Each 5 g sachet contains testosterone 0.050 g.
Excipients/Inactive Ingredients: Carbomer 980, Isopropyl myristate, 96% Ethanol, Sodium hydroxide, Purified water.

30 pack, 1 times a day

Endogenous androgens, principally testosterone, secreted by the testes and its major metabolite DHT (dihydrotestosterone), are responsible for the development of the external and internal genital organs and for maintaining the secondary sexual characteristics (stimulating hair growth, deepening of the voice, development of the libido); for a general effect on protein anabolism; for development of skeletal muscle and body fat distribution; for a reduction in urinary nitrogen, sodium, potassium, chloride, phosphate and water excretion.

Testosterone does not produce testicular development: it reduces the pituitary secretion of gonadotropins.

The effects of testosterone in some target organs arise after peripheral conversion of testosterone to oestradiol, which then binds to oestrogen receptors in the target cell nucleus e.g. the pituitary, fat, brain, bone and testicular Leydig cells.

Pharmacokinetics: The percutaneous absorption of testosterone ranges from approximately 9% to 14% of the applied dose.
Following percutaneous absorption, testosterone diffuses into the systemic circulation at relatively constant concentrations during the 24 hour cycle.
Serum testosterone concentrations increase from the first hour after an application, reaching steady-state from day two. Daily changes in testosterone concentrations are then of similar amplitude to those observed during the circadian rhythm of endogenous testosterone. The percutaneous route therefore avoids the blood distribution peaks produced by injections. It does not produce supra-physiological hepatic concentrations of the steroid in contrast to oral androgen therapy.

Administration of 5 g of ANDROGEL produces an average testosterone concentration increase of approximately 2.5 ng/mL (8.7 nmol/L) in plasma.

When treatment is stopped, testosterone concentrations start decreasing approximately 24 hours after the last dose. Concentrations return to baseline approximately 72 to 96 hours after the final dose.

The major active metabolites of testosterone are dihydrotestosterone and oestradiol.

Testosterone is excreted, mostly in urine, and in faeces as conjugated testosterone metabolites.

Toxicology: Preclinical safety data: Testosterone has been found to be non-mutagenic in vitro using the reverse mutation model (Ames test) or hamster ovary cells. A relationship between androgen treatment and certain cancers has been found in studies on laboratory animals. Experimental data in rats have shown increased incidences of prostate cancer after treatment with testosterone.
Sex hormones are known to facilitate the development of certain tumours induced by known carcinogenic agents. No correlation between these findings and the actual risk in human beings has been established.

Indications/Uses

Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical signs and biochemical tests (see Precautions).

Dosage/Direction for Use

Cutaneous use.
Adult and Elderly men: 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 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 application.

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 ANDROGEL. 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 (and up to one week). 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.

Children: ANDROGEL is not indicated for use in children and has not been evaluated clinically in males under 18 years of age.