Testosterone 1%(50mg)gel 5gm Pkt
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
Feb 2000
DEA Schedule
Schedule III
Overview
What is this medicine?
Testosterone gel is a medication used to replace the natural hormone testosterone in men who have low levels of it. It helps improve symptoms like low energy, low sex drive, and muscle weakness. It's applied to the skin once a day.
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 according to the package insert instructions before the first use. Some products may come in packets or pumps, so be sure to follow the specific instructions for your product.
After Applying the Medication
Wait for the recommended amount of time before bathing, showering, or swimming. Check the package insert for specific guidance on how long to wait.
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.
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 this medication.
Storage and Disposal
Store this 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
If you miss a dose, apply it as soon as you remember.
If it's 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 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 according to the package insert instructions before the first use. Some products may come in packets or pumps, so be sure to follow the specific instructions for your product.
After Applying the Medication
Wait for the recommended amount of time before bathing, showering, or swimming. Check the package insert for specific guidance on how long to wait.
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.
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 this medication.
Storage and Disposal
Store this 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
If you miss a dose, apply it as soon as you remember.
If it's 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 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 or breasts.
- Wash your hands thoroughly with soap and water immediately after applying the gel.
- Allow the gel to dry completely for at least 5 minutes before dressing.
- Cover the application site with clothing after the gel has dried to prevent transfer to others.
- Avoid swimming, showering, or washing the application site for at least 2 hours after applying the gel.
- If skin-to-skin contact with another person is anticipated, wash the application site thoroughly with soap and water beforehand.
- Store the gel at room temperature, away from moisture and heat.
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:
50 mg (one 5gm packet of 1% gel) applied once daily to the shoulders, upper arms, or abdomen.
Dose Range:
50 - 100 mg
Condition-Specific Dosing:
initialDose:
Start with 50 mg daily. Adjust dose based on serum testosterone levels and clinical response.
maximumDose:
Do not exceed 100 mg daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (contraindicated for hypogonadism in children due to risk of premature epiphyseal closure)
Adolescent:
Not established (contraindicated for hypogonadism in children due to risk of 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.
Severe:
No specific dose adjustment recommended, use with caution. Monitor for fluid retention.
Dialysis:
Not available, use with caution. Monitor for fluid retention.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution. Monitor for fluid retention and liver function.
Pharmacology
Mechanism of Action
Testosterone, an endogenous androgen, and its active metabolite, dihydrotestosterone (DHT), bind to androgen receptors in target tissues (e.g., prostate, seminal vesicles, epididymis, skeletal muscle, skin, hair follicles, bone), regulating gene expression and promoting the development and maintenance of male primary and secondary sexual characteristics. It also affects erythropoiesis, bone density, lipid metabolism, and mood.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 9-14% of the applied testosterone dose is absorbed systemically.
Tmax:
Approximately 4 hours after application.
FoodEffect:
Not applicable for transdermal administration.
Distribution:
Vd:
Approximately 1 L/kg (for endogenous testosterone).
ProteinBinding:
Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin).
CnssPenetration:
Yes, testosterone can cross the blood-brain barrier.
Elimination:
HalfLife:
Endogenous testosterone has a half-life of 10-100 minutes. The effective half-life from transdermal gel is longer due to a skin reservoir effect, allowing for once-daily dosing.
Clearance:
Approximately 10 mL/min/kg (for endogenous testosterone).
ExcretionRoute:
Approximately 90% in urine (as conjugates of testosterone and its metabolites), 10% in feces (primarily as unconjugated metabolites).
Unchanged:
Very little unchanged testosterone is excreted.
Pharmacodynamics
OnsetOfAction:
Clinical effects (e.g., improved libido, energy) may be observed within weeks, but full therapeutic effects (e.g., muscle mass, bone density) may take several months.
PeakEffect:
Steady-state serum testosterone concentrations are typically achieved within 2-3 days of daily application.
