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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 supplementation does not result in progression of atherosclerosis
Source: Endocrinology News From Medical News Today [2015.08.12]
Among older men with low testosterone levels, testosterone administration for 3 years compared with placebo did not result in a significant difference in the rates of change in atherosclerosis...

Testosterone therapy may improve heart health for older men
Source: Stroke News From Medical News Today [2015.08.12]
Researchers have observed that patients whose low testosterone levels returned to normal with therapy also experienced a reduced risk of heart attack and stroke.

Normalization of testosterone level after testosterone replacement therapy
Source: Endocrinology News From Medical News Today [2015.08.06]
Normalization of testosterone level after testosterone replacement therapy could decrease risk of cardiovascular events and mortality in menPatients with low testosterone levels who have then...

Testosterone Treatments Won't Help Men With Ejaculatory Issues
Source: MedicineNet Clinical Trials Specialty [2015.07.10]
Title: Testosterone Treatments Won't Help Men With Ejaculatory Issues
Category: Health News
Created: 7/9/2015 12:00:00 AM
Last Editorial Review: 7/10/2015 12:00:00 AM

Men with 'low testosterone' have higher rates of depression
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2015.07.02]
Researchers at the George Washington University (GW), led by Michael S. Irwig, M.D.

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: 2015-08-12

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