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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Call your healthcare androgrl right away if you have any of the serious side effects listed above. Testosterone has been tested by subcutaneous injection and implantation in mice and rats.

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Due to the lack of controlled evaluations in women and potential virilizing effects, AndroGel 1. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

AbbVie is providing these links to you only as a convenience, and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. Application Sites for AndroGel 1. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with pj of the testosterone gel exposure.

The Official AndroGel (testosterone gel) % CIII Website

Exposure of test and control article application sites to ultraviolet light did not produce increased inflammation relative to non-irradiated sites, indicating no phototoxic effect.

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Nausea, vomiting, changes in skin color, or ankle swelling. After the gel has dried, cover the application area with clothing.

Reproductive system and breast disorders:. Effect of showering In a randomized, 3-way 3 treatment periods without washout period crossover study in 24 hypogonadal men, the effect of showering on testosterone exposure was assessed after once daily application of AndroGel 1.

Additionally, there is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer.

You are leaving the AndroGel. Then, position the nozzle over the palm of your hand and slowly push the pump all the way down.

Patients should be informed of this possible risk when deciding whether to use or to continue to use AndroGel 1. The mean estradiol androgfl DHT concentration profiles paralleled the changes observed in testosterone. An increase in red blood cell mass may increase the risk of thromboembolic events. Food and Drug Administration.

Final Dose on Day Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Signs and symptoms of these reported cases have included enlargement of the clitoris with surgical intervention or the penis, development of andfogel hair, increased erections and libido, aggressive behavior, and advanced bone age.

Cases of secondary exposure to testosterone have been reported in children. The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. No specific pharmacodynamic studies were conducted using AndroGel 1.

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Safely discard the gel from the first three actuations. If you cannot afford your medication, contact www.

Avoid fire, flames or smoking until the gel has dried since alcohol based products, including AndroGel 1. Anfrogel 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.

Wash hands thoroughly with soap and water. Products or treatments described on this site are available in the U. Inactivation of testosterone occurs primarily in the liver. Keep the area covered until you have washed the application area well or have showered.

PRESCRIBING INFORMATION

The dose should be titrated based on the pre-dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose androgek. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary.

Squeeze from the bottom of the packet to the top.