Generic Name: testosterone

Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Male Hypogonadism

Management of congenital or acquired primary hypogonadism such as that resulting from orchidectomy or from testicular failure caused by cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

Management of congenital or acquired hypogonadotropic hypogonadism such as that resulting from idiopathic gonadotropin or gonadotropin-releasing hormone (luteinizing hormone-releasing hormone) deficiency or from pituitary-hypothalamic injury caused by tumors, trauma, or radiation. Should be used in the treatment of hypogonadotropic hypogonadism only in patients uninterested in or unable to achieve fertility.

Considered the androgen of choice for the treatment of androgen deficiency (e.g., hypogonadism) and AIDS wasting in HIV-infected men.

May be used to stimulate puberty when the diagnosis is well established in carefully selected males with delayed puberty (designated an orphan drug by FDA for this use).

Some experts (e.g., American College of Rheumatology) recommend that men who develop low serum testosterone concentrations (<300 ng/mL) while receiving long-term corticosteroid therapy receive testosterone replacement therapy in an attempt to treat hypogonadism and possibly reduce the risk of corticosteroid-induced osteoporosis†.

Clinical evidence to date regarding testosterone therapy in aging men suggests some beneficial effects (e.g., on body composition, strength, bone density, frailty, cognitive function, mood, sexual function, quality of life), but risks relating to benign prostatic hyperplasia and prostate cancer need to be quantified. The Institute of Medicine states that the nature and extent of therapeutic benefits in older men require additional study.

Not indicated for the treatment of erectile dysfunction† in men with normal testosterone concentrations.

Breast Cancer

Palliative treatment of androgen-responsive, advanced, inoperable, metastatic (skeletal) breast cancer in women who are 1–5 years postmenopausal and in premenopausal women who have benefited from oophorectomy.

Poorly tolerated (see Virilization under Cautions); other hormonal agents (e.g., tamoxifen, anastrozole, letrozole, exemestane) currently are preferred for this use.

Misuse and Abuse

Has been misused and abused by athletes, bodybuilders, weight lifters, and others to enhance athletic performance or physique†.

Medical and sports experts (e.g., International Olympic Committee) consider such use to be inappropriate and unacceptable because of known adverse effects and potential long-term sequelae and because such use by athletes is contrary to the rules and ethical principles of athletic competition.

Dosage and Administration

General

Male Hypogonadism

• Individualize dosage according to the condition being treated; the severity of symptoms; the patient’s age, gender, and history of prior androgenic therapy; and the specific testosterone preparation being used.
• Monitor every 3–4 months during the first year of testosterone replacement and periodically thereafter (e.g., every 4–6 months) for response and tolerance.

Delayed Puberty

• Prior to initiation of therapy, fully discuss the potential risk of therapy with the patient and his parents.
• Take into consideration the chronological and skeletal ages of the patient, both in determining the initial dosage and in adjusting the dosage.
• Perform radiographic examination of the hand and wrist at 6-month intervals to determine the rate of bone maturation and to assess the effect of therapy on the epiphyseal centers. (See Pediatric Use under Cautions.)

Breast Cancer

• Administer only under supervision of a qualified clinician experienced in the treatment of breast cancer.
• May occasionally appear to accelerate progression of the disease; monitor patients closely.
• Discontinue the drug if hypercalcemia occurs, since this may indicate progression of metastases to the bone.

Administration

Administer testosterone topically or intrabuccally.

Administer testosterone cypionate and testosterone enanthate by deep IM injection; not for IV administration.

IM Administration

Administer by deep IM injection into the upper outer quadrant of the gluteus maximus.

Topical Administration

Gel

AndroGel^®: Apply gel topically once daily, preferably in the morning, to clean, dry, intact skin on the shoulders and upper arms and/or abdomen. Do not apply to the genitals.

AndroGel^® unit-dose packet: Upon opening the unit-dose packet, squeeze the entire contents into the palm of the hand and immediately apply to the application site. Alternatively, squeeze a portion of the contents into the palm of the hand and immediately apply to application site; repeat procedure until entire contents of the packet has been applied.

