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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Additionally, there is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer. Conversely, anndrogel the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Hypertension, vasodilation hot flushesvenous thromboembolism Secondary Exposure to Testosterone in Children Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing andeogel of testosterone gel products.

AndroGel % | FULL Prescribing Information |

Dose titrations on Days 14, 28, and 42 resulted in final doses of To ensure proper dosing, the dose should be titrated based on the pre-dose morning serum testosterone concentration from a single blood draw at approximately 14 days and 28 days after starting treatment or following dose adjustment.

Repeat until entire contents have been applied. The following additional adverse reactions have been reported in women: Patients should be informed that treatment with androgens may androfel to adverse reactions which include:. Subscribe to receive email notifications whenever new articles are androhel. Table 1 describes the dose adjustments required at each titration step.

Let the application site dry completely before putting on a t-shirt. On the 7th day of each treatment period, hypogonadal men took a shower with soap and water at either 2, 6, or 10 hours after drug application. NDC Number Package Size 88 g pump each pump dispenses 60 metered pump actuations oi each pump actuation containing The following adverse reactions have andrgel been reported in men: Gynecomastia, mastodynia, prostatic enlargement, testicular atrophy, oligospermia, priapism frequent or prolonged erections.

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Peliosis hepatis can be a life-threatening or fatal complication. Acne, alopecia, application site reaction discolored hair, dry skin, erythema, paresthesia, pruritus, rashskin dry, pruritus, sweating.

Subscribe to free Drugs. No studies were andrgoel involving patients with renal impairment. Because clinical trials are 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.

All patients were started at a daily dose of Testosterone is teratogenic and may cause fetal harm.

Other side effects include more erections than are normal for you or erections that last a long time. Gynecomastia may develop and persist in patients being treated with androgens, including AndroGel 1.

In addition, serum testosterone concentration should be assessed periodically thereafter. Dosage and Administration for AndroGel 1. Gynecomastia, mastodynia, prostatic enlargement, testicular atrophy, oligospermia, priapism frequent or prolonged erections Respiratory disorders: Prostate cancer Nervous system disorders: AndroGel Rating 89 User Reviews 7.

Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration 2. Physicians should advise patients of the reported signs and symptoms of secondary exposure, which may include the following: 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.

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When using packets, the entire contents should be squeezed into the palm of the hand and immediately applied to the application sites. These men usually have low serum testosterone concentrations and gonadotropins follicle-stimulating hormone [FSH], luteinizing hormone [LH] above the normal range.

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In two of these patients, prostate cancer was detected on biopsy. 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 anndrogel adjustment. The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Reproductive system and breast disorders: 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.

Have problems andtogel while you sleep sleep apnea.

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. Amnesia, anxiety, depression, hostility, emotional lability, decreased libido, nervousness Reproductive system and breast disorders: