Classes
DEA Class; Rx
Common Brand Names; Striant
- Androgens
Description
Primary androgen in humans synthesized by testes, ovaries, and adrenal cortex; available in a variety of dosage forms
Primarily used in males with primary hypogonadism or with hypogonadism due to medical conditions; may be used for a limited duration for constitutional delay of puberty; used off-label in men with sexual dysfunction due to low testosterone associated with aging
Not recommended for low testosterone status alone due to aging due to potential risk for cardiovascular events and stroke
Indications
Primary hypogonadism (congenital or acquired): Testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals; these men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above 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 testosterone serum concentrations but have gonadotropins in the normal or low range
Contraindications
Male breast or prostate cancer
Hypersensitivity to ingredients, including soy
Women who are breast feeding, may become pregnant or are pregnant
Adverse Effects
Gum or mouth irritation
Abnormal taste
Gum pain or tenderness
Gum edema
Headache
Warnings
Edema with or without congestive heart failure, may be a complication in patients with pre-existing cardiac, renal, or hepatic disease
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids; anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions
Potential for gynecomastia
Risk of sleep apnea in susceptible patients
Increase risk of BPH and prostate cancer in elderly; monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH
Increased hematocrit (polycythemia), reflective of increased red blood cell mass, may require discontinuation; increases risk for thromboemolism; monitor serum testosterone, prostate specific antigen (PSA), liver function, lipid concentrations, hematocrit and hemoglobin periodically
Skin burns reported at application site in patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI); because transdermal testosterone patch contains aluminum, it is recommended to remove system before undergoing MRI
Venous thromboembolism, including DVT and PE reported in patients using testosterone products; these observations have included patients with and without polycythemia; evaluate signs or symptoms consistent with DVT or PE; if venous thromboembolic event suspected, discontinue treatment with testosterone and initiate appropriate workup and management
Pregnancy and Lactation
Pregnancy Category: X
Lactation: Contraindicated
Maximum Dosage
Dependent on indication for therapy, as well as route of administration and specific product chosen for use.
Dependent on indication for therapy, as well as route of administration and specific product chosen for use.
Dependent on indication for therapy, as well as route of administration and specific product chosen for use.
Dependent on indication for therapy, as well as route of administration and specific product chosen for use.
Safety and efficacy have not been established.
How supplied
Testosterone Buccal System
tablet, buccal: Schedule III
- 30mg