AndroGel^® metered-dose pump: Collect gel in the palm of the hand by pressing the pump firmly and fully; apply to application site. This can be done one pump actuation at a time or after completion of all pump actuations needed for the daily dose. Alternatively, apply the gel directly to application site (direct application prevents loss of gel during transfer to hand). Prime pump by depressing 3 times before using the pump for the first dose; discard gel so that household members or pets are not exposed to the gel (i.e., rinse down sink).

Testim^®: Apply gel topically once daily, preferably in the morning, to clean, dry, intact skin on the shoulders and/or upper arms Do not apply to abdomen or genitals. Upon opening the unit-dose tube, squeeze the entire contents into the palm of the hand and immediately apply to the application site.

Wash hands with soap and water after application of the gel.

After the gel has dried, cover the site with clothing (e.g., a shirt) in order to prevent transfer to another individual.

Manufacturer of AndroGel^® recommends waiting ≥5–6 hours and the manufacturer of Testim^® recommends waiting ≥2 hours after application before showering or swimming. However, showering or swimming after the elapse of just 1 hour should have a minimal effect on the amount of testosterone gel absorbed if done very infrequently.

Transdermal System

Apply the transdermal system to clean, dry area of skin on the back, abdomen, upper arm, or thigh by firmly pressing the system with the adhesive side touching the skin. Do not apply to the scrotum or to oily, damaged, or irritated areas of the skin.

To avoid burn-like blisters, do not apply systems over bony prominences or on a part of the body that may be subject to prolonged pressure during sleep or sitting (e.g., the deltoid region of the upper arm, the greater trochanter of the femur, the ischial tuberosity).

Apply once daily at night (e.g., 10 p.m.). Leave transdermal system in place for 24 hours; after 24 hours, remove system and apply a new system. Apply system immediately after removal from its protective pouch and removal of the protective liner.

To minimize and/or prevent potential skin irritation, apply each transdermal system at a different site, with ≥1 week between applications to a particular site.

Mild skin irritation may be ameliorated with topical hydrocortisone 0.5 or 1% cream after system removal; alternatively, apply a small amount of triamcinolone acetonide 0.1% cream to the skin under the drug reservoir (do not use ointment formulations because they may reduce testosterone absorption).

Transdermal system does not need to be removed during sexual intercourse or while showering or bathing.

Intrabuccal Administration

Press the extended-release buccal (transmucosal) tablet against the gum above the upper left or right incisor twice daily (morning and evening) about 12 hours apart. These tablets will adhere to the gum and do not dissolve completely; do not chew or swallow. Dislodge and remove the tablet after 12 hours. Alternate application sites above the left and right upper incisors.

Consult manufacturer’s patient information for instructions on proper intrabuccal administration and removal of the tablet.

If the tablet fails to properly adhere to the gum or falls off within the first 8 hours, replace the old tablet with a new one. The new tablet may remain in place until the time of the next regularly scheduled dose (i.e., 12 hours after the original buccal tablet was administered). If the buccal tablet falls off after 8 hours but before 12 hours, replace the original tablet with one that can serve as the second dose for that day.

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Available as testosterone; dosage expressed in terms of testosterone. Also available as testosterone enanthante or testosterone cypionate; dosage expressed in terms of the salts.

AndroGel^® unit-dose packets contain 2.5 or 5 g of gel (25 or 50 mg of testosterone). Each depression of the metered-dose pump delivers 1.25 g of gel (12.5 mg of testosterone) after priming.

Testim^® unit-dose tubes contain 5 g of gel (50 mg of testosterone).

Pediatric Patients

Male Hypogonadism

Delayed Puberty

IM

Dosage regimens vary. Some clinicians recommend that lower dosages be used initially, followed by gradual increases in dosage as puberty progresses; subsequently, the dosage may be decreased to maintenance levels. Other clinicians state that higher dosages are required initially to induce pubertal changes and lower dosages can then be used for maintenance therapy after puberty.

Usual dosage of testosterone enanthate: 50–200 mg every 2–4 weeks for a limited period of time (e.g., 4–6 months).

Adults

Male Hypogonadism

IM

Usual dosage: 50–400 mg of testosterone cypionate or testosterone enanthate every 2–4 weeks.

