Testosterone Enan 200mg/ml Mdv 5ml
It is used to treat breast cancer in certain people.It is used to treat low testosterone levels.It is used in certain children when puberty is delayed.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Androgen
Pharmacologic Class
Androgen receptor agonist
Pregnancy Category
Category X
FDA Approved
Jul 1954
DEA Schedule
Schedule III
Overview
What is this medicine?
Testosterone enanthate is a man-made form of testosterone, a natural male hormone. It is given by injection into a muscle to treat conditions in men who do not produce enough natural testosterone, a condition called hypogonadism. It helps with symptoms like low sex drive, fatigue, and loss of muscle mass.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is administered via injection into a muscle. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique and help you identify the correct injection site. It is essential to choose a site that is free from irritation, tenderness, bruising, redness, scaliness, hardness, scarring, or stretch marks.
Before administering the injection, wash your hands thoroughly. Inspect the solution for cloudiness, leakage, or particles, and do not use it if you notice any of these issues. The solution should be colorless to faintly yellow; if the color changes, do not use it.
After injecting the medication, dispose of the needle in a designated sharps disposal container. Do not reuse needles or other equipment. When the container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storing and Disposing of Your Medication
Store this medication at room temperature, avoiding freezing and moisture. Keep it in a dry location, such as a closet or cupboard, and avoid storing it in a bathroom. Ensure that all medications are kept out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at once or take extra doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is administered via injection into a muscle. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique and help you identify the correct injection site. It is essential to choose a site that is free from irritation, tenderness, bruising, redness, scaliness, hardness, scarring, or stretch marks.
Before administering the injection, wash your hands thoroughly. Inspect the solution for cloudiness, leakage, or particles, and do not use it if you notice any of these issues. The solution should be colorless to faintly yellow; if the color changes, do not use it.
After injecting the medication, dispose of the needle in a designated sharps disposal container. Do not reuse needles or other equipment. When the container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storing and Disposing of Your Medication
Store this medication at room temperature, avoiding freezing and moisture. Keep it in a dry location, such as a closet or cupboard, and avoid storing it in a bathroom. Ensure that all medications are kept out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at once or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Administer injections exactly as prescribed by your doctor. Do not inject more often or in larger amounts than directed.
- Do not share this medication with anyone else, as it is a controlled substance and can be abused.
- Maintain a healthy diet and exercise routine to support overall health and muscle mass.
- Report any new or worsening symptoms to your doctor promptly.
- Keep all appointments for blood tests and follow-up visits to monitor your treatment and check for 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:
50 to 400 mg intramuscularly every 2 to 4 weeks
Dose Range:
50 - 400 mg
Condition-Specific Dosing:
maleHypogonadism:
50 to 400 mg IM every 2 to 4 weeks, adjusted based on clinical response and serum testosterone levels.
delayedPubertyMales:
50 to 200 mg IM every 2 to 4 weeks for a limited duration (e.g., 4-6 months).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (contraindicated in prepubertal males for non-hypogonadal indications due to risk of premature epiphyseal closure)
Adolescent:
For delayed puberty in males: 50 to 200 mg IM every 2 to 4 weeks for a limited duration (e.g., 4-6 months). Dosing should be individualized and carefully monitored.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for fluid retention.
Moderate:
No specific dose adjustment recommended, but monitor for fluid retention.
Severe:
Use with caution; monitor for fluid retention and potential exacerbation of renal disease.
Dialysis:
Use with caution; monitor for fluid retention and potential exacerbation of renal disease. Not dialyzable.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function tests.
Moderate:
Use with caution; monitor liver function tests. May require dose reduction.
Severe:
Contraindicated in severe hepatic impairment due to risk of cholestatic hepatitis and liver tumors.
Confidence:
Medium
Pharmacology
Mechanism of Action
Testosterone enanthate is an ester of the naturally occurring androgen, testosterone. It is converted to testosterone in vivo. Testosterone acts by binding to androgen receptors in target tissues, forming a hormone-receptor complex that translocates to the nucleus. This complex then binds to specific DNA sequences (androgen response elements), regulating gene transcription and protein synthesis. This leads to the development and maintenance of male primary and secondary sexual characteristics, including growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution.
