Testosterone 1.62% Gel (60 Pumps)
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 2009
DEA Schedule
Schedule III
Overview
What is this medicine?
Testosterone gel is a medication applied to the skin to replace the natural hormone testosterone in men who have low levels (hypogonadism). It helps improve symptoms like low energy, low sex drive, and muscle weakness. It's important to apply it correctly and prevent others, especially women and children, from coming into contact with the treated skin.
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's 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 to prevent spreading it to other parts of your body or to other people.
Use this medication at the same time every day to maintain a consistent routine.
Be aware that different products may have varying strengths, so read and follow the label carefully to ensure you're using the correct dosage.
Avoid applying this medication to sensitive areas, such as the genitals, and keep it out of your eyes.
If you're using a pump, prime it before the first use, following the instructions in the package insert.
After applying the medication, wait for the recommended amount of time before bathing, showering, or swimming. Check the package insert for specific guidance.
Allow the medication to dry completely before covering the treated area with clothing.
To minimize fire risk, avoid exposure to flames, sparks, or smoking until the medication is dry.
Apply this medication to clean, dry, healthy skin, and make sure you're using it on the correct area of the body, as specified in the package insert.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature, avoiding freezing temperatures.
Keep it in a dry place, away from bathrooms and areas prone to moisture.
* Protect the medication from heat, open flames, or sparks.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's 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 to prevent spreading it to other parts of your body or to other people.
Use this medication at the same time every day to maintain a consistent routine.
Be aware that different products may have varying strengths, so read and follow the label carefully to ensure you're using the correct dosage.
Avoid applying this medication to sensitive areas, such as the genitals, and keep it out of your eyes.
If you're using a pump, prime it before the first use, following the instructions in the package insert.
After applying the medication, wait for the recommended amount of time before bathing, showering, or swimming. Check the package insert for specific guidance.
Allow the medication to dry completely before covering the treated area with clothing.
To minimize fire risk, avoid exposure to flames, sparks, or smoking until the medication is dry.
Apply this medication to clean, dry, healthy skin, and make sure you're using it on the correct area of the body, as specified in the package insert.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature, avoiding freezing temperatures.
Keep it in a dry place, away from bathrooms and areas prone to moisture.
* Protect the medication from heat, open flames, or sparks.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Apply the gel to clean, dry, intact skin of the shoulders, upper arms, or abdomen. Do not apply to the genitals, breasts, or broken skin.
- Wash 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 2-5 hours after application (refer to specific product instructions).
- Inform healthcare providers about all medications, supplements, and herbal products being used.
- Regular follow-up appointments and blood tests are crucial to monitor testosterone levels and potential side effects.
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: 40.5 mg (2 pumps) of testosterone applied once daily to shoulders, upper arms, or abdomen.
Dose Range:
20.25 - 81 mg
Condition-Specific Dosing:
hypogonadism:
Adjust dose based on serum testosterone levels and clinical response. The daily dose can range from 20.25 mg (1 pump) to 81 mg (4 pumps).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (contraindicated for use in children due to risk of adverse effects on bone maturation and sexual development)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; specific dose adjustment not established. Monitor for fluid retention.
Dialysis:
Not available; use with caution and monitor for fluid retention.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Use with caution; specific dose adjustment not established. Monitor for fluid retention.
Severe:
Use with caution; specific dose adjustment not established. Monitor for fluid retention.
Confidence:
Medium
Pharmacology
Mechanism of Action
Testosterone is an endogenous androgen responsible for the normal growth and development of 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, leading to androgenic and anabolic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 9-14% (transdermal absorption varies)
Tmax:
Approximately 4 hours (for serum testosterone after application)
FoodEffect:
Not applicable for transdermal gel.
Distribution:
Vd:
Approximately 1 L/kg
ProteinBinding:
Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration:
Limited (metabolized to active metabolites in CNS)
Elimination:
HalfLife:
Approximately 10-100 minutes (endogenous testosterone); effective half-life after transdermal application is longer due to continuous absorption from skin reservoir.
