Testosterone 1% Gel(25mg)30x2.5gm
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. 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 accidental exposure to other parts of your body or 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 instructions 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 only.
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 accidental exposure to other parts of your body or 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 instructions 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 only.
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 once daily, preferably in the morning.
- 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 after the gel has dried 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).
- Avoid skin-to-skin contact with women or children at the application site to prevent secondary exposure.
- If contact occurs, the exposed individual should wash the affected area with soap and water immediately.
- 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: 50 mg of testosterone (one 5 g packet of 1% gel or two 2.5 g packets of 1% gel) applied once daily to clean, dry, intact skin of the shoulders, upper arms, or abdomen. The 25mg packet is typically used for dose titration or as a lower starting dose.
Dose Range:
25 - 100 mg
Condition-Specific Dosing:
maleHypogonadism:
Initial dose: 50 mg daily. Adjust dose based on serum testosterone levels and clinical response. The dose may be adjusted between 25 mg and 100 mg daily. Serum testosterone levels should be measured approximately 14 days after initiation of therapy or dose adjustment.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in males under 18 years of age. Use in children is contraindicated due to risk of virilization in females and premature epiphyseal closure in males.)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but caution advised.
Moderate:
No specific dose adjustment recommended, but caution advised.
Severe:
No specific dose adjustment recommended, but caution advised. Monitor for fluid retention.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but caution advised.
Moderate:
No specific dose adjustment recommended, but caution advised. Monitor for fluid retention and liver function.
Severe:
No specific dose adjustment recommended, but caution advised. Monitor for fluid retention and liver function. Contraindicated in severe liver disease due to risk of cholestatic hepatitis and jaundice.
Pharmacology
Mechanism of Action
Endogenous androgens, including testosterone and dihydrotestosterone (DHT), 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 tissues, where it is converted to DHT by 5-alpha reductase or aromatized to estradiol. These hormones then modulate gene expression, leading to androgenic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 9-14% of applied testosterone is absorbed systemically. A transdermal reservoir is formed in the stratum corneum.
Tmax:
Approximately 2-4 hours after application, with steady-state concentrations achieved within 2-4 days of daily application.
FoodEffect:
Not applicable for topical gel.
Distribution:
Vd:
Approximately 1 L/kg (for endogenous testosterone)
ProteinBinding:
Approximately 98% bound to plasma proteins, primarily sex hormone-binding globulin (SHBG) and albumin.
CnssPenetration:
Limited, but testosterone can cross the blood-brain barrier.
Elimination:
HalfLife:
Approximately 10-100 minutes (for endogenous testosterone in plasma, but effective half-life from transdermal application is longer due to reservoir effect, leading to sustained levels over 24 hours).
Clearance:
Approximately 10 mL/min/kg (for endogenous testosterone)
ExcretionRoute:
Approximately 90% of a testosterone dose is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; about 6% is excreted in the feces, mostly in the unconjugated form.
Unchanged:
<6% (in urine)
Pharmacodynamics
OnsetOfAction:
Within days to weeks for clinical effects (e.g., libido, energy). Serum testosterone levels reach steady-state within 2-4 days.
PeakEffect:
Within 2-4 hours post-application for serum levels; clinical effects may take several weeks to months.
DurationOfAction:
Approximately 24 hours (due to sustained release from skin reservoir).
Safety & Warnings
BLACK BOX WARNING
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE. Cases of secondary exposure resulting in virilization of children and women have been reported. Testosterone gel can transfer from the patient to other individuals upon direct contact. Patients should be advised to strictly adhere to recommended instructions for use, especially regarding application site, hand washing, and covering the application site.
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you 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 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 attention 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 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 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 attention 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 (e.g., unexpected hair growth, acne, voice changes, enlarged clitoris in females; enlarged penis/clitoris, pubic hair, aggressive behavior in children).
- Signs of prostate problems (difficulty urinating, frequent urination, blood in urine).
