The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) medication guide for Testosterone. For Testosterone Undecanoate, REMS includes elements to assure safe use and implementation system . For additional information: /REMS
US BOXED WARNINGS :
Pulmonary Oil Microembolism (POME) Reactions And Anaphylaxis :
-Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
-Following each injection of testosterone undecanoate observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.
Secondary Exposure To Topical Testosterone :
-Virilization has been reported in children who were secondarily exposed to topical testosterone products.
-Children should avoid contact with unwashed or unclothed application sites in men using testosterone topical.
-Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
Safety and efficacy have not been established in patients younger than 18 years.
Testosterone Enanthate and Testosterone Implant are indicated for delayed puberty in adolescent patients.
Testosterone Cypionate: Safety and efficacy have not been established in patients younger than 12 years.
Consult WARNINGS section for additional precautions.
Injectable steroids are injected into muscle tissue, not into the veins. They are slowly released from the muscles into the rest of the body, and may be detectable for months after last use. Injectable steroids can be oil-based or water-based. Injectable anabolic steroids which are oil-based have longer half-life than water-based steroids. Both steroid types have much longer half-lives than oral anabolic steroids. And this is proving to be a drawback for injectables as they have high probability of being detected in drug screening since their clearance times tend to be longer than orals. Athletes resolve this problem by using injectable testosterone early in the cycle then switch to orals when approaching the end of the cycle and drug testing is imminent.
Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of Testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained Testosterone than prescribed and continuing Testosterone despite adverse events or against medical advice.
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A 2006 study determined that 1-testosterone has a high androgenic and anabolic potency even without being metabolized, so it can be characterized as a typical anabolic steroid. 1-Testosterone binds in a manner that is highly selective to the androgen receptor (AR) and has a high potency to stimulate AR-dependent transactivation . In vivo , an equimolar dose of 1-testosterone has the same potency to stimulate the growth of the prostate , the seminal vesicles and the androgen-sensitive levator ani muscle as the reference anabolic steroid testosterone propionate , but, unlike testosterone propionate, 1-testosterone also increases liver weight.