Warnings and Precautions 5. FORTESTA is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:. Prior to initiating, FORTESTA confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.
The dose can be adjusted between a minimum of 10 mg of testosterone and a maximum of 70 mg of testosterone. In addition, serum testosterone concentration should be assessed periodically thereafter. Table 1 describes the dose adjustments required at each titration step. Once the application site is dry, the site should be covered 2 подружки решили наказать 1 любовника поимев его стрампоном clothing [see Clinical Pharmacology Wash hands thoroughly with soap and water.
Avoid applying the gel to the thigh adjacent to the scrotum. The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application [see Clinical Pharmacology To obtain a full first dose, it is necessary to prime the canister pump.
To do so, with the canister in the upright position, slowly 2 подружки решили наказать 1 любовника поимев его стрампоном fully depress the actuator eight times. 2 подружки решили наказать 1 любовника поимев его стрампоном first three actuations may result in no discharge of gel.
Safely discard the gel from the first eight actuations. It is only necessary to prime the pump before the first dose. Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from FORTESTA-treated skin: One pump actuation delivers 10 mg of testosterone.
Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel.
In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age. The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product. Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician.
Testosterone gel should be promptly discontinued until the cause of virilization has been identified. Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone.
Check hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually.
If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration.
An increase in red blood cell mass may increase the risk of thromboembolic events. Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men.
To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events MACEsuch as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives.
Counsel patients concerning the serious adverse reactions associated with abuse 2 подружки решили наказать 1 любовника поимев его стрампоном testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. With large doses of exogenous androgens, including FORTESTA, spermatogenesis may be suppressed through feedback inhibition of pituitary FSH which could possibly lead to adverse effects on semen parameters including sperm count.
Prolonged use of high doses of orally active alpha-alkyl androgens e. Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with testosterone enanthate 2 подружки решили наказать 1 любовника поимев его стрампоном produced multiple hepatic adenomas.
Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease [see Adverse Reactions 6. The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases. Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy.
Regular monitoring of serum calcium concentrations is recommended in these patients.
Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adverse reactions occurred in The most common adverse reaction reported in this study was skin reactions associated with the site of application During the 90 day trial 5 patients 3.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure Table 4. Secondary Exposure to Testosterone in Children Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products.
Signs and symptoms of these reported cases have included enlargement of the clitoris with surgical intervention or the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure.
In a few cases, however, enlarged genitalia did not fully return to age appropriate normal size, and bone age remained modestly greater than chronological age. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported. Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease insulin requirements. Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio INR and prothrombin 2 подружки решили наказать 1 любовника поимев его стрампоном are recommended in patients taking anticoagulants, especially at 2 подружки решили наказать 1 любовника поимев его стрампоном initiation and termination of androgen therapy.
The concurrent administration of testosterone with adrenocorticotropic hormone ACTH or corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.
Pregnancy Category X [see Contraindications 4 ]. Testosterone is teratogenic and may cause fetal harm.
Exposure of a female fetus to androgens may result in varying degrees of virilization. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be made aware of the potential hazard to the fetus.
Although it is not known how much testosterone transfers into human milk, FORTESTA is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants.
Testosterone and other androgens may adversely affect lactation [see Contraindications 4 ]. Improper use may result in acceleration of bone age and premature closure of epiphyses. There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing FORTESTA to determine whether efficacy in those over 65 years of age differs from younger subjects.
Additionally, there are insufficient long-term safety data in geriatric patients 2 подружки решили наказать 1 любовника поимев его стрампоном assess the potential risks of cardiovascular disease and prostate cancer. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH. 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 2 подружки решили наказать 1 любовника поимев его стрампоном anabolic androgenic steroids AASand not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders.
There have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.
Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. The following adverse reactions have also been reported in men: The following additional adverse reactions have been reported in women: The following adverse reactions have been reported in male and female adolescents: Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Behaviors Associated with Addiction. Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:. Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug.
Individuals taking 2 подружки решили наказать 1 любовника поимев его стрампоном doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented. There is a single report of acute overdosage after parenteral administration of an approved testosterone product in the literature.
Treatment of overdosage would consist of discontinuation of FORTESTA, washing the application site with soap and water, and appropriate symptomatic and supportive care.
Each pump actuation provides 10 mg of testosterone and each container is capable of dispensing pump actuations. One pump actuation dispenses 0. Testosterone USP is a white to almost white powder described chemically as beta hydroxyandrostenone.
Endogenous androgens, including testosterone and dihydrotestosterone DHTare responsible for the normal growth and development of the male sex organs and for the maintenance of secondary sex characteristics. These effects include the growth and maturation of the prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Testosterone and DHT are necessary for the normal development of secondary sex characteristics. Male hypogonadism, a clinical 2 подружки решили наказать 1 любовника поимев его стрампоном resulting from insufficient secretion of testosterone, has two main etiologies.
FORTESTA provides continuous transdermal delivery of testosterone for 24 hours following a single application to clean, dry, intact skin of the front and inner thighs Figure 1. Distribution Circulating testosterone is primarily bound in the serum to sex hormone-binding globulin SHBG and albumin. Metabolism Testosterone is metabolized to various keto steroids through two different pathways.
The major active metabolites of testosterone are estradiol and DHT. Excretion There is considerable variation in the half-life of testosterone concentration as reported in the literature, ranging from 10 to minutes.
Inactivation of testosterone occurs primarily in the liver. Potential for testosterone transfer The potential for testosterone transfer from healthy males dosed with FORTESTA to healthy females was evaluated in a placebo-controlled, three-way crossover study. The washout period 2 подружки решили наказать 1 любовника поимев его стрампоном approximately 29 days.
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