Testosterone 1%(50mg) Gel 5gm Pk
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 applied to the skin to replace the natural hormone testosterone in men who have low levels. It helps improve symptoms like low energy, low sex drive, and muscle weakness caused by low testosterone.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only on your skin, as directed. It is essential to wash your hands before and after applying the medication.
Application Instructions
Apply the medication at the same time every day.
Be aware that different products may have varying strengths, so carefully read and follow the label instructions.
Avoid getting the medication on other parts of your body or on other people.
Do not apply the medication to the genital area.
Keep the medication out of your eyes.
Special Instructions for Pump and Packet Products
If using a pump, prime it before the first use, following the instructions in the package insert.
After applying the medication, wait for a specified time before bathing, showering, or swimming. Refer to the package insert for detailed information.
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.
Location-Specific Application
Certain products are designed for use on specific areas of the body. Be sure to read the package insert to understand where to apply the medication.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep 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. Use this medication only on your skin, as directed. It is essential to wash your hands before and after applying the medication.
Application Instructions
Apply the medication at the same time every day.
Be aware that different products may have varying strengths, so carefully read and follow the label instructions.
Avoid getting the medication on other parts of your body or on other people.
Do not apply the medication to the genital area.
Keep the medication out of your eyes.
Special Instructions for Pump and Packet Products
If using a pump, prime it before the first use, following the instructions in the package insert.
After applying the medication, wait for a specified time before bathing, showering, or swimming. Refer to the package insert for detailed information.
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.
Location-Specific Application
Certain products are designed for use on specific areas of the body. Be sure to read the package insert to understand where to apply the medication.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep 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 gel once daily at the same time each day, preferably in the morning.
- Apply 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 gel 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 (check specific product instructions).
- To prevent transfer to women or children, avoid skin-to-skin contact with the application site. If contact occurs, the exposed individual should wash the area with soap and water immediately.
- Store 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 5 gm packet or 4 pump actuations) applied once daily to clean, dry, intact skin of the shoulders, upper arms, or abdomen.
Dose Range:
25 - 100 mg
Condition-Specific Dosing:
initial:
50 mg once daily
maintenance:
Adjusted based on serum testosterone levels and clinical response, typically ranging from 25 mg to 100 mg daily.
Pediatric Dosing
Neonatal:
Not established (Contraindicated)
Infant:
Not established (Contraindicated)
Child:
Not established (Contraindicated)
Adolescent:
Not established (Contraindicated for hypogonadism; safety and efficacy not established in males under 18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution. Monitor for fluid retention.
Dialysis:
Not available. Use with caution and monitor for fluid retention.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution. Monitor for fluid retention and liver function.
Severe:
No specific dose adjustment recommended, but use with caution. Monitor for fluid retention and liver function.
Confidence:
Medium
Pharmacology
Mechanism of Action
Testosterone is an endogenous androgen. Androgens are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Testosterone acts by binding to androgen receptors in target cells, leading to gene transcription and protein synthesis. In some target tissues (e.g., prostate, seminal vesicles, epididymis), testosterone is converted to dihydrotestosterone (DHT) by 5-alpha reductase, which then binds to the androgen receptor.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 9-14% (transdermal absorption is variable)
Tmax:
Approximately 4 hours 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 (some penetration, but clinical significance for CNS effects is complex)
Elimination:
HalfLife:
Approximately 10-100 minutes (for circulating testosterone, but sustained release from gel provides longer effective half-life)
Clearance:
Approximately 1000 mL/min
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:
Serum testosterone levels begin to rise within 30 minutes of application, reaching steady state within 2-4 days.
PeakEffect:
Peak serum concentrations typically occur 4 hours after application.
DurationOfAction:
Once daily application maintains therapeutic testosterone levels for 24 hours.
Confidence:
Medium
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 instructions for use, including covering the application site with clothing after the gel has dried, and washing hands thoroughly with soap and water 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 with symptoms of VTE immediately.
