Androgel

Replacement therapy for male hypogonadism when testosterone deficiency has been clinically & biologically confirmed.

Adult & elderly 2 pump actuations (40.5 mg testosterone) once daily at approx the same time, preferably in the morning. Max: 4 pump actuations or 81 mg testosterone/day.

Hypersensitivity. Confirmed or suspected prostate cancer or breast carcinoma.

Not indicated for male sterility or impotence. May accelerate the progression of subclinical prostate cancer & benign prostatic hyperplasia. Perform regular rectal exam & PSA assay at least once a yr in any patient receiving testosterone treatment, & twice a yr in elderly & patients at risk of prostate cancer. Caution in cancer patients at risk of hypercalcaemia & associated hypercalciuria related to bone metastases; regularly monitor blood Ca levels. Risk of severe complications characterised by oedema, w/ or w/o CHF, in patients w/ severe heart, liver, or kidney failure or ischemic heart disease; increased BP; thromboembolic events; aggravated epilepsy & migraine; increased sleep apnoea particularly in at-risk patients w/ obesity or chronic resp disease; insulin sensitivity improvement; gynaecomastia; inadvertent testosterone transfer. Monitor testosterone levels before treatment & at regular intervals. Regularly monitor Hb, haematocrit (to detect polycythaemia), liver function & lipid panel in patients on long-term androgen treatment. Reconsider & discontinue treatment in case of severe reaction at the application site. Suppressed spermatogenesis w/ high doses of exogenous androgens. May produce +ve reaction in anti-doping tests. Contains ethanol; may cause burning sensation on damaged skin. Flammable until dry. Do not prescribe in patients at major risk of non-compliance w/ precaution (eg, severe alcoholism, drug abuse or severe psychiatric disorders). May decrease thyroxin-fixing globulin levels, resulting in reduced T4 serum conc & increased T3 & T4 resin uptake. Not to be used by women. Pregnant women must avoid contact w/ Androgel application sites. Not indicated for use in pregnant or breastfeeding women. Safety & efficacy have not been established in boys <18 yr. Consider decreased physiological testosterone values in patients >65 yr.

Mood swings, affective disorders, anger, aggression, impatience, insomnia, abnormal dreams, increased libido; acne, alopecia, dry skin, skin lesions, contact dermatitis, hair color changes, rash, application site hypersensitivity/pruritus; increased PSA, increased haematocrit or Hb.

Increased effect of oral anticoagulants. Increased risk of oedemas w/ ACTH or corticosteroids. Reduction in antidiabetic medicines may be considered due to improved insulin sensitivity.

Androgens & Related Synthetic Drugs

G03BA03 - testosterone ; Belongs to the class of 3-oxoandrosten (4) derivative androgens used in androgenic hormone preparations.

Rx