Testosterone 1.62%(20.25mg/1.25gm)
WARNING: Wash the site where the drug was used before it touches anyone else's skin.Do not let this drug or the treated area touch anyone else's skin. They could have side effects from touching this drug. Cover the treated area with clothes.If a female or a child touches the gel, they will need to wash their skin with soap and water. @ COMMON USES: It is used to treat low testosterone levels.
Drug Class
Androgen
Pharmacologic Class
Androgen receptor agonist
Pregnancy Category
Category X
FDA Approved
Aug 2010
DEA Schedule
Schedule III
Overview
What is this medicine?
Testosterone gel 1.62% is a medication applied to the skin to replace the natural hormone testosterone in men who have a medical condition called hypogonadism, where their body doesn't produce enough testosterone. It helps improve symptoms like low energy, reduced sex drive, and muscle weakness.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only on your skin, as directed. It is essential to wash your hands before and after applying the medication.
Application Instructions
Apply the medication at the same time every day.
Be aware that different products may have varying strengths, so carefully read and follow the label instructions.
Avoid getting the medication on other parts of your body or on other people.
Do not apply the medication to the genital area.
* Keep the medication out of your eyes.
Special Instructions for Pump and Packet Products
If you are using a pump, you will need to prime it before the first use. Follow the priming instructions provided in the package insert. If you are using a packet, follow the instructions for application.
Post-Application Instructions
After applying the medication, wait for the recommended amount of time before bathing, showering, or swimming. Refer to the package insert for specific guidance. Allow the medication to dry completely before covering the treated area with clothing. Avoid exposure to fire, flames, or smoking until the medication is dry.
Skin Preparation and Application
Apply the medication to clean, dry, healthy skin. Certain products are designed for specific areas of the body, so be sure to read the package insert to understand where to apply the medication.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures. Keep it in a dry place, avoiding storage in a bathroom. Protect the medication from heat or open flames.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only on your skin, as directed. It is essential to wash your hands before and after applying the medication.
Application Instructions
Apply the medication at the same time every day.
Be aware that different products may have varying strengths, so carefully read and follow the label instructions.
Avoid getting the medication on other parts of your body or on other people.
Do not apply the medication to the genital area.
* Keep the medication out of your eyes.
Special Instructions for Pump and Packet Products
If you are using a pump, you will need to prime it before the first use. Follow the priming instructions provided in the package insert. If you are using a packet, follow the instructions for application.
Post-Application Instructions
After applying the medication, wait for the recommended amount of time before bathing, showering, or swimming. Refer to the package insert for specific guidance. Allow the medication to dry completely before covering the treated area with clothing. Avoid exposure to fire, flames, or smoking until the medication is dry.
Skin Preparation and Application
Apply the medication to clean, dry, healthy skin. Certain products are designed for specific areas of the body, so be sure to read the package insert to understand where to apply the medication.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures. Keep it in a dry place, avoiding storage in a bathroom. Protect the medication from heat or open flames.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Apply the gel once daily at approximately the same time each morning, to clean, dry, intact skin of the shoulders, upper arms, or abdomen. Do not apply to the genitals, breasts, or broken skin.
- Wash your hands thoroughly with soap and water immediately after applying the gel.
- Allow the application site to dry completely before dressing. Cover the application site with clothing to prevent transfer to others.
- Avoid swimming, showering, or washing the application site for at least 2 hours after application.
- To prevent accidental transfer to women or children, avoid skin-to-skin contact with others at the application site. If contact occurs, the exposed skin should be washed immediately with soap and water.
- Store at room temperature, away from moisture and heat. Keep out of reach of children and pets.
Available Forms & Alternatives
Available Strengths:
- Testosterone Cyp 200mg/ml Sdv 1ml
- Testosterone Cyp 200mg/ml Mdv 10ml
- Testosterone Cyp 200mg/ml Mdv 10ml
- Testosterone Enan 200mg/ml Mdv 5ml
- Testosterone Cyp 100mg/ml Mdv 10ml
- Testosterone 1%(50mg)gel 5gm Pkt
- Testosterone 1% (12.5mg/1.25gm)pump
- Testosterone 1%(50mg) Gel 5gm Udt
- Testosterone 10mg/act Gel(120pumps)
- Testosterone 1% Gel(25mg)30x2.5gm
- Testosterone 1%(50mg) Gel 5gm Pk
- Testosterone 30mg/act Solution
- Testosterone 30mg/act Topsolution
- Testosterone 1.62% Gel (60 Pumps)
- Testosterone 10mg/act Gel(120pumps)
- Testosterone 30mg/act Solution
- Testosterone 1.62% Gel (60 Pumps)
- Testosterone 1.62%(20.25mg/1.25gm)
- Testosterone 1%(50mg) Gel 5gm Pk
- Testosterone 1.62%(40.5mg/2.5gm)pkt
- Testosterone 1.62%(20.25mg/1.25gm)
- Testosterone Cyp 100mg/ml Mdv 10ml
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose of 20.25 mg (1 pump actuation) of testosterone applied once daily to the shoulders, upper arms, or abdomen.
