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Testosterone (Testosterone Cypionate) - Summary

 
 



WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

  • Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].
  • Children should avoid contact with any unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration (2.2), Warnings and Precautions (5.2)].
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration (2.2), Warnings and Precautions (5.2) and Patient Counseling Information (17)].
 

TESTOSTERONE SUMMARY

Testosterone gel is a clear, colorless hydroalcoholic gel containing testosterone. The active pharmacologic ingredient in testosterone gel is testosterone, an androgen.

Testosterone is an androgen indicated for 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 conditions such as 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.

Important limitations of use:

  • •Safety and efficacy of testosterone gel 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. (1, 12.3)

See all Testosterone indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Testosterone

Testosterone VTE Risk; Novel Clot Buster Flops Again; Saturated Fat Culpability
Source: MedPage Today Cardiology [2016.12.02]
(MedPage Today) -- Cardiovascular Daily wraps up the top cardiology news of the week

Blood Clot Risk Highest in First 6 Months of Testosterone Therapy
Source: Medscape Diabetes & Endocrinology Headlines [2016.12.01]
The risk of venous thromboembolism is substantially increased in the first 6 months after starting testosterone therapy, say researchers whose findings support recent warnings over the treatment.
Medscape Medical News

Medical News Today: Testosterone treatment may cause blood clots
Source: Featured Health News from Medical News Today [2016.12.01]
The number of men seeking testosterone replacement therapy has soared in recent decades. New research looks at some of the potential harms.

Testosterone treatment may cause blood clots
Source: Seniors / Aging News From Medical News Today [2016.12.01]
The number of men seeking testosterone replacement therapy has soared in recent decades. New research looks at some of the potential harms.

Testosterone Therapy May Be Linked to Serious Blood Clots
Source: MedicineNet Deep Vein Thrombosis Specialty [2016.12.01]
Title: Testosterone Therapy May Be Linked to Serious Blood Clots
Category: Health News
Created: 11/30/2016 12:00:00 AM
Last Editorial Review: 12/1/2016 12:00:00 AM

more news >>

Published Studies Related to Testosterone

Testosterone replacement therapy in older male subjective memory complainers: double-blind randomized crossover placebo-controlled clinical trial of physiological assessment and safety. [2015]
Testosterone replacement therapy (TRT) has been investigated in older men as a preventative treatment against Alzheimer's disease and dementia. However, previous studies have been contradictory... Our study suggests TRT is safe and well-tolerated in this Indonesian cohort, yet longitudinal studies with larger cohorts are needed to assess TRT further, and to establish whether TRT reduces dementia risk.

Testosterone induces erythrocytosis via increased erythropoietin and suppressed hepcidin: evidence for a new erythropoietin/hemoglobin set point. [2014]
hematocrit remain unclear... CONCLUSIONS: Testosterone-induced increase in hemoglobin and hematocrit is

Effect of testosterone treatment on constitutional and sexual symptoms in men with type 2 diabetes in a randomized, placebo-controlled clinical trial. [2014]
constitutional and sexual symptoms in men with type 2 diabetes (T2D)... CONCLUSIONS: In this trial, T treatment did not substantially improve

The role of androgen receptor CAG repeat polymorphism and other factors which affect the clinical response to testosterone replacement in metabolic syndrome and type 2 diabetes: TIMES2 sub-study. [2013]
TRT in the TIMES2 study... CONCLUSION: AR CAG affected the response of some variables to TRT in the TIMES2

Mechanical muscle function and lean body mass during supervised strength training and testosterone therapy in aging men with low-normal testosterone levels. [2013]
24-week study... CONCLUSION: Strength training in aging men with low-normal testosterone levels

more studies >>

Reports of Suspected Testosterone Side Effects

Drug Ineffective (56)Blood Testosterone Decreased (21)Drug Administered AT Inappropriate Site (19)Fatigue (15)Accidental Exposure (15)Blood Testosterone Increased (14)Asthenia (14)Pulmonary Embolism (12)Headache (12)Alopecia (12)more >>


Page last updated: 2016-12-02

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