Testosterone 1% (12.5mg/1.25gm)pump
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 hormone testosterone in men who have low levels (hypogonadism). It helps restore normal testosterone levels, which can improve symptoms like low energy, reduced libido, and muscle weakness.
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.
Application Instructions
1. Wash your hands before and after applying the medication.
2. Apply the medication at the same time every day.
3. Be aware that different products may have different strengths, so read and follow the label carefully.
4. Avoid getting the medication on other parts of your body or on other people.
5. Do not apply the medication to the genitals.
6. Keep the medication out of your eyes.
Special Instructions for Pump and Packet Products
If you are using a pump product, you will need to prime it before the first use. Follow the priming instructions provided in the package insert. If you are using a packet product, follow the instructions for application.
Post-Application Instructions
After applying the medication:
- Wait for the recommended amount of time before bathing, showering, or swimming. Check the package insert for specific instructions.
- 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.
Application Site
Certain products are designed for use on specific parts of the body. Make sure you understand where to apply this medication. Refer to the package insert for more detailed information.
Storage and Disposal
To store this medication:
- Keep it at room temperature.
- Do not freeze the medication.
- Store it in a dry place, avoiding bathrooms.
- Protect the medication from heat or open flames.
Missed Dose
If you miss a dose:
- Use the missed dose as soon as you remember.
- If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
- Do not use two doses at the same time or take 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.
Application Instructions
1. Wash your hands before and after applying the medication.
2. Apply the medication at the same time every day.
3. Be aware that different products may have different strengths, so read and follow the label carefully.
4. Avoid getting the medication on other parts of your body or on other people.
5. Do not apply the medication to the genitals.
6. Keep the medication out of your eyes.
Special Instructions for Pump and Packet Products
If you are using a pump product, you will need to prime it before the first use. Follow the priming instructions provided in the package insert. If you are using a packet product, follow the instructions for application.
Post-Application Instructions
After applying the medication:
- Wait for the recommended amount of time before bathing, showering, or swimming. Check the package insert for specific instructions.
- 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.
Application Site
Certain products are designed for use on specific parts of the body. Make sure you understand where to apply this medication. Refer to the package insert for more detailed information.
Storage and Disposal
To store this medication:
- Keep it at room temperature.
- Do not freeze the medication.
- Store it in a dry place, avoiding bathrooms.
- Protect the medication from heat or open flames.
Missed Dose
If you miss a dose:
- Use the missed dose as soon as you remember.
- If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
- Do not use two doses at the same time or take extra doses.
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, breasts, or broken skin.
- Wash your hands thoroughly with soap and water immediately after applying the gel.
- Allow the gel to dry completely for at least 5 minutes before dressing.
- Cover the application site with clothing after the gel has dried to prevent transfer to others.
- Avoid swimming, showering, or washing the application site for at least 2-5 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.
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 of 50 mg (4 pump actuations) of testosterone applied once daily to the shoulders, upper arms, or abdomen. Dose may be adjusted based on serum testosterone levels.
Dose Range:
25 - 100 mg
Condition-Specific Dosing:
hypogonadism:
Initial dose of 50 mg (4 pump actuations) of testosterone applied once daily. Adjust dose based on serum testosterone levels, not to exceed 100 mg (8 pump actuations) daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients. Use in delayed puberty is off-label and requires specialized medical supervision.)
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
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.
Dialysis:
Not available
Pharmacology
Mechanism of Action
Exogenous testosterone diffuses across cell membranes and binds to androgen receptors in target tissues (e.g., prostate, seminal vesicles, epididymis, testes, skeletal muscle, bone, kidney, liver, central nervous system, skin, hair follicles). The hormone-receptor complex then translocates to the nucleus, where it binds to DNA and stimulates gene transcription and protein synthesis, leading to the development and maintenance of male primary and secondary sexual characteristics.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 9-14% (transdermal)
Tmax:
2-4 hours after application
FoodEffect:
Not applicable (transdermal administration)
Distribution:
Vd:
Not precisely defined for transdermal, but widely distributed in tissues.
ProteinBinding:
>98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration:
Limited, but affects mood and libido
Elimination:
HalfLife:
Variable (e.g., 10-100 minutes for endogenous testosterone; steady-state levels achieved over days with transdermal application)
Clearance:
Not precisely defined for transdermal
ExcretionRoute:
Renal (approx. 90% as metabolites), Fecal (approx. 10% as metabolites)
Unchanged:
<6% (urinary excretion of unchanged testosterone)
Pharmacodynamics
OnsetOfAction:
Gradual, over days to weeks (for clinical effects)
PeakEffect:
Steady-state serum testosterone levels typically achieved within 2-4 weeks of daily application.
