What forms is testosterone gel 1.62% (testosterone) available in?

Testosterone Gel 1.62% Formulations

Testosterone gel 1.62% is available in two forms: a metered-dose pump that delivers 20.25 mg of testosterone per actuation in 1.25 g of gel, and unit-dose packets available in two strengths—20.25 mg in 1.25 g and 40.5 mg in 2.5 g. 1

Available Formulations

The FDA-approved testosterone gel 1.62% comes in the following specific forms:

• Metered-dose pump: Each pump actuation delivers precisely 20.25 mg of testosterone in 1.25 g of gel 1

• Unit-dose packets:

  • Small packet: 20.25 mg of testosterone in 1.25 g of gel 1
  • Large packet: 40.5 mg of testosterone in 2.5 g of gel 1

Physical Characteristics

• The gel is a clear, colorless formulation containing testosterone USP as the active ingredient 1

• Inactive ingredients include carbomer homopolymer type C (carbopol 980), ethyl alcohol, isopropyl myristate, purified water, and sodium hydroxide 1

• The formulation has increased viscosity compared to other testosterone gels, which reduces the volume needed for application 2

Application Sites

• The gel should be applied to clean, dry, intact skin of the shoulders and upper arms 1

• Alternative application to the abdomen is also acceptable, though a rotation method between abdomen and upper arms/shoulders was used in pivotal trials 1

• The gel dries in less than 5 minutes and leaves no residue 3

Clinical Considerations

• The metered-dose pump allows for precise dose titration in 20.25 mg increments, facilitating individualized dosing 1

• Unit-dose packets provide pre-measured amounts that eliminate the need for dose measurement but offer less flexibility than the pump 1

• Hands should be washed immediately after application to minimize transfer risk to others 4

• The application site should be covered with clothing once dry to prevent unintentional transfer to partners or children through skin-to-skin contact 4