Dose Range:
20.25 - 81 mg
Condition-Specific Dosing:
hypogonadism:
Initial dose 20.25 mg (1 pump actuation) once daily. Dose can be adjusted based on serum testosterone levels and clinical response, up to a maximum of 81 mg (4 pump actuations) daily. Serum testosterone levels should be measured approximately 2-4 weeks after initiation of therapy or dose adjustment, preferably in the morning.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (contraindicated for use in pediatric patients due to risk of adverse effects on bone maturation and virilization)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution and monitor for fluid retention.
Moderate:
No specific dose adjustment recommended, but use with caution and monitor for fluid retention.
Severe:
No specific dose adjustment recommended, but use with caution and monitor for fluid retention. Testosterone is primarily metabolized by the liver, but metabolites are excreted renally.
Dialysis:
Not specifically studied; use with caution and monitor for fluid retention and adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but use with caution and monitor for adverse effects.
Moderate:
Use with caution; testosterone is extensively metabolized by the liver. Monitor liver function tests and for signs of adverse effects.
Severe:
Use with caution; testosterone is extensively metabolized by the liver. Monitor liver function tests and for signs of adverse effects. Contraindicated in severe liver disease.
Pharmacology
Mechanism of Action
Exogenous testosterone diffuses across cell membranes and binds to androgen receptors in target tissues. The testosterone-receptor complex then translocates to the nucleus, where it binds to DNA and stimulates gene transcription, leading to the synthesis of various proteins. In some tissues (e.g., prostate, seminal vesicles, epididymis), testosterone is converted to dihydrotestosterone (DHT) by 5-alpha-reductase, which then binds to the androgen receptor. In other tissues (e.g., bone, brain, adipose tissue), testosterone is converted to estradiol by aromatase, which mediates some of testosterone's effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 9-14% of applied dose (variable)
Tmax:
Approximately 2-4 hours after application
FoodEffect:
Not applicable for topical administration
Distribution:
Vd:
Approximately 1 L/kg (for endogenous testosterone)
ProteinBinding:
Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration:
Limited (testosterone can cross the blood-brain barrier, but the extent of penetration for topical application is not fully quantified)
Elimination:
HalfLife:
Endogenous testosterone: 10-100 minutes; however, the effective half-life from transdermal gel is longer due to a reservoir effect in the skin, leading to sustained release over 24 hours.
Clearance:
Approximately 1300 mL/min (for endogenous testosterone)
ExcretionRoute:
Primarily renal (approximately 90% as conjugates of testosterone and its metabolites) and fecal (approximately 6% as unconjugated metabolites)
Unchanged:
<6% (in urine)
Pharmacodynamics
OnsetOfAction:
Gradual, clinical effects typically observed over weeks to months (e.g., libido, mood, energy). Serum testosterone levels reach steady state within 2-4 weeks.
PeakEffect:
Peak serum testosterone levels occur approximately 2-4 hours post-application.
DurationOfAction:
Approximately 24 hours (applied once daily)
Safety & Warnings
BLACK BOX WARNING
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
âĸ Virilization in children and women can occur following secondary exposure to testosterone gel. Cases of secondary exposure have been reported in children ranging from 9 months to 10 years of age and have included pubic hair development, enlarged penis or clitoris, premature pubarche, accelerated bone age, increased libido, and aggressive behavior. In most cases, these signs and symptoms regressed with removal of the testosterone exposure. In a few cases, enlarged clitoris and phallus did not fully return to age-appropriate normal size. Increased hair growth, acne, and voice deepening have been reported in women.
âĸ Patients should be advised to strictly adhere to the instructions for use, especially regarding the application site, hand washing, and covering the application site with clothing after the product has dried.
âĸ Virilization in children and women can occur following secondary exposure to testosterone gel. Cases of secondary exposure have been reported in children ranging from 9 months to 10 years of age and have included pubic hair development, enlarged penis or clitoris, premature pubarche, accelerated bone age, increased libido, and aggressive behavior. In most cases, these signs and symptoms regressed with removal of the testosterone exposure. In a few cases, enlarged clitoris and phallus did not fully return to age-appropriate normal size. Increased hair growth, acne, and voice deepening have been reported in women.