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 instructions for use, including covering the application site with clothing after the gel has dried, and washing hands thoroughly with soap and water 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 with symptoms of VTE immediately.
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Prolonged or frequent erections
Urination 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 during sleep
Excessive daytime sleepiness
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Skin color changes
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 immediately if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. 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 unusual symptoms, 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 medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Prolonged or frequent erections
Urination 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 during sleep
Excessive daytime sleepiness
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Skin color changes
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 immediately if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. 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 unusual symptoms, 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 virilization in women or children (e.g., new or increased body hair, acne, voice changes, enlarged clitoris in females; enlarged penis, pubic hair, aggressive behavior in children). Seek immediate medical attention.
- Signs of blood clots (e.g., pain, swelling, warmth, redness in a leg; sudden shortness of breath, chest pain). Seek immediate medical attention.
- Signs of prostate problems (e.g., difficulty urinating, frequent urination, blood in urine).
- Signs of fluid retention (e.g., swelling in ankles or feet, sudden weight gain).
- Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, severe stomach pain).
- Worsening of sleep apnea (loud snoring, stopping breathing during sleep).
- Breast tenderness or enlargement.
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 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.
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 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. 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 condition may worsen in some individuals taking testosterone.
This medication may cause 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 increased cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood. Discuss this with your doctor.
Regularly undergo blood work and other laboratory tests as advised by your doctor. This medication may affect the results of certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor.
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. If you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, contact your doctor immediately.
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these can include aggressive behavior, enlarged sex organs, and premature pubic hair growth. In females, possible effects include a deepened voice, changes in body hair, or acne. If this occurs, inform your doctor promptly. If a pregnant woman is exposed to the gel or solution, contact your doctor immediately.
Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging. Discuss the risks and benefits with your doctor.
High doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may not be reversible 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 condition may worsen in some individuals taking testosterone.
This medication may cause 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 increased cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood. Discuss this with your doctor.
Regularly undergo blood work and other laboratory tests as advised by your doctor. This medication may affect the results of certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor.
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. If you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, contact your doctor immediately.
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these can include aggressive behavior, enlarged sex organs, and premature pubic hair growth. In females, possible effects include a deepened voice, changes in body hair, or acne. If this occurs, inform your doctor promptly. If a pregnant woman is exposed to the gel or solution, contact your doctor immediately.
Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging. Discuss the risks and benefits with your doctor.
High doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may not be reversible after stopping the medication. If you have concerns, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Excessive testosterone levels (may lead to polycythemia, fluid retention, mood changes, virilization in women/children)
- Irritability, aggression
- Acne
- Hair loss
What to Do:
Discontinue medication and seek medical attention. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Anticoagulants (e.g., Warfarin): May increase anticoagulant effect, leading to increased risk of bleeding. Monitor INR/PT closely.
- Corticosteroids (e.g., Prednisone): Concomitant use may increase the risk of edema.
Moderate Interactions
- Insulin and Oral Hypoglycemics: Testosterone may decrease blood glucose, requiring adjustment of antidiabetic medication dosage.
- Adrenocorticotropic Hormone (ACTH): May increase risk of edema.
- Thyroid Hormones: May decrease levels of thyroid-binding globulin, leading to increased free thyroid hormone levels (though clinical significance is often minimal).
Minor Interactions
- Cyclosporine: Potential for increased cyclosporine levels (rare).
Monitoring
Baseline Monitoring
Serum Testosterone (total and free)
Rationale: To confirm diagnosis of hypogonadism and establish baseline for treatment efficacy.
Timing: Prior to initiation of therapy, typically in the morning (8 AM - 10 AM).
Hematocrit (Hct) and Hemoglobin (Hgb)
Rationale: To assess for polycythemia, a common adverse effect of testosterone therapy.
Timing: Prior to initiation of therapy.
Prostate-Specific Antigen (PSA)
Rationale: To screen for prostate cancer, as testosterone therapy may stimulate prostate growth.
