Dosing & Uses
Dosage Forms & Strengths
patch, transdermal: Schedule III
- 2mg/24hr
- 4mg/24hr
gel, transdermal: Schedule III
- 1% (12.5mg/actuation) (Androgel)
- 1.62% (20.25mg/actuation) (Androgel)
- 10mg/actuation (1 pump actuation dispenses 0.5 g of gel) (Fortesta)
- 12.5mg/actuation (Vogelxo)
- 20.25mg/1.25g
- 25mg/2.5g
- 40.5mg/2.5g
- 50mg/5g (Testim)
- 50mg/unit dose pack (Vogelxo)
ointment, topical: Schedule III
- 2%
solution, topical: Schedule III
- 30mg/actuation (90mL) (Axiron)
cream, transdermal: Schedule III
- 2%
Testosterone Deficiency
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
Androderm
- 4 mg/day initially, applied patch to back, abdomen, arm, or thigh (not to scrotum) at bedtime; do not use 2 mg/day patches to achieve 4 mg dose
- Nonvirilized: 2 mg/day initially
- Usual dosing range: 2-6 mg/day
AndroGel
- 1%: 50 mg/day initially, applied topically to shoulders, upper arms, or abdomen (not to genitals) each morning; titrated PRN according to predose serum testosterone levels (25 mg/2.5 g, 50 mg/5 g); not to exceed 100 mg/day
- 1.62%: 40.5 mg (2 pump actuations) daily initially, applied topically to shoulders or upper arms (not to abdomen or genitals) each morning; titrated between 20.25 mg (1 pump actuation) and 81 mg (4 pump actuations) according to predose serum testosterone levels; not to excee 81 mg/day
- Measure serum testosterone levels 14 and 28 days after initiation, then periodically thereafter
Testim
- 50 mg/day, applied topically to shoulders and upper arms (not to genitals) each morning; may be increased to 100 mg PRN (50 mg/5 g)
Axiron
- 60 mg/day, applied topically to axilla (1 pump actuation applied to each axilla) each morning; titrated according to serum testosterone levels obtained from single blood draw 2-8 hours after application and ≥14 days after treatment initiation or dosage adjustment
Fortesta
- 40 mg (4 pump actuations) daily initially, applied topically to thighs each morning; titrated according to serum testosterone levels obtained from single blood draw 2 hours after application and approximately 14 and 35 days after treatment initiation or dosage adjustment
- Measure serum testosterone concentrations periodically
Vogelxo
- 50 mg (1 unit dose pack or 4 pump actuations) topically qDay at about the same time each day
Dose Adjustment Based on Testosterone Levels
Androderm
- >930 ng/dL: Decrease to 2 mg/day
- 400-930 ng/dL: Continue 4 mg/day
- <400 ng/dL: Increase dose to 6 mg/day (as one 4 mg/day and one 2 mg/day)
Androgel 1%
- Less than normal range: Increase dose from 50 mg to 75 mg or from 75 mg to 100 mg once daily
- Greater than normal range: Decrease dose; discontinue if consistently above normal at dose of 50 mg/day
Androgel 1.62%
- >750 ng/dL: Decrease dose by 20.25 mg/day
- >350 ng/dL: Maintain current dose
- <350 ng/dL: Increase dose by 20.25 mg/day
Fortesta
- Base adjustment on total serum testosterone concentrations 2 hours after application
- ≥2500 ng/dL: Decrease by 20 mg/day
- ≥1250 ng/dL to <2500 ng/dL: Decrease dose by 10 mg/day
- ≥500 ng/dL to <1250 ng/dL: Maintain current dose
- <500 ng/dL: Increase dose by 10 mg/day
Axiron
- >1050 ng/dL: Decrease 60 mg daily dose (2 pump actuation) to 30 mg/day (1 pump actuation); discontinue if levels >1050 ng/dL persist after dose reduction
- <300 ng/dL: Increase current dose by 1 pump actuation/day (30 mg)
Testim
- Less than normal range: Increase dose from 50 mg/day to 100 mg/day
- Greater than normal range: Decrease daily dose
Vogelxo
- Measure morning (predose) serum testosterone concentrations ~14 days after initiation of therapy to ensure proper serum testosterone concentrations are achieved
- If level is below normal range (ie, 300-1,000 ng/dL), increase dose to 100 mg qDay; not to exceed 100 mg/day
Vulvar Dystrophy (Orphan)
Orphan indication sponsor
- Star Pharmaceuticals, Inc, 1990 NW 44th Street, Pompano Beach, FL 33064
Administration
Prior to initiating therapy, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range
Do not apply any transdermal testosterone product to genitals
Androderm
- Apply to back, abdomen, arm, or thigh
Testim
- Apply to shoulders or upper arms
AndroGel
- 1%: Apply to shoulders, upper arms, or abdomen (not to genitals)
- 1.62%: Apply to shoulders or upper arms (not to abdomen or genitals)
Axiron
- Apply to clean, dry intact skin of axilla, not to any other body regions (including abdomen and genitals)
- Patients should wash hands with soap and water immediately after application and should cover application site with clothing after solution has dried
- Wash application site thoroughly with soap and water before any situation in which skin-to-skin contact of application site with another person is anticipated
- Application site and dose are not interchangeable with those of other topical testosterone products
Fortesta