- Signs of blood clots (pain, swelling, warmth, redness in leg; sudden shortness of breath, chest pain).
- Signs of fluid retention (swelling in ankles, feet, or hands; sudden weight gain).
- Signs of liver problems (yellowing of skin or eyes, dark urine, severe stomach pain, nausea, vomiting).
- Severe skin irritation at the application site.
- 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, such as foods or drugs. 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, including 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, such as foods or drugs. 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, including 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. Be sure to 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.
Individuals with sleep apnea should consult their doctor, as this condition may worsen with testosterone treatment.
This medication can cause high blood pressure, which may increase the risk of heart attack, stroke, or death from heart disease. Have your blood pressure checked regularly, as advised by your doctor. If you have pre-existing high blood pressure or heart disease, discuss this with your doctor.
Treatment with this medication may lead to elevated cholesterol and triglyceride levels. Although the impact of these changes on heart health is not fully understood, 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.
As an anabolic steroid, this medication has the potential for abuse and misuse, which can lead to dependence and severe health problems, including cardiovascular issues, stroke, liver damage, and mental or mood disorders. Discuss the risks with your doctor.
In some individuals with cancer, high calcium levels have been reported with medications similar to this one. If you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, contact your doctor immediately.
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these can include aggressive behavior, enlarged sex organs, and premature pubic hair growth. In females, possible effects include a deepened voice, changes in body hair, or acne. If this occurs, inform the doctor promptly. If a pregnant woman is exposed to the gel or solution, contact the doctor immediately.
Older adults (65 years and older) should exercise caution when using this medication, as they may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging. Discuss the potential benefits and risks 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, consult your doctor.
If you have diabetes, you will need to closely monitor your blood sugar levels.
There may be an increased risk of developing prostate cancer associated with this medication. Be sure to discuss this with your doctor.
Men with an enlarged prostate should be aware that their symptoms may worsen while using this drug. If this occurs, contact your doctor promptly.
Individuals with sleep apnea should consult their doctor, as this condition may worsen with testosterone treatment.
This medication can cause high blood pressure, which may increase the risk of heart attack, stroke, or death from heart disease. Have your blood pressure checked regularly, as advised by your doctor. If you have pre-existing high blood pressure or heart disease, discuss this with your doctor.
Treatment with this medication may lead to elevated cholesterol and triglyceride levels. Although the impact of these changes on heart health is not fully understood, 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.
As an anabolic steroid, this medication has the potential for abuse and misuse, which can lead to dependence and severe health problems, including cardiovascular issues, stroke, liver damage, and mental or mood disorders. Discuss the risks with your doctor.
In some individuals with cancer, high calcium levels have been reported with medications similar to this one. If you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, contact your doctor immediately.
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these can include aggressive behavior, enlarged sex organs, and premature pubic hair growth. In females, possible effects include a deepened voice, changes in body hair, or acne. If this occurs, inform the doctor promptly. If a pregnant woman is exposed to the gel or solution, contact the doctor immediately.
Older adults (65 years and older) should exercise caution when using this medication, as they may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging. Discuss the potential benefits and risks 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, consult your doctor.
Overdose Information
Overdose Symptoms:
- High testosterone levels (above normal range)
- Polycythemia (high red blood cell count, leading to symptoms like headache, dizziness, fatigue)
- Fluid retention (edema)
- Mood changes (irritability, aggression)
- Acne
- Hair loss
What to Do:
Discontinue testosterone gel and/or reduce the dose. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Major Interactions
- Anticoagulants (e.g., warfarin): May increase anticoagulant activity, leading to increased risk of bleeding. Monitor INR/PT closely.
- Corticosteroids (e.g., prednisone): Concomitant use may increase the risk of edema, especially in patients with cardiac, renal, or hepatic disease.
Moderate Interactions
- Insulin and oral hypoglycemic agents: Androgens may decrease blood glucose levels, potentially requiring a reduction in insulin or oral hypoglycemic dosage.
