Testosteronedrug info

5000 MG testosterone 0.01 MG/MG Topical Gel [Testim]

What it is used for

TESTIM is indicated for testosterone 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 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): 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.

Limitations of Use: Safety and efficacy of TESTIM in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. Safety and efficacy of TESTIM in males less than 18 years old have not been established. Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. TESTIM is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary Hypogonadism (Congenital or Acquired) Hypogonadotropic Hypogonadism Limitations of Use: Safety and efficacy of TESTIM in men with “age-related hypogonadism” have not been established. Safety and efficacy of TESTIM in males less than 18 years old have not been established. Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 15, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Description

TESTIM (testosterone gel) is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen. TESTIM provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms. One 5-g or two 5-g tubes of TESTIM contains 50 mg or 100 mg of testosterone, respectively, to be applied daily to the skin’s surface. Approximately 10% of the applied testosterone dose is absorbed across skin of average permeability during a 24-hour period. The active pharmacological ingredient in TESTIM is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-β hydroxyandrost-4-en-3-one. The structural formula is shown in the following figure: Testim may have an alcoholic/musk odor. Inactive ingredients in TESTIM are purified water, pentadecalactone, carbopol, acrylates, propylene glycol, glycerin, polyethylene glycol, ethanol (74%), and tromethamine. Chemical Structure of testosterone

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 15, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.

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