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 features & biochemical tests.
Dosage/Direction for Use
Adult & elderly men Apply 5 g once daily at the same time, preferably in the morning. Max: Not exceeding 10 mg daily.
Contraindications
Hypersensitivity. Known or suspected prostate cancer or breast carcinoma.
Special Precautions
Not for male sterility or impotence. Discontinue if severe application site reaction develops; in patients suffering from severe cardiac, hepatic or renal insufficiency. Increased risk of sleep apnoea in patients w/ risk factors eg, obesity & chronic resp disease. Risk of testosterone transfer. Hypercalcaemia; HTN; epilepsy, migraine; ischemic heart disease; major risk of non-compliance w/ safety instructions eg, severe alcoholism & psychiatric disorders, drug abuse. Development of acne or hair modification. May produce +ve reaction in anti-doping tests. Perform careful & regular monitoring of prostate gland & breast by digital rectal exam & serum PSA estimation at least once yrly & twice yrly in elderly. Regular monitor serum Ca conc. Periodically check Hb, hematocrit, liver function, & determine lipid profile. Observe a long interval between application & sexual intercourse; wear Tshirt covering application site, during contact period or to shower before sexual intercourse. Not to be used by women. Males <18 yr. Pregnant women should avoid contact w/ application sites. Not to be used in pregnancy & lactation. Childn.
Adverse Reactions
Application site reaction, erythema, acne, dry skin. Changes in lab tests (polycythaemia, lipids); headache; prostatic disorders; gynaecomastia, mastodynia; dizziness, paraesthesia, 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.
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 topical gel 50 mg
Packing/Price
5 g x 30 × 1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in