HEALEY PHARMA (UK) LIMITED
HEALEY PHARMA (UK) LIMITED
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CIMETIDINE 200 mg/2 mL INJECTION
COMPOSITION:
Each ampoule contains 200 mg Cimetidine per 2 mL.
PHARMACOLOGICAL ACTION:
Cimetidine is a histamine H2-receptor antagonist. Its main action is to inhibit gastric acid secretion. It also inhibits competitively the other actions of histamine mediated by H2-receptors. The decrease in gastric acid secretion occurs regardless of the nature of the physiological stimulus to secretion, i.e. basal or unstimulated secretion, is reduced. Both the volume of secretion and the concentration of acid in the secretion are reduced.
INDICATIONS:
The treatment of benign gastric and duodenal ulcers, reflux oesophagitis, Zollinger-Ellison syndrome and in other conditions associated with gastric hypersecretory states, such as systemic mastocytosis and multiple endocrine adenomas. It is also indicated at reduced dosage for duodenal ulcer recurrence in selected patients.
CONTRA-INDICATIONS:
Lenamet is not recommended for minor digestive complaints. It is also not recommended for patients with impaired renal function.
DOSAGE AND DIRECTIONS FOR USE:
The dose with intravenous or intramuscular injections, is normally 200 mg. Injections may be repeated at 4 or 6 hourly intervals.
The 200 mg injection for intravenous use should be diluted in 0,9% Normal Saline (or other compatible solution) to a total volume of 20 mL and given very slowly, at least over 2 minutes.
The dose by intravenous infusion is usually 50 to 100 mg/hour for 2 hours and repeated at 4 to 6 hourly intervals. The maximum infusion rate should not usually exceed 150 mg/hour or 2 mg/kg body mass/hour. Intravenous infusion is preferred in patients where cardiovascular impairment is present.
Lenamet injection has been shown to be compatible with Dextrose (5 and 10 %), and Normal Saline (0,9 %) solutions for intravenous infusion and the resultant solution is stable for 1 week at normal room temperature.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Constipation or diarrhoea, muscle pain, dizziness, tiredness and skin rash may occur. Gynaecomastia or galactorrhoea, increases in serum-transaminase values, increases in plasma-creatinine values and interstitial nephritis have been reported. Blood disorders such as thrombocytopenia, granulocytopenia, agranulocytosis and pancytopenia have been reported.
Neural dysfunction has been encountered, particularly with high doses in elderly patients, patients with organic brain syndrome and in association with impaired renal excretion. The effects include confusion, slurred speech, delirium, hallucinations, and coma. Cases of fever, which cleared on withdrawal of Lenamet have been reported. Acute pancreatitis, cardiac arrhythmias, allergic reactions, arthralgia, myalgia, hypotension and loss of libido may occur.
STORAGE INSTRUCTIONS:
Store in a cool place below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.