Alprostadil

UK SPC (Alprostadil 10 micrograms powder for solution for injection) §4.2 — this is the INTRACAVERNOSAL product for erectile dysfunction. Dose must be individualised by careful titration under supervision by a physician; the injection must be done under sterile conditions and the site cleansed with an alcohol swab. Diagnostic use (aid to aetiologic diagnosis): in subjects without evidence of neurological dysfunction, 20 micrograms injected into the corpus cavernosum and massaged through the penis (over 80% may be expected to respond to a single 20 microgram dose); in subjects with erectile dysfunction caused by neurologic disease/trauma the diagnostic dose must not exceed 10 micrograms and an initial dose of 5 micrograms is likely to be appropriate. If an ensuing erection persists for more than one hour, detumescent therapy (SPC §4.9) should be employed before the subject leaves the clinic to prevent priapism; at discharge the penis must be completely flaccid. During treatment titration: if there is no response to the administered dose, the next higher dose may be given within 1 hour; if there is a response, allow at least a 1-day interval before the next dose. The first injections must be done by medically trained personnel; self-administration only after proper training and assessment of the patient's skill and competence, with regular monitoring (e.g. every 3 months) particularly in the initial stages when dose adjustments may be needed. Reconstitute with the 1 mL prefilled diluent syringe and discard any unused contents of the vial or syringe. IMPORTANT — the openFDA label in this bundle is a DIFFERENT product and indication: alprostadil injection given by continuous intravenous infusion to neonates (ductus arteriosus maintenance). Its regimen is recorded under paedDose and must NOT be applied to the intracavernosal product.

SEPARATE PRODUCT AND INDICATION — this is the US alprostadil injection label for neonates (US prescribing information, DOSAGE AND ADMINISTRATION), NOT the UK intracavernosal product from which the adult dose above is taken. Begin infusion with 0.05 to 0.1 micrograms alprostadil per kilogram of body weight per minute; 0.1 micrograms per kilogram of body weight per minute is the recommended starting dose based on clinical studies, although adequate clinical response has been reported using a starting dose of 0.05 micrograms per kilogram of body weight per minute. After a therapeutic response is achieved (increased pO2 in infants with restricted pulmonary blood flow, or increased systemic blood pressure and blood pH in infants with restricted systemic blood flow), reduce the infusion rate to the lowest possible dosage that maintains the response — reducing from 0.1 to 0.05 to 0.025 to 0.01 micrograms per kilogram of body weight per minute. Dilution: dilute 1 mL of alprostadil injection with sodium chloride injection USP or dextrose injection USP; prepare fresh infusion solutions every 24 hours and discard any solution more than 24 hours old. Apnoea has been reported in about 12% of neonates treated. US labelling may differ from UK — clinician to verify against the UK SPC for the intravenous neonatal product, which was not fetched in this bundle.