ANDROGEL PI PDF

AndroGel % is an androgen indicated for replacement Draft ANDROGEL % (testosterone gel) Prescribing Information (PI) received. These highlights do not include all the information needed to use ANDROGEL % safely and effectively. See full prescribing information for ANDROGEL. ANDROGEL┬«. Testosterone gel 1%. This leaflet is part III of a three-part “Product Monograph” published when ANDROGEL was approved for.

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Medically reviewed on Nov 1, For dosage and administration of AndroGel 1. Dose Adjustment To ensure proper dosing, serum testosterone concentrations should androge, measured at intervals. Adnrogel addition, serum testosterone concentrations should be assessed periodically. After applying the gel, the application site should be allowed to dry prior to dressing. Hands should be washed thoroughly with soap and water after application.

The entire contents should be squeezed into the palm of the hand and immediately applied to the application sites. Alternately, patients may squeeze a portion of the gel from the packet into the palm of the hand and apply to application sites. Repeat until entire contents have been applied.

Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance. 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 androgsl 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.

Prescribing Information | AndroGel (testosterone gel) % CIII

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.

Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. 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. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions [see Drug Abuse and Dependence 9 ].

However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives.

PRESCRIBING INFORMATION

Counsel patients concerning qndrogel serious adverse reactions associated with abuse of 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.

Prolonged use of high doses of orally active alpha-alkyl androgens anerogel. Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease [see Adverse Reactions 6.

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The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with androge factors such as obesity or chronic lung diseases [see Adverse Reactions 6. 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, androtel there is no clinical evidence of thyroid dysfunction. Because clinical trials pj 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 practice.

Clinical Trials in Hypogonadal Men. There were two with a non-palpable testis and one with slight right testicular tenderness.

Two patients reported serious adverse events considered possibly related to treatment: Discontinuation for adverse events in this study included: During the initial 6-month study, the mean change in PSA values had a statistically significant increase of 0. There was no additional statistically significant increase observed in mean PSA from 6 months through 36 months. The overall mean change from baseline in serum PSA values for the entire group from month 6 to 36 was 0.

In two of these patients, prostate cancer was detected on biopsy. Because the 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 3.

Secondary Exposure to Testosterone in Children Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarket surveillance. 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 androbel 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. Wndrogel in insulin sensitivity or glycemic control may occur in patients treated with androgens.

In diabetic patients, the metabolic effects of androgens may decrease blood anfrogel 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 time are recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.

The concurrent use 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 apprised of the potential hazard to a fetus. 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. Additionally, there is insufficient long-term safety data in geriatric patients to 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. No studies were conducted in patients with hepatic impairment. 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 AASand not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders.

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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.

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 supratherapeutic 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 one report of acute overdosage with use of an approved injectable testosterone product: Testosterone USP is a white to practically white crystalline powder chemically described as beta hydroxyandrostenone.

The structural formula is:. These ingredients are not pharmacologically active. Endogenous androgens, including testosterone and dihydrotestosterone DHTare responsible for the normal growth and development of the male sex organs and for maintenance anddrogel secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal chord 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 syndrome resulting from insufficient secretion of testosterone, has two main etiologies.

The skin serves as a reservoir for the sustained release of testosterone into the systemic circulation. Absorption of testosterone anrrogel the blood continues for the entire hour dosing interval.

Serum concentrations approximate the steady-state concentration by the end of the first 24 hours and are at steady state by the second or third day of dosing. Circulating testosterone is primarily bound androtel the serum to sex hormone-binding globulin SHBG and albumin.

Testosterone is metabolized to various keto steroids through two different pathways. The major active metabolites of testosterone are estradiol and dihydrotestosterone DHT.

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. When a shirt covered the nadrogel site sthe transfer of testosterone from the males to the female partners was completely prevented.

The Official AndroGel (testosterone gel) % CIII Website

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma.