- Approval Id
- 4707d66a6528a799
- Drug Name
- ANDROGEL 50MG
- Product Name
- ANDROGEL 50MG
- Approval Number
- SIN13162P
- Approval Date
- 2005-12-22
- Registrant
- PHARMED IMPORT & EXPORT PTE LTD
- Licence Holder
- PHARMED IMPORT & EXPORT PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- GEL
- Dosage
- <p>4.2 Posology and method of administration</p>
<p>Cutaneous use.</p>
<p>Adult and Elderly men</p>
<p>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.</p>
<p>The application should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, and both arms and abdomen.</p>
<p>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.</p>
<p>Do not apply to the genital areas as the high alcohol content may cause local irritation.</p>
<p>Steady state plasma testosterone concentrations are reached approximately on the 2<sup>nd</sup> 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 3<sup>rd</sup> 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.</p>
<p>Children</p>
<p>ANDROGEL is not indicated for use in children and has not been evaluated clinically in males under 18 years of age.</p>
- Route Of Administration
- CUTANEOUS
- Indication Info
- <p>4.1 Therapeutic indications</p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Contraindications
- <p>4.3 Contraindications</p>
<p>ANDROGEL is contraindicated:</p>
<p>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.</p>
- Pharma Manufacturer Name
- PHARMED IMPORT & EXPORT PTE LTD
