Androgel

Androgel

testosterone

Manufacturer:

Besins Healthcare

Distributor:

The Glory Medicina
/
DKSH
Concise Prescribing Info
Contents
Testosterone
Indications/Uses
Testosterone deficiency in men >18 yr.
Dosage/Direction for Use
Apply 5 g once daily at approx the same time, preferably in the morning, as a thin layer over clean, dry, healthy skin of the shoulders, arms or stomach. Max: 10 g daily.
Contraindications
Hypersensitivity. Patients w/ prostate or breast cancer.
Special Precautions
Measure testosterone levels before treatment & perform regular check-ups (at least once a yr) during treatment. May be transferred to another person during close contact & relatively prolonged skin contact w/ the gel application area if no precaution is taken. Wash hands w/ soap & water after application. Allow gel to dry for at least 3-5 min before dressing. Do not apply to genital areas (penis & testes) as high alcohol content may cause local irritation. Not for treatment of male sterility or impotence. May increase risk of benign prostatic hypertrophy or prostate cancer. May cause severe complications in the form of oedema w/ or w/o CHF in patients w/ severe heart, liver or kidney disease. May cause a rise in BP. Reports of worsening of breathing problems during sleep in predisposed individuals, particularly obese patients or patients w/ resp disease. Patients w/ bone cancer may develop increased Ca levels in blood or urine. Patients receiving testosterone replacement treatment over long periods of time may develop polycythaemia. Pre-existing migraine or epilepsy may deteriorate. May decrease levels of thyroxin-binding globulin. May produce +ve reaction in antidoping tests. Concomitant use w/ oral anticoagulants, insulin or corticosteroids. Pregnant women should avoid contact w/ application sites. Not to be used by women or childn.
Adverse Reactions
Headache, hair loss, painful/tender/enlarged breasts, changes in prostate gland, diarrhoea, dizziness, paresthesia, increased BP, mood changes, changes in lab tests (increased RBC, lipids), skin hypersensitivity & stinging.
Drug Interactions
Potential interaction w/ oral anticoagulants & corticosteroids.
MIMS Class
Androgens & Related Synthetic Drugs
ATC Classification
G03BA03 - testosterone ; Belongs to the class of 3-oxoandrosten (4) derivative androgens used in androgenic hormone preparations.
Presentation/Packing
Form
Androgel gel 50 mg
Packing/Price
30 × 1's
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