Composition
Each ampoule contains:
Active ingredient: Ranitidine hydrochloride equivalent to ranitidine 50 mg.
Excipients: Disodium hydrogen phosphate, potassium dihydrogen phosphate, sodium chloride, water for injection q.s. to 2 ml.

Pharmaceutical form and presentation
Injectable solution.
Box of 5ampoules of 2 mL.

Pharmaco-therapeutic class
Antiulcerant (A02B A02).

Therapeutic indications
Treatment of duodenal ulcer, benign gastric ulcer, post-operative ulcer, reflux oesophagitis, Zollinger-Ellison syndrome and conditions where reduction of gastric secretion and acid output is desirable.
Prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients, the prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson’s syndrome), particularly obstetric patients during labour.

Contra-indications
Patients with known hypersensitivity to any component of the preparation.

Precautions for use
Treatment with a histamine H2-antagonist may mask the symptoms associated with carcinoma of the stomach and may therefore delay the diagnosis of the condition. Accordingly, where gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with Dudine is instituted.
Ranitidine is excreted via the kidney, therefore plasma levels of the drug are increased in patients with renal impairment. Accordingly, it is recommended in such patients that Dudine be administered at doses of 25 mg.
Bradycardia in association with rapid administration of Dudine injection has been reported rarely, usually in patients with factors predisposing to cardiac rhythm disturbances. Recommended rates of administration should not be exceeded.
It has been reported that the use of higher than recommended doses if intravenous H2-antagonoist has been associated with rises in liver enzymes when treatment has been extended beyond five days.
Although clinical reports of acute intermittent porphyria associated with ranitidine administration have been rare and inconclusive, ranitidine should be avoided in patients with a history of this condition.

Interactions
Ranitidine does not inhibit the hepatic cytochrome P450-linked mixed function oxygenase system. Accordingly, ranitidine does not potentiale the actions of drugs which are inactivated by this enzyme; these include diazepam, lignocaine, phenytoin, propanolol, theophylline and warfarin.

Special warnings
Dudine 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. Dudine is also excreted in human breast milk. Like other drugs, Dudine should only be used during pregnancy and nursing if considered essential.

Posology and administration
Adults (including elderly):
Dudine injection may be given either 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, which may be repeated every six to eight hours; or as an intemittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals, or as an intramuscular injection of 50 mg (2 mL) every six to eight hours.
In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding for peptic ulceration, parenteral administration may be continued until oral feeding commences. Patients considered to be still at risk may be then be treated with Dudine film-coated tablets.
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 continous intravenous infusion of 0.125 – 0.250 mg/kg/hr may be preferred.
In patients considered to be at risk of developing acid aspiration syndrome, Dudine injection, 50 mg may be given intramuscularly or by slow intravenous injection in 45 to 60 minutes before induction of general anesthesia.
Children:
The use of Dudine injection in children has not been evaluated.

Overdosage
Dudine is very specific inaction and accordingly, no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy shouldbegiven as appropriate. If need be, the drug may be removed from the plasma by haemodialysis.

Side effects
The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to ranitidine therapy has not been established in many cases.
Transcient and reversible changes in liver function tests can occur. There have been occasional reports of hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice. These was uasully reversible. Acute pancreatitis has been reported rarely.
Leucopenia and thrombocytopenia have occurred rarely in patients. These are usually reversible. Rare cases of agranulocytosis or of pancytopenia, sometimes with marrow hypoplasia, or aplasia have been reported.
Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension, anaphylactic shock) have been seen rarely following the parenteral and oral administration of ranitidine. These reactions have occasionally occurred after a single dose.
As with other H2 receptor antagonists there have been rare reports of bradycardia, A-V block and asystole.
Headache, sometimes severe, and dizziness have been reported in a very small proportion of patients. Rare cases of reversible mental confusion, depression and hallucinations have been reported, predominantly in severely ill and elderly patients. In addition, reversible involuntary movement disorders have been reported rarely.
Skin rash has been reported, including rare cases of erythema multiforme. Rare cases of vasculitis and alopecia have been reported.
Reversible impotence have been reported rarely.
Musculoskeletal symptoms such as arthralgia and myalgia have been reported rarely.
No clinically significant interference with endocrine or gonadal function has been reported. There have been a few reports of breast symptoms (swelling and/or discomfort) in men taking ranitidine; some cases have resolved on continued ranitidine treatment. Discontinuation of therapy may be necessary in order to establish the underlying cause.

Shelf-life
24 months.
All unused admixtures of Dudine Injection with infusion fluids should be discarded 24 hours after preparation.
Do not take this medicine after the expiry date indicated on the pack.

Storage
Store between 15-30 degree C; avoid freezing.
Keep out of reach of children.