Intrinsa

Company: Procter & Gamble Pharmaceuticals Ltd.
Legal category: Prescription. GMS. Sport prohibited.
Active ingredient: Testosterone 8.4mg (300mcg/24hrs).
Description: Thin, clear, oval matrix-type transdermal patch.
Presentation: 8, €32.77.
Indications: Treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant oestrogen therapy.

Pharmacology: Testosterone, the primary circulating androgen in women, is a naturally occurring steroid, secreted by the ovaries and adrenal glands. In premenopausal women, the rate of production of testosterone is 100 to 400mcg/24 hrs, of which half is contributed by the ovary as either testosterone or a precursor. Serum levels of androgens fall as women age. In women, who have undergone bilateral oophorectomy, serum levels of testosterone decline by approximately 50% within days after surgery.
Dosage: Adult: Apply one patch twice weekly to a clean, dry area of skin on the lower abdomen below the waist, rotating application site. Maximum one patch at a time. Evaluate treatment within 3-6 months of initiation. Elderly: Over 60 years, limited data. Children: Not indicated.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Known, suspected or past history of breast cancer or oestrogen-dependent neoplasia, or any other condition consistent with the contraindications for the use of oestrogen. Pregnancy, lactation.
Special precautions: Not recommended: Naturally menopausal women, women on concomitant conjugated equine oestrogens. Monitor for potential androgenic undesirable effects (acne, changes in hair growth or hair loss); signs of virilisation may be irreversible, consider discontinuation. Discontinue if local hypersensitivity occurs. Little information available on long-term safety, including effects on breast tissue, cardiovascular system and increase in insulin resistance. Monitor for breast cancer. Caution: Cardiovascular risk factors (particularly hypertension), known cardiovascular disease; monitor carefully, specifically for changes in blood pressure and weight. May decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Pre-existing cardiac, renal, or hepatic disease: Oedema may occur (at doses higher than delivered by the patch).
Drug interactions: Anticoagulants.
Adverse drug reactions: Insomnia, migraine, voice deepening, acne, alopecia, hirsutism, breast pain, increased weight.
Full prescribing information and references available from Procter & Gamble Pharmaceuticals Ltd. Telephone: +44 (1784) 474900. Fax: +44 (1784) 474705.