Testosterone 30mg/act Topsolution
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
Nov 2010
DEA Schedule
Schedule III
Overview
What is this medicine?
Testosterone topical solution is a medication containing the male hormone testosterone. It is used to treat men who have low testosterone levels (hypogonadism) due to certain medical conditions. It helps restore normal testosterone levels, which can improve symptoms like low energy, reduced sex drive, and mood changes.
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. It is essential to use this medication as directed and follow all instructions carefully.
Apply this medication only to your skin, as directed. Do not take it by mouth.
Wash your hands before and after applying the medication.
Use the medication at the same time every day to establish a routine.
Be aware that different products may have varying strengths, so read and follow the label instructions carefully.
Avoid getting the medication on other parts of your body or on other people. Do not apply it to the genitals.
Keep the medication out of your eyes.
Special Instructions for Pump or Packet Products
If you are using a pump product, you will need to prime it before the first use. Follow the instructions in the package insert to prime the pump correctly.
If you are using a packet product, follow the instructions provided.
After Applying the Medication
After applying the medication, wait for the recommended amount of time before bathing, showering, or swimming. Refer to the package insert for specific instructions.
Let the medication dry completely before covering the area with clothing.
Avoid exposure to fire, flames, or smoking until the medication is dry.
Application Instructions
Apply the medication to clean, dry, healthy skin in the armpit using the provided applicator. Avoid using your fingers or hand to rub the medication into the skin.
Alternate armpits with each dose to minimize skin irritation.
Allow the skin to dry completely between applications.
If you use an antiperspirant or deodorant, apply it at least 2 minutes before applying this medication.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the medication 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, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed and follow all instructions carefully.
Apply this medication only to your skin, as directed. Do not take it by mouth.
Wash your hands before and after applying the medication.
Use the medication at the same time every day to establish a routine.
Be aware that different products may have varying strengths, so read and follow the label instructions carefully.
Avoid getting the medication on other parts of your body or on other people. Do not apply it to the genitals.
Keep the medication out of your eyes.
Special Instructions for Pump or Packet Products
If you are using a pump product, you will need to prime it before the first use. Follow the instructions in the package insert to prime the pump correctly.
If you are using a packet product, follow the instructions provided.
After Applying the Medication
After applying the medication, wait for the recommended amount of time before bathing, showering, or swimming. Refer to the package insert for specific instructions.
Let the medication dry completely before covering the area with clothing.
Avoid exposure to fire, flames, or smoking until the medication is dry.
Application Instructions
Apply the medication to clean, dry, healthy skin in the armpit using the provided applicator. Avoid using your fingers or hand to rub the medication into the skin.
Alternate armpits with each dose to minimize skin irritation.
Allow the skin to dry completely between applications.
If you use an antiperspirant or deodorant, apply it at least 2 minutes before applying this medication.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the medication 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, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply the solution to clean, dry skin of the axilla (armpit) once daily, preferably in the morning. Do not apply to other areas of the body.
- Wash your hands thoroughly with soap and water immediately after applying the solution.
- Allow the application site to dry completely before dressing. Once dry, cover the application site with clothing to prevent transfer to others.
- Avoid skin-to-skin contact with women or children, especially pregnant women, at the application site. If contact occurs, the exposed skin should be washed immediately with soap and water.
- Do not swim or shower for at least 2 hours after application.
- Store the medication at room temperature, away from heat and open flame (it is flammable).
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:
30 mg (1 actuation) applied to the axilla once daily, preferably in the morning.
Dose Range:
30 - 90 mg
Condition-Specific Dosing:
hypogonadism:
Initial dose 30 mg/day. May be titrated up to 60 mg/day (2 actuations) or 90 mg/day (3 actuations) based on serum testosterone levels and clinical response. Doses higher than 90 mg/day have not been evaluated.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Contraindicated due to risk of virilization and premature epiphyseal closure)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended; use with caution.
Moderate:
No specific dose adjustment recommended; use with caution and monitor for fluid retention.
Severe:
No specific dose adjustment recommended; use with caution and monitor for fluid retention.
Dialysis:
Considerations: Use with caution; monitor for fluid retention and adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended; use with caution and monitor liver function.
