Composition
Inj 10 mcg/20 mcg: Alprostadil 10 mcg/20 mcg; powder in vial plus diluent in pre-filled syringe, needles. Urethral Suppository 125 mcg/250 mcg/500 mcg/1mg: Alprostadil 125 mcg/250 mcg/500 mcg
Indications & Dosage
Aid to diagnosis and treatment of erectile dysfunction: BY INTRACAVERNOSAL INJ: Adults: Initially 2.5 mcg by intra-cavernosal injection. If necessary increase in 2.5 mcg increments to max 60 mcg. Max frequency of use, once daily and 3 times per wk. Children: Not applicable. BY URETHRAL APPLICATION: Adults: Initially 250 mcg intraurethral suppository administration. Increase or decrease for subsequent doses according to response. Max 2 doses in 24 hr and not more than 7 doses in 7 days. See literature. Children: Not recommended.
Administration
The intracavernosal injection must be administered under sterile conditions. The injection site is usually along the dorsolateral aspect of the proximal third of the penis. Avoid visible vein. Alternate the side of the penis that is injected and the injection site; cleanse the injection site with an alcohol swab.
Stability
All formulations of alprostadil are intended for sin-gle use only and should be discarded after use. Aqueous solution: Store alprostadil injection frozen at 20C- 10o C (4F-14F) until dispensed. After dispensing, store in a freezer at 20C-10C for upto 3 months. do not refreeze once removed from the foil wrapping, use the solution in the ampule im-mediately after allowing it to warm to room temperature or discard it. Use open ampoules of alprostadil injection immediately. Sterile powder: Store at 2C-8C (36F-46F) until dispensed. After dispensing, store at or below 25C (77F) for 3 months or until expiration date, whichever occurs first. Use the reconstituted solution within 24 hours when stored at or-below 25C (77F) and do not refrigerate or freeze.
Contraindications
Penile implants or when sexual activity medically inadvisable (e.g. orthostatic hypotension, myocardial infarction, and syncope), not for use with other agents for erectile dysfunction, predisposition to prolonged erection (as in thrombocythemia, polycythemia, sickle cell anaemia, multiple myeloma or leukaemia). Urethral application is contra-indicated in balanitis, severe curvature, severe hypospadias, urethral stricture and urethritis
Precautions
Anatomical deformations of penis (painful erection more likely), follow up regularly to detect signs of penile fibrosis; consider discontinuation if angulation, cavernosal fibrosis or Peyronies disease develop, priapism; patients should be instructed to report any erection lasting 4 hours or longer
Interactions
Warfarin, heparin.
Side Effects
Burning sensation or tension in penis during erection, penile fibrosis, erythema, testicular or perineal pain, penile deviations, haemosiderin deposits in penis, priapism, changes in blood pressure, cardiac arrhythmias, dizziness, headache, vagal shock, collapse, Peyronies disease, muscle spasm, and peripheral vascular disorders. Urethral application; urethral irritation