Pharmacokinetics
Absorption:
Bioavailability:
100% (after IM injection, as the ester is slowly hydrolyzed to testosterone)
Tmax:
Approximately 7 days (for testosterone after IM injection of enanthate)
FoodEffect:
Not applicable (IM administration)
Distribution:
Vd:
Not available (for testosterone, approximately 1 L/kg)
ProteinBinding:
Approximately 98% (to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration:
Limited (testosterone can cross the blood-brain barrier, but its direct CNS effects are complex and not fully characterized for therapeutic doses)
Elimination:
HalfLife:
Approximately 4.5 days (for testosterone enanthate, reflecting the release from the oil depot); 10-100 minutes (for testosterone itself)
Clearance:
Not available (for testosterone, approximately 1300 mL/min)
ExcretionRoute:
Renal (approximately 90% as metabolites), Fecal (approximately 6% as metabolites)
Unchanged:
Less than 6% (excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Weeks to months for full therapeutic effect (e.g., muscle mass, libido)
PeakEffect:
Approximately 7 days after injection (peak serum testosterone levels)
DurationOfAction:
2 to 4 weeks (due to slow release from oil depot)
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Venous Thromboembolism (VTE): Cases of VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products. Evaluate patients with symptoms of VTE and discontinue testosterone therapy if a VTE is suspected. Cardiovascular Risk: Some studies have suggested an increased risk of major adverse cardiovascular events (MACE) with testosterone therapy, particularly in older men with pre-existing cardiovascular disease or risk factors. Patients should be informed of this potential risk. Abuse Potential: Testosterone is a Schedule III controlled substance. Abuse of testosterone, alone or in combination with other anabolic androgenic steroids, can lead to serious cardiovascular and psychiatric adverse reactions. Patients should be advised of the potential for abuse and dependence.
Side Effects
Urgent 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 or dripping urine stream
+ Frequent urination
Loss of bladder control
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide
Enlarged breasts or breast pain
Shortness of breath, significant weight gain, or swelling in the arms or legs
Upset stomach or vomiting
Trouble breathing during sleep
Excessive daytime sleepiness
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Skin color changes
Changes in testicle size or shape
For females: deepening voice, facial hair, acne, or changes in menstrual cycle
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Trouble speaking or swallowing
Liver problems, which can be life-threatening. Seek medical help if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Headache
Acne
Diarrhea
Mood swings
Fatigue or weakness
Sleep disturbances
Irritation at the site of application
This list is not exhaustive. 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 or dripping urine stream
+ Frequent urination
Loss of bladder control
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide
Enlarged breasts or breast pain
Shortness of breath, significant weight gain, or swelling in the arms or legs
Upset stomach or vomiting
Trouble breathing during sleep
Excessive daytime sleepiness
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Skin color changes
Changes in testicle size or shape
For females: deepening voice, facial hair, acne, or changes in menstrual cycle
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Trouble speaking or swallowing
Liver problems, which can be life-threatening. Seek medical help if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Headache
Acne
Diarrhea
Mood swings
Fatigue or weakness
Sleep disturbances
Irritation at the site of application
This list is not exhaustive. 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:
- Swelling in your ankles, feet, or hands (fluid retention)
- Shortness of breath, chest pain, or pain/swelling in your leg (signs of blood clot)
- Difficulty urinating, frequent urination, or blood in urine (signs of prostate issues)
- Yellowing of skin or eyes, dark urine, severe stomach pain (signs of liver problems)
- Nausea, vomiting, changes in skin color, or ankle swelling (signs of too much testosterone)
- Changes in mood, aggression, or irritability
- New or worsening sleep apnea (interrupted breathing during sleep)
- Breast tenderness or enlargement (gynecomastia)
- Frequent or persistent erections, or changes in sexual desire
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 conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you are a male patient with a history of breast or prostate cancer.
If you have been diagnosed with any of the following health conditions: heart disease, kidney disease, or liver disease.
If you are pregnant or think you may be pregnant. This medication is contraindicated during pregnancy, and you should not take it if you are pregnant.
* If you are breastfeeding. You should not breastfeed while taking this medication, as it may pose risks to your baby.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you are a male patient with a history of breast or prostate cancer.
If you have been diagnosed with any of the following health conditions: heart disease, kidney disease, or liver disease.
If you are pregnant or think you may be pregnant. This medication is contraindicated during pregnancy, and you should not take it if you are pregnant.
* If you are breastfeeding. You should not breastfeed while taking this medication, as it may pose risks to your baby.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Monitoring and Precautions
If you have diabetes (high blood sugar), you will need to closely monitor your blood sugar levels.
There may be an increased risk of prostate cancer; discuss this with your doctor.
If you have an enlarged prostate, your symptoms may worsen while taking this medication. Contact your doctor if this occurs.
If you have sleep apnea, consult with your doctor, as this medication may exacerbate the condition.
Regular blood pressure checks are crucial, as this medication can cause high blood pressure, which may increase the risk of heart attack, stroke, or death from heart disease.
