Generic Name and Formulations:
Testosterone 50mg (in 5g gel); per tube or packet; 12.5mg (in 1.25g gel) per actuation; metered-dose pump.
Upsher-Smith Laboratories, Inc.
Indications for VOGELXO:
Testosterone replacement therapy.
Limitations Of use:
Not established in men with age-related hypogonadism.
Prior to treatment, confirm diagnosis by ensuring serum testosterone is below normal range as measured in the AM on at least 2 separate days. Advise patients to strictly adhere to recommended instructions. Apply to clean, dry intact skin of the shoulders and/or upper arms at the same time each day; do not apply to the genitals or abdomen. ≥18yrs: initially 50mg (1 tube or packet, or 4 pump actuations) once daily; measure morning, pre-dose serum testosterone levels approx. 14 days after initiation to ensure response. May increase to 100mg (2 tubes or packets, or 8 pump actuations) once daily based on serum testosterone concentration; max 100mg once daily. Wash hands after application. Allow gel to dry completely before dressing.
<18yrs: not established.
Male breast or prostate carcinoma. Pregnancy (Cat.X). Nursing mothers.
Secondary exposure to testosterone.
Not for use in women. Not interchangeable with other topical testosterone products. Other persons (esp. children) must avoid contact with application site. Secondary exposure to testosterone; promptly discontinue if signs of virilization in children and women occurs, until cause is identified. Monitor for worsening BPH. Evaluate for prostate cancer prior to and during therapy. Monitor hematocrit prior to initiation, 3–6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. Preexisting cardiac, renal or hepatic disease (discontinue if edema occurs). Obesity. Chronic lung diseases. Testosterone and/or other anabolic androgenic steroid abuse. Periodically monitor serum testosterone, PSA, liver function, and lipid profile. Monitor serum calcium if risk of hypercalcemia. Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Product is flammable. Elderly.
May affect insulin sensitivity or glycemic control; reduce dose of antidiabetics. Monitor INR and PT with concomitant oral anticoagulants. Concomitant corticosteroids may increase fluid retention. May decrease thyroxine-binding globulins.
Application site reactions, increased hematocrit, increased blood pressure, headache; sleep apnea, polycythemia, azoospermia (w. large doses), venous thromboembolism (evaluate and discontinue if suspected), edema, gynecomastia, virilization in children.
Tubes, pkts (5g)—1, 30; Pump 75g (60 metered 1.25g doses)—2
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