Moderate:
Use with caution; monitor liver function and adverse effects closely.
Severe:
Use with caution; contraindicated in severe hepatic impairment due to potential for cholestatic hepatitis and jaundice.
Pharmacology
Mechanism of Action
Testosterone, an endogenous androgen, is responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. It acts by binding to androgen receptors in target tissues, forming a hormone-receptor complex that translocates to the nucleus and interacts with DNA to regulate gene expression. This leads to protein synthesis and cellular differentiation.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (topical absorption is incomplete and variable among individuals)
Tmax:
Approximately 2-4 hours after application
FoodEffect:
Not applicable for topical solution; however, application to skin that is not clean and dry may affect absorption.
Distribution:
Vd:
Approximately 1 L/kg (for endogenous testosterone)
ProteinBinding:
Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration:
Limited (small amounts may cross the blood-brain barrier)
Elimination:
HalfLife:
Approximately 10-100 minutes (endogenous testosterone); steady-state levels achieved with daily topical application.
Clearance:
Approximately 10 mL/min/kg (for endogenous testosterone)
ExcretionRoute:
Primarily renal (approximately 90% as metabolites) and fecal (approximately 6% as metabolites)
Unchanged:
Less than 6% (excreted unchanged in urine and feces)
Pharmacodynamics
OnsetOfAction:
Gradual, clinical effects typically observed over weeks to months (e.g., libido, energy, mood improvements). Serum testosterone levels reach steady-state within 14-28 days.
PeakEffect:
Corresponds to steady-state serum testosterone levels, typically achieved within 2-4 weeks of consistent daily application.
DurationOfAction:
Continuous with daily application; effects persist as long as treatment is maintained.
Safety & Warnings
BLACK BOX WARNING
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE. Cases of secondary exposure resulting in virilization of children and women have been reported. Testosterone topical solution can transfer from the treated individual to others. Patients should be advised to strictly adhere to the recommended instructions for use, especially regarding covering the application site with clothing after the solution has dried, and washing hands thoroughly after application. ANDROGENS, INCLUDING TESTOSTERONE TOPICAL SOLUTION, MAY INCREASE THE RISK OF CARDIOVASCULAR EVENTS AND PROSTATE CANCER. Long-term safety data are not available.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Prolonged or frequent erections (priapism)
Urinary problems: difficulty passing urine, painful urination, weak urine flow, or frequent urination
Loss of bladder control
New or worsening behavioral or mood changes, such as depression or suicidal thoughts
Enlarged breasts or breast pain
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Nausea or vomiting
Sleep apnea (trouble breathing while sleeping)
Excessive daytime sleepiness
Weakness on one side of the body, speech or thinking difficulties, balance problems, drooping on one side of the face, or blurred vision
Skin color changes
Changes in testicle size or shape
Blood Clots and Liver Problems
Seek immediate medical attention if you experience:
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing
Liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes (jaundice)
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 discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Headache
Acne
Diarrhea
Mood swings
Fatigue or weakness
Sleep disturbances
* Irritation at the application site
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Prolonged or frequent erections (priapism)
Urinary problems: difficulty passing urine, painful urination, weak urine flow, or frequent urination
Loss of bladder control
New or worsening behavioral or mood changes, such as depression or suicidal thoughts
Enlarged breasts or breast pain
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Nausea or vomiting
Sleep apnea (trouble breathing while sleeping)
Excessive daytime sleepiness
Weakness on one side of the body, speech or thinking difficulties, balance problems, drooping on one side of the face, or blurred vision
Skin color changes
Changes in testicle size or shape
Blood Clots and Liver Problems
Seek immediate medical attention if you experience:
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing
Liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes (jaundice)
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 discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Headache
Acne
Diarrhea
Mood swings
Fatigue or weakness
Sleep disturbances
* Irritation at the application site
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 in females, enlarged penis in males, aggressive behavior)
- Swelling in your ankles, feet, or hands (fluid retention)
- Breast tenderness or enlargement
- Difficulty urinating, increased urination frequency, or other changes in urination (may indicate prostate issues)
- Shortness of breath, especially during sleep (may indicate worsening sleep apnea)
- Yellowing of the skin or eyes (jaundice), dark urine, or light-colored stools (signs of liver problems)
- Chest pain, shortness of breath, or leg swelling (signs of potential cardiovascular events)
- Mood swings, irritability, or aggression
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 symptoms 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.