- Apply to clean, dry, intact skin of thighs, not to genitals or any other body regions
- Patients should wash hands with soap and water immediately after application and should cover application site with clothing after gel has dried
- Wash application site thoroughly with soap and water before any situation in which skin-to-skin contact of application site with another person is anticipated
- Application site and dose are not interchangeable with those of other topical testosterone products
Vogelxo
- Apply to clean, dry, intact skin
- Apply to shoulders and/or upper arms
- Do not apply to the genitals or abdomen
- f morning pre-dose serum testosterone concentration is below the normal range, increase dose to 100 mg
Limitations of use
Safety and efficacy of testosterone in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Safety and efficacy of testosterone in males less than 18 years old have not been established
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (5)
- cyclosporine
testosterone topical increases effects of cyclosporine by decreasing metabolism. Avoid or Use Alternate Drug.
- lonafarnib
testosterone topical will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.
- pexidartinib
testosterone topical and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.
- pretomanid
testosterone topical, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.
- sotorasib
sotorasib will decrease the level or effect of testosterone topical by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.
Monitor Closely (14)
- atogepant
testosterone topical will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- avapritinib
testosterone topical will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- axitinib
testosterone topical increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- carbamazepine
testosterone topical increases toxicity of carbamazepine by decreasing metabolism. Use Caution/Monitor.
- finerenone
testosterone topical will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.
- flibanserin
testosterone topical will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.
- insulin degludec
testosterone topical increases effects of insulin degludec by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of antidiabetic medication.
- insulin degludec/insulin aspart
testosterone topical increases effects of insulin degludec/insulin aspart by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of antidiabetic medication.
- insulin inhaled
testosterone topical increases effects of insulin inhaled by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of antidiabetic medication.
- ivacaftor
testosterone topical increases levels of ivacaftor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor when coadministered with weak CYP3A4 inhibitors .
- lemborexant
testosterone topical will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.
- mipomersen
mipomersen, testosterone topical. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Both drugs have potential to increase hepatic enzymes; monitor LFTs.
- tazemetostat
testosterone topical will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tinidazole
testosterone topical will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
Minor (39)
- acarbose
testosterone topical increases effects of acarbose by pharmacodynamic synergism. Minor/Significance Unknown.
- androstenedione
androstenedione increases effects of testosterone topical by pharmacodynamic synergism. Minor/Significance Unknown.
- budesonide
testosterone topical, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- chlorpropamide
testosterone topical increases effects of chlorpropamide by pharmacodynamic synergism. Minor/Significance Unknown.
- cortisone
testosterone topical, cortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- deflazacort
testosterone topical, deflazacort. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- dexamethasone
testosterone topical, dexamethasone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- epoetin alfa
testosterone topical increases effects of epoetin alfa by pharmacodynamic synergism. Minor/Significance Unknown. Androgens may be used to decrease necessary dose of epoetin alfa.
- fludrocortisone
testosterone topical, fludrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- glimepiride
testosterone topical increases effects of glimepiride by pharmacodynamic synergism. Minor/Significance Unknown.
- glipizide
testosterone topical increases effects of glipizide by pharmacodynamic synergism. Minor/Significance Unknown.
- glyburide
testosterone topical increases effects of glyburide by pharmacodynamic synergism. Minor/Significance Unknown.
- hydrocortisone
testosterone topical, hydrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- insulin aspart
testosterone topical increases effects of insulin aspart by pharmacodynamic synergism. Minor/Significance Unknown.