Some clinicians recommend testosterone cypionate or testosterone enanthate dosage of 50–100 mg every 7–10 days or 100–150 mg every 2 weeks. While dosage of 300 mg every 3 weeks also may be considered for convenience, such dosing is associated with wider testosterone fluctuations and generally is inadequate to ensure a consistent clinical response. Serum total testosterone concentrations generally should exceed 250–300 ng/dL just before the next dose.

Adult males with prepubertal onset of hypogonadism who are going through puberty for the first time with testosterone replacement: Initially, 50 mg every 3–4 weeks; increase dosage gradually in subsequent months as tolerated up to full replacement within 1 year.

Attainment of full virilization may require up to 3–4 years of IM testosterone replacement.

Topical (Gel)

AndroGel^® and Testim^®: Apply 50 mg of testosterone (5 g of 1% gel) once daily, preferably in the morning; this dose delivers about 5 mg of testosterone systemically. Adjust dosage according to serum testosterone concentrations obtained approximately 14 days after initiating daily application of the gel.

AndroGel^®: If serum testosterone concentrations are below the normal range or the clinical response is inadequate, the dosage can be increased initially to 75 mg of testosterone (7.5 g of 1% gel) and, if necessary, subsequently to 100 mg of testosterone (10 g of 1% gel).

Testim^®: If serum testosterone concentrations are below the normal range or the clinical response is inadequate, the dosage can be increased to 100 mg of testosterone (10 g of 1% gel).

Topical (Transdermal System)

Usual initial dosage is 1 system delivering 5 mg/24 hours or 2 systems delivering 2.5 mg/24 hours applied to the skin nightly.

Adjust dosage according to morning serum testosterone concentrations. Depending on requirements, increase dosage to 7.5 mg once daily (administered nightly as 1 system delivering 5 mg/24 hours plus 1 system delivering 2.5 mg/24 hours or as 3 systems delivering 2.5 mg/24 hours) or decrease dosage to 2.5 mg once daily (administered nightly as 1 system delivering 2.5 mg/24 hours).

Intrabuccal

30 mg (1 extended-release transmucosal tablet) twice daily (morning and evening) about 12 hours apart. Serum testosterone concentration may be determined just prior to the morning dose at 4–12 weeks after initiation of intrabuccal therapy; if total serum testosterone concentration is excessive, discontinue intrabuccal therapy and consider alternative treatments.

Breast Cancer

IM

200–400 mg of testosterone cypionate or testosterone enanthate every 2–4 weeks.

Cautions

Contraindications

• Men with breast cancer or known or suspected prostate cancer.
• Known hypersensitivity to testosterone, testosterone cypionate, testosterone enanthate, or any ingredient in the formulation.
• Some manufacturers state that testosterone is contraindicated in patients with serious cardiac, renal, or hepatic disease.
• Manufacturers of testosterone cypionate and testosterone enanthate injections (preparations indicated for the treatment of breast cancer) state that androgens are contraindicated in women who are or may become pregnant. Manufacturers of buccal and topical testosterone preparations state that these preparations should not be used in women.

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Fetal/Neonatal Morbidity

May cause fetal harm; dose-related virilization of the external genitalia (e.g., clitoral hypertrophy, abnormal vaginal development, fusion of genital folds to form a scrotal-like structure) of female fetus reported, particularly when exposure to androgens occurs during the 1st trimester.

Hepatic Effects

Potentially serious and/or life-threatening adverse hepatic effects (e.g., peliosis hepatis, hepatic adenomas, hepatocellular carcinoma, cholestatic hepatitis, jaundice) associated with prolonged use of high dosages of androgens (e.g., testosterone enanthate). Discontinuance of androgen therapy following development of hepatocellular carcinoma does not always result in regression of the tumor.

If cholestatic jaundice or hepatitis occurs or if liver function test results become abnormal during therapy, discontinue the drug and investigate the etiology of these disorders. Drug-induced jaundice usually is reversible following discontinuance of the drug.