DurationOfAction:
Continuous with daily application
Safety & Warnings
BLACK BOX WARNING
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
âĸ Virilization in children and women can occur with secondary exposure to testosterone gel. Cases of secondary exposure have been reported in children ranging from 9 months to 10 years of age and have included pubic hair development, enlarged penis or clitoris, premature pubarche, accelerated bone age, increased libido, and aggressive behavior. In most cases, these signs and symptoms regressed with removal of the testosterone gel exposure. In a few cases, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained accelerated. Exposure to testosterone gel in women has resulted in signs of virilization, such as deepening of the voice, hirsutism, acne, and clitoromegaly.
âĸ Testosterone gel should be prescribed only to patients who agree to and understand the importance of following the instructions for application and for avoiding secondary exposure to testosterone gel.
âĸ Virilization in children and women can occur with secondary exposure to testosterone gel. Cases of secondary exposure have been reported in children ranging from 9 months to 10 years of age and have included pubic hair development, enlarged penis or clitoris, premature pubarche, accelerated bone age, increased libido, and aggressive behavior. In most cases, these signs and symptoms regressed with removal of the testosterone gel exposure. In a few cases, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained accelerated. Exposure to testosterone gel in women has resulted in signs of virilization, such as deepening of the voice, hirsutism, acne, and clitoromegaly.
âĸ Testosterone gel should be prescribed only to patients who agree to and understand the importance of following the instructions for application and for avoiding secondary exposure to testosterone gel.
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 experience 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 or dizziness
+ Passing out
+ Changes in eyesight
Prolonged or frequent erections
Urinary 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 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:
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 concerns or questions, 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 experience 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 or dizziness
+ Passing out
+ Changes in eyesight
Prolonged or frequent erections
Urinary 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 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:
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 concerns or questions, 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, deepening voice, acne, enlarged clitoris, early puberty in children)
- Swelling of ankles, feet, or hands (fluid retention)
- Difficulty urinating, increased urination, or changes in urine stream (may indicate prostate issues)
- Breast tenderness or enlargement
- Shortness of breath, chest pain, or leg swelling (signs of blood clot or heart issues)
- Yellowing of skin or eyes (jaundice), dark urine, or severe stomach pain (signs of liver problems)
- Mood changes, irritability, or aggression
- Sleep disturbances, especially worsening 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. 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 modify 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 modify 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 can cause high blood pressure, which may increase the risk of heart attack, stroke, or death from heart disease. Have your blood pressure checked regularly, as advised by your doctor. If you have pre-existing high blood pressure or heart disease, discuss this with your doctor.
Treatment with this medication may lead to increased cholesterol and triglyceride levels. 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. 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 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, 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 the doctor promptly. If a pregnant woman is exposed to the gel or solution, contact the doctor immediately.
Individuals 65 years or 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 this with your doctor.
High doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may be irreversible even after stopping the medication. If you have concerns, discuss them with your doctor.
If you have diabetes, you will need to closely monitor your blood sugar levels.
There may be an increased risk of developing prostate cancer associated with this medication. Discuss this with your doctor.
Men with an enlarged prostate should be aware that their symptoms may worsen while using this drug. If this occurs, contact your doctor promptly.
If you have sleep apnea, consult with your doctor, as this condition may worsen in some individuals taking testosterone.
This medication can cause high blood pressure, which may increase the risk of heart attack, stroke, or death from heart disease. Have your blood pressure checked regularly, as advised by your doctor. If you have pre-existing high blood pressure or heart disease, discuss this with your doctor.
Treatment with this medication may lead to increased cholesterol and triglyceride levels. 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. 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 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, 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 the doctor promptly. If a pregnant woman is exposed to the gel or solution, contact the doctor immediately.
Individuals 65 years or 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 this with your doctor.
High doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may be irreversible even after stopping the medication. If you have concerns, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Acne
- Hirsutism (excessive hair growth)
- Virilization (development of male characteristics in women)
- Gynecomastia (breast enlargement in men)
- Polycythemia (abnormally high red blood cell count)
- Irritability or aggression
What to Do:
There is no specific antidote for testosterone overdose. Management is supportive. Discontinue the medication or reduce the dose. Contact a poison control center (1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Anticoagulants (e.g., warfarin): May increase anticoagulant activity, leading to increased risk of bleeding. Close monitoring of INR/PT is required.