- insulin detemir
testosterone topical increases effects of insulin detemir by pharmacodynamic synergism. Minor/Significance Unknown.
- insulin glargine
testosterone topical increases effects of insulin glargine by pharmacodynamic synergism. Minor/Significance Unknown.
- insulin glulisine
testosterone topical increases effects of insulin glulisine by pharmacodynamic synergism. Minor/Significance Unknown.
- insulin lispro
testosterone topical increases effects of insulin lispro by pharmacodynamic synergism. Minor/Significance Unknown.
- insulin NPH
testosterone topical increases effects of insulin NPH by pharmacodynamic synergism. Minor/Significance Unknown.
- insulin regular human
testosterone topical increases effects of insulin regular human by pharmacodynamic synergism. Minor/Significance Unknown.
- metformin
testosterone topical increases effects of metformin by pharmacodynamic synergism. Minor/Significance Unknown.
- methylprednisolone
testosterone topical, methylprednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- miglitol
testosterone topical increases effects of miglitol by pharmacodynamic synergism. Minor/Significance Unknown.
- nateglinide
testosterone topical increases effects of nateglinide by pharmacodynamic synergism. Minor/Significance Unknown.
- pioglitazone
testosterone topical increases effects of pioglitazone by pharmacodynamic synergism. Minor/Significance Unknown.
- prednisolone
testosterone topical, prednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- prednisone
testosterone topical, prednisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- repaglinide
testosterone topical increases effects of repaglinide by pharmacodynamic synergism. Minor/Significance Unknown.
- rosiglitazone
testosterone topical increases effects of rosiglitazone by pharmacodynamic synergism. Minor/Significance Unknown.
- ruxolitinib
testosterone topical will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- ruxolitinib topical
testosterone topical will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- saw palmetto
saw palmetto decreases effects of testosterone topical by pharmacodynamic antagonism. Minor/Significance Unknown.
- saxagliptin
testosterone topical increases effects of saxagliptin by pharmacodynamic synergism. Minor/Significance Unknown.
- sitagliptin
testosterone topical increases effects of sitagliptin by pharmacodynamic synergism. Minor/Significance Unknown.
- tacrolimus
testosterone topical increases effects of tacrolimus by decreasing metabolism. Minor/Significance Unknown.
- tolazamide
testosterone topical increases effects of tolazamide by pharmacodynamic synergism. Minor/Significance Unknown.
- tolbutamide
testosterone topical increases effects of tolbutamide by pharmacodynamic synergism. Minor/Significance Unknown.
- triamcinolone acetonide injectable suspension
testosterone topical, triamcinolone acetonide injectable suspension. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- vildagliptin
testosterone topical increases effects of vildagliptin by pharmacodynamic synergism. Minor/Significance Unknown.
Adverse Effects
>10%
Pruritus at application site (37%)
Skin reactions at application site (16.1%)
Blisters under skin (12%)
1-10%
Erythema at application site (7%)
Vesicles at application site (6%)
Allergic contact dermatitis (4%)
Burning at application site (3%)
Induration at application site (3%)
Frequency Not Defined
Abnormal dreams
Acne
Anaphylaxis
Bladder irritability
Breast soreness
Cholestatic jaundice
Deep vein thrombosis
Dry skin
Fatigue
Gynecomastia
Headache
Insomnia
Menstrual irregularities
Priapism
Suppression of factors II, V, VII
Virilization
Postmarketing Reports
Vascular Disorders: Venous thromboembolism
Cardiovascular disorders: Myocardial infarction, stroke
Blood and lymphatic disorders: Polycythemia
Warnings
Black Box Warnings
Virilization can occur in children and women after secondary exposure to testosterone gel preparations
Children and women should avoid contact with testosterone application sites on men using testosterone gel
Testosterone gel users should adhere to recommended instructions for use
Contraindications
Males with breast or prostate cancer
Hypersensitivity
Breast feeding women
Pregnancy
Cautions
Use with caution in patients with chronic lung disease, obesity, advanced age, or preexisting cardiac, renal, or hepatic disease
Employ caution with prolonged use of high doses, which may be associated with hepatic effects