âĸ Patients should be advised to strictly adhere to the instructions for use, especially regarding the application site, hand washing, and covering the application site with clothing after the product has dried.
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Prolonged or frequent erections
Urinary problems, such as:
+ Trouble passing urine
+ Pain while passing urine
+ Weak or dripping urine stream
+ Frequent urination
Loss of bladder control
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide
Enlarged breasts or breast pain
Shortness of breath, significant weight gain, or swelling in the arms or legs
Upset stomach or vomiting
Trouble breathing during sleep
Excessive daytime sleepiness
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Changes in skin color
Changes in testicle size or shape
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Trouble speaking or swallowing
Liver problems, which can be life-threatening. Seek medical attention immediately if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:
Headache
Acne
Diarrhea
Emotional changes
Fatigue or weakness
Trouble sleeping
* Irritation at the site of application
This is not an exhaustive list of possible side effects. If you have concerns or questions, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Prolonged or frequent erections
Urinary problems, such as:
+ Trouble passing urine
+ Pain while passing urine
+ Weak or dripping urine stream
+ Frequent urination
Loss of bladder control
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide
Enlarged breasts or breast pain
Shortness of breath, significant weight gain, or swelling in the arms or legs
Upset stomach or vomiting
Trouble breathing during sleep
Excessive daytime sleepiness
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Changes in skin color
Changes in testicle size or shape
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Trouble speaking or swallowing
Liver problems, which can be life-threatening. Seek medical attention immediately if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:
Headache
Acne
Diarrhea
Emotional changes
Fatigue or weakness
Trouble sleeping
* Irritation at the site of application
This is not an exhaustive list of possible side effects. If you have concerns or questions, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of virilization in women or children (e.g., new or increased body hair, acne, voice changes, enlarged clitoris/penis, aggressive behavior). Seek immediate medical attention if these occur.
- Signs of fluid retention (e.g., swelling in ankles, feet, or hands, sudden weight gain).
- Symptoms of prostate problems (e.g., difficulty urinating, frequent urination, weak urine stream, blood in urine).
- Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, unusual tiredness, nausea, vomiting).
- Signs of blood clots (e.g., pain, swelling, warmth, or redness in a leg or arm; sudden shortness of breath or chest pain).
- Signs of sleep apnea (e.g., loud snoring, daytime sleepiness, pauses in breathing during sleep).
- Breast tenderness or enlargement (gynecomastia).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you are a male with a history of breast or prostate cancer.
If you have any pre-existing medical conditions, such as heart disease, kidney disease, or liver disease.
If you are female, as this medication is not approved for use in women. Additionally, if you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential risks with your doctor, as this medication may harm an unborn baby.
* If the patient is a child, as this medication is not intended for pediatric use.
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. This will help ensure your safety while taking this medication. Always consult your doctor before starting, stopping, or modifying the dose of any medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you are a male with a history of breast or prostate cancer.
If you have any pre-existing medical conditions, such as heart disease, kidney disease, or liver disease.
If you are female, as this medication is not approved for use in women. Additionally, if you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential risks with your doctor, as this medication may harm an unborn baby.
* If the patient is a child, as this medication is not intended for pediatric use.
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. This will help ensure your safety while taking this medication. Always consult your doctor before starting, stopping, or modifying the dose of any medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If you have diabetes, you will need to closely monitor your blood sugar levels.
There may be an increased risk of developing prostate cancer associated with this medication. Discuss this with your doctor.
Men with an enlarged prostate should be aware that their symptoms may worsen while using this medication. If this occurs, contact your doctor promptly.
Individuals with sleep apnea should consult their doctor, as this condition may worsen with testosterone treatment.
This medication can cause high blood pressure, which may increase the risk of heart attack, stroke, or death from heart disease. Have your blood pressure checked regularly, as advised by your doctor. If you have pre-existing high blood pressure or heart disease, discuss this with your doctor.
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood, so it is crucial to discuss this with your doctor.
Regularly undergo blood work and other laboratory tests as directed by your doctor. Be aware that this medication may affect the results of certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor and discuss this further.
As an anabolic steroid, this medication has the potential for abuse and misuse, which can lead to dependence and severe health problems, including cardiovascular issues, stroke, liver damage, and mental or mood disorders. Discuss the risks with your doctor.
In some individuals with cancer, medications like this one have caused high calcium levels. If you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, contact your doctor immediately.
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these can include aggressive behavior, enlarged sex organs, and premature pubic hair growth. In females, possible effects include a deepened voice, changes in body hair, or acne. If this occurs, inform the doctor promptly.