DurationOfAction:
Daily application maintains therapeutic testosterone levels.
Safety & Warnings
BLACK BOX WARNING
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE AND VENOUS THROMBOEMBOLISM (VTE)
Secondary Exposure to Testosterone:
Cases of secondary exposure to testosterone resulting in virilization of children and women have been reported. Testosterone gel can transfer from the patient to other individuals. Patients should be advised to strictly adhere to the recommended instructions for use, especially regarding covering the application site and washing hands after application.
Venous Thromboembolism (VTE):
Cases of venous thromboembolism, including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products. Evaluate patients presenting with symptoms of VTE.
Secondary Exposure to Testosterone:
Cases of secondary exposure to testosterone resulting in virilization of children and women have been reported. Testosterone gel can transfer from the patient to other individuals. Patients should be advised to strictly adhere to the recommended instructions for use, especially regarding covering the application site and washing hands after application.
Venous Thromboembolism (VTE):
Cases of venous thromboembolism, including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products. Evaluate patients presenting with symptoms of VTE.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 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 urinating
+ 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 only minor ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Headache
Acne
Diarrhea
Emotional changes
Fatigue or weakness
Sleep disturbances
* 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, consult 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 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 urinating
+ 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 only minor ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Headache
Acne
Diarrhea
Emotional changes
Fatigue or weakness
Sleep disturbances
* 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, consult 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 testosterone transfer to women or children: unexpected hair growth, acne, voice changes, enlarged clitoris (in women), enlarged penis/pubic hair/aggressive behavior (in children).
- Signs of prostate problems: difficulty urinating, frequent urination (especially at night), weak urine stream.
- Signs of blood clots: pain, swelling, warmth, or redness in a leg; sudden shortness of breath; chest pain.
- Signs of fluid retention: swelling in your ankles, feet, or hands.
- Signs of liver problems: nausea, vomiting, dark urine, yellowing of the skin or eyes (jaundice).
- Breast tenderness or enlargement.
- Worsening of sleep apnea (loud snoring, stopping breathing during sleep).
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.
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 suitable for children. Do not administer this medication to a child.
To ensure safe treatment, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to assess potential interactions and determine the safety of taking this medication with your other treatments. Never start, stop, or change 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 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.
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 suitable for children. Do not administer this medication to a child.
To ensure safe treatment, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to assess potential interactions and determine the safety of taking this medication with your other treatments. Never start, stop, or change the dosage of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Diabetes Management
If you have high blood sugar (diabetes), you will need to closely monitor your blood sugar levels while taking this drug.
Prostate Cancer Risk
There may be an increased risk of prostate cancer associated with this medication. Discuss this risk with your doctor.
Enlarged Prostate
If you have an enlarged prostate, your symptoms may worsen while using this drug. Contact your doctor if you experience any changes.
Sleep Apnea
If you have sleep apnea, consult with your doctor, as this medication may exacerbate the condition.
Blood Pressure Monitoring
High blood pressure has been reported with this medication. Have your blood pressure checked regularly, as advised by your doctor. Elevated blood pressure can increase the risk of heart attack, stroke, or death from heart disease. If you have high blood pressure or heart disease, discuss this with your doctor.
Cholesterol and Triglyceride Levels
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood. Discuss this with your doctor.
Lab Tests and Monitoring
Have your blood work and other lab tests performed as directed by your doctor. This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug.
Blood Clots
Blood clots have been reported with this medication. If you have a history of blood clots, inform your doctor.
Anabolic Steroid Abuse
This medication is an anabolic steroid, which has been associated with abuse and misuse. Anabolic steroid abuse can lead to dependence and severe health problems, including heart or blood vessel problems, stroke, liver problems, and mental or mood disorders. Discuss this with your doctor.
High Calcium Levels
In some individuals with cancer, high calcium levels have been reported with medications like this one. Seek medical attention immediately if you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.