May increase risk of prostate cancer
Risk of gynecomastia when used for male hypogonadism
May change serum lipid profile; use with caution in patients who have history of mycoardial infarction (MI) or coronary artery disease (CAD)
Large doses may suppress spermatogenesis
May increase hematocrit, which requires dose adjustment or discontinuation; monitor serum testosterone, prostate specific antigen (PSA), liver function, lipid concentrations, hematocrit and hemoglobin periodically
May cause hypercalcemia in patients with prolonged immolibization or cancer
Anabolic activity of androgens may enhance hypoglycemia
Children: Risks of inappropriate genital enlargement, premature pubic hair, advanced bone age, increased libido, and aggressive behavior
Fortesta: Exogenous administration of androgens may lead to azoospermia; sleep apnea may occur in those with risk factors; preparation is flammable until dry
Discontinue if urethral obstruction develops in patients with benign prostatic hyperplasia (BPH); monitor patients with BPH for worsening of signs and symptoms of BPH
Edema with or without congestive heart failure, may be a complication in patients with pre-existing cardiac, renal, or hepatic disease; use with caution
May worsen sleep apnea in some male patients
Evaluate patients for cardiovascular risk factors prior to initiating therapy and monitor closely during therapy
Use caution in patients with diseases that may be exacerbated by fluid retention, including cardiac, hepatic, or renal dysfunction; not recommended for men with poorly controlled heart failure
Monitor women for virilization when treating for metastatic breast cancer
Geriatric patients may be at greater risk for prostatic hyperplasia, prostate cancer, fluid retention, and increase in transaminase levels
Increased hematocrit (polycythemia), reflective of increased red blood cell mass, may require discontinuation; increases risk for thromboemolism
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
Testosterone has been subject to abuse, typically at doses higher than recommended for approved indication and in combination with other anabolic androgenic steroids; anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions; if testosterone abuse suspected, check serum testosterone concentrations to ensure they are within therapeutic range; consider possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events
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
Cardiovascular risks
- Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with the use of testosterone replacement therapy
- January 31, 2014: FDA is investigating risk of stroke, MI, and death in men taking prescription testosterone drugs; investigation was prompted by findings from 2 studies suggesting increased risk of MI in men who take testosterone
- In one study, analysis of 55,593 men with history of MI showed that men >65 years had 2-fold increase in MI risk within 90 days of filling initial prescription for testosterone drug; among younger men (<65 years) with history of heart disease, MI risk was increased 2- to 3-fold
- This study confirmed results of earlier, much smaller study, which found that older men, many with underlying heart disease, had 30% increased chance of death, MI, and stroke after receiving testosterone therapy
Pregnancy & Lactation
Pregnancy
Contraindicated in pregnant women; drug is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action; exposure of female fetus to androgens may result in varying degrees of virilization
Infertility
- During treatment with large doses of exogenous androgens, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis; reduced fertility is observed in some men taking testosterone replacement therapy; testicular atrophy, subfertility, and infertility have been reported in men who abuse anabolic androgenic steroids; with either type of use, the impact on fertility may be irreversible
Animal data
- In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring; these studies did not meet current standards for nonclinical development toxicity studies
Lactation
Drug is not indicated for use in women
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Endogenous androgen; promotes growth and development of male sex organs and maintains secondary sex characteristics in androgen-deficient males
Absorption
Duration: 24-48 hr (gel)
Peak plasma time: 2-6 hr
Peak effect: 3-24 months
Distribution
Protein bound: 98%
Vd: 75-122 L/kg