If a pregnant woman is exposed to the gel or solution, contact the doctor immediately.
Individuals 65 years or older should use this medication with caution, as they may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging. Discuss the use of this medication with your doctor.
High doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may be irreversible even after stopping the medication. If you have concerns, discuss them with your doctor.
If you have diabetes, you will need to closely monitor your blood sugar levels.
There may be an increased risk of developing prostate cancer associated with this medication. Discuss this with your doctor.
Men with an enlarged prostate should be aware that their symptoms may worsen while using this medication. If this occurs, contact your doctor promptly.
Individuals with sleep apnea should consult their doctor, as this condition may worsen with testosterone treatment.
This medication can cause high blood pressure, which may increase the risk of heart attack, stroke, or death from heart disease. Have your blood pressure checked regularly, as advised by your doctor. If you have pre-existing high blood pressure or heart disease, discuss this with your doctor.
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood, so it is crucial to discuss this with your doctor.
Regularly undergo blood work and other laboratory tests as directed by your doctor. Be aware that this medication may affect the results of certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor and discuss this further.
As an anabolic steroid, this medication has the potential for abuse and misuse, which can lead to dependence and severe health problems, including cardiovascular issues, stroke, liver damage, and mental or mood disorders. Discuss the risks with your doctor.
In some individuals with cancer, medications like this one have caused high calcium levels. If you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, contact your doctor immediately.
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these can include aggressive behavior, enlarged sex organs, and premature pubic hair growth. In females, possible effects include a deepened voice, changes in body hair, or acne. If this occurs, inform the doctor promptly.
If a pregnant woman is exposed to the gel or solution, contact the doctor immediately.
Individuals 65 years or older should use this medication with caution, as they may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging. Discuss the use of this medication with your doctor.
High doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may be irreversible even after stopping the medication. If you have concerns, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Excessive androgen effects (e.g., acne, hirsutism, virilization, gynecomastia, priapism, irritability)
- Fluid retention/edema
- Erythrocytosis (high red blood cell count)
What to Do:
There is no specific antidote for testosterone overdose. Management is supportive. Discontinue the medication and initiate symptomatic and supportive care. Contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention immediately.
Drug Interactions
Major Interactions
- Oral Anticoagulants (e.g., Warfarin): May increase anticoagulant activity, leading to increased risk of bleeding. Mechanism: Possible inhibition of hepatic metabolism of anticoagulants or changes in clotting factors. Close monitoring of INR/PT is required.
- Corticosteroids (e.g., Prednisone): Concomitant use may increase the risk of fluid retention and edema, especially in patients with cardiac, hepatic, or renal disease. Mechanism: Additive effect on fluid retention.
Moderate Interactions
- Insulin and Oral Hypoglycemics: Testosterone may decrease blood glucose levels, potentially reducing insulin requirements in diabetic patients. Mechanism: Improved insulin sensitivity or decreased glucose production. Monitor blood glucose levels.
- Thyroid Hormones: Testosterone may decrease levels of thyroxine-binding globulin (TBG), leading to decreased total T4 levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged. Mechanism: Alteration of protein binding. Clinical significance is usually minimal, but monitor thyroid function if symptoms arise.
- Cyclosporine: Limited data suggest testosterone may increase cyclosporine levels. Mechanism: Possible inhibition of cyclosporine metabolism. Monitor cyclosporine levels if co-administered.
Monitoring
Baseline Monitoring
Serum Testosterone (total)
Rationale: To confirm diagnosis of hypogonadism and establish baseline for dose titration.
Timing: Before initiation of therapy, morning sample (between 8 AM and 10 AM).
Prostate-Specific Antigen (PSA)
Rationale: To screen for pre-existing prostate cancer or benign prostatic hyperplasia (BPH) in men over 40 or with risk factors.
Timing: Before initiation of therapy (in appropriate patients).
Hematocrit (Hct) / Hemoglobin (Hgb)
Rationale: To establish baseline and monitor for erythrocytosis.
Timing: Before initiation of therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver conditions.
Timing: Before initiation of therapy.
Lipid Panel
Rationale: To assess baseline cardiovascular risk factors.
Timing: Before initiation of therapy.
Routine Monitoring
Serum Testosterone (total)
Frequency: 2-4 weeks after initiation or dose adjustment, then every 6-12 months once stable.
Target: 300-1000 ng/dL (or within the mid-normal range for healthy young men)
Action Threshold: If levels are consistently above 1000 ng/dL, reduce dose or discontinue. If levels are consistently below 300 ng/dL, consider dose increase.
Hematocrit (Hct) / Hemoglobin (Hgb)
Frequency: At 3 months and 6 months after initiation, then annually.
