from stress ulceration in seriously ill patients and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson’s Syndrome),
particularly obstetric patients during labour.
Children (3 to 18 years): Short term treatment of peptic ulcer. Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.

Injection
Adults: Zantac Injection is indicated for the treatment of duodenal ulcer, benign
gastric ulcer, post – operative ulcer, reflux oesophagitis, Zollinger – Ellison
Syndrome and the following conditions where reduction of gastric secretion
and acid output is desirable.
The prophylaxis of gastrointestinal haemorrhage from stress ulceration in
seriously ill patients and before general anaesthesia in patients considered to
be at risk of acid aspiration (Mendelson’s Syndrome), particularly obstetric
patients during labour.
Children (6 months to 18 years): Zantac Injection is indicated for the short term treatment of peptic ulcer and the treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.

Ranitidine is contraindicated for patients known to have hypersensitivity to any component of the preparation.

Pregnancy and lactation, pediatrics. Treatment with H2-receptor antagonists may mask symptoms associated with carcinoma of the stomach. Impaired renal function, hepatic dysfunction.

Rarely, malaise, dizziness, somnolence, insomnia, vertigo. Headache, arrhythmias, constipation, diarrhea, nausea, vomiting, abdominal discomfort/pain, rash, rare cases of hypersensitivity reactions.
For full details see prescribing information.

Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment.
Interactions occur by several mechanisms including:
Inhibition of cytochrome P450-linked mixed function oxygenase system: Ranitidine at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by this enzyme system such as diazepam, lidocaine, phenytoin, propranolol and theophylline. There have been reports of altered prothrombin time with coumarin anticoagulants (e.g. warfarin). Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.
Competition for renal tubular secretion: 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.g such as those used in the treatment of ZollingerEllison syndrome) may reduce the excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs.
Alteration of gastric pH: The bioavailability of certain drugs may be affected. This can result in either an increase in absorption (e.g. triazolam, midazolam, glipizide) or a decrease in absorption (e.g. ketoconazole, atazanavir, delaviridine, gefitnib).

Pregnancy: Ranitidine crosses the placenta but therapeutic doses administered to obstetric patients in labour or undergoing caesarean section have been without any adverse effect on labour, delivery or subsequent neonatal progress. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.
Lactation: Ranitidine is excreted in human breast milk. Like other drugs, Ranitidine should only be used during nursing if considered essential.

Symptoms and Signs: Ranitidine is very specific in action and no particular problems are expected following overdose with Ranitidine formulations.
Treatment: Symptomatic and supportive therapy should be given as appropriate.