Testosterone 1%(50mg) Gel 5gm Udt
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 spreading it to other parts of your body or to others.
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 come in pumps, while others come in packets.
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.
Important Application Instructions
Certain products are designed for specific areas of the body. 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 Instructions
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 others.
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 come in pumps, while others come in packets.
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.
Important Application Instructions
Certain products are designed for specific areas of the body. 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 Instructions
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 once daily at approximately the same time each morning to clean, dry, intact skin of the shoulders, upper arms, or abdomen. Do not apply to the genitals or breasts.
- 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 showering, swimming, or washing the application site for at least 2 hours after application.
- To prevent transfer to others, avoid skin-to-skin contact with women or children at the application site. If contact occurs, the exposed skin should be washed immediately with soap and water.
- Inform healthcare providers about all medications, supplements, and herbal products being used.
- Attend all scheduled doctor appointments and laboratory tests to monitor testosterone levels and other health markers.
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:
initialDose:
Start with 50 mg daily. Adjust dose based on serum testosterone levels and clinical response.
doseAdjustment:
Dose may be adjusted between 25 mg and 100 mg daily. Serum testosterone levels should be measured approximately 14 and 28 days after starting treatment or dose adjustment. The target testosterone concentration is in the eugonadal range (300-1000 ng/dL).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in males <18 years of age. Use in children could result in precocious puberty and premature epiphyseal closure.)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; no specific dose adjustment recommended, but monitoring for fluid retention may be prudent.
Dialysis:
Considerations: No specific data, but monitor for fluid retention and adjust dose if necessary.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Use with caution; no specific dose adjustment recommended, but monitoring for fluid retention and liver function may be prudent.
Severe:
Use with caution; no specific dose adjustment recommended, but monitoring for fluid retention and liver function may be prudent. Testosterone is metabolized by the liver.
Pharmacology
Mechanism of Action
Testosterone is an endogenous androgen. Androgens are responsible for the normal growth and development of male sex organs and for maintenance of secondary sex characteristics. Testosterone acts by binding to androgen receptors in target tissues, leading to gene transcription and protein synthesis. In some tissues, testosterone is converted to dihydrotestosterone (DHT) by 5-alpha reductase, which is a more potent androgen.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 9-14% of applied testosterone is absorbed systemically.
Tmax:
Approximately 4 hours after application.
FoodEffect:
Not applicable for topical gel.
Distribution:
Vd:
Not specifically reported for topical gel, but testosterone distributes widely in body tissues.
ProteinBinding:
Approximately 98% bound to plasma proteins, primarily sex hormone-binding globulin (SHBG) and albumin.
CnssPenetration:
Limited (Testosterone can cross the blood-brain barrier, but systemic levels from topical application are the primary concern).
Elimination:
HalfLife:
Approximately 10-100 minutes (endogenous testosterone); however, the effective half-life after topical application is longer due to continuous absorption from the skin reservoir, leading to sustained levels.
Clearance:
Not specifically reported for topical gel.
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:
Very small percentage.
Pharmacodynamics
OnsetOfAction:
Serum testosterone levels begin to increase within hours of first application.
PeakEffect:
Steady-state serum testosterone concentrations are generally achieved by approximately 2-4 days of daily application.
DurationOfAction:
Daily application maintains steady-state levels.
Safety & Warnings
BLACK BOX WARNING
WARNING: 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 others in close contact, resulting in adverse reactions. Patients should be advised to strictly adhere to recommended application instructions and precautions. WARNING: INCREASED RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS AND VENOUS THROMBOEMBOLISM. An increased risk of myocardial infarction, stroke, and venous thromboembolism (including deep vein thrombosis and pulmonary embolism) has been reported in association with testosterone therapy.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Prolonged or frequent erections
Urination problems, such as:
+ Trouble passing urine
+ Pain while passing urine
+ Weak urine stream or dribbling
+ 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
Changes in skin color
Changes in testicle size or shape
Signs of a blood clot, such as:
+ 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
Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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, 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 immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Prolonged or frequent erections
Urination problems, such as:
+ Trouble passing urine
+ Pain while passing urine
+ Weak urine stream or dribbling
+ 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
Changes in skin color
Changes in testicle size or shape
Signs of a blood clot, such as:
+ 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
Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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, 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 secondary exposure in women or children (e.g., increased body hair, acne, voice deepening, enlarged clitoris in females; enlarged penis/clitoris, pubic hair, aggressive behavior in children).
- Signs of blood clots (e.g., pain, swelling, warmth in leg; sudden shortness of breath; chest pain).
- Signs of heart attack or stroke (e.g., chest pain, shortness of breath, weakness on one side of the body, slurred speech).
- Signs of prostate problems (e.g., difficulty urinating, frequent urination, blood in urine).
- Swelling of ankles, feet, or hands (fluid retention).
- Breast tenderness or enlargement.
- Nausea, vomiting, yellowing of skin or eyes (signs of liver problems).
- Difficulty breathing during sleep (worsening of sleep apnea).
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, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This will help ensure your safety while taking this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This will help ensure your safety while taking this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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.
Individuals with sleep apnea should consult their doctor, as this condition may worsen with testosterone treatment.
This medication may cause high blood pressure, which can 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. The impact of these changes on heart health is not fully understood, so it is crucial to discuss this with your doctor.
Regularly undergo blood work and other laboratory tests as recommended by your doctor. Be aware that 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 and discuss the potential risks.
This medication is classified as 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 elevated 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 the doctor promptly. If a pregnant woman is exposed to the gel or solution, contact the doctor immediately.
Older adults (65 and above) 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, 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.
