DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Testosterone (Testosterone Cypionate) - Indications and Dosage



Testosterone is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

  • •Primary Hypogonadism (congenital or acquired) - testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range.
  • •Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Important limitations of use:

  • •Safety and efficacy of testosterone gel in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].
  • •Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. (1, 12.3)


Dosing and Dose Adjustment

The recommended starting dose of testosterone gel is 50 mg of testosterone (4 pump actuations, two 25 mg packets, or one 50 mg packet), applied topically once daily in the morning to the shoulders and upper arms and/or abdomen area (preferably at the same time every day).

Dose Adjustment

To ensure proper dosing, serum testosterone levels should be measured at intervals. If the serum testosterone concentration is below the normal range, the daily testosterone gel dose may be increased from 50 mg to 75 mg and from 75 mg to 100 mg for adult males as instructed by the physician (see Table 1, Dosing Information for testosterone gel). If the serum testosterone concentration exceeds the normal range, the daily testosterone gel dose may be decreased. If the serum testosterone concentration consistently exceeds the normal range at a daily dose of 50 mg, testosterone gel therapy should be discontinued. In addition, serum testosterone concentration should be assessed periodically.

Administration Instructions

Testosterone gel should be applied to clean, dry, healthy, intact skin of the right and left upper arms/shoulders and/or right and left abdomen. Area of application should be limited to the area that will be covered by the patient’s short sleeve T- shirt. Do not apply testosterone gel to any other part of the body including the genitals, chest or back. Testosterone gel should be evenly distributed between the right and left upper arms/shoulders or both sides of the abdomen.

The prescribed daily dose of testosterone gel should be applied to the right and left upper arms/shoulders and/or right/left abdomen as shown in the shaded areas in the figure below.


After applying the gel, the application site should be allowed to dry prior to dressing. Hands should be washed with soap and water after testosterone gel has been applied. Avoid fire, flames or smoking until the gel has dried since alcohol based products, including testosterone gel, are flammable.

The patient should be advised to avoid swimming or showering for at least 5 hours after the application of testosterone gel.

Multi-Dose Pump

To obtain a full first dose, it is necessary to prime the canister pump. To do so, with the canister in the upright position, slowly and fully depress the actuator three times. Safely discard the gel from the first three actuations. It is only necessary to prime the pump before the first dose. After the priming procedure, patients should completely depress the pump one time (actuation) for every 12.5 mg of testosterone required to achieve the daily prescribed dosage. The product should be delivered directly into the palm of the hand and then applied to the desired application sites. Alternatively, testosterone gel can be applied directly to the application sites.

Table 1 provides dosing information for adult males.

  •   Table 1: Dosing Guidelines for Using the Multi-Dose Pump

Prescribed Daily Dose

Number of Pump Actuations

50 mg

4 (once daily)

75 mg

6 (once daily)

100 mg

8 (once daily)


The entire contents should be squeezed into the palm of the hand and immediately applied to the application sites. Alternately, patients may squeeze a portion of the gel from the packet into the palm of the hand and apply to application sites. Repeat until entire contents have been applied.

Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from testosterone gel-treated skin:

  • •Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel.
  • •Patients should wash their hands immediately with soap and water after applying testosterone gel.
  • •Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the gel has dried.
  • •Prior to any situation in which skin-to-skin contact with the application site is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue.
  • •In the event that unwashed or unclothed skin to which testosterone gel has been applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.


Testosterone gel for topical use is available as follows:

  • •A metered-dose pump. Each pump actuation delivers 12.5 mg of testosterone in 1.25 g of gel.
  • •A unit dose packet containing 25 mg of testosterone provided in 2.5 g of gel.
  • •A unit dose packet containing 50 mg of testosterone provided in 5 g of gel.


Testosterone gel is supplied in non-aerosol, metered-dose pumps that deliver 12.5 mg of testosterone per complete pump actuation. The pumps are composed of plastic and stainless steel and an LDPE/aluminum foil inner liner encased in rigid plastic with a polypropylene cap. Each 88 g metered-dose Pump is capable of dispensing 75 g of gel or 60 metered pump actuations; each pump actuation dispenses 1.25 g of gel containing 12.5 mg of testosterone.

NDC Number

Package Size


2 x 75 g pumps (each pump dispenses 60 metered pump actuations with each pump actuation containing 12.5 mg of testosterone in 1.25 g of gel)

Testosterone gel is also supplied in unit-dose aluminum foil packets in cartons of 30.

Each packet of 2.5 g or 5 g gel contains 25 mg or 50 mg testosterone, respectively.

NDC Number

Package Size


30 packets (25 mg of testosterone in 2.5 g of gel per packet)


30 packets (50 mg of testosterone in 5 g of gel per packet)

16.2 Storage and Handling

Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.]

16.3 Disposal

Used testosterone gel pumps or used testosterone gel packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017