Adult Dosing

Androgen-deficient male

• 10-50 mg PO qd

Delayed puberty male

• Doses are generally in the lower range of the doses for hypogonadism
• 10 mg PO qd x 4-6 months

Metastatic breast CA in female

• 50-200 mg PO qd

Pediatric Dosing

Androgen-deficient male

• 10-50 mg PO qd

Delayed puberty male

• Doses are generally in the lower range of the doses for hypogonadism
• 10 mg PO qd x 4-6 months

[Outline]

• Adult Dosing
• Pediatric Dosing

• Replacement therapy in the following conditions associated with a deficiency or absence of endogenous testosterone
• Males
• Primary hypogonadism (congenital or acquired)
• Hypogonadotropic hypogonadism (congenital or acquired)
• Delayed puberty
• Females
• Secondarily advancing inoperable metastatic (skeletal) mammary cancer in women who are 1-5 years postmenopausal

• Hypersensitivity to any of the ingredients of the product
• Male breast CA
• Prostate CA
• Pregnancy
• Breastfeeding

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined; use with caution

See Supplemental Patient Information

• Methyltestosterone may cause hypercalcemia in patients with breast cancer; discontinue treatment if this occurs
• Prolonged use of high doses can cause peliosis hepatis which can be life-threatening or fatal, and hepatic neoplasms including hepatocellular carcinoma
• Low doses methyltestosterone may lead to cholestatic hepatitis, and jaundice, if such conditions occur with abnormal liver function tests consider discontinuation of therapy
• Geriatric patients are at an increased risk of prostatic hypertrophy and prostatic carcinoma
• Edema with or without congestive heart failure is a serious complication in patients with preexisting cardiac, renal, or hepatic disease; discontinue the drug and initiate diuretic therapy
• Gynecomastia may occur and persist in patients being treated for hypogonadism
• Use cautiously in healthy males with delayed puberty. Monitor effect on bone maturation by assessing bone age of the wrist and hand every 6 months. Methyltestosterone may accelerate bone maturation in children without producing compensatory gain in linear growth resulting adult stature
• Avoid use for enhancement of athletic performance
• Observe women for development of signs of virilization; discontinue use if such signs are noted
• Determine urine and serum calcium levels in women with disseminated breast carcinoma during the course of therapy
• Monitor Hg, HCT, LFTs, and periodic (every 6 months) X-ray examinations of bone age in prepubertal males

Cautions: Use cautiously in

• Hepatic impairment
• Cardiovascular disorder
• CHF
• Sensitivity to fluid retention
• Elderly patients
• Diabetes mellitus
• Hypercalcemia
• Benin prostatic hypertrophy
• Hyperlipidemia
• Delayed puberty (males)

Supplemental Patient Information

• Instruct patient to report if there are frequent or persistent erections of the penis
• Advise male patients receiving androgens for delayed puberty to have bone development evaluated every six months
• Instruct female patients to report if hoarseness, acne, changes in menstrual periods or more hair on the face occurs
• Advise patient to report if nausea, vomiting, changes in skin color or ankle swelling occurs

Pregnancy Category:X

Breastfeeding: Safety unknown. Due to the potential to cause serious adverse reactions in nursing infants, manufacturer recommends discontinuation of breastfeeding, or discontinuation of treatment, taking into account the importance of the drug to the mother

• CV: Hypertension, edema, CHF, elevated BP
• CNS: Headache
• NEURO: Generalized paresthesia
• PSYCHIATRY: Anxiety, depression
• GI: Nausea, cholestatic jaundice, alterations in liver function tests, hepatocellular neoplasms, peliosis hepatis
• GU: Amenorrhea, menstrual irregularities, clitoral enlargement, BPH, priapism, testicular atrophy, gynecomastia, urinary hesitancy/retention
• HEMA: Suppression of clotting factors (II, V, VII, and X), bleeding, leukopenia, polycythemia
• METABOLIC: Inhibition of gonadotropin secretion and virilization, retention of (sodium, chloride, water, potassium, calcium and inorganic phosphates), increased serum cholesterol, sever hypercalcemia
• DERM: Hirsutism, male pattern of baldness, acne
• EENT: Deepening of voice
• HEPA: Hepatotoxicity
• REPRODUCTIVE: Increased/decreased libido
• MISC: Anaphylactoid reactions

• Androgen; activates androgen receptor by conversion to estradiol and activation of certain estrogen receptors
• Metabolized by liver and gut; CYP450: Unknown
• Excreted in urine (90%) and feces (6%)
• Half-life: 6-8 hrs

US Trade Name(s)

• Android 10
• Android 25
• Methitest
• Testred

US Availability

methyltestosterone

• TABS: 10, 25 mg

Android 10

• TABS: 10 mg

Android 25

• TABS: 25 mg

Methitest

• TABS: 10 mg

Testred

• CAPS: 10 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Endocrine/Metabolic

Sex Hormones

Androgens & Anabolic Steroids

Urologic

Sex Hormones

Androgens & Anabolic Steroids

Pricing data from www.DrugStore.com in U.S.A.

• Testred 10 MG CAPS [Bottle] (VALEANT)
  60 mg = $1281.53
  180 mg = $3785.12

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Android 10 MG Oral Capsule

Ingredient(s): Methyltestosterone

Imprint: ICN;0901

Color(s): Red

Shape: Capsule

Size (mm): 18.00

Score: 1

Inactive Ingredient(s): corn starch / gelatin / fd&c blue #1 / fd&c red #40

Drug Label Author:
Valeant Pharmaceuticals, Inc.

DEA Schedule:
CIII