Target: Hct <50-54%
Action Threshold: If Hct >50% (or >54% depending on guideline), reduce dose, temporarily discontinue, or consider phlebotomy.
Prostate-Specific Antigen (PSA)
Frequency: Annually (in appropriate patients, e.g., men >40 with risk factors for prostate cancer or >50 without risk factors).
Target: Age-dependent, typically <4 ng/mL
Action Threshold: Significant increase from baseline, or values >4 ng/mL, warrant further urological evaluation.
Digital Rectal Exam (DRE)
Frequency: Annually (in appropriate patients).
Target: Normal prostate exam
Action Threshold: Abnormal findings (e.g., nodule, induration) warrant further urological evaluation.
Liver Function Tests (LFTs)
Frequency: Periodically, or if symptoms of hepatic dysfunction occur.
Target: Within normal limits
Action Threshold: Significant elevations warrant investigation and potential discontinuation.
Lipid Panel
Frequency: Periodically (e.g., annually).
Target: Optimal lipid profile
Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.
Symptom Monitoring
- Signs of virilization in women or children (e.g., voice deepening, hirsutism, clitoromegaly, menstrual irregularities)
- Signs of fluid retention/edema (e.g., swelling of ankles, feet, hands)
- Symptoms of benign prostatic hyperplasia (BPH) or prostate cancer (e.g., urinary urgency, frequency, nocturia, decreased stream)
- Changes in mood, libido, energy levels
- Sleep apnea (worsening or new onset)
- Breast tenderness or gynecomastia
- Skin irritation at application site
Special Patient Groups
Pregnancy
Testosterone is contraindicated in pregnant women. It can cause virilization of the female fetus, including clitoral enlargement, abnormal vaginal development, and fusion of the labia. Exposure during pregnancy should be avoided.
Trimester-Specific Risks:
First Trimester:
High risk of virilization of female fetus.
Second Trimester:
High risk of virilization of female fetus.
Third Trimester:
High risk of virilization of female fetus.
Lactation
Testosterone is contraindicated in breastfeeding women. It is unknown if testosterone is excreted in human milk, but due to the potential for serious adverse reactions in the breastfed infant (e.g., virilization), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
High risk of virilization and other adverse effects.
Pediatric Use
Testosterone gel is not indicated for use in pediatric patients. Exposure can cause premature epiphyseal closure (stunting growth), accelerated bone age, and virilization (e.g., pubic hair, enlarged genitalia, aggressive behavior). Accidental secondary exposure to children is a serious concern and has led to adverse events.
Geriatric Use
Geriatric patients treated with androgens may be at an increased risk for the development of prostate hyperplasia and prostate carcinoma. There is also an increased risk of cardiovascular events (e.g., myocardial infarction, stroke) in older men receiving testosterone therapy, particularly those with pre-existing cardiovascular disease or risk factors. Close monitoring for prostate and cardiovascular adverse events is recommended.
Clinical Information
Clinical Pearls
- Emphasize strict adherence to application instructions and precautions to prevent secondary exposure to women and children, which is a Black Box Warning.
- Testosterone gel should be applied to clean, dry, intact skin of the shoulders, upper arms, or abdomen. Avoid application to other areas, especially genitals or breasts.
- Patients should wash hands thoroughly with soap and water immediately after application and cover the application site with clothing once dry.
- Monitor hematocrit closely due to the risk of erythrocytosis, which can increase the risk of thromboembolic events.
- Regular monitoring of serum testosterone levels, PSA, and DRE is crucial, especially in older men, due to potential prostate effects.
- Testosterone therapy is not indicated for 'age-related' decline in testosterone without a confirmed diagnosis of hypogonadism and associated symptoms.
- Inform patients about the potential for fluid retention and advise them to report any signs of edema.
Alternative Therapies
- Other testosterone formulations: Testosterone injections (intramuscular, subcutaneous), testosterone patches (transdermal), testosterone buccal system, testosterone nasal gel, testosterone implants (pellets).
- For hypogonadism (if central): Gonadotropin-releasing hormone (GnRH) agonists (e.g., leuprolide) or human chorionic gonadotropin (hCG) to stimulate endogenous testosterone production (off-label for primary hypogonadism).
- Selective Estrogen Receptor Modulators (SERMs) like clomiphene citrate (off-label) to stimulate endogenous testosterone production in some cases of secondary hypogonadism.
Cost & Coverage
Average Cost:
Varies widely, typically $400-$700+ per 75gm pump (approx. 30 days supply)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand), Tier 1 or 2 (for generic), often requires prior authorization and/or step therapy for hypogonadism diagnosis.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.