Androgel 16.2mg Testosterone Gel 88gm tube

✔️ Side Effects

The most frequently reported adverse reaction (≥5%) is an increase in prostate-specific antigen (PSA) levels.

✔️ Dosage and Administration

Before initiating therapy, the diagnosis of hypogonadism should be confirmed by measuring morning serum testosterone levels on at least two separate occasions, ensuring values are below the normal range.

The recommended starting dose of AndroGel 1.62% is 40.5 mg of testosterone, applied once daily in the morning (equivalent to two pump actuations or one 40.5 mg packet).

The gel should be applied to clean, dry, intact skin of the shoulders and upper arms only. It should not be applied to the abdomen, chest, genitals, axillae, knees, or other body areas.

Dose adjustment:
Dosage may be adjusted between 20.25 mg and 81 mg of testosterone daily (1 to 4 pump actuations or corresponding packets). Dose titration should be based on pre-dose morning serum testosterone levels measured approximately 14 and 28 days after initiating therapy or after dose modification. Periodic monitoring should continue thereafter.

After application, patients should wash their hands thoroughly with soap and water and cover the application site with clothing once the gel has dried. The application area should be washed with soap and water before any anticipated skin-to-skin contact with another person.

✔️ Interaction

Androgens may reduce blood glucose levels and potentially lower insulin requirements in diabetic patients

Altered anticoagulant effects may occur; closer monitoring of INR and prothrombin time is recommended

Concomitant use with ACTH or corticosteroids may increase fluid retention; caution is advised, especially in patients with cardiac, renal, or hepatic disease

✔️ Contraindications

Men with breast carcinoma or known or suspected prostate cancer

Pregnant women, as testosterone may cause fetal harm

✔️ Pregnancy and Lactation

AndroGel 1.62% is contraindicated in pregnancy. Testosterone is teratogenic and may cause fetal harm based on animal studies and its mechanism of action. This product is not intended for use in women.

✔️ Precautions and Warnings

• Monitor patients with benign prostatic hyperplasia (BPH) for worsening symptoms
• Prevent accidental exposure to women and children; secondary exposure may result in virilization
• Discontinue therapy if signs of virilization occur until the cause is identified
• Cases of venous thromboembolism, including deep vein thrombosis and pulmonary embolism, have been reported
• Some post-marketing studies suggest an increased risk of myocardial infarction and stroke
• Exogenous androgen therapy may suppress spermatogenesis and cause azoospermia
• Edema, with or without congestive heart failure, may occur in patients with underlying cardiac, renal, or hepatic disease
• Sleep apnea may develop or worsen in susceptible individuals
• Regular monitoring of serum testosterone, PSA, hemoglobin, hematocrit, liver function tests, and lipid profile is recommended
• The gel is flammable until fully dry

✔️ Storage:

Store below 30°C, protected from light and moisture. Keep out of reach of children.