ZANTAC Injection (Aqueous solution) Ref.[7070] Active ingredients: Ranitidine

(See section 5.2 Pharmacokinetic properties – Other special – populations)

Posology

Adults (including elderly) / Adolescents (12 years and over)

Zantac Injection may be given either as a slow (over 2 minutes) intravenous injection up to a maximum of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every 6 to 8 hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at 6 to 8 hour intervals, or as an intramuscular injection of 50 mg (2 ml) every 6 to 8 hours.

Prophylaxis of haemorrhage from stress ulceration or recurrent haemorrhage

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 with Zantac tablets 150 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 0.125-0.250 mg/kg/hr may be preferred.

Prophylaxis of Mendleson’s syndrome

In patients considered to be at risk of developing acid aspiration syndrome, Zantac Injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

Children / Infants (6 months to 11 years)

(See section 5.2 Pharmacokinetic properties) – Other special populations

Zantac injection may be given as a slow (over 2 minutes) i.v. injection up to a maximum of 50 mg every 6 to 8 hours.

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, Zantac 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 (2.0 mg/kg or 2.5 mg/kg, maximum 50 mg) may be administered as a slow intravenous infusion over 10 minutes, either with a syringe pump followed by a 3 mL flush with normal saline over 5 min, or following dilution with normal saline to 20 mL. Maintenance of pH>4.0 can be achieved by intermittent infusion of 1.5 mg/kg every 6 h to 8 h. Alternatively treatment can be continuous, administering a loading dose of 0.45 mg/kg followed by a continuous infusion of 0.15 mg/kg/hr.

Neonates (under 1 month)

(See section 5.2 – Pharmacokinetic properties – Other special populations)

Patients over 50 years of age

See section 5.2 Pharmacokinetic properties – Other special populations

Patients with renal impairment

Accumulation of ranitidine with resulting elevated plasma concentrations will occur in patients with renal impairment (creatinine clearance less than 50 ml/min). Accordingly, it is recommended in such patients that ranitidine be administered in doses of 25 mg.

Method of administration

Intravenous or intramuscular injection.

For instructions on dilution of the medicinal product before administration, see section 6.6.

Symptoms and signs

Zantac is very specific in action and accordingly, no particular problems are expected following overdosage with the drug.

Treatment

Symptomatic and supportive therapy should be given as appropriate.

Shelf life: 36 months unopened.

Store below 25°C, protect from light.

Zantac Injection should not be autoclaved.

2 ml colourless Type I glass ampoules.

Pack size: 5 ampoules.

Zantac Injection has been shown to be compatible with the following intravenous infusion fluids:

0.9% Sodium Chloride BP
5% Dextrose BP
0.18% Sodium Chloride and 4% Dextrose BP
4.2% Sodium Bicarbonate BP
Hartmann’s Solution.

All unused admixtures of Zantac Injection with infusion fluids should be discarded 24 hours after preparation.

Although compatibility studies have only been undertaken in polyvinyl chloride infusion bags (in glass for Sodium Bicarbonate BP) and a polyvinyl chloride administration set it is considered that adequate stability would be conferred by the use of a polyethylene infusion bag.