If you have high blood pressure or heart disease, discuss the potential risks with your doctor.
Treatment with this medication may lead to elevated cholesterol and triglyceride levels. The impact of these changes on heart health is unknown; consult with your doctor.
Adhere to your doctor's recommendations for regular blood work and lab tests, as this medication may affect certain test results. Inform all your healthcare providers and lab personnel that you are taking this medication.
Blood Clots and Anabolic Steroid Risks
Blood clots have been reported in patients taking this medication. If you have a history of blood clots, inform your doctor.
This medication is an anabolic steroid, which has been associated with abuse and misuse. Anabolic steroid abuse can lead to dependence and severe health problems, including heart or blood vessel issues, stroke, liver problems, and mental or mood disorders. Discuss the risks with your doctor.
Additional Warnings
High calcium levels have been reported in some patients with cancer taking medications like this one. Seek immediate medical attention if you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging; discuss alternative treatments with your doctor.
High doses of this medication may affect sperm production in males and potentially impact fertility. If you have concerns, consult with your doctor.
Special Considerations for Children
If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children.
This medication may affect growth in children and teens; regular growth checks may be necessary. Consult with your doctor to discuss the potential risks and benefits.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Monitoring and Precautions
If you have diabetes (high blood sugar), you will need to closely monitor your blood sugar levels.
There may be an increased risk of prostate cancer; discuss this with your doctor.
If you have an enlarged prostate, your symptoms may worsen while taking this medication. Contact your doctor if this occurs.
If you have sleep apnea, consult with your doctor, as this medication may exacerbate the condition.
Regular blood pressure checks are crucial, as this medication can cause high blood pressure, which may increase the risk of heart attack, stroke, or death from heart disease.
If you have high blood pressure or heart disease, discuss the potential risks with your doctor.
Treatment with this medication may lead to elevated cholesterol and triglyceride levels. The impact of these changes on heart health is unknown; consult with your doctor.
Adhere to your doctor's recommendations for regular blood work and lab tests, as this medication may affect certain test results. Inform all your healthcare providers and lab personnel that you are taking this medication.
Blood Clots and Anabolic Steroid Risks
Blood clots have been reported in patients taking this medication. If you have a history of blood clots, inform your doctor.
This medication is an anabolic steroid, which has been associated with abuse and misuse. Anabolic steroid abuse can lead to dependence and severe health problems, including heart or blood vessel issues, stroke, liver problems, and mental or mood disorders. Discuss the risks with your doctor.
Additional Warnings
High calcium levels have been reported in some patients with cancer taking medications like this one. Seek immediate medical attention if you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging; discuss alternative treatments with your doctor.
High doses of this medication may affect sperm production in males and potentially impact fertility. If you have concerns, consult with your doctor.
Special Considerations for Children
If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children.
This medication may affect growth in children and teens; regular growth checks may be necessary. Consult with your doctor to discuss the potential risks and benefits.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Abdominal pain
- Headache
- Dizziness
- Irritability
- Fluid retention (edema)
- Cholestatic jaundice (yellowing of skin/eyes)
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. Discontinuation of the drug may be necessary.
Drug Interactions
Major Interactions
- Oral anticoagulants (e.g., Warfarin): May increase anticoagulant effect, leading to increased bleeding risk. Requires close INR monitoring and potential dose adjustment of anticoagulant.
- 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 hypoglycemics: Testosterone may decrease blood glucose levels, requiring dose adjustment of antidiabetic agents.
- Thyroid hormones: Testosterone may decrease levels of thyroid-binding globulin, leading to decreased total T4 levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, and clinical hypothyroidism is rare.
- Cyclosporine: Potential for increased cyclosporine levels, though data are limited.
Monitoring
Baseline Monitoring
Serum Testosterone (total and free)
Rationale: To confirm diagnosis of hypogonadism and establish baseline for therapeutic monitoring.
Timing: Prior to initiation of therapy
Hematocrit (Hct) and Hemoglobin (Hgb)
Rationale: Testosterone can stimulate erythropoiesis, leading to polycythemia/erythrocytosis.
Timing: Prior to initiation of therapy
Prostate-Specific Antigen (PSA)
Rationale: To screen for prostate cancer and establish baseline, as testosterone can stimulate prostate growth.
Timing: Prior to initiation of therapy (in males âĨ40 years old or with risk factors)
Lipid Panel (Total Cholesterol, HDL, LDL, Triglycerides)
Rationale: Testosterone therapy can affect lipid profiles.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function, as testosterone can rarely cause hepatic dysfunction.
Timing: Prior to initiation of therapy
Digital Rectal Exam (DRE)
Rationale: To screen for prostate abnormalities.
Timing: Prior to initiation of therapy (in males âĨ40 years old or with risk factors)
Routine Monitoring
Serum Testosterone (total)
Frequency: 3-6 months after initiation, then annually or as clinically indicated
Target: Trough levels (just before next injection) should be in the mid-normal range (e.g., 300-1000 ng/dL).
Action Threshold: Levels consistently above or below target range may require dose adjustment.
Hematocrit (Hct)
Frequency: 3-6 months after initiation, then annually or as clinically indicated
Target: <54%
Action Threshold: If Hct >50%, reduce dose or temporarily discontinue. If Hct >54%, discontinue therapy until Hct decreases, then restart at a lower dose or consider phlebotomy.
Prostate-Specific Antigen (PSA) and Digital Rectal Exam (DRE)
Frequency: 3-6 months after initiation, then annually (for males âĨ40 years old or with risk factors)
Target: Stable or within age-appropriate limits.
Action Threshold: Significant increase in PSA or abnormal DRE warrants urological evaluation.
Lipid Panel
Frequency: Annually or as clinically indicated
Target: Within normal limits or individualized targets.
Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.
Liver Function Tests (LFTs)
Frequency: Periodically, especially if symptoms of hepatic dysfunction occur
Target: Within normal limits.
Action Threshold: Elevated LFTs may require dose reduction or discontinuation.
Bone Mineral Density (BMD)
Frequency: Considered in patients with long-standing hypogonadism or at risk for osteoporosis, typically after 1-2 years of therapy.
Target: Improved or stable BMD.
Action Threshold: Not applicable for routine monitoring, but for assessing long-term benefit.
Symptom Monitoring
- Changes in libido or sexual function
- Mood changes (irritability, depression)
- Sleep disturbances (e.g., worsening sleep apnea)
- Fluid retention (edema, weight gain)
- Breast tenderness or enlargement (gynecomastia)
- Urinary symptoms (e.g., frequency, urgency, difficulty urinating)
- Skin changes (acne, oily skin)
- Hair changes (male pattern baldness, increased body hair)
- Signs of liver problems (yellowing skin/eyes, dark urine, severe stomach pain)
- Signs of blood clots (pain, swelling, warmth in leg; chest pain, shortness of breath)
- Signs of prostate issues (difficulty urinating, frequent urination, blood in urine)
Special Patient Groups
Pregnancy
Testosterone enanthate is contraindicated in pregnant women. It can cause virilization of the female fetus, including clitoral enlargement, abnormal vaginal development, and fusion of genital folds. There is no indication for use in females.
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 enanthate 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 (e.g., virilization) and the lack of an indication for use in females, it should not be used during lactation.
Infant Risk:
High risk of virilization and other adverse effects; unknown if excreted in milk.
Pediatric Use
Use in pediatric patients should be limited to specific indications like delayed puberty in males, and only under strict medical supervision. It is contraindicated in prepubertal males for non-hypogonadal indications due to the risk of premature epiphyseal closure and adverse effects on growth and development. Long-term safety and efficacy in pediatric patients are not fully established.
Geriatric Use
Older men treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostate carcinoma. Increased risk of cardiovascular events and fluid retention. Close monitoring of PSA, DRE, Hct, and cardiovascular status is essential. Lower starting doses and slower titration may be considered.
Clinical Information
Clinical Pearls
- Testosterone enanthate is a long-acting ester, allowing for less frequent injections (typically every 2-4 weeks) compared to propionate.
- Always confirm hypogonadism with at least two morning serum testosterone measurements before initiating therapy.
- Monitor hematocrit closely due to the risk of polycythemia, which can increase the risk of thrombotic events.
- Regular prostate monitoring (PSA and DRE) is crucial, especially in older men, due to the potential for prostate stimulation.
- Educate patients about the signs and symptoms of fluid retention, cardiovascular events, and potential for abuse.
- Therapy should be individualized based on patient response, symptom improvement, and laboratory values, not solely on achieving a specific testosterone level.
- Consider the potential for worsening sleep apnea in patients with pre-existing conditions.
Alternative Therapies
- Testosterone cypionate (IM injection)
- Testosterone undecanoate (IM injection, oral capsule)
- Testosterone transdermal patch
- Testosterone topical gel/solution
- Testosterone buccal system
- Testosterone subcutaneous pellets (e.g., Testopel)
Cost & Coverage
Average Cost:
Not available per 5ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization and diagnosis confirmation)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with a separate patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, 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.