Individuals with sleep apnea should consult their doctor, as this condition may worsen with testosterone treatment.
This medication may cause high blood pressure, which can 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. The impact of these changes on heart health is not fully understood, so it is crucial to discuss this with your doctor.
Regularly undergo blood work and other laboratory tests as recommended by your doctor. Be aware that 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 and discuss the potential risks.
This medication is classified as 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 elevated 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 the doctor promptly. If a pregnant woman is exposed to the gel or solution, contact the doctor immediately.
Older adults (65 and above) 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, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- High testosterone levels (may not have immediate acute symptoms but can lead to long-term adverse effects)
- Polycythemia (excess red blood cells)
- Fluid retention
- Mood changes (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 Center).
Drug Interactions
Major Interactions
- Anticoagulants (e.g., warfarin): May increase anticoagulant activity, leading to increased risk of bleeding.
- Corticosteroids (e.g., prednisone): Concomitant use may increase the risk of edema.
Moderate Interactions
- Insulin and oral hypoglycemics: Testosterone may decrease blood glucose and insulin requirements in diabetic patients.
- Thyroid hormones: May alter thyroid hormone binding globulin levels, but usually no clinical significance.
Monitoring
Baseline Monitoring
Serum Testosterone (total)
Rationale: To confirm diagnosis of hypogonadism and establish baseline for dose titration.
Timing: Prior to initiation of therapy (usually two morning 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 and all men âĨ50 years.
Hematocrit (Hct)
Rationale: To assess for polycythemia, a common adverse effect of testosterone therapy.
Timing: Prior to initiation of therapy.
Lipid Panel
Rationale: To assess cardiovascular risk factors, as testosterone may affect lipid profiles.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function, especially in patients with pre-existing hepatic impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Testosterone (total)
Frequency: Approximately 14 and 28 days after starting treatment or dose adjustment, then every 3-6 months once stable.
Target: 300-1000 ng/dL (eugonadal range)
Action Threshold: If consistently above 1000 ng/dL, reduce dose or discontinue. If consistently below 300 ng/dL, consider dose increase.
Hematocrit (Hct)
Frequency: At baseline, at 3-6 months, 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: At 3-6 months, then annually (or more frequently based on clinical judgment and patient risk factors).
Target: Stable or within normal limits for age.
Action Threshold: Significant increase from baseline or age-specific norms warrants further urological evaluation.
Digital Rectal Exam (DRE)
Frequency: At 3-6 months, then annually (or more frequently based on clinical judgment and patient risk factors).
Target: Normal findings.
Action Threshold: Abnormal findings (e.g., nodule, induration) warrant further urological evaluation.
Lipid Panel
Frequency: Annually.
Target: Within normal limits.
Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.
Symptom Monitoring
- Signs of fluid retention (e.g., ankle swelling, weight gain)
- Symptoms of benign prostatic hyperplasia (BPH) worsening (e.g., urinary frequency, urgency, nocturia, decreased stream)
- Breast tenderness or enlargement (gynecomastia)
- Skin irritation at application site
- Mood changes, irritability, aggression
- Sleep apnea worsening
- Signs of deep vein thrombosis (DVT) or pulmonary embolism (PE) (e.g., leg pain/swelling, shortness of breath, chest pain)
- Signs of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of body, slurred speech)
Special Patient Groups
Pregnancy
Testosterone is contraindicated in pregnant women. It can cause virilization of the female fetus.
Trimester-Specific Risks:
First Trimester:
High risk of virilization of female fetus.
Second Trimester:
High risk of virilization of female fetus.
Third Trimester:
High risk of virilization of female fetus.
Lactation
Testosterone is contraindicated in breastfeeding women. It is unknown if testosterone is excreted in human milk, but due to the potential for serious adverse reactions in the breastfed infant, use is not recommended.
Infant Risk:
Potential for serious adverse reactions, including virilization.
Pediatric Use
Safety and efficacy not established in males <18 years of age. Use in children could result in precocious puberty and premature epiphyseal closure. Contraindicated in females and children due to risk of virilization from secondary exposure.
Geriatric Use
No specific dose adjustment is generally required based on age alone. However, geriatric patients may have an increased risk of prostate disorders (BPH, prostate cancer) and cardiovascular events. Close monitoring of PSA, DRE, Hct, and cardiovascular status is essential.
Clinical Information
Clinical Pearls
- Emphasize strict adherence to application instructions and precautions to prevent secondary exposure, especially to women and children.
- Always confirm hypogonadism with at least two morning serum testosterone measurements before initiating therapy.
- Monitor hematocrit closely, especially in the first year of therapy, as polycythemia is a common and potentially serious side effect.
- Counsel patients on the potential for worsening sleep apnea and fluid retention.
- Regular prostate monitoring (PSA and DRE) is crucial, particularly in older men.
- Testosterone therapy is not indicated for age-related decline in testosterone levels in men with normal testosterone levels.
- Patients should be advised that the gel is flammable until dry.
Alternative Therapies
- Testosterone topical solution (e.g., Axiron)
- Testosterone transdermal patch (e.g., Androderm)
- Testosterone buccal system (e.g., Striant)
- Testosterone nasal gel (e.g., Natesto)
- Testosterone subcutaneous pellets (e.g., Testopel)
- Testosterone intramuscular injection (e.g., Depo-Testosterone, Aveed)
- Oral testosterone undecanoate (e.g., Jatenzo, Kyzatrex, Tlando)
Cost & Coverage
Average Cost:
$400 - $600 per 30 packets/pumps (50mg/day equivalent)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or 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 substance taken, the amount, and the time it occurred.