Generic drug of the therapeutic class: Endocrinology
active ingredients: Testosterone
laboratory: Besins International
Substitution treatment of male hypogonadism by testosterone deficiency confirmed by clinical and biological signs (see warnings and precautions for use).
Dosage ANDROGEL 25 mg Gel Box of 30 sachets-dose
- Adult and elderly subject:
. The recommended dosage is 5 g of gel (or 50 mg of testosterone) applied once a day at about the same time, preferably in the morning. The daily dose will be adapted by the doctor according to the clinical or biological response of each patient, without exceeding 10 g of gel per day. Dose adjustment should be done in increments of 2.5 g of gel.
. The application must be done by the patient himself, on clean, dry and healthy skin, on the shoulders, arms or abdomen.
. After opening the sachets, the total contents should be removed from the sachet and applied immediately to the skin. The gel should be spread simply in thin layer on the skin. It is not necessary to rub the skin. Allow to dry for at least 3 to 5 minutes before getting dressed.
. Wash hands with soap and water after application.
. Do not apply on the genitals because of the high alcohol content that can cause local irritation.
. The steady state of plasma testosterone concentrations is reached approximately from the 2nd day of treatment with ANDROGEL. Dosage adjustment is based on testosterone, measured from the third day of treatment in the morning before application (and up to one week). If the plasma testosterone concentration is high, the dosage may be decreased. If the concentration is low, the dosage can be increased, without exceeding 10 g of gel per day.
ANDROGEL is not indicated in children and has not been clinically studied in boys under 18 years of age.
- ANDROGEL is contraindicated:
. in case of known hypersensitivity to testosterone or any other component of the gel,
. in case of prostate cancer or breast carcinoma, suspected or confirmed.
- Children: ANDROGEL is not indicated in children and has not been clinically studied in boys under 18 years of age. - Pregnancy and breastfeeding: ANDROGEL is for men only. ANDROGEL is not indicated for pregnant or lactating women. No clinical study has been performed in women with this treatment. Pregnant women should avoid contact with ANDROGEL application sites. This product may have virilizing side effects on the fetus. In case of contact, wash with water and soap as soon as possible.
Androgel side effects
- At the recommended dosage of 5 g of gel per day, the most commonly observed adverse reactions were skin reactions (10%): application site reaction, erythema, acne, dry skin.
- The other undesirable effects reported in controlled clinical trials with ANDROGEL (1% - <10%) are:
Organ system: Common side effects (> 1/100, <1/10) .
. Hematological and lymphatic system disorders: Alterations in the biological assessment (polycythemia, lipids).
. General disorders and administration site conditions: Headache.
. Renal and urinary disorders: Prostatic disorders.
. Reproductive system and breast disorders: Gynecomastia, mastodynia.
. Nervous system disorders: Dizziness, paresthesia, amnesia, hyperesthesia.
. Psychiatric disorders: Mood disorders.
. Vascular disorders: Hypertension.
. Gastrointestinal disorders: Diarrhea.
. Skin and subcutaneous tissue disorders: Alopecia, urticaria.
In patients treated for hypogonadism, it is common to observe gynecomastia that may persist.
Other known adverse effects of oral or injectable testosterone treatments have been described in the literature and are:
Organ system: Undesirable effects .
. Metabolism and Nutrition Disorders: Weight gain, electrolyte changes (sodium retention, chloride, potassium, calcium, inorganic phosphate and water) at high dose and / or prolonged therapy.
. Musculoskeletal disorders: Muscle cramps.
. Nervous system disorders: Nervousness, depression, aggression.
. Respiratory disorders: Sleep apnea.
. Hepatobiliary disorders: Very rare cases of jaundice and disruption of liver function tests.
. Skin and appendages disorders: Various skin reactions such as acne, seborrhea and baldness.
. Reproductive system and breast disorders: Changes in libido, increased frequency of erections; high doses of testosterone frequently induce a reversible interruption or decrease in spermatogenesis, resulting in a decrease in testicular size. Testosterone replacement therapy for male hypogonadism may in rare cases result in persistent and painful erections (priapism), abnormalities of the prostate, prostate cancer *, urinary obstruction.
. General disorders and administration site conditions: Administration of high or long-term testosterone may occasionally increase the occurrence of fluid retention and edema; hypersensitivity reactions may occur.
* Data on the risk of prostate cancer associated with testosterone therapy do not support a causal relationship.
- Other known side effects, although rare, associated with excessive testosterone dosages include hepatic neoplasms.
- Due to the presence of alcohol, frequent applications on the skin can cause irritation and dryness of the skin.