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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To obtain a full first dose, it is necessary to prime the canister pump.

The other patient did not undergo repeat PSA testing. AndroGel testosterone gel 1. Patients using AndroGel 1.

PRESCRIBING INFORMATION

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. Call your healthcare provider right away if you have any of ahdrogel serious side effects listed above. Showering at 10 hours after drug application had no effect on bioavailability. The prescribed daily dose of AndroGel 1. Dose titrations on Days 14, 28, and 42 resulted in final doses of The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.

Regular monitoring of serum calcium concentrations is recommended in these patients. If a venous thromboembolic event is suspected, discontinue treatment with AndroGel 1.

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Among previous placebo patients, andtogel of 28 By clicking Subscribe, I agree to the Drugs. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility. In most cases, these signs andtogel symptoms regressed with removal of the exposure to testosterone gel. Talk to your healthcare provider before taking this medicine if you have any of the above conditions.

A unit dose packet containing Nausea, vomiting, changes in skin color, or ankle swelling. 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.

Abnormal liver function tests e. Dose Adjustment To ensure proper dosing, serum testosterone concentrations should be measured at intervals. Amnesia, anxiety, depression, hostility, emotional lability, decreased libido, nervousness Reproductive system and breast disorders: There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and anddogel effects.

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AndroGel % | FULL Prescribing Information |

For more information, ask your healthcare provider or pharmacist. Two patients reported serious adverse events considered possibly related to treatment: Patients returned to the clinic on Day 14, Day 28, and Day 42 for predose serum total testosterone assessments. Amnesia, anxiety, depression, hostility, emotional lability, decreased libido, nervousness. In a few cases, however, enlarged genitalia did not fully return to age appropriate normal size, and bone age pl modestly greater than chronological age.

Because clinical trials are xndrogel 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. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse anrogel.

There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing pl despite adverse events or against medical advice. Patients could agree to continue in an open-label, active treatment maintenance period of the study for an additional days.