Giới Thiệu

Giới Thiệu

The active pharmacological ingredient in Vogelxo is testosterone. Each metered-dose pump container is capable of dispensing 60 pump actuations. Four pump actuations or eight pump actuations contain 50 mg or 100 mg of testosterone, respectively. One 5-g or two 5-g tubes/packets of Vogelxo contains 50 mg or 100 mg of testosterone, respectively.
Signs and symptomshave included enlargement of the penis or clitoris, development of pubic hair,increased erections and libido, aggressive behavior, and advanced bone age. The concurrent use of testosterone with corticosteroidsmay result in increased fluid retention and requires careful monitoringparticularly in patients with cardiac, renal or hepatic disease. In diabetic patients, the metaboliceffects of androgens may decrease blood glucose and, therefore, may necessitatea decrease in the dose of anti-diabetic medication. In at leastone reported case, the reporter considered the possibility of secondaryexposure from items such as the testosterone gel user's shirts and/or otherfabrics, such as towels and sheets see WARNINGS AND PRECAUTIONS. Signs and symptoms of these reported cases haveincluded enlargement of the clitoris (with surgical intervention) or of the penis, development of pubic hair, increased erections and libido, aggressivebehavior, and advanced bone age. Cases of secondary exposure to testosterone resulting invirilization of children have been reported in postmarketing surveillance oftestosterone gel products.
The average daily DHTconcentration produced by testosterone gel 100 mg at Day 30 was 555 (± 293)pg/mL and by testosterone gel 50 mg at Day 30 was 346 (± 212) pg/mL. The average daily testosteroneconcentration produced by testosterone gel 100 mg at Day 30 was 612 (± 286)ng/dL and by testosterone gel 50 mg at Day 30 was 365 (± 187) ng/dL. In a single dose, replicate crossover study, when Vogelxo100 mg was applied, absorption of testosterone into the blood continued for theentire 24 hour dosing period. Alcohol-based products, including Vogelxo, are flammable;therefore, patients should be advised to avoid fire, flame or smoking until theVogelxo has dried.
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