Clearance:
Approximately 13.2 L/hr
ExcretionRoute:
Approximately 90% in urine (as conjugates of testosterone and its metabolites), 6% in feces (unconjugated metabolites)
Unchanged:
Less than 6% (in urine)
Pharmacodynamics
OnsetOfAction:
Within days to weeks for clinical effects (e.g., libido, energy); serum levels stabilize within 2-3 days.
PeakEffect:
Weeks to months for full therapeutic effects.
DurationOfAction:
Daily application maintains therapeutic levels.
Safety & Warnings
BLACK BOX WARNING
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
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 resulted in adverse events including 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 some cases, enlarged genitalia did not fully return to age-appropriate normal size. Secondary exposure to testosterone gel can also occur in women. Adverse events reported in women include deepening of the voice, hirsutism, acne, clitoromegaly, and changes in menstrual cycles. To minimize the potential for secondary exposure, patients should be advised to wash their hands immediately with soap and water after application of testosterone gel and to cover the application site with clothing once the gel has dried. See WARNINGS and PRECAUTIONS for additional information.
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 resulted in adverse events including 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 some cases, enlarged genitalia did not fully return to age-appropriate normal size. Secondary exposure to testosterone gel can also occur in women. Adverse events reported in women include deepening of the voice, hirsutism, acne, clitoromegaly, and changes in menstrual cycles. To minimize the potential for secondary exposure, patients should be advised to wash their hands immediately with soap and water after application of testosterone gel and to cover the application site with clothing once the gel has dried. See WARNINGS and PRECAUTIONS for additional information.
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 immediate medical attention:
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
Urination 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 while sleeping
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 help 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
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 questions or concerns about side effects, 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 immediate medical attention:
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
Urination 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 while sleeping
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 help 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
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 questions or concerns about side effects, 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 secondary exposure in women or children: unexpected hair growth, acne, voice changes, enlarged clitoris/penis, aggressive behavior.
- Signs of fluid retention: swelling in ankles or feet, sudden weight gain.
- Signs of prostate issues: difficulty urinating, frequent urination, blood in urine.
- Signs of polycythemia: dizziness, headache, fatigue, shortness of breath.
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe nausea/vomiting.
- Signs of blood clots: pain, swelling, warmth, or redness in a leg, sudden chest pain, shortness of breath.
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.
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. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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.
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. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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 drug. If this occurs, contact your doctor promptly.
If you have sleep apnea, consult with your doctor, as this medication may exacerbate the condition in some individuals.
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. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.
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 an anabolic steroid, and misuse or abuse of anabolic steroids 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. Be aware of the signs of high calcium levels, such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, and contact your doctor immediately if you experience any of these symptoms.
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, or premature pubic hair growth. In females, possible effects include a deepened voice, changes in body hair, or acne. If this occurs, contact the doctor promptly. If a pregnant woman is exposed to the gel or solution, contact the doctor immediately.
If you are 65 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 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 drug. If this occurs, contact your doctor promptly.
If you have sleep apnea, consult with your doctor, as this medication may exacerbate the condition in some individuals.
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. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.
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 an anabolic steroid, and misuse or abuse of anabolic steroids 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. Be aware of the signs of high calcium levels, such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, and contact your doctor immediately if you experience any of these symptoms.
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, or premature pubic hair growth. In females, possible effects include a deepened voice, changes in body hair, or acne. If this occurs, contact the doctor promptly. If a pregnant woman is exposed to the gel or solution, contact the doctor immediately.
If you are 65 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 stopping the medication. If you have concerns, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Irritability
- Acne
- Increased hair growth
- Fluid retention
- Polycythemia (high red blood cell count)
What to Do:
Discontinue the medication and contact a healthcare provider immediately. For accidental ingestion or significant exposure, call Poison Control at 1-800-222-1222.
