Testosterone

TESTOSTERONE

Manufacturer: Amneal Pharmaceuticals NY LLC

Score: 148.0

Quick Summary

Testosterone topical solution is used for replacement therapy in males with conditions associated with a deficiency or absence of endogenous testosterone. The solution delivers physiologic circulating testosterone that approximates normal concentration ranges seen in healthy men. Key clinical findings indicate the importance of proper dosing and monitoring to achieve desired serum testosterone concentrations. Important safety information includes warnings about secondary exposure to testosterone, contraindications in men with carcinoma of the breast or known/suspected carcinoma of the prostate, and potential adverse reactions. Main dosing recommendations involve starting with 60 mg of testosterone applied once daily, with adjustments based on serum testosterone concentrations. Special population considerations include use during pregnancy, nursing, pediatric use, and geriatric use, with specific guidelines and precautions for each group.

Key Clinical Findings and Indications

Replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Primary hypogonadism (congenital or acquired)
Hypogonadotropic hypogonadism (congenital or acquired)

Important Safety Information

Warning

Secondary exposure to testosterone can occur, and patients should be advised to strictly adhere to recommended instructions for use.

Contraindications

Men with carcinoma of the breast or known/suspected carcinoma of the prostate
Pregnant or breastfeeding women

Adverse Reactions

Skin application site reactions
Increased hematocrit
Headache
Diarrhea
Vomiting
Increased serum PSA

Dosing Recommendations

General Guidance

Dose adjustments can be made based on serum testosterone concentrations, with decreases or increases in 30 mg increments.

Hypogonadism

Adult Dose

60 mg of testosterone applied once daily

Pediatric Dose

Not established for males <18 years old

Special Population Considerations

Pregnancy

Testosterone topical solution is contraindicated during pregnancy or in women who may become pregnant
Testosterone is teratogenic and may cause fetal harm

Nursing Mothers

Testosterone topical solution is contraindicated in nursing women
Testosterone may adversely affect lactation

Pediatric Use

Safety and efficacy not established in males <18 years old
Improper use may result in acceleration of bone age and premature closure of epiphyses

Geriatric Use

Insufficient numbers of geriatric patients in controlled clinical studies
Potential incremental risk of cardiovascular disease and prostate cancer

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