- Thyroid hormones: May decrease levels of thyroid-binding globulin, leading to increased free thyroid hormone levels. No clinical significance usually, but monitor in patients on thyroid replacement.
Monitoring
Baseline Monitoring
Serum Total Testosterone
Rationale: To confirm diagnosis of hypogonadism and establish baseline for dose titration.
Timing: Prior to initiation of therapy (morning levels, two separate measurements).
Prostate-Specific Antigen (PSA)
Rationale: To screen for pre-existing prostate cancer or benign prostatic hyperplasia (BPH) and monitor for prostate changes.
Timing: Prior to initiation of therapy (in men âĨ40 years with risk factors for prostate cancer, or âĨ50 years).
Hematocrit (Hct) and Hemoglobin (Hb)
Rationale: To assess for polycythemia, a common adverse effect of testosterone therapy.
Timing: Prior to initiation of therapy.
Lipid Panel
Rationale: To assess cardiovascular risk factors, as testosterone may affect lipid profiles.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function, especially in patients with pre-existing hepatic impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Total Testosterone
Frequency: Approximately 14 days after initiation or dose adjustment, then 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 consistently above 1000 ng/dL, reduce dose or discontinue. If consistently below 300 ng/dL, consider dose increase.
Prostate-Specific Antigen (PSA)
Frequency: 3-6 months after initiation, then annually (or more frequently based on clinical judgment and risk factors).
Target: Stable or within age-appropriate normal limits.
Action Threshold: Significant increase from baseline or age-specific normal, or abnormal digital rectal exam (DRE), warrants urological evaluation.
Hematocrit (Hct)
Frequency: 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.
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.
Liver Function Tests (LFTs)
Frequency: As clinically indicated, especially if signs of hepatic dysfunction.
Target: Within normal limits.
Action Threshold: Significant elevations may require discontinuation.
Symptom Monitoring
- Signs of prostate enlargement (e.g., urinary hesitancy, frequency, nocturia)
- Breast tenderness or enlargement (gynecomastia)
- Fluid retention (edema, weight gain)
- Mood changes, irritability, aggression
- Sleep apnea (worsening or new onset)
- Skin reactions at application site (redness, irritation, blistering)
- Signs of secondary exposure in women or children (e.g., virilization in females, premature puberty in children)
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Testosterone is teratogenic and can cause 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
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 contraindicated.
Infant Risk:
High risk of virilization and other serious adverse effects.
Pediatric Use
Contraindicated in children. Safety and efficacy have not been established. Use in children can cause premature epiphyseal closure and precocious puberty in males, and virilization in females.
Geriatric Use
Use with caution in elderly men. Increased risk of benign prostatic hyperplasia (BPH) and prostate cancer. More frequent monitoring of PSA and DRE is recommended. Increased risk of cardiovascular events and polycythemia.
Clinical Information
Clinical Pearls
- Emphasize strict adherence to application instructions and precautions to prevent secondary exposure, especially to children and women.
- Rotate application sites daily to minimize skin irritation.
- Advise patients that the full therapeutic effects may not be seen for several weeks to months.
- Remind patients that testosterone therapy is a long-term treatment and requires ongoing monitoring.
- Counsel patients on the importance of regular blood tests (testosterone, Hct, PSA) and follow-up appointments.
- Be aware of the potential for abuse, especially in athletes or bodybuilders, due to its Schedule III classification.
Alternative Therapies
- Testosterone topical solutions (e.g., Axiron)
- Testosterone transdermal patches (e.g., Androderm)
- Testosterone injections (intramuscular or subcutaneous, e.g., testosterone cypionate, enanthate)
- Testosterone buccal systems (e.g., Striant)
- Testosterone pellets (subdermal, e.g., Testopel)
- Oral testosterone undecanoate (e.g., Jatenzo, Kyzatrex)
Cost & Coverage
Average Cost:
$300 - $600 per 30 packets (25mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand), Tier 1 or 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 consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.
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 consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.