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SIDE EFFECTS
The following convention has been utilised for the classification of undesirable effects: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (1/10,000).
Adverse event frequencies have been estimated from spontaneous reports from post-marketing data.
Blood & Lymphatic System Disorders
Very Rare: Blood count changes (leucopenia, thrombocytopenia).
These are usually reversible. Agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or marrow aplasia.
Immune System Disorders
Rare: Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain).
Very Rare: Anaphylactic shock
These events have been reported after a single dose.
Psychiatric Disorders
Very Rare: Reversible mental confusion, depression and hallucinations.
These have been reported predominantly in severely ill and elderly patients.
Nervous System Disorders
Very Rare: Headache (sometimes severe), dizziness and reversible involuntary movement disorders.
Eye Disorders
Very Rare: Reversible blurred vision.
There have been reports of blurred vision, which is suggestive of a change in accommodation.
Cardiac Disorders
Very Rare: As with other H2 receptor antagonists bradycardia, A-V Block and asystole.
Vascular Disorders
Very Rare: Vasculitis.
Gastrointestinal Disorders
Very Rare: Acute pancreatitis. Diarrhoea.
Hepatobiliary Disorders
Rare: Transient and reversible changes in liver function tests.
Very Rare Hepatitis (hepatocellular, hepatocanaticular or mixed) with or without jaundice, these were usually reversible.
Skin and Subcutaneous Tissue Disorders
Rare: Skin Rash.
Very Rare: Erythema multiforme, atopecia.
Muscutoskeletal and Connective Tissue Disorders
Very Rare: Muscutoskeletal symptoms such as arthralgia and myalgia.
Renal and Urinary Disorders
Very rare: Acute interstitial nephritis.
Reproductive System and Breast Disorders
Very Rare: Reversible impotence. Breast symptoms in men.
OVERDOSAGE
Ranitidine is very specific in action and no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If need be, the drug may be removed from the plasma by haemodialysis.
PHARMACEUTICAL PRECAUTIONS
Storage Conditions Store below 25°C. Protect from light.
Zantac Injection should not be autoclaved.
Shelf Life
The shelf life is indicated on the packaging.
FURTHER INFORMATION
Pharmacology
Zantac is a specific, rapidly acting histamine H2-antagonist. It inhibits basal and stimulated secretion of gastric acid, reducing both the volume and the acid and pepsin content of the secretion.
Pharmacokinetics
Absorption of ranitidine after intramuscular injection is rapid and peak plasma concentrations are usually achieved within 15 minutes of administration.
Ranitidine is not extensively metabolised. Elimination of the drug is primarily by tubular secretion. The elimination half-life is 2-3 hours.
In balance studies with 150 mg 3H-ranitidine 93% of an intravenous dose was excreted in urine and 5% in faeces; 60-70% of an oral dose was excreted in urine and 26% in faeces. Analysis of urine excreted in the first 24 hours after dosing showed that 70% of the intravenous dose and 35% of the oral dose were eliminated unchanged. The metabolism of ranitidine is similar after both oral and intravenous dosing; about 6% of the dose being excreted in urine as the N-oxide, 2% as the S-oxide, 2% as desmethylranitidine and 1-2% as the furoic acid analogue.
Instructions for Use/Handling
Zantac Injection is 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.
Unused admixtures 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 polyvinyl chloride administration sets it is considered that adequate stability would be conferred by the use of a polyethylene infusion bag.
Break the ampoule as below before
use :-
1) Hold the ampoule with the spot
uppermost. If any of the solution is in the stem of the ampoule, tap or
shake it down into the body of the ampoule.
2) Hold the ampoule with the spot
uppermost. Break the stem of the ampoule off in a downwards direction.
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