Additionally, please note the following:
This medication is not approved for use in females. If you are female, you should not take this medication, as it may harm an unborn baby if taken during pregnancy. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss this with your doctor.
This medication is not intended for children. Do not administer this medication to a child.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your complete medical history
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting 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 symptoms 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.
Additionally, please note the following:
This medication is not approved for use in females. If you are female, you should not take this medication, as it may harm an unborn baby if taken during pregnancy. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss this with your doctor.
This medication is not intended for children. Do not administer this medication to a child.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your complete medical history
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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. Be sure to discuss this with your doctor.
For individuals with an enlarged prostate, symptoms may worsen while using this drug. If this occurs, contact your doctor promptly.
If you have sleep apnea, consult with your doctor, as this condition may worsen in some individuals taking testosterone.
This medication has been associated with the development of high blood pressure. Follow your doctor's instructions for regular blood pressure checks.
High blood pressure can increase the risk of heart attack, stroke, or death from heart disease. If you have pre-existing high blood pressure or heart disease, discuss this with your doctor.
Treatment with this medication may lead to elevated cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood, so be sure to discuss this with your doctor.
Regularly undergo blood work and other laboratory tests as advised by your doctor.
This medication may interfere with certain laboratory tests. 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.
This medication is classified as an anabolic steroid. Abuse and misuse of anabolic steroids can lead to dependence and severe health problems, including cardiovascular issues, stroke, liver problems, and mental or mood disorders. Discuss the risks with your doctor.
In some individuals with cancer, medications like this one have been linked to high calcium levels. Immediately contact your doctor if you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.
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, contact your doctor right away.
If a pregnant individual comes into contact with the gel or solution, contact your doctor immediately.
For individuals 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging. Discuss this with your doctor.
High doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may be irreversible even after the medication is discontinued. 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. Be sure to discuss this with your doctor.
For individuals with an enlarged prostate, symptoms may worsen while using this drug. If this occurs, contact your doctor promptly.
If you have sleep apnea, consult with your doctor, as this condition may worsen in some individuals taking testosterone.
This medication has been associated with the development of high blood pressure. Follow your doctor's instructions for regular blood pressure checks.
High blood pressure can increase the risk of heart attack, stroke, or death from heart disease. If you have pre-existing high blood pressure or heart disease, discuss this with your doctor.
Treatment with this medication may lead to elevated cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood, so be sure to discuss this with your doctor.
Regularly undergo blood work and other laboratory tests as advised by your doctor.
This medication may interfere with certain laboratory tests. 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.
This medication is classified as an anabolic steroid. Abuse and misuse of anabolic steroids can lead to dependence and severe health problems, including cardiovascular issues, stroke, liver problems, and mental or mood disorders. Discuss the risks with your doctor.
In some individuals with cancer, medications like this one have been linked to high calcium levels. Immediately contact your doctor if you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.
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, contact your doctor right away.
If a pregnant individual comes into contact with the gel or solution, contact your doctor immediately.
For individuals 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging. Discuss this with your doctor.
High doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may be irreversible even after the medication is discontinued. If you have concerns, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Excessive virilization (e.g., severe acne, hirsutism, voice deepening)
- Polycythemia (abnormally high red blood cell count, leading to symptoms like headache, dizziness, fatigue)
- Fluid retention/edema
What to Do:
Seek immediate medical attention. Discontinue the medication and contact your doctor or poison control center (Call 1-800-222-1222). Symptomatic and supportive care should be provided.
Drug Interactions
Major Interactions
- Warfarin (and other oral anticoagulants)
- Corticosteroids
Moderate Interactions
- Insulin and oral hypoglycemic agents
- Thyroid hormones
Monitoring
Baseline Monitoring
Serum Testosterone (total)
Rationale: To confirm diagnosis of hypogonadism and establish baseline for treatment efficacy.
Timing: Morning (between 8 AM and 10 AM) prior to initiation of therapy.