Timing: Prior to initiation of therapy (in men over 40-50 years old).
Digital Rectal Exam (DRE)
Rationale: To screen for prostate abnormalities.
Timing: Prior to initiation of therapy (in men over 40-50 years old).
Lipid Panel (Total Cholesterol, HDL, LDL, Triglycerides)
Rationale: Testosterone therapy may affect lipid profiles.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function, though transdermal testosterone has less hepatic impact than oral forms.
Timing: Prior to 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 normal physiological 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: At baseline, 3-6 months after initiation, then annually.
Target: <50%
Action Threshold: If Hct >50%, reduce dose or temporarily discontinue therapy until Hct returns to acceptable levels. Consider phlebotomy if persistent.
Prostate-Specific Antigen (PSA) and Digital Rectal Exam (DRE)
Frequency: At baseline, 3-6 months after initiation, then annually (for men over 40-50 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 or as clinically indicated.
Target: Within normal limits.
Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.
Bone Mineral Density (BMD)
Frequency: Consider for men with osteoporosis or at high risk, typically after 1-2 years of therapy.
Target: Improvement or stabilization.
Action Threshold: Not applicable for direct dose adjustment, but guides overall management.
Symptom Monitoring
- Signs of virilization in women or children (e.g., voice deepening, hirsutism, clitoromegaly, premature puberty)
- Signs of fluid retention (e.g., ankle swelling, weight gain)
- Symptoms of benign prostatic hyperplasia (BPH) or prostate cancer (e.g., urinary frequency, urgency, nocturia, difficulty voiding)
- Mood changes, irritability, aggression
- Sleep apnea (worsening or new onset)
- Breast tenderness or enlargement (gynecomastia)
- Skin irritation at application site
Special Patient Groups
Pregnancy
Contraindicated. Testosterone can cause fetal harm when administered to a pregnant woman. Exposure to androgens during pregnancy may lead to virilization of the external genitalia 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
Contraindicated. It is not known whether testosterone is excreted in human milk. However, due to the potential for serious adverse reactions in the breastfed infant, including virilization, testosterone gel is contraindicated in breastfeeding women.
Infant Risk:
High risk of virilization and other adverse effects.
Pediatric Use
Contraindicated in males under 18 years of age due to lack of established safety and efficacy. Use in children can cause premature epiphyseal closure and precocious puberty. Cases of secondary exposure leading to virilization in children have been reported.
Geriatric Use
Use with caution. Older men treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostate carcinoma. Regular monitoring of PSA and DRE is crucial. Increased risk of cardiovascular events and polycythemia may also be present.
Clinical Information
Clinical Pearls
- Emphasize strict adherence to application instructions and precautions to prevent secondary exposure, especially to women and children.
- Patients should be advised that the gel is flammable until dry.
- Regular monitoring of testosterone levels, hematocrit, and prostate health (PSA, DRE) is critical for safe and effective therapy.
- Counsel patients on the signs and symptoms of polycythemia, fluid retention, and potential cardiovascular events.
- Consider alternative formulations (e.g., injections, patches) if patient adherence to gel application or transfer precautions is a concern.
- Testosterone therapy is not indicated for age-related decline in testosterone levels in men who are otherwise healthy.
Alternative Therapies
- Other testosterone formulations (e.g., injectable testosterone cypionate/enanthate, testosterone patches, buccal testosterone, nasal testosterone, subcutaneous pellets)
- Lifestyle modifications (e.g., weight loss, exercise) for mild cases of hypogonadism
- Gonadotropin-releasing hormone (GnRH) agonists/antagonists (for specific conditions like prostate cancer, not for hypogonadism)
- Selective Estrogen Receptor Modulators (SERMs) like clomiphene (off-label use to stimulate endogenous testosterone production)
Cost & Coverage
Average Cost:
Varies widely, typically $300-$600 per 30-day supply (30 x 5gm packets or 1 pump bottle)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand), Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 quantity, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 quantity, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.