Androgel

Androgel

testosterone

Manufacturer:

Besins Healthcare

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Testosterone
Indications/Uses
Replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical signs & biochemical tests.
Dosage/Direction for Use
Adult & elderly men Apply 5 g once daily in the morning. Max: 10 g daily.
Contraindications
Hypersensitivity. Known or suspected prostatic cancer or breast carcinoma. Childn. Women. Pregnancy & lactation.
Special Precautions
Not recommended for treatment of male sterility or impotence. Preexisting prostatic cancer. Regular monitoring of the prostate gland & breast is recommended in accordance w/ digital rectal exam & serum prostatic specific antigen (PSA) estimation. Subclinical prostatic cancer; benign prostatic hyperplasia; cancer patients at risk of hypercalcaemia & associated hypercalciuria due to bone metastases. Monitor serum Ca conc, Hb, haematocrit & liver function tests. Severe cardiac, hepatic or renal insufficiency; ischemic heart disease, HTN. Epilepsy, migraine; obesity & chronic resp disease. Not recommended for patients w/ severe alcoholism, drug abuse or severe psychiatric disorders. Males <18 yr.
Adverse Reactions
Application site reaction, erythema, acne, dry skin; changes in laboratory tests, headache, prostatic disorders, gynecomastia, mastodynia, dizziness, paresthesia, amnesia, hyperaesthesia, mood disorders, HTN, diarrhoea, alopecia, urticaria.
Drug Interactions
Increased effect of oral anticoagulants. Increased risk of developing oedema by ACTH or corticosteroids. Decreased levels of thyroxin-binding globulin.
ATC Classification
G03BA03 - testosterone ; Belongs to the class of 3-oxoandrosten (4) derivative androgens used in androgenic hormone preparations.
Presentation/Packing
Form
Androgel topical gel 50 mg
Packing/Price
5 g x 30 × 1's
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