Prostate-Specific Antigen (PSA)
Rationale: To screen for pre-existing prostate cancer and monitor for prostate changes.
Timing: Prior to initiation of therapy (for men âĨ40 years old or with risk factors).
Hematocrit (Hct)
Rationale: To assess for polycythemia, a common adverse effect of testosterone therapy.
Timing: Prior to initiation of therapy.
Lipid Panel
Rationale: To assess cardiovascular risk factors, as testosterone may affect lipid profiles.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function, especially in patients with pre-existing hepatic impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Testosterone (total)
Frequency: 2-4 weeks after initiation or dose adjustment, then every 6-12 months.
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)
Frequency: Baseline, 3-6 months after initiation, then annually.
Target: <54%
Action Threshold: If Hct >54%, reduce dose, temporarily discontinue therapy, or consider phlebotomy.
Prostate-Specific Antigen (PSA)
Frequency: Annually for men âĨ40 years old or with risk factors, or more frequently if clinically indicated.
Target: Age-dependent, typically <4 ng/mL
Action Threshold: Significant increase from baseline or age-specific normal range, or abnormal digital rectal exam (DRE), warrants further urological evaluation.
Lipid Panel
Frequency: Annually or as clinically indicated.
Target: Normal ranges for LDL, HDL, triglycerides.
Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.
Liver Function Tests (LFTs)
Frequency: As clinically indicated, especially in patients with hepatic impairment or symptoms of liver dysfunction.
Target: Normal ranges
Action Threshold: Significant elevations warrant investigation and potential discontinuation.
Symptom Monitoring
- Signs of virilization in women or children (e.g., acne, hirsutism, voice deepening, clitoromegaly)
- Fluid retention/edema (swelling of ankles, feet, hands)
- Breast tenderness or enlargement (gynecomastia)
- Changes in urinary habits (e.g., frequency, urgency, nocturia, difficulty urinating) indicative of benign prostatic hyperplasia (BPH) or prostate cancer
- Mood changes, irritability, aggression
- Sleep apnea (worsening or new onset)
- Skin irritation at application site
Special Patient Groups
Pregnancy
Contraindicated. Testosterone can cause virilization of a female fetus, leading to severe birth defects.
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
Contraindicated. It is unknown if testosterone is excreted in human milk, but due to the potential for serious adverse reactions in the nursing infant, especially virilization, it should not be used by breastfeeding women.
Infant Risk:
High risk of virilization and other adverse effects.
Pediatric Use
Contraindicated. Safety and efficacy have not been established in pediatric patients. Use in children can cause virilization, premature epiphyseal closure (stunting growth), and accelerated bone maturation.
Geriatric Use
Use with caution. Older men treated with androgens may be at increased risk for the development of prostate hypertrophy and prostate cancer. Increased risk of cardiovascular events and fluid retention. Close monitoring of PSA, Hct, and cardiovascular status 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 significant safety concern.
- Monitor hematocrit closely due to the risk of polycythemia; dose reduction or phlebotomy may be required if Hct exceeds 54%.
- Testosterone therapy is contraindicated in men with known or suspected prostate cancer or breast cancer.
- Topical testosterone formulations avoid first-pass hepatic metabolism, which may reduce the risk of liver toxicity compared to oral alkylated androgens.
- Patients should be advised that the full therapeutic effects may take several weeks to months to become apparent.
- Regular monitoring of serum testosterone levels is crucial to ensure levels are within the therapeutic range and to avoid supraphysiological levels.
Alternative Therapies
- Other testosterone formulations (e.g., gels [AndroGel, Testim, Fortesta], transdermal patches [Androderm], buccal tablets [Striant], injectable solutions [Testosterone Cypionate, Testosterone Enanthate], subcutaneous pellets [Testopel], nasal gel [Natesto])
- Gonadotropin-releasing hormone (GnRH) agonists/antagonists (for central hypogonadism, though less common for primary hypogonadism)
- Lifestyle modifications (e.g., weight loss, exercise) for some cases of functional hypogonadism.
Cost & Coverage
Average Cost:
$300 - $600 per 30-day supply (e.g., 60 actuations)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (varies by insurance plan)
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, which is a patient fact sheet that provides important information. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult with 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.