Drug Name:Testosterone Patch
Product License Number
Drug Description:Testosterone Patch is applicable for testosterone replacement therapy in male patients with hypogonadia (e.g. post testectomy, anorchia, orchiditis, Klinefelter syndrome, hypopituitarism, endocrinologic impotence) and also indicated for treating partial androgen deficiency syndrome in middle-aged and senile men.
Pharmaceutical ingredients
Chemical Name: 17 β-hydroxy-3-oxo-4-androstene
Molecular Formula: C19H28O2
Molecular Weight: 288.42
The principal adjuvant of Testosterone Patch is: acrylic acid pressure sensitive adhesive
Drug Specifications
16.3 mg (3.3cm×3.03cm)
Drug application
[Dosage and Administration]
Use at the same time at around 10:00 each night. Upon removal of the protective film, apply the patch on clean and dry skin without wounds at the back, the abdomen, the upper am or the medial region of thighs and press it, the margins in particular, with a palm for about 10 seconds to ensure close contact.

 
Use four patches per time, once daily. Replace the patches once every 24 hours.
To ensure appropriate administered dose, morning serum testosterone concentration should be monitored periodically. The morning serum testosterone concentration should be determined after the delivery system has been used for one week. If the serum testosterone concentration is confirmed out of the normal range (reference value: 8.40-34.7 nmol/L), the administered dose should be increased or reduced.
To avoid or reduce local skin irritation, the administration site should be changed daily.
 
[Precautions]
1.     The physician should be timely informed if the user presents with any of the following conditions:
Too frequent or prolonged penile erection;
Nausea, vomiting, jaundice or ankle swelling;
Respiratory disorders, including sleep-related respiratory disturbance.
2.     For patients with a past history of heart, kidney or liver diseases, edema with or without congestive heart failure may occur. In case of this, use of the drug should be discontinued and, as appropriate, treatment using diuretics should be administered.
3.     It is reported that topical use of testosterone solution may lead to masculinization of the female partner. Creams for percutaneous administration may leave residual testosterone on the skin. If this product is, due to carelessness, transferred to the female partner’s body, it should be immediately removed and the affected skin site should be cleaned. It will be necessary to go to the hospital for help if the female partner presents with hair distribution changes or significantly more acnes.
4.      Laboratory examination
(1) For patients receiving androgen therapy for a long time, periodic hemoglobin and hematocrit tests are necessary (for detecting erythrocytosis).
(2) Liver function test, prostate specific antigen (PSA) test, total cholesterol test and high-density lipoprotein (LDL) test should be carried out regularly. If the PSA rises excessively fast or is >4 ng/mL, the drug should be withdrawn.
(3) To ensure appropriate administered dose, regular determination of the serum testosterone concentration is recommended.
5.      This product should be used with caution in athletes.