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Active ingredient: Testosterone - Brands, Medical Use, Clinical Data

Brands, Medical Use, Clinical Data

Drug Category

  • Androgens

Dosage Forms

  • Capsule
  • Gel
  • Liquid
  • Patch
  • Solution
  • Suspension

Brands / Synonyms

Andriol; Andro; Andro 100; Andro L.A. 200; Androderm; Androgel; Android 10; Android 25; Android 5; Androlin; Andronaq; Andronate 100; Andronate 200; Andropatch; Andropository 200; Andrusol; Andryl 200; Axiron; Beta Testosterone; CDB 111C; Cristerona T; Cristerone T; Dea No. 4000; Delatest; Delatestryl; Depo-Testosterone; Depo-Testosterone Cypionate; Depotest; Dofsol; Everone 200; Fortesta; Geno-Cristaux Gremy; Homosteron; Homosterone; Libigel; Malerone; Malestrone; Malogen in Oil; Malogen, Aquaspension Injection; Mertestate; Metandren; Methyltestosterone; Neo-Hombreol F; Neo-Testis; Neotestis; Oreton; Oreton F; Oreton Methyl; Oreton-F; Orquisteron; Perandren; Percutacrine Androgenique; Primotest; Primoteston; Relibra; Scheinpharm Testone-Cyp; Striant; Sustanon; Sustanone; Sustason 250; Synandrol F; T-Cypionate; TES; Teslen; Testamone 100; Testandrone; Testaqua; Testex; Testiculosterone; Testim; Testobase; Testoderm; Testoderm Tts; Testogel; Testoject-50; Testolin; Testopel Pellets; Testopropon; Testosteroid; Testosteron; Testosterona [Inn-Spanish]; Testosterone; Testosterone and Its Esters; Testosterone Cypionate; Testosterone Enanthate; Testosterone Hydrate; Testosterone Propionate; Testosterone [Ban:Inn]; Testosteronum [Inn-Latin]; Testostosterone; Testoviron; Testoviron Schering; Testoviron T; Testred; Testred Cypionate 200; Testrin-P.A; Testro Aq; Testrone; Testryl; Trans-Testosterone; Virilon; Virilon IM; Virormone; Virosterone

Indications

For replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Pharmacology

Testosterone is a steroid hormone from the androgen group. Testosterone is primarily secreted in the testes of males and the ovaries of females although small amounts are secreted by the adrenal glands. It is the principal male sex hormone and an anabolic steroid. In both males and females, it plays key roles in health and well-being. Examples include enhanced libido, energy, immune function, and protection against osteoporosis. On average, the adult male body produces about twenty times the amount of testosterone than an adult female's body does.

Mechanism of Action

The effects of testosterone in humans and other vertebrates occur by way of two main mechanisms: by activation of the androgen receptor (directly or as DHT), and by conversion to estradiol and activation of certain estrogen receptors. Free testosterone (T) is transported into the cytoplasm of target tissue cells, where it can bind to the androgen receptor, or can be reduced to 5α-dihydrotestosterone (DHT) by the cytoplasmic enzyme 5α-reductase. DHT binds to the same androgen receptor even more strongly than T, so that its androgenic potency is about 2.5 times that of T. The T-receptor or DHT-receptor complex undergoes a structural change that allows it to move into the cell nucleus and bind directly to specific nucleotide sequences of the chromosomal DNA. The areas of binding are called hormone response elements (HREs), and influence transcriptional activity of certain genes, producing the androgen effects.

Absorption

Approximately 10% of the testosterone dose applied on the skin surface is absorbed into systemic circulation

Toxicity

Side effects include amnesia, anxiety, discolored hair, dizziness, dry skin, hirsutism, hostility, impaired urination, paresthesia, penis disorder, peripheral edema, sweating, and vasodilation.

Biotrnasformation / Drug Metabolism

Testosterone is metabolized to 17-keto steroids through two different pathways. The major active metabolites are estradiol and dihydrotestosterone (DHT).

Contraindications

Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate.

AndroGel® is not indicated for use in women, has not been evaluated in women, and must not be used in women.

Pregnant women should avoid skin contact with AndroGel® application sites in men. Testosterone may cause fetal harm. In the event that unwashed or unclothed skin to which AndroGel® has been applied does come in direct contact with the skin of a pregnant woman, the general area of contact on the woman should be washed with soap and water as soon as possible. In vitro studies show that residual testosterone is removed from the skin surface by washing with soap and water.

AndroGel® should not be used in patients with known hypersensitivity to any of its ingredients, including testosterone USP that is chemically synthesized from soy.

Drug Interactions

Oxyphenbutazone: Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.

Insulin: In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Propranolol: In a published pharmacokinetic study of an injectable testosterone product, administration of testosterone cypionate led to an increased clearance of propranolol in the majority of men tested.

Corticosteroids: The concurrent administration of testosterone with ACTH or corticosteroids may enhance edema formation; thus, these drugs should be administered cautiously, particularly in patients with cardiac or hepatic disease.

Drug/Laboratory Test Interactions

Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

 

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