Drug Interactions
Major Interactions
- Anticoagulants (e.g., Warfarin)
- Corticosteroids (e.g., Prednisone)
Moderate Interactions
- Insulin and oral hypoglycemic agents
- Diuretics (especially loop diuretics)
Confidence Interactions
Monitoring
Baseline Monitoring
Serum Testosterone (total and free)
Rationale: To confirm diagnosis of hypogonadism and establish baseline levels.
Timing: Before initiation of therapy, typically in the morning.
Hematocrit/Hemoglobin
Rationale: To assess for polycythemia, a common adverse effect of testosterone therapy.
Timing: Before initiation of therapy.
Prostate-Specific Antigen (PSA)
Rationale: To screen for prostate cancer, as testosterone can stimulate prostate growth.
Timing: Before initiation of therapy (in men âĨ40 years old).
Digital Rectal Exam (DRE)
Rationale: To screen for prostate abnormalities.
Timing: Before initiation of therapy (in men âĨ40 years old).
Lipid Panel
Rationale: To assess cardiovascular risk factors, as testosterone may affect lipid profiles.
Timing: Before initiation of therapy.
Routine Monitoring
Serum Testosterone (total)
Frequency: Approximately 14 days after initiation or dose adjustment, then periodically (e.g., every 3-6 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/Hemoglobin
Frequency: At 3-6 months after initiation, then annually.
Target: <54%
Action Threshold: If hematocrit >54%, reduce dose, discontinue temporarily, or perform phlebotomy.
PSA and DRE
Frequency: At 3-6 months after initiation, then annually (in men âĨ40 years old).
Target: Stable or within normal limits for age.
Action Threshold: Significant increase in PSA or abnormal DRE warrants further urological evaluation.
Lipid Panel
Frequency: Annually.
Target: Within normal limits.
Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.
Symptom Monitoring
- Signs of fluid retention (e.g., ankle swelling, weight gain)
- Symptoms of benign prostatic hyperplasia (BPH) worsening (e.g., urinary frequency, urgency, nocturia)
- Signs of sleep apnea worsening
- Mood changes, irritability, aggression
- Breast tenderness or enlargement (gynecomastia)
- Skin reactions at application site (e.g., redness, irritation)
- Signs of secondary exposure in women or children (e.g., virilization in women, premature puberty in children)
Special Patient Groups
Pregnancy
Testosterone is contraindicated in pregnant women. It can cause virilization of the female fetus.
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 nursing infant, it should not be used.
Infant Risk:
High risk of virilization and other adverse effects.
Pediatric Use
Contraindicated in children due to the risk of adverse effects on bone maturation (premature epiphyseal closure) and sexual development (precocious puberty). Safety and efficacy have not been established.
Geriatric Use
No specific dose adjustment is typically required based on age alone. However, geriatric patients may be at increased risk for prostate enlargement, prostate cancer, and cardiovascular events. Close monitoring of PSA, DRE, hematocrit, and cardiovascular status is recommended.
Clinical Information
Clinical Pearls
- Emphasize strict adherence to application instructions and precautions to prevent secondary exposure, which is a black box warning.
- Patients should be educated on the signs and symptoms of polycythemia, fluid retention, and prostate issues.
- Testosterone gel should be applied to clean, dry, intact skin and allowed to dry completely before dressing. Avoid showering/swimming for several hours post-application.
- Regular monitoring of serum testosterone, hematocrit, PSA, and DRE is crucial for safe and effective therapy.
- Consider alternative formulations (e.g., injections, patches) if patient compliance with gel application or risk of secondary exposure is a concern.
- Testosterone therapy is not indicated for age-related decline in testosterone levels in men with normal baseline levels.
Alternative Therapies
- Testosterone cypionate injection
- Testosterone enanthate injection
- Testosterone undecanoate oral capsule
- Testosterone transdermal patch
- Testosterone buccal system (Striant)
- Testosterone implantable pellets (Testopel)
Cost & Coverage
Average Cost:
$400 - $700 per 60 pump container
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand); Tier 1 (for generic)
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 provides crucial information for patients. Please read this guide carefully and review it again whenever your prescription is refilled. 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 quantity, and the time it occurred.