Bactracillin G Benzathine
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FDA Labeling Changes
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Uses
Testosterone gel is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
- Primary hypogonadism (congenital or acquired) – testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol, heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH)) above the normal range.
- Hypogonadotropic hypogonadism (congenital or acquired) – gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations but have gonadotropins in the normal or low range.
Limitations of use:
- Safety and efficacy of testosterone gel in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
- Safety and efficacy of testosterone gel in males <18 years old have not been established [see Use in Specific Populations (8.4)].
History
There is currently no drug history available for this drug.
Other Information
Testosterone gel is a clear, colorless, odorless, gel containing testosterone. Testosterone gel is available in a metered-dose pump. Each pump actuation provides 10 mg of testosterone and each container is capable of dispensing 120 pump actuations. One pump actuation dispenses 0.5 g of gel.
The active pharmacologic ingredient in Testosterone gel is testosterone. Testosterone USP is a white to almost white powder described chemically as 17-beta hydroxyandrost-4-en-3-one.
Pharmacologically inactive ingredients in testosterone gel are: propylene glycol, purified water, ethanol, 2-propanol, oleic acid, carbomer 1382, triethanolamine and butylated hydroxytoluene.
Sources
Bactracillin G Benzathine Manufacturers
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Aspen Veterinary Resources
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Bactracillin G Benzathine | Qualitest Pharmaceuticals
Prior to initiating, testosterone gel confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.
2.1 Dosing and Dose AdjustmentThe recommended starting dose of testosterone gel is 40 mg of testosterone (4 pump actuations) applied once daily to the thighs in the morning. The dose can be adjusted between a minimum of 10 mg of testosterone and a maximum of 70 mg of testosterone. To ensure proper dosing, the dose should be titrated based on the serum testosterone concentration from a single blood draw 2 hours after applying testosterone gel at approximately 14 days and 35 days after starting treatment or following dose adjustment. In addition, serum testosterone concentration should be assessed periodically thereafter. Table 1 describes the dose adjustments required at each titration step.
Table 1 - Dose Adjustment Criteria Total Serum Testosterone Concentration 2 hours
Post Testosterone Gel Application Dose Titration Equal to or greater than 2,500 ng/dL Decrease daily dose by 20 mg (2 pump actuations) Equal to or greater than 1,250 and less than 2,500 ng/dL Decrease daily dose by 10 mg (1 pump actuation) Equal to or greater than 500 and less than 1,250 ng/dL No change: continue on current dose Less than 500 ng/dL Increase daily dose by 10 mg (1 pump actuation)The application site and dose of testosterone gel are not interchangeable with other topical testosterone products.
2.2 Administration InstructionsTestosterone gel should be applied directly to clean, dry, intact skin of the front and inner thighs. Do not apply testosterone gel to the genitals or other parts of the body. Patients should be instructed to use one finger to gently rub testosterone gel evenly onto the front and inner area of each thigh as directed in Table 2.
Table 2 – Application of Testosterone Gel Total Dose of
Testosterone Total Pump
Actuations Pump Actuations per Thigh Thigh #1 Thigh #2 10 mg 1 1 0 20 mg 2 1 1 30 mg 3 2 1 40 mg 4 2 2 50 mg 5 3 2 60 mg 6 3 3 70 mg 7 4 3Once the application site is dry, the site should be covered with clothing [see Clinical Pharmacology (12.3)]. Wash hands thoroughly with soap and water. Avoid applying the gel to the thigh adjacent to the scrotum. Avoid fire, flames or smoking until the gel has dried since alcohol based products, including testosterone gel, are flammable.
The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application [see Clinical Pharmacology (12.3)].
To obtain a full first dose, it is necessary to prime the canister pump. To do so, with the canister in the upright position, slowly and fully depress the actuator eight times. The first three actuations may result in no discharge of gel. Safely discard the gel from the first eight actuations. It is only necessary to prime the pump before the first dose.
Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from testosterone gel-treated skin:
Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel. Testosterone gel should only be applied to the front and inner thighs (area of application should be limited to the area that will be covered by the patient’s shorts or pants). Patients should wash their hands immediately with soap and water after applying testosterone gel. Patients should cover the application site(s) with clothing (e.g., shorts of sufficient length or pants) after the gel has dried. Prior to any situation in which skin-to-skin contact with the application site is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue. In the event that unwashed or unclothed skin to which testosterone gel has been applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible.
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