Accidental Exposure
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these effects may include aggressive behavior, enlarged sex organs, or premature pubic hair growth. In females, these effects may include a deepened voice, changes in body hair, or acne. If someone who is pregnant touches the gel or solution, contact your doctor immediately.
Geriatric Use
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Low Testosterone Treatment
This medication is not approved for treating low testosterone levels caused by aging. Discuss this with your doctor.
Reproductive Effects
High doses of this medication may affect sperm production in males, potentially impacting fertility. If you have concerns, discuss this with your doctor.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Diabetes Management
If you have high blood sugar (diabetes), you will need to closely monitor your blood sugar levels while taking this drug.
Prostate Cancer Risk
There may be an increased risk of prostate cancer associated with this medication. Discuss this risk with your doctor.
Enlarged Prostate
If you have an enlarged prostate, your symptoms may worsen while using this drug. Contact your doctor if you experience any changes.
Sleep Apnea
If you have sleep apnea, consult with your doctor, as this medication may exacerbate the condition.
Blood Pressure Monitoring
High blood pressure has been reported with this medication. Have your blood pressure checked regularly, as advised by your doctor. Elevated blood pressure can increase the risk of heart attack, stroke, or death from heart disease. If you have high blood pressure or heart disease, discuss this with your doctor.
Cholesterol and Triglyceride Levels
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood. Discuss this with your doctor.
Lab Tests and Monitoring
Have your blood work and other lab tests performed as directed by your doctor. This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug.
Blood Clots
Blood clots have been reported with this medication. If you have a history of blood clots, inform your doctor.
Anabolic Steroid Abuse
This medication is an anabolic steroid, which has been associated with abuse and misuse. Anabolic steroid abuse can lead to dependence and severe health problems, including heart or blood vessel problems, stroke, liver problems, and mental or mood disorders. Discuss this with your doctor.
High Calcium Levels
In some individuals with cancer, high calcium levels have been reported with medications like this one. Seek medical attention immediately if you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.
Accidental Exposure
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these effects may include aggressive behavior, enlarged sex organs, or premature pubic hair growth. In females, these effects may include a deepened voice, changes in body hair, or acne. If someone who is pregnant touches the gel or solution, contact your doctor immediately.
Geriatric Use
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Low Testosterone Treatment
This medication is not approved for treating low testosterone levels caused by aging. Discuss this with your doctor.
Reproductive Effects
High doses of this medication may affect sperm production in males, potentially impacting fertility. If you have concerns, discuss this with your doctor.
Overdose Information
Overdose Symptoms:
- Excessive virilization (e.g., severe acne, excessive hair growth, voice deepening)
- Aggression or irritability
- Fluid retention (edema)
- Polycythemia (excess red blood cells, leading to symptoms like headache, dizziness, fatigue)
What to Do:
In case of suspected overdose, discontinue the medication and seek medical attention. Symptomatic and supportive care should be provided. For immediate concerns, call a poison control center (1-800-222-1222 in the US) or emergency services.
Drug Interactions
Major Interactions
- Anticoagulants (e.g., Warfarin): May increase anticoagulant effect, requiring dose reduction of the anticoagulant and more frequent INR monitoring.
- Corticosteroids: Concomitant use may increase the risk of edema, especially in patients with cardiac, renal, or hepatic disease.
Moderate Interactions
- Insulin and Oral Hypoglycemics: Testosterone may decrease blood glucose, potentially requiring a reduction in the dose of antidiabetic agents.
- Thyroid Hormones: Testosterone may decrease concentrations of thyroxine-binding globulin, leading to decreased total T4 and increased free T4. Clinical significance is usually minimal, but monitoring may be needed.
- Immunosuppressants (e.g., Cyclosporine): Potential for increased cyclosporine levels, though data is limited.
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 (Hct) and Hemoglobin (Hgb)
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 and benign prostatic hyperplasia (BPH) in men aged 40 and older, as testosterone can stimulate prostate growth.