GU Effects

Priapism or excessive sexual stimulation possible, especially in geriatric men. Oligospermia and decreased ejaculatory volume may also occur in men receiving excessive dosage or prolonged administration of testosterone. If any of these adverse effects occur, discontinue the drug temporarily. If therapy is restarted, use lower dosages.

Possible increased risk for the development of prostatic hyperplasia and prostate cancer, particularly in geriatric patients. Testosterone therapy has been associated with increases in PSA (of 0.3 ng/mL) in men with hypogonadism. Evaluate geriatric patients and other patients with known clinical or demographic risk factors for prostate cancer for the presence of the disease prior to initiation of testosterone replacement therapy. Perform rectal prostate examinations at baseline and periodically thereafter. Baseline and annual determinations of PSA also recommended in older men, particularly in those >50 years of age.

Acute urethral obstruction possible in patients with benign prostatic hypertrophy who receive IM testosterone cypionate.

Gynecomastia frequently develops and occasionally persists. Consider concomitant use of an aromatase inhibitor or surgery.

Fluid Retention

Edema, with or without CHF, possible as a result of sodium and water retention and may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. (See Contraindications under Cautions.)

If edema occurs and is considered a serious complication, discontinue the drug and, if necessary, initiate diuretic therapy.

Hypercalcemia

Possible hypercalcemia resulting from osteolysis, especially in immobile patients and in women with metastatic breast cancer. In patients with cancer, hypercalcemia may indicate progression of metastases to the bone. Monitor urine and serum calcium concentrations frequently during the course of androgen therapy in women with metastatic breast cancer.

If hypercalcemia occurs, discontinue the drug and institute appropriate measures to reduce serum calcium concentrations.

Sleep Apnea

May potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.

If manifestations of sleep apnea occur or worsen during therapy, perform sleep studies. If sleep apnea is confirmed, decrease the dosage or discontinue the drug.

Some clinicians consider a history of sleep apnea to be a relative contraindication to testosterone therapy.

Misuse and Abuse

Potential for serious adverse effects (e.g., increased aggression, antisocial behavior, manic episode, depression, changes in libido, increased risk of cardiovascular disease, hepatotoxicity) associated with misuse and abuse of androgens (see Misuse and Abuse under Uses); testosterone preparations currently subject to control under the Federal Controlled Substances Act of 1970, as amended by the Anabolic Steroids Control Act of 1990 and 2004, as schedule III (C-III) drugs.

Sensitivity Reactions

Allergic contact dermatitis possible with transdermal systems. Topical application of testosterone gel (i.e., AndroGel^®) is not associated with phototoxicity. Hypersensitivity reactions (e.g., anaphylactoid reactions, skin manifestations) rarely reported with testosterone.

General Precautions

Virilization

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Virilization, including deepening of the voice, hirsutism, and clitoral enlargement, occurs commonly in females receiving testosterone therapy; these changes may not be reversible following discontinuance of the drug.

Monitor women receiving testosterone therapy for signs of virilization (e.g., deepening of the voice, hirsutism, clitoromegaly, menstrual irregularities). If virilization occurs, discontinue therapy.

See Transfer of Topically Administered Testosterone to Other Individuals under Cautions.

Lipid Abnormalities

Androgens may alter serum cholesterol concentration. Although lipid abnormalities generally do not develop during testosterone replacement therapy because of aromatization of testosterone to estradiol, consider the possibility that such changes could occur and use testosterone with caution in patients with a history of MI or CAD.

Perform a lipid profile at baseline and after 6–12 months; adjust therapy accordingly.

Hematologic Effects

Supraphysiologic concentrations of testosterone can stimulate erythropoiesis. To detect polycythemia, perform periodic hemoglobin and hematocrit determinations in patients receiving long-term therapy.

Some clinicians consider hyperviscosity to be a relative contraindication to testosterone therapy.

Transfer of Topically Administered Testosterone to Other Individuals

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Possible transfer of testosterone from patients treated with topical gel to their sexual partners or other individuals in close physical contact. (See Pregnancy under Cautions.)

If unwashed or unclothed skin to which testosterone gel has been applied comes in contact with the skin of another individual, the general area of contact should be washed with soap and water as soon as possible.

