Adult Dosing
Endogenous testosterone deficiency or absence in adult male
- 11mg (2 sprays; 1 spray in each nostril) tid
- Max dose: 33mg
Note: - Serum total testosterone concentrations should be checked periodically, as early as one month after initiating therapy
- Discontinue therapy if total testosterone concentrations consistently exceed 1050 ng/dL
- Consider an alternate therapy if total testosterone concentrations consistently below 300mg/dL
Pediatric Dosing
- Safety and effectiveness in pediatric patients and males less than 18 years old have not been established
[Outline]
See Supplemental Patient Information
- Nasal adverse reactions like nasopharyngitis, rhinorrhea, epistaxis, nasal discomfort and nasal scabbing have been reported
- Therapy is not recommended for patients with history of nasal disorders, nasal or sinus surgery, nasal fracture within 6 months, deviated nasal septum, mucosal inflammatory disorders (Sjogren’s syndrome) and sinus disease
- Not recommended for use with other nasally administered drugs, other than sympathomimetics
- Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms. Evaluate patients for prostate cancer before initiating therapy and re-evaluate 3-6 months after initiation of treatment
- Increased hematocrit, reflective of increased red blood cell mass, requires discontinuation
- Check hematocrit before starting testosterone treatment and 3-6 months after starting testosterone as increase in red blood cells may increase risk thromboembolic events
- Venous thromboembolic events like deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported. Discontinue therapy if venous thromboembolic event is suspected
- Therapy is not indicated for use in women
- Spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH), may affect sperm count
- Long term use of high doses of orally active 17-alpha-alkyl androgens (methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatitis, hepatic neoplasms, cholestatic hepatitis, and jaundice)
- Edema, with or without CHF, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease
- Gynecomastia may develop and persist in patients being treated with androgens
- Therapy may potentiate sleep apnea, especially those with risk factors like obesity and chronic lung disease
- Monitor the lipid profile periodically, changes in serum lipid profile may require discontinuation of therapy
- Androgens should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria)
- Therapy may decrease concentrations of thyroxine-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4
Supplemental Patient Information
- Patient should be advised to prime the pump by depressing it 10 times before first use
- Administer therapy only intranasally and not to other parts of the body
- Patient should be advised to report any change in their health like urinary habits, breathing, sleep, mood, nasal irritation or rhinitis
Pregnancy Category:X
Breastfeeding: According to manufacturer's data; therapy is contraindicated in nursing mother.
