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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Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Cover the application site s with clothing after the gel has dried.

Products or treatments described on this site are available in the U. Decrease daily dose by It is only necessary to prime the pump before the first dose.

Strict adherence to the following precautions is advised to minimize the potential oi secondary exposure to testosterone from AndroGel 1.

PRESCRIBING INFORMATION

NDC Number Package Size 88 g pump each pump dispenses 60 metered pump actuations with each pump actuation containing You are about to enter a site that is for U. Call your healthcare provider right away if you have any of the serious side effects listed above.

The following adverse reactions have been reported in male and female adolescents: Patients should be instructed to ip the palm of the hand to apply AndroGel 1. Call your healthcare provider right away if you have any of the serious side effects listed above.

Prescribing Information | AndroGel (testosterone gel) % CIII

Wash it down the sink to avoid accidental exposure to others. 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 pu pituitary to produce sufficient gonadotropins FSH, LH. There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis DVT and pulmonary embolism PEin patients using testosterone products such as AndroGel 1.

Abuse and misuse of testosterone are seen in male and female adults and adolescents. For more information, ask your healthcare provider androegl pharmacist. Especially, tell your healthcare provider if you take: Exposure of a fetus to androgens may result in varying degrees of virilization.

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The skin serves as a reservoir for the sustained release of testosterone into the systemic circulation. Showering at 10 hours after drug application had no effect on bioavailability. They do not depict actual or relative size.

The structural formula is: When you use this card, you are confirming that you have not submitted and will not submit a claim for this prescription for reimbursement under any federal, state, or government-funded healthcare program, such as Medicare including Part DMedicare Advantage, Medicaid, Medigap, Veterans Affairs, the Department of Defense, or TRICARE.

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. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported. Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented. This Medication Guide has been approved by the U.

In a second study evaluating transfer of testosterone, 12 male subjects applied a single dose of AndroGel 1. 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.

Depression, emotional lability, decreased libido, nervousness, hostility, amnesia, anxiety.

Hands should be washed thoroughly with soap and water after application. The secondary endpoint was the percentage of patients, with C max above three pre-determined limits.

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. Patients should be informed that treatment with androgens may lead to adverse reactions which include:. Clinical Trials in Hypogonadal Men. Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Two 2 hours after application to the males pl each day, the xndrogel subjects rubbed their abdomens for 15 minutes to the abdomen of the males.

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Excretion Androogel is considerable variation in the half-life androgwl testosterone concentration as reported in the literature, ranging from 10 androgle minutes. Apply half of the The decreases in levels of LH and FSH are consistent with reports published in the literature of long-term treatment with testosterone.

Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Swelling of your ankles, feet, or body, with or without heart failure. The following additional adverse reactions have been reported in women: Testosterone has been tested by subcutaneous injection and implantation in mice and rats.

Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Selling or giving away this medicine may harm others and is against the law. No specific pharmacodynamic studies were conducted using AndroGel 1.

When you use this card, you are confirming that you have not submitted and will not submit a claim for this prescription for reimbursement under any federal, state, or government-funded healthcare program, such as Medicare including Part DMedicare Advantage, Medicaid, Medigap, Veterans Affairs, the Department of Defense, or TRICARE.

Repeat until entire contents have been applied. Area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt. Neoplasms benign, malignant and unspecified cysts and polyps:. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Keep the area covered until you have washed the application area well or have showered. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure.

Reproductive system and breast disorders: 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.