Testosterone Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Hypogonadism - Male

Parenteral: Short-acting (testosterone solution and propionate): 25 mg to 50 mg IM 2 to 3 times a week.
Long-acting (enanthate and cypionate): 50 to 400 mg IM every 2 to 4 weeks.
Subcutaneous implant: 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months.

Topical:
Transdermal Film: 2.5 to 5 mg applied to the back, abdomen, upper arm, or upper thigh once a day, preferably at night.
Gel (in tubes, packets or spray): 5 g applied once daily, preferably in the morning. May increase as needed to a maximum of 10 g once a day.

Buccal: 30 mg patch to the gum region twice daily; morning and evening (about 12 hours apart). Patch should be placed just above the incisor tooth. With each application, the patch should be rotated to alternate sided of the mouth.

Testosterone 30 mg/1.5 mL transdermal solution:
Starting dose is 60 mg of testosterone (1 pump actuation of 30 mg of testosterone to each axilla), applied once daily, at the same time each morning. The dose of testosterone may be decreased from 60 mg (2 pump actuations) to 30 mg (1 pump actuation) or increased from 60 mg to 90 mg (3 pump actuations) or from 90 mg to 120 mg (4 pump actuations) based on the serum testosterone concentration from a single blood draw 2 to 8 hours after applying the solution and at least 14 days after starting treatment or following dose adjustment.

Testosterone 10 mg/0.5 g transdermal gel:
Starting dose is 40 mg of testosterone (4 pump actuations of 30 mg to clean, dry intact skin of the front and inner thighs), applied once daily, at the same time each morning. Let application site dry before putting on pants or shorts. The dose can be adjusted between a minimum of 10 mg of testosterone (1 pump actuation) and a maximum of 70 mg of testosterone (7 pump actuations) on the basis of total serum testosterone concentrations 2 hours post application. The dose should be titrated based on the serum testosterone concentration from a single blood draw 2 hours after applying and at approximately 14 days and 35 days after starting treatment or following dose adjustment. In addition, serum testosterone concentration should be assessed periodically thereafter.

Testosterone 20.25 mg/1.25 g transdermal gel:
Starting dose 40.5 mg of testosterone (2 pump actuations), applied topically to the shoulders and upper arms once daily in the morning. The dose can be adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation) and a maximum of 81 mg of testosterone (4 pump actuations). The dose should be titrated based on the pre dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment. Additionally, serum testosterone concentration should be assessed periodically thereafter.

Usual Adult Dose for Breast Cancer-Palliative

Parenteral: Short-acting (testosterone solution and propionate): 50 mg to 100 mg IM 2 to 3 times a week.
Long-acting (enanthate and cypionate): 200 to 400 mg IM every 2 to 4 weeks.
Subcutaneous implant: 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months

Testosterone is approved by the FDA for the palliation of androgen responsive metastatic breast cancer in women who are 1 to 5 years postmenopausal or who are proven to have a hormone-dependent tumor noted by previous beneficial response to castration.

Female patients should be observed for signs of virilization. Women should be instructed to report any hoarseness, acne, changes in menstrual periods, or increases in facial hair. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. A decision may be made by the patient and the physician that some virilization will be tolerated during the treatment for malignant disease.

Usual Adult Dose for Postpartum Breast Pain

Parenteral: Short-acting (testosterone solution and propionate): 25 mg to 50 mg IM for 3 to 4 days, starting at the time of delivery.

Usual Pediatric Dose for Delayed Puberty - Male

Parenteral:
Initiation of pubertal growth: Long-acting (enanthate and cypionate): 40 to 50 mg/square meter IM monthly until the growth rate falls to prepubertal levels.
Terminal growth phase: Long-acting (enanthate and cypionate): 100 mg/square meter IM monthly until the growth ceases.
Maintenance virilizing dose: Long-acting (enanthate and cypionate): 100 mg/square meter intramuscular twice monthly.

Subcutaneous implant: 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months.

Dosages used to treat delayed puberty are generally started at the lower end of the dosing range and titrated according to patient response and tolerance. The duration of therapy should be limited to 4 to 6 months. Serum concentrations of testosterone should be determined following 3 to 4 weeks of daily use. If desired results have not been achieved at 6 to 8 weeks an alternative testosterone regimen should be considered.

Wrist and hand bone age should be assessed prior to initiation of testosterone therapy and every 6 months to monitor bone maturation. Exogenous androgen therapy can accelerate bone maturation without producing a compensatory gain in linear growth. Use over long periods can result in fusion of the epiphyseal growth centers and termination of the growth process.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

The intramuscular preparation should be inspected visually for particulate matter and discoloration prior to administration. Warming and shaking the vial should re dissolve any crystals that may have formed. The rewarmed product poses no risk to patient safety, efficacy, or product quality.

Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

Dialysis

Data not available

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for testosterone (Testim, Androgel, Axiron, Foresta, and testosterone gel by Teva). It includes a Medication Guide. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

Wash hands thoroughly after application of topical products.

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