Hormones 2016

Leuprorelin Acetate
Laboratory test interferences
• ↑ LFT’s, BUN, serum calcium, uric acid, glucose, lipids, WBC, PT,
• ↓ serum potassium, platelets (Institute, 2014).
Overdose
There is no clinical experience with the effects of an acute overdose of
leuprorelin acetate. In animal studies, doses of up to 500 times the
recommended human dose resulted in dyspnoea, decreased activity and
local irritation at the injection site. In cases of overdosage, the patients
should be monitored closely and management should be symptomatic and
supportive (emc, 2016).
Shelf life
36 months unopened.
Once reconstituted with sterile vehicle, the suspension should be administered
immediately (emc, 2016).
Warning
Development or aggravation of diabetes may occur, therefore diabetic
patients may require more frequent monitoring of blood glucose during
treatment with Prostap.
Hepatic dysfunction and jaundice with elevated liver enzyme levels
have been reported. Therefore, close observation should be made and
appropriate measures taken if necessary.
Hypotension and worsening of depression have been reported.
The ability to drive and use machinery may be impaired due to visual
disturbances and dizziness.
Toxicity
In rats subcutaneous administration of 250 to 500 times the recommended
human dose, expressed on a per body weight basis, resulted in dyspnoea,
decreased activity, and local irritation at the injection site. There is no
evidence at present that there is a clinical counterpart of this phenomenon.
In early clinical trials with leuprolide acetate doses as high as 20 mg/day
for up to two years caused no adverse effects differing from those observed
with the 1 mg/day dose (drugbank, 2013f).
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Version 2016.3576– – Document LATEXed – 1st May 2016
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