Androderm^® transdermal system has an occlusive backing that prevents the partner from coming in contact with testosterone in the system; the system does not need to be removed during sexual intercourse. Transfer of the transdermal system itself from the patient’s body to that of his partner is unlikely.

Specific Populations

Pregnancy

Category X. (See Fetal/Neonatal Morbidity and also Contraindications under Cautions.)

Avoid transfer of testosterone from topical preparations of the drug to pregnant women. (See Transfer of Topically Administered Testosterone to Other Individuals under Cautions.)

If unwashed or unclothed skin to which testosterone topical gel has been applied comes in direct contact with the skin of a pregnant woman, wash the general area of contact with soap and water as soon as possible.

Lactation

Not known whether testosterone is distributed into milk. Use not recommended.

Pediatric Use

Safety and efficacy not established for topical testosterone gel or extended-release buccal (transmucosal) testosterone tablets in children <18 years of age; testosterone transdermal systems in males <15 years of age; or testosterone cypionate in children <12 years of age.

May accelerate bone maturation without producing compensatory gain in linear growth, possibly resulting in compromised adult stature. The younger the child, the greater the risk of testosterone compromising final mature stature. Use with extreme caution in children and only under the supervision of a specialist who is aware of the adverse effects of testosterone on bone maturation. Perform radiographic examination of the hand and wrist every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers.

Geriatric Use

No substantial differences in safety and efficacy of extended-release buccal (transmucosal) testosterone tablets in geriatric patients relative to younger adults.

Possible increased risk of developing prostatic hypertrophy and prostate cancer during androgen therapy. (See GU Effects under Cautions.)

Common Adverse Effects

Acne, flushing of the skin, gynecomastia, increased or decreased libido, habituation, edema, local irritation at the site of application (with topical or intrabuccal administration).

Interactions

Specific Drugs

Pharmacokinetics

Absorption

Bioavailability

Testosterone is absorbed systemically through the skin following topical application as a gel or transdermal system and through the gum and cheek following administration as an extended-release buccal (transmucosal) tablet.

Following oral administration, bioavailability is low secondary to metabolism in the GI mucosa during absorption and on first pass through the liver.

Following topical application of testosterone gel (AndroGel^® 1%, Testim^® 1%) to the skin, the skin surface serves as a reservoir for sustained release of the hormone into systemic circulation; approximately 10% of a testosterone dose applied topically to the skin as the 1% gel is absorbed into systemic circulation.

Cypionate and enanthate esters of testosterone are absorbed slowly from the lipid tissue phase at the IM injection site, achieving peak serum concentrations about 72 hours after IM injection.

Onset

Increases in serum testosterone concentrations are apparent within 30 minutes of topical application of a 100-mg testosterone dose of AndroGel^® gel; physiologic concentrations generally are achieved within 4 hours.

Physiologic concentrations are achieved within 24 hours of topical application of a 50- or 100-mg testosterone dose Testim^® gel; percutaneous absorption continues for the entire 24-hour dosing interval.

Following topical application of the transdermal testosterone system, peak plasma concentrations are achieved in 6–12 hours.

Following application of an extended-release buccal (transmucosal) tablet, peak plasma concentrations are achieved in 10–12 hours.

Duration

Following discontinuance of daily topical application of AndroGel^® gel, serum testosterone concentrations remain within the normal range for 24–48 hours but return to pretreatment levels by the 5th day after the last application.

Testosterone concentrations return toward baseline within about 24 hours following removal of the transdermal system.

Following removal of the extended-release buccal (transmucosal) tablet, serum testosterone concentrations decline to below normal range within 2–4 hours.

Testosterone cypionate and enanthate have a prolonged (up to 2–4 weeks) duration of action following IM administration.

Plasma Concentrations

Administration of 10 or 5 g of AndroGel^® gel daily results in average daily serum testosterone concentrations of 794 or 566 ng/dL, respectively, at day 30.

Administration of 10 or 5 g of Testim^® gel daily results in average daily serum testosterone concentrations of 612 or 365 ng/dL, respectively, at day 30.

In patients receiving the transdermal system, average daily serum testosterone concentrations reportedly are 498 ng/dL at steady state.

