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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Increase daily dose by Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Acne, alopecia, application site reaction discolored hair, dry skin, erythema, paresthesia, pruritus, rashskin dry, pruritus, sweating Vascular disorders: Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus or pituitary to produce sufficient gonadotropins FSH, LH.

Prior to situations in which direct skin-to-skin contact is anticipated, patients should wash the application site s thoroughly with soap and water to remove any testosterone residue. Elevated Hgb, Hct polycythemia. Figure 3 summarizes the pharmacokinetic profile of total testosterone in patients completing days of AndroGel 1.

The other patient did not undergo repeat PSA testing. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives.

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This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Testosterone and other androgens may adversely affect lactation [see Contraindications 4 ].

PRESCRIBING INFORMATION

Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. The mean estradiol and DHT concentration profiles paralleled the changes observed in testosterone. Keep the area covered until you have washed the application area well or have showered.

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. Average serum testosterone concentrations over 24 hours C avg observed when AndroGel 1. After the gel has dried, cover the application area with clothing.

Potential for testosterone transfer. Metabolism Testosterone is metabolized to various keto steroids through two different pathways. In patients treated with AndroGel 1. Myocardial infarction, stroke Endocrine disorders: Wash the application site s thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

NDC Number Package Size 88 g pump each pump dispenses 60 metered pump actuations with each pump actuation containing Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.

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Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Products or treatments described on this site are available in the U.

Secondary exposure to testosterone in children and women can occur with the use of testosterone gel in men. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Topical testosterone products may have ancrogel doses, strengths, or application instructions that may result in different systemic exposure.

AndroGel – FDA prescribing information, side effects and uses

Hands should be washed thoroughly with soap and water after application. There was no additional statistically significant increase observed in mean PSA from 6 months through 36 months.

The major active metabolites of testosterone are estradiol and dihydrotestosterone DHT. 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.

Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men.