Androgel

Androgel

testosterone

Manufacturer:

Besins Healthcare
Concise Prescribing Info
Contents
Testosterone
Indications/Uses
Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features & biochemical tests.
Dosage/Direction for Use
Adult & elderly men Apply 50 mg once daily preferably in the morning on shoulders, arms or abdomen. Max: 100 mg.
Contraindications
Hypersensitivity. Known or suspected prostatic cancer or breast carcinoma.
Special Precautions
Exclude pre-existing prostatic cancer prior to initiation of treatment. Perform regular monitoring of prostate gland & breast in accordance w/ digital rectal exam & serum prostatic specific antigen (PSA) estimation once/twice yrly for patient at risk. May accelerate the progression of sub-clinical prostatic cancer & benign prostatic hyperplasia. Cancer patients at risk of hypercalcaemia & associated hypercalciuria due to bone metastases, need Ca conc monitoring. Regularly monitor Hb, haematocrit, LFTs & lipid profile in long term use. Improves insulin sensitivity, monitor glucose level & HbA1c. Severe cardiac, hepatic or renal insufficiency, ischemic heart disease; HTN; thrombophilia or risk factors for VTE; epilepsy, migraine; obesity & chronic resp disease. Monitor testosterone level at baseline & at regular intervals during treatment. Review & discontinue treatment if severe application site reaction develops. May produce a +ve reaction in anti-doping tests. Cover application area once dried to avoid testosterone transfer risk. Wait at least 1 hr before showering or bathing after applying the medicine. May cause burning sensation on damaged skin. The product is flammable until dry. Not to be used by women. Spermatogenesis may be reversibly suppressed. Not indicated for use in pregnant or breastfeeding women; childn & males <18 yr.
Adverse Reactions
Application site reaction, erythema, acne, dry skin; mood disorders; dizziness, paraesthesia, amnesia, hyperaesthesia; HTN; diarrhoea; alopecia, urticaria; gynaecomastia, mastodynia, prostatic disorders; headache; changes in lab tests (polycythaemia, lipids), increased haematocrit, RBC count, Hb.
Drug Interactions
Increased effect of oral anticoagulants. Increased risk of developing oedema by ACTH or corticosteroids. Decreased levels of thyroxin binding globulin. Changes in insulin sensitivity, glucose tolerance, glycaemic control, blood glucose & HbA1c levels.
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 (Rp650,000/boks)
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