Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Besins Healthcare (UK) Limited, 1st Floor, 28 Poland Street, London, W1F 8QN, United Kingdom
Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests (see 4.4 Special warnings and precautions for use).
Cutaneous use.
The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day. The adjustment of posology should be achieved by 2.5 g of gel steps.
The application should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms or abdomen.
After opening the sachets, the total contents must be extracted from the sachet and applied immediately onto the skin. The gel has just to be simply spread on the skin gently as a thin layer. It is not necessary to rub it on the skin. Allow drying for at least 3-5 minutes before dressing. Wash hands with soap and water after applications.
Do not apply to the genital areas as the high alcohol content may cause local irritation.
Steady state plasma testosterone concentrations are reached approximately on the 2nd day of treatment by Testogel. In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application from the 3rd day on after starting treatment (one week seems reasonable). The dose may be reduced if the plasma testosterone concentrations are raised above the desired level. If the concentrations are low, the dosage may be increased, not exceeding 10 g of gel per day.
Testogel is not indicated for use in children and has not been evaluated clinically in males under 18 years of age.
Only one case of acute testosterone overdose following an injection has been reported in the literature. This was a case of a cerebrovascular accident in a patient with a high plasma testosterone concentration of 114 ng/ml (395 nmol/l). It would be most unlikely that such plasma testosterone concentrations be achieved using the transdermal route.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
5 g in sachet (PET/Aluminium/LDPE).
Boxes of 1, 2, 7, 10, 14, 28, 30, 50, 60, 90 or 100 sachets.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