In patients receiving the extended-release buccal tablet, average daily serum testosterone concentrations are 520–550 ng/dL at steady state.

Distribution

Plasma Protein Binding

Approximately 30–40% of testosterone in plasma is bound to sex hormone binding globulin (SHBG), 2% remains unbound (free), and the rest is bound to albumin and other proteins.

Special Populations

SHBG-binding capacity is high in prepubertal children, declines during puberty and adulthood, and increases again during the later decades of life.

Elimination

Metabolism

Metabolized principally in the liver to various 17-ketosteroids via 2 different pathways.

Elimination Route

Excreted principally in urine (90%) and also in feces (6%).

Half-life

Testosterone: Plasma half-life ranges from 10–100 minutes.

Testosterone cypionate after IM injection: Plasma half-life is approximately 8 days.

Stability

Storage

Buccal (Transmucosal)

Extended-release Tablets

20–25°C. Protect from heat and moisture.

Topical

Gel

25°C (may be exposed to 15–30°C).

Transdermal System

25°C (may be exposed to 15–30°C).

Parenteral

Injection

20–25°C. Protect from light; do not freeze.

A precipitate may form if testosterone cypionate or testosterone enanthate injection is stored at low temperatures; the precipitate will dissolve after shaking and warming to room temperature.

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Injection

Use of a wet needle or syringe may cause testosterone enanthate solutions to become cloudy; potency is not affected.

Actions

• Replaces diminished or absent endogenous testicular hormone in hypogonadal males.
• Endogenous androgens are essential hormones that are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics.
• Androgens are responsible for the growth spurt that occurs during adolescence and for the eventual termination of linear growth that results from fusion of the epiphyseal growth centers.
• Large doses of androgens may suppress spermatogenesis.
• Increases protein anabolism and decreases amino acid catabolism; improves nitrogen balance only when there is sufficient intake of calories and protein.
• Androgens reportedly stimulate the production of erythrocytes, apparently by enhancing production of erythropoietic stimulating factor.

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

• Risk of virilization in females. Advise female patients receiving testosterone therapy and female partners of patients treated with topical testosterone preparations (e.g., gel, transdermal systems) to contact their clinician if they notice changes in body hair distribution, substantial increases in acne, or other manifestations of virilization.
• Risk of priapism; importance of adult or adolescent males informing their clinician if too frequent or persistent penile erections occur.
• Importance of periodic assessments to determine the rate of bone maturation in prepubertal males receiving testosterone therapy for delayed puberty.
• Importance of patients informing their clinician of nausea, vomiting, changes in skin color, ankle swelling, or breathing disturbances (e.g., sleep apnea).
• Importance of instructing patients in the proper use (see Administration under Dosage and Administration) and disposal of testosterone preparations and of providing patients a copy of manufacturer’s patient information.
• Importance of advising patients receiving therapy with extended-release buccal tablets to regularly inspect the gum region where the tablet is applied and to report any abnormality to their clinician.
• For patients using gel preparations, importance of avoiding fire, flames, and smoking until gel has dried.
• Importance of women informing their clinician if they are or plan to become pregnant or to breast-feed.
• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses.
• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Most preparations containing testosterone or its salts, esters, or ethers are subject to control under the Federal Controlled Substances Act of 1970, as amended by the Anabolic Steroids Control Act of 1990 and 2004, as schedule III (C-III) drugs. However, manufacturers of certain preparations containing androgenic anabolic steroid hormones (principally combinations that also include estrogens) have applied for and obtained for their products(s) an exemption from the record-keeping and other regulatory requirements of the Federal Controlled Substances Act. Under provisions of the Act, specific products can be exempted from such control by the Attorney General, in consultation with the Secretary of Health and Human Services, if the product is determined not to possess any significant potential for abuse because of concentration, preparation, combination, and/or delivery system. Because regulatory requirements for a given preparation containing an androgenic anabolic steroid may be subject to change based on these provisions, the manufacturer should be contacted when specific clarification about a preparation’s status is required.

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

AHFS Drug Information. © Copyright, 1959-2009, Selected Revisions June 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.