ANDROID 10
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ANDROID 10 (ANDROID 10).
Androgen receptor agonist; testicular androgen responsible for development and maintenance of male sex characteristics and anabolic effects; increases protein synthesis and muscle mass.
| Metabolism | Hepatic metabolism via CYP3A4; undergoes extensive first-pass metabolism; metabolites primarily excreted renally. |
| Excretion | Renal: 90% as glucuronide and sulfate conjugates, 6% as unchanged drug; fecal: 4%. |
| Half-life | 8 hours; clinical context: steady-state achieved in 2-3 days, dosing interval 8-12 hours. |
| Protein binding | 97-99% bound primarily to sex hormone-binding globulin (SHBG) and albumin. |
| Volume of Distribution | 0.5-1.0 L/kg; indicates extensive distribution into tissues and organs. |
| Bioavailability | Oral: low (variable, ~5-20% due to first-pass metabolism); intramuscular: 100%. |
| Onset of Action | Oral: 30-60 minutes for symptomatic relief of hypogonadism; intramuscular: 2-4 hours. |
| Duration of Action | Oral: 4-6 hours; intramuscular (as enanthate or cypionate): 2-4 weeks. |
Testosterone undecanoate 750 mg (3 mL) intramuscular injection every 10 weeks, or testosterone cypionate 50-400 mg intramuscular injection every 2-4 weeks. For gel formulations: 50-100 mg transdermally once daily.
| Dosage form | TABLET |
| Renal impairment | No specific dose adjustment required for renal impairment; monitor serum testosterone levels and clinical response. For severe renal impairment (GFR <30 mL/min), consider increased monitoring due to potential fluid retention. |
| Liver impairment | Contraindicated in patients with severe hepatic dysfunction (Child-Pugh class C). For mild to moderate impairment (Child-Pugh class A or B), use with caution and consider dose reduction; monitor liver function tests regularly. |
| Pediatric use | Not recommended for use in children; safety and efficacy not established. For delayed puberty in adolescent males: testosterone enanthate 50-200 mg intramuscularly every 2-4 weeks, titrated to response, with monitoring of bone age. |
| Geriatric use | Start at low end of dosing range (e.g., testosterone cypionate 50 mg intramuscularly every 4 weeks or gel 25 mg daily) due to potential increased sensitivity and risk of prostatic hypertrophy or cardiovascular events. Monitor serum testosterone, hematocrit, and prostate-specific antigen (PSA). |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ANDROID 10 (ANDROID 10).
| Breastfeeding | Methyltestosterone and ethinyl estradiol are excreted in breast milk. Methyltestosterone may cause virilization in female infants. Ethinyl estradiol may reduce milk production and quality. M/P ratio not available. Breastfeeding is contraindicated. |
| Teratogenic Risk | Android 10 is a combination of methyltestosterone and ethinyl estradiol. Methyltestosterone is an androgen; exposure during pregnancy, particularly during the first trimester, can cause virilization of the female fetus. Ethinyl estradiol is contraindicated in pregnancy due to risk of fetal harm. Use is contraindicated in all trimesters. |
■ FDA Black Box Warning
None
| Serious Effects |
Men with carcinoma of the prostate or breast; history of hypersensitivity to testosterone or any component; women who are pregnant or may become pregnant (risk of fetal harm); patients with severe hepatic or cardiac disease.
| Precautions | Risk of hepatotoxicity; use with caution in patients with liver disease. Monitor liver function, lipid profile, and prostate-specific antigen (PSA). May cause fluid retention, gynecomastia, priapism, and sleep apnea. Not for use in women who are pregnant or breastfeeding. May accelerate growth of prostate cancer and benign prostatic hyperplasia. Androgenic effects may cause virilization in women. |
| Food/Dietary | No known food interactions. However, methyltestosterone can increase appetite and cause weight gain; a balanced diet is recommended. |
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| Fetal Monitoring | If inadvertent exposure occurs, monitor for signs of virilization in female fetus (e.g., clitoromegaly, labial fusion) via ultrasound. Monitor maternal liver function, lipid profile, and blood pressure regularly due to androgen and estrogen components. |
| Fertility Effects | Methyltestosterone can suppress spermatogenesis in males and cause menstrual irregularities in females due to androgenic effects. Ethinyl estradiol, as a component of combined hormonal contraceptives, suppresses ovulation. Both may impair fertility during use; effects are usually reversible upon discontinuation. |
| Clinical Pearls | Android 10 is a brand name for methyltestosterone, an androgen and anabolic steroid. Use is restricted to replacement therapy in males with hypogonadism or delayed puberty due to androgen deficiency. Monitor liver function due to risk of peliosis hepatis and hepatocellular carcinoma. Contraindicated in males with breast or prostate cancer. Can cause erythrocytosis; monitor hematocrit. Discontinue if signs of virilization in women or priapism in men. Use caution in elderly due to increased risk of prostatic hypertrophy. |
| Patient Advice | Take exactly as prescribed; do not increase dose or frequency without consulting your doctor. · Report signs of liver problems: yellowing of skin or eyes, dark urine, light-colored stools, abdominal pain. · Notify your doctor if you experience swelling of ankles or feet, trouble breathing, or persistent erections lasting more than 4 hours. · May cause aggressive behavior, mood swings, or depression; contact your doctor if these occur. · Do not take if you are pregnant or breastfeeding. · Keep all appointments for blood tests and liver function monitoring. |