- Corticosteroids: Concomitant use may increase the risk of edema, especially in patients with pre-existing cardiac, renal, or hepatic disease.
Moderate Interactions
- Insulin and Oral Hypoglycemics: Testosterone may decrease blood glucose levels, potentially requiring a reduction in the dose of antidiabetic agents.
- Thyroid Hormones: Testosterone may decrease levels of thyroxine-binding globulin (TBG), resulting in decreased total T4 levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.
Monitoring
Baseline Monitoring
Serum Testosterone (total and free)
Rationale: To confirm diagnosis of hypogonadism and establish baseline for dose titration.
Timing: Prior to initiation of therapy (usually 2-3 morning samples)
Prostate-Specific Antigen (PSA)
Rationale: To screen for pre-existing prostate cancer or benign prostatic hyperplasia (BPH) in men aged >40 years.
Timing: Prior to initiation of therapy
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: 2-4 weeks after initiation or dose adjustment, then every 6-12 months
Target: 300-1000 ng/dL (trough levels, measured approximately 2-4 hours after application)
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 3 months and 6 months after initiation, then annually
Target: <54%
Action Threshold: If Hct >54%, discontinue therapy until Hct decreases, then restart at a lower dose or consider phlebotomy.
Prostate-Specific Antigen (PSA)
Frequency: Annually (in men >40 years old)
Target: Age-dependent, typically <4 ng/mL
Action Threshold: If PSA increases significantly or is outside normal limits, refer to urologist for further evaluation (e.g., prostate biopsy).
Digital Rectal Exam (DRE)
Frequency: Annually (in men >40 years old)
Target: Normal prostate size and consistency
Action Threshold: Any abnormalities (e.g., nodules, induration) require urological referral.
Lipid Panel
Frequency: Periodically (e.g., annually)
Target: Optimal lipid levels (e.g., LDL <100 mg/dL)
Action Threshold: Manage dyslipidemia as per clinical guidelines.
Liver Function Tests (LFTs)
Frequency: Periodically (e.g., annually), or if symptoms of hepatic dysfunction occur
Target: Within normal limits
Action Threshold: Elevated LFTs may require dose reduction or discontinuation.
Symptom Monitoring
- Signs of virilization in women or children (e.g., voice deepening, hirsutism, clitoromegaly, menstrual irregularities)
- Fluid retention (e.g., edema, weight gain)
- Breast tenderness or enlargement (gynecomastia)
- Urinary symptoms (e.g., frequency, urgency, nocturia, difficulty urinating) indicative of BPH exacerbation
- Mood changes (e.g., irritability, aggression, depression)
- Sleep apnea exacerbation
- Skin reactions at application site (e.g., irritation, rash)
- Acne
- Hair loss (scalp)
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Testosterone 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, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
High risk of virilization and other adverse effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not indicated for use in children. Use in delayed puberty is off-label and requires careful consideration and specialized medical supervision due to potential for premature epiphyseal closure and virilization.
Geriatric Use
Geriatric patients treated with androgens may be at an increased risk for the development of benign prostatic hyperplasia (BPH) and prostate cancer. Increased risk of cardiovascular events (e.g., MI, stroke) has been reported in some studies, though data are conflicting. Careful monitoring for prostate and cardiovascular health is essential.
Clinical Information
Clinical Pearls
- Emphasize the importance of proper application technique and strict adherence to instructions to minimize the risk of secondary exposure to women and children.
- Advise patients to apply the gel to clean, dry, intact skin and to wash hands thoroughly after application.
- Counsel patients to cover the application site with clothing once the gel has dried and to avoid skin-to-skin contact with others at the application site.
- Regular monitoring of serum testosterone levels, hematocrit, and PSA is crucial for safe and effective therapy.
- Patients should be educated on the signs and symptoms of potential adverse effects, including virilization in others, fluid retention, and prostate issues.
Alternative Therapies
- Testosterone injections (e.g., testosterone cypionate, testosterone enanthate)
- Testosterone patches (e.g., Androderm)
- Testosterone buccal system (e.g., Striant)
- Testosterone pellets (e.g., Testopel)
- Testosterone nasal gel (e.g., Natesto)
- Human Chorionic Gonadotropin (hCG) (off-label for hypogonadism, primarily for fertility preservation)
- Clomiphene citrate (off-label for secondary hypogonadism)
Cost & Coverage
Average Cost:
$300 - $600 per 75g pump (approx. 30-day supply)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (varies by insurance plan)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 amount, and the time it occurred.