Metabolism
Metabolized in liver to glucuronic and sulfuric acid conjugates
Metabolites: Testosterone glucuronic conjugate (activity unknown), testosterone sulfuric acid conjugate (activity unknown), testosterone-19-d3
Elimination
Half-life: 10-100 min
Renal clearance: 2 L/min
Excretion: Urine (90%), feces (6%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Natesto nasal - | 5.5 mg/0.122 gram/actuation gel |  | |
| Natesto nasal - | 5.5 mg/0.122 gram/actuation gel |  | |
| testosterone transdermal - | 1.62 % (40.5 mg/2.5 gram) gel |  | |
| testosterone transdermal - | 1 % (25 mg/2.5gram) gel |  | |
| testosterone transdermal - | 30 mg/actuation (1.5 mL) solution |  | |
| testosterone transdermal - | 1.62 % (20.25 mg/1.25 gram) gel |  | |
| testosterone transdermal - | 1.62 % (40.5 mg/2.5 gram) gel |  | |
| testosterone transdermal - | 1 % (25 mg/2.5gram) gel |  | |
| testosterone transdermal - | 20.25 mg/1.25 gram (1.62 %) gel |  | |
| testosterone transdermal - | 50 mg/5 gram (1 %) gel |  | |
| testosterone transdermal - | 1 % (25 mg/2.5gram) gel |  | |
| testosterone transdermal - | 20.25 mg/1.25 gram (1.62 %) gel |  | |
| testosterone transdermal - | 30 mg/actuation (1.5 mL) solution |  | |
| testosterone transdermal - | 1.62 % (40.5 mg/2.5 gram) gel |  | |
| testosterone transdermal - | 1 % (50 mg/5 gram) gel |  | |
| testosterone transdermal - | 1 % (50 mg/5 gram) gel |  | |
| testosterone transdermal - | 20.25 mg/1.25 gram (1.62 %) gel |  | |
| testosterone transdermal - | 1 % (25 mg/2.5gram) gel |  | |
| testosterone transdermal - | 50 mg/5 gram (1 %) gel |  | |
| testosterone transdermal - | 20.25 mg/1.25 gram (1.62 %) gel |  | |
| testosterone transdermal - | 30 mg/actuation (1.5 mL) solution |  | |
| testosterone transdermal - | 1.62 % (40.5 mg/2.5 gram) gel |  | |
| testosterone transdermal - | 1.62 % (20.25 mg/1.25 gram) gel |  | |
| testosterone transdermal - | 30 mg/actuation (1.5 mL) solution |  | |
| testosterone transdermal - | 1 % (50 mg/5 gram) gel |  | |
| testosterone transdermal - | 1 % (50 mg/5 gram) gel |  | |
| testosterone transdermal - | 12.5 mg/ 1.25 gram (1 %) gel |  | |
| testosterone transdermal - | 12.5 mg/ 1.25 gram (1 %) gel |  | |
| testosterone transdermal - | 1 % (50 mg/5 gram) gel |  | |
| testosterone transdermal - | 50 mg/5 gram (1 %) gel |  | |
| testosterone transdermal - | 10 mg/0.5 gram /actuation gel |  | |
| testosterone transdermal - | 50 mg/5 gram (1 %) gel |  | |
| testosterone transdermal - | 10 mg/0.5 gram /actuation gel |  | |
| testosterone transdermal - | 50 mg/5 gram (1 %) gel |  | |
| AndroGel transdermal - | 1.62 % (40.5 mg/2.5 gram) gel |  | |
| AndroGel transdermal - | 1 % (25 mg/2.5gram) gel |  | |
| AndroGel transdermal - | 1 % (25 mg/2.5gram) gel |  | |
| AndroGel transdermal - | 1 % (50 mg/5 gram) gel |  | |
| AndroGel transdermal - | 20.25 mg/1.25 gram (1.62 %) gel |  | |
| AndroGel transdermal - | 1.62 % (20.25 mg/1.25 gram) gel |  | |
| Fortesta transdermal - | 10 mg/0.5 gram /actuation gel |  | |
| Testim transdermal - | 50 mg/5 gram (1 %) gel |  | |
| Testim transdermal - | 50 mg/5 gram (1 %) gel |  | |
| Androderm transdermal - | 4 mg/24 hr transdermal system |  | |
| Androderm transdermal - | 2 mg/24 hour transdermal system |  | |
| Androderm transdermal - | 4 mg/24 hr transdermal system |  | |
| Androderm transdermal - | 2 mg/24 hour transdermal system |  | |
| Testopel implant - | 75 mg pellet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
testosterone transdermal
TESTOSTERONE GEL PUMP 2% - TRANSDERMAL
(tes-TOS-ter-one)
COMMON BRAND NAME(S): Fortesta
WARNING: Children accidentally exposed to this medication by direct contact with someone using it may absorb this drug through their skin. If this occurs, the child may have unwanted side effects due to testosterone gel. Children should avoid contact with any unwashed or unclothed area where the medication has been applied. Tell both of your doctors right away if you notice unexpected signs of puberty in a child such as unusual increase in size of genitals (penis or clitoris), early development of pubic hair, increased erections (in boys) or sex drive, or aggressive behavior. To decrease this risk, carefully follow all directions for the proper use of this drug.
USES: This medicated gel contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels.Testosterone helps the body to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.This drug should not be used by women.
HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using testosterone gel and each time you get a refill. Learn how to use the pump and how to apply the gel correctly. If you have any questions, ask your doctor or pharmacist.There are many testosterone products available for use on the skin. They may have different amounts of testosterone and may not have the same effects. Read the dosing instructions carefully for each product. Do not change products without asking your doctor or pharmacist.Follow the instructions for priming the pump if you are using it for the first time.Apply the medication to clean, dry skin on the front and inner thigh(s) as directed by your doctor, usually once daily in the morning. Pump this medication directly onto the thigh(s). Use one finger to rub the gel in evenly. Apply only to areas that would be fully covered by clothing (shorts or pants). Avoid applying this medication to broken, irritated skin. Do not apply this medication to other areas of the body including to the genitals (penis or scrotum) or to the area of the thighs next to the genitals. Do not let others apply this medication to your body.Dosage is based on your medical condition, laboratory tests, and response to treatment. Follow your doctor's instructions carefully on the exact number of pumps for each dose.After applying this medication, wash your hands thoroughly with soap and water to reduce the risk of accidentally spreading it from your hands to other people. Wait a few minutes for the application site to dry completely before dressing. Be sure to always wear clothing (such as shorts or pants) to cover the application site until you wash the areas well with soap and water. To get the best effect, wait at least 2 hours before showering/swimming to allow the drug to be absorbed through the skin.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.Misuse or abuse of testosterone can cause serious side effects such as heart disease (including heart attack), stroke, liver disease, mental/mood problems, abnormal drug-seeking behavior, or improper bone growth (in adolescents). Do not increase your dose or use this drug more often or for longer than prescribed. When testosterone is misused or abused, you may have withdrawal symptoms (such as depression, irritability, tiredness) when you suddenly stop using the drug. These symptoms may last from weeks to months.This medication is flammable until dry. Let the gel dry before smoking or going near an open flame.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Redness/irritation at the application site and acne may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, severe stomach/abdominal pain, dark urine, yellowing eyes/skin, swelling hands/ankles/feet, breast pain/enlargement, very slow/shallow/difficult breathing (possibly while sleeping), difficulty urinating, increased urination (especially at night), mental/mood changes (such as depression, agitation, hostility), testicle pain/tenderness, fast/irregular heartbeat.Get medical help right away if you have any very serious side effects, including: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.In patients with diabetes, especially those taking insulin, testosterone may decrease your blood sugar. Be prepared to treat low blood sugar while you are using this medication. Tell your doctor right away if you have symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet.Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section.Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: breast cancer (males), prostate problems (such as cancer, enlarged prostate or BPH), difficulty breathing during sleep (apnea), high cholesterol level, bone cancer, diabetes, heart problems (such as heart failure, heart attack), stroke, blood clots (such as in the leg, lungs).Direct contact with the application site can expose others to this medication. Women and children should avoid contact with any unwashed or unclothed area where the medication has been applied. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water. If a woman or child makes contact with the application area, that area on the woman or child should be washed well with soap and water right away.If this medication accidentally gets into your eyes, rinse the eyes right away with clean, warm water. Get medical help right away if necessary.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Some men, particularly older adults, are at a higher risk for developing enlarged prostate or prostate cancer while using this medication. Your risk of prostate problems should be checked by your doctor before you start testosterone.Children may be more sensitive to the side effects of this drug. In children, it may affect bone growth. Monitor your child's height periodically.This medication can affect fertility in males. Ask your doctor for more details.This medication should not be used by women. Women accidentally exposed to this medication may have side effects due to testosterone gel. If you notice symptoms in a woman such as changes in body hair or a large increase in acne, talk to her doctor and your doctor right away. Women who are pregnant or breast-feeding must avoid contact with this medication. This medication may harm an unborn or breast-feeding baby. Consult your doctor for more details.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as warfarin).This medication may interfere with certain laboratory tests (including thyroid function tests, creatinine level), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others. Sharing it is against the law.Lab and/or medical tests (such as PSA, cholesterol, hemoglobin/hematocrit, testosterone blood levels, prostate exams) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.This medication has been prescribed for your current condition only. Do not use it later for another problem unless your doctor directs you to do so. A different medication may be necessary in that case.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom or near an open flame. Do not freeze. Keep all medications away from children and pets, and throw out used pumps in a secure trash can.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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