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.
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function, especially if hepatic impairment is suspected.
Timing: Before initiation of therapy.
Routine Monitoring
Serum Testosterone (total)
Frequency: 3-6 months after initiation, then annually. Measure approximately 2-4 hours after application.
Target: 300-1000 ng/dL (or within the mid-normal range for healthy young men).
Action Threshold: If consistently above target range, reduce dose or discontinue. If consistently below, consider dose increase or alternative therapy.
Hematocrit (Hct)
Frequency: At 3-6 months after initiation, then annually.
Target: <54%
Action Threshold: If Hct >54%, discontinue therapy until Hct decreases, then restart at a lower dose or consider phlebotomy.
Prostate-Specific Antigen (PSA)
Frequency: Annually (in men âĨ40 years old). More frequently if baseline PSA is elevated or if there are prostate symptoms.
Target: Age-dependent, typically <4 ng/mL for most men.
Action Threshold: Significant increase from baseline or values above age-specific norms warrant further urological evaluation.
Digital Rectal Exam (DRE)
Frequency: Annually (in men âĨ40 years old).
Target: Normal prostate exam.
Action Threshold: Abnormal findings (e.g., nodules, induration) warrant further urological evaluation.
Lipid Panel
Frequency: Periodically, as clinically indicated.
Target: Optimal lipid levels.
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, premature puberty)
- Signs of benign prostatic hyperplasia (BPH) or prostate cancer (e.g., urinary hesitancy, frequency, nocturia, decreased stream)
- Breast tenderness or enlargement (gynecomastia)
- Edema (swelling of ankles, feet, or hands)
- Sleep apnea (worsening or new onset)
- Mood changes (e.g., irritability, aggression)
- Signs of blood clots (e.g., leg pain/swelling, shortness of breath, chest pain)
- Skin irritation at application site
Special Patient Groups
Pregnancy
Testosterone is contraindicated in pregnant women. Exposure to testosterone during pregnancy can result in virilization of a 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 breastfed infant, use is not recommended.
Infant Risk:
High risk of adverse effects, including virilization, in the breastfed infant.
Pediatric Use
Testosterone gel is not indicated for use in pediatric patients. Use in children can cause premature epiphyseal closure, leading to stunted growth, and premature sexual development. Safety and efficacy have not been established.
Geriatric Use
Geriatric patients treated with androgen therapy may be at an increased risk for the development of benign prostatic hyperplasia (BPH) and prostate cancer. Increased monitoring for prostate-related adverse events is recommended. Older patients may also be at increased risk for cardiovascular events and fluid retention.
Clinical Information
Clinical Pearls
- Emphasize strict adherence to application instructions to prevent secondary testosterone transfer to women or children, which can cause virilization.
- Advise patients that the gel must be applied to clean, dry, intact skin and allowed to dry completely before dressing or contact with others.
- Regular monitoring of serum testosterone, hematocrit, and PSA is crucial for safety and efficacy.
- Testosterone therapy is indicated only for men with clinically significant hypogonadism confirmed by laboratory testing, not for age-related decline in testosterone without symptoms.
- Patients should be educated on the signs and symptoms of potential adverse effects, including polycythemia, prostate issues, fluid retention, and cardiovascular events.
- Consider alternative formulations (e.g., injections, patches) if patient adherence to gel application or concerns about secondary transfer are significant.
Alternative Therapies
- For symptoms of hypogonadism not requiring testosterone replacement (e.g., erectile dysfunction, low libido), other medications or lifestyle interventions may be considered depending on the underlying cause.
- For male infertility associated with hypogonadism, specific fertility treatments may be pursued instead of or in conjunction with testosterone replacement (note: exogenous testosterone can suppress spermatogenesis).
Cost & Coverage
Average Cost:
$300 - $600 per 30 packets (50mg/packet)
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 provides crucial information for patients. 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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.