Skip to main content
Isomer
  1. Home
  2. Automated
  3. List of product information
  4. ANDROGEL 50MG [SIN13162P]

ANDROGEL 50MG [SIN13162P]

Active ingredients: ANDROGEL 50MG

Last updated 26 October 2025

Product Info

ANDROGEL 50MG

[SIN13162P]

Product information

Active Ingredient and Strength

TESTOSTERONE 1% - 0.05 G

Dosage Form

GEL

Manufacturer and Country

LABORATOIRES BESINS INTERNATIONAL - FRANCE
BESINS MANUFACTURING BELGIUM - BELGIUM

Registration Number

SIN13162P

Licence Holder

PHARMED IMPORT & EXPORT PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

NA

4.1 Therapeutic indications

Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical signs and biochemical tests (see 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Cutaneous use.

Adult and Elderly men

The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day. The adjustment of posology should be achieved by 2.5 g of gel steps.

The application should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, and both arms and abdomen.

After opening the sachets, the total contents must be extracted from the sachet and applied immediately onto the skin. The gel has just to be simply spread on the skin gently as a thin layer. It is not necessary to rub it on the skin. Allow drying for at least 3–5 minutes before dressing. Wash hands with soap and water after application.

Do not apply to the genital areas as the high alcohol content may cause local irritation.

Steady state plasma testosterone concentrations are reached approximately on the 2nd day of treatment by ANDROGEL. In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application from the 3rd day on after starting treatment (and up to one week). The dose may be reduced if the plasma testosterone concentrations are raised above the desired level. If the concentrations are low, the dosage may be increased, not exceeding 10 g of gel per day.

Children

ANDROGEL is not indicated for use in children and has not been evaluated clinically in males under 18 years of age.

4.3 Contraindications

ANDROGEL is contraindicated:

In cases of known or suspected prostatic cancer or breast carcinoma, in cases of known hypersensitivity to testosterone or to any other constituent of the gel.