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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Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. The following adverse reactions have also been reported in men: Effect of hand washing In a randomized, open-label, single-dose, 2-way crossover study in 16 healthy male subjects, the effect of hand washing on the amount of residual testosterone on the hands was evaluated.

With large doses of exogenous androge, including AndroGel 1.

Androgens and anabolic steroids. Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy.

The Official AndroGel (testosterone gel) % CIII Website

After applying the gel, the application site should be allowed to dry prior to dressing. Reproductive system and breast disorders:. The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.

The skin serves as a reservoir for the sustained release of testosterone into the systemic circulation. Dose titrations on Days 14, 28, and 42 resulted in final doses of It is important to adhere to all recommended monitoring. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. Testosterone and other androgens may adversely affect lactation [see Contraindications 4 ].

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Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure adnrogel the hypothalamus or pituitary to produce sufficient gonadotropins FSH, LH.

AndroGel % | FULL Prescribing Information |

These photos can be used only for identification by shape, color, and imprint. Then, position the nozzle over the palm of your hand and slowly push the pump all the way down. Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. The other patient did not undergo repeat PSA anndrogel.

Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated. These adverse reactions included 6 reports of PSA increased, 2 androgek hematocrit increased, and 1 each of triglycerides increased and prostate cancer. Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

Products or treatments described on this site are available in the U. Po exposure to testosterone can produce signs of virilization.

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The dose can be adjusted between a minimum of Especially, tell your healthcare provider if you take: Headache, dizziness, sleep apnea, insomnia. Signs and symptoms have included enlargement of the abdrogel or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age.

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Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it ahdrogel not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Headache, dizziness, sleep apnea, insomnia Psychiatric disorders: Abnormal liver function tests e.

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Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Neither of these patients discontinued the study due to application site adverse reactions.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Products or treatments described on this site are available in the U.

It can help restore your testosterone levels back to normal. Testosterone, often in combination with other anabolic androgenic steroids AASand not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. Among previous placebo patients, 3 of 28 Serum concentrations of testosterone were monitored in female subjects for 24 hours after contact occurred. AbbVie is not responsible for the content of any such site or any further links from such site.

Patients could continue in an open-label, non-comparative, maintenance period for an additional days [see Clinical Studies 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. Taking greater dosages than prescribed Continued drug use despite medical and social problems due to drug use Spending significant time to obtain the drug when supplies of the drug are interrupted Giving a higher priority to drug use than other obligations Having difficulty in discontinuing the drug despite desires and attempts to do so Experiencing withdrawal symptoms upon abrupt discontinuation of use Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug.