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Testim

Testim

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Questions & Answers

Side Effects & Adverse Reactions

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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): 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.

Limitations of use:


  • Safety and efficacy of Testim 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 [see Dosage and Administration (2) and Clinical Pharmacology (12.3)].

History

There is currently no drug history available for this drug.

Other Information

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:

Chemical Structure of testosterone

Inactive ingredients in Testim are purified water, pentadecalactone, carbopol, acrylates, propylene glycol, glycerin, polyethylene glycol, ethanol (74%), and tromethamine.

Testim Manufacturers


  • A-s Medication Solutions Llc
    Testim (Testosterone) Gel [A-s Medication Solutions Llc]
  • Stat Rx Usa
    Testim (Testosterone) Gel [Stat Rx Usa]
  • Physicians Total Care, Inc.
    Testim (Testosterone) Gel [Physicians Total Care, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Testim (Testosterone) Gel [Lake Erie Medical Dba Quality Care Products Llc]
  • A-s Medication Solutions Llc
    Testim (Testosterone) Gel [A-s Medication Solutions Llc]
  • Auxilium Pharmaceuticals, Inc.
    Testim (Testosterone) Gel [Auxilium Pharmaceuticals, Inc.]

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