WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
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Virilization has been reported in children who were secondarily exposed to topical testosterone products
[see Warnings and Precautions ]
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Children should avoid contact with unwashed or unclothed application sites in men using AXIRON
[see Dosage and Administration and Warnings and Precautions]
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Healthcare providers should advise patients to strictly adhere to recommended instructions for use
[see Dosage and Administration Warnings and Precautions and Patient Counseling Information]
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AXIRON SUMMARY
AXIRON (testosterone) topical solution is a clear, colorless, single phase solution containing 30 mg of testosterone in 1.5 mL of AXIRON solution for topical administration through the axilla. The active pharmacologic ingredient in AXIRON is testosterone.
AXIRON is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
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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 (FSH, LH) above the normal range.
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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 AXIRON in males <18 years old have not been established [see Use in Specific Populations].
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NEWS HIGHLIGHTSMedia Articles Related to Axiron (Testosterone)
Low Testosterone (Low T)
Source: MedicineNet Iron Overload Specialty [2017.06.23]
Title: Low Testosterone (Low T)
Category: Symptoms and Signs
Created: 5/22/2015 12:00:00 AM
Last Editorial Review: 6/23/2017 12:00:00 AM
Published Studies Related to Axiron (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
Clinical Trials Related to Axiron (Testosterone)
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism [Active, not recruiting]
This is to study the effect of replacing testosterone on different inflammatory cells in
type 2 diabetics with low testosterone levels.
A Study of Axiron® in Healthy Participants [Completed]
The study involves application of Axiron to each underarm. The study will evaluate the
transfer of testosterone from underarms to the clothing items that the participant is
wearing and other fabric items washed with participant's' clothes. The study is
approximately 6 days, not including screening. Screening is required within 28 days prior to
the start of the study.
Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women [Completed]
Female sexual dysfunction (FSD) is an established side effect of Selective serotonin
reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing
symptoms such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia.
Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder
(HSDD) in women has been demonstrated in studies including naturally and surgically
menopausal women, either alone or in combination with estrogen, with or without progestin
therapy.
TRADE-Testosterone Replacement and Dutasteride Effectiveness [Completed]
The purpose of this research study is to determine whether the combination of the male
hormone testosterone [T] in gel form and the oral drug dutasteride [D], used to shrink large
prostate glands can safely reduce the size of the prostate gland and symptoms of prostate
enlargement (called benign prostatic hyperplasia [BPH]) compared to T treatment alone in men
with low testosterone (called hypogonadism).
Pharmacokinetic Study of Testosterone Enanthate [Completed]
Reports of Suspected Axiron (Testosterone) Side Effects
Pulmonary Embolism (7),
Thrombosis (6),
Deep Vein Thrombosis (6),
Blood Testosterone Decreased (5),
Confusional State (3),
Urticaria (3),
Skin Burning Sensation (3),
Dyspnoea (3),
Syncope (3),
Prostatitis (2), more >>
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Page last updated: 2017-06-23
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