Composition: Testosterone 15mg with a release rate of approximately 6mg testosterone over 24 hours.
Presentation: Transdermal patch with a surface area of 60cm2.
Storage and stability: Store at room temperature (up to 30C).
Action: Androgen. Testosterone is responsible for the normal growth and development of the male sexual organs and for the formation and maintenance of secondary sexual characteristics.
Indications: Therapy of all forms of clinically significant testosterone deficiency in adult males.
Contraindications: Women. Hypersensitivity to testosterone or other ingredients. Androgens should not be used in men who have carcinoma of the breast or suspected or diagnosed carcinoma of the prostate.
Dosage and administration: The patches should be applied once daily, preferably early in the morning, to clean, dry, shaved, scrotal skin. The patch should remain there for 22 to 24 hours. A fresh patch should be applied each day. Patches should not be worn during swimming, bathing or showering. A patch may be removed temporarily for not more than two hours during the wearing period. There has been no clinical experience of use in males below 18 years. See summary of product characteristics (SPC).
Overdosage: A testosterone level of up to 395nmol/L has been reported and was associated with cerebrovascular events. It is unlikely that transdermal administration would result in such levels.
Precautions, drug interactions, etc: As for other androgens. See SPC.
Side effects: The most commonly reported side effects in trials were application site reactions, rash and pruritus. Other adverse reactions reported were prostatic disorder, headache, acne, asthenia and nervousness. Alopecia, increased libido, vasodilatation, emotional lability, seborrhoea, hirsutism, polycythaemia, generalised paraesthesia and abnormal liver function tests are possible but uncommon. See SPC.
Net price: 30 patches £53.70.
Supplier: Ferring Pharmaceuticals Ltd, The Courtyard, Waterside Drive, Langley, Slough SL3 6EZ. Tel 01753 214800, fax 01753 214801.
Legal class: POM.