Depo-Testosterone 200mg/ml Sdv 1ml
It is used to treat low testosterone levels.
Drug Class
Androgen
Pharmacologic Class
Androgen receptor agonist
Pregnancy Category
Category X
FDA Approved
Aug 1979
DEA Schedule
Schedule III
Overview
What is this medicine?
Testosterone cypionate is a man-made form of testosterone, a natural male hormone. It's given as an injection into a muscle to treat men who don't produce enough natural testosterone (a condition called hypogonadism). It helps restore normal testosterone levels, which can improve symptoms like low energy, low sex drive, 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. 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.
Before giving the injection, wash your hands thoroughly. Ensure you understand where to administer the injection. If you are unsure, consult with your doctor. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Inspect the solution before use. Do not use if it is cloudy, leaking, or contains particles. The solution should be colorless to faint yellow. If the color changes, do not use it.
After use, dispose of needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for disposal. If you have any questions, consult with your doctor or pharmacist.
Storage and Disposal
Store this medication at room temperature, avoiding freezing. Keep it in the original container to protect it from light and store it in a dry place. Do not store it in a bathroom.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take 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. 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.
Before giving the injection, wash your hands thoroughly. Ensure you understand where to administer the injection. If you are unsure, consult with your doctor. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Inspect the solution before use. Do not use if it is cloudy, leaking, or contains particles. The solution should be colorless to faint yellow. If the color changes, do not use it.
After use, dispose of needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for disposal. If you have any questions, consult with your doctor or pharmacist.
Storage and Disposal
Store this medication at room temperature, avoiding freezing. Keep it in the original container to protect it from light and store it in a dry place. Do not store it in a bathroom.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Administer injections exactly as prescribed by your doctor. Do not inject more frequently or in larger amounts than directed.
- Do not share this medication with anyone else, as it can be abused and has serious risks.
- Report any new or worsening symptoms to your doctor promptly.
- Maintain a healthy lifestyle, including regular exercise and a balanced diet, as advised by your healthcare provider.
- Keep all appointments for blood tests and physical exams to monitor your response to treatment and check for side effects.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
50-400 mg intramuscularly every 2 to 4 weeks
Dose Range:
50 - 400 mg
Condition-Specific Dosing:
maleHypogonadism:
50-400 mg IM every 2-4 weeks, adjusted based on clinical response and serum testosterone levels.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (contraindicated for growth promotion due to risk of epiphyseal closure)
Adolescent:
Not established (contraindicated for growth promotion due to risk of epiphyseal closure)
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; no specific dose adjustment provided. Monitor for fluid retention.
Moderate:
Use with caution; no specific dose adjustment provided. Monitor for fluid retention.
Severe:
Use with caution; no specific dose adjustment provided. Monitor for fluid retention.
Dialysis:
Not specifically studied; use with caution and monitor closely for adverse effects.
Hepatic Impairment:
Mild:
Use with caution; no specific dose adjustment provided. Monitor liver function.
Moderate:
Use with caution; no specific dose adjustment provided. Monitor liver function.
Severe:
Contraindicated in severe hepatic impairment due to risk of cholestatic hepatitis and jaundice.
Pharmacology
Mechanism of Action
Testosterone cypionate is an ester of the androgen testosterone. Testosterone is the primary endogenous androgen, responsible for the development and maintenance of male secondary sexual characteristics. It acts by binding to androgen receptors in target tissues, forming a hormone-receptor complex that translocates to the nucleus, where it binds to DNA and stimulates gene transcription and protein synthesis. This leads to the growth and development of male sex organs, maintenance of secondary sex characteristics, and anabolic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (IM injection, bypasses first-pass metabolism)
Tmax:
Approximately 6-9 days after intramuscular injection
FoodEffect:
Not applicable (IM injection)
Distribution:
Vd:
Not readily available for testosterone cypionate specifically, but testosterone has a large volume of distribution.
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 the cypionate ester is designed for slow release)
Elimination:
HalfLife:
Approximately 8 days (for testosterone cypionate ester)
Clearance:
Not readily available for testosterone cypionate specifically, but testosterone clearance is rapid.
ExcretionRoute:
Mainly renal (approximately 90% as conjugates of testosterone and its metabolites), approximately 10% in feces.
Unchanged:
Very little unchanged testosterone is excreted.
Pharmacodynamics
OnsetOfAction:
Gradual, over several days to weeks, due to slow release from the oil depot.
PeakEffect:
Peak serum testosterone levels typically occur 6-9 days after injection.
DurationOfAction:
Approximately 2-4 weeks, depending on the dose and individual patient factors.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache 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 dripping
+ 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 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Headache
Acne
Diarrhea
Emotional changes
Fatigue or weakness
Trouble sleeping
* Irritation at the site of application
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache 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 dripping
+ 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 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Headache
Acne
Diarrhea
Emotional changes
Fatigue or weakness
Trouble sleeping
* Irritation at the site of application
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Swelling in ankles, feet, or hands (fluid retention)
- Difficulty breathing, especially at night (may indicate worsening sleep apnea or heart failure)
- Chest pain, shortness of breath, or leg pain/swelling (signs of blood clots)
- Changes in urination (difficulty, increased frequency, blood in urine)
- Nausea, vomiting, yellowing of skin or eyes (jaundice), dark urine (signs of liver problems)
- Unusual breast tenderness or enlargement
- Mood changes, aggression, or irritability
- Prolonged or painful erections (priapism)
- Skin rash or allergic reaction
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 breast or prostate cancer.
If you have a history of heart disease, kidney disease, or liver disease.
If you are pregnant, plan to become pregnant, or are breastfeeding. Please note that this medication is not approved for use in pregnant or breastfeeding women. If you are in one of these categories, discuss your situation with your doctor.
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
If you are a male with breast or prostate cancer.
If you have a history of heart disease, kidney disease, or liver disease.
If you are pregnant, plan to become pregnant, or are breastfeeding. Please note that this medication is not approved for use in pregnant or breastfeeding women. If you are in one of these categories, discuss your situation with your doctor.
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
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, 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.
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, consult your doctor.
If you have sleep apnea, discuss this with your doctor, as this medication may worsen sleep apnea in some individuals.
Potential Side Effects and Risks
Treatment with this medication may lead to increased cholesterol and triglyceride levels; the impact of these changes on heart health is unknown. Discuss this with your doctor.
Regular blood work and lab tests are necessary, as this medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication.
Blood clots have been reported with this medication; if you have a history of blood clots, inform your doctor.
This medication is an anabolic steroid, which can be abused and misused, leading to dependence and severe health problems, including heart or blood vessel problems, stroke, liver problems, and mental or mood disorders. Discuss the risks with your doctor.
Special Considerations
High calcium levels have been reported in some individuals with cancer taking medications like this one. Seek medical attention immediately 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 this with your doctor.
Large doses of this medication may affect sperm production in males and potentially impact fertility. If you have concerns, discuss this with your doctor.
Pediatric Patients
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 adolescents; regular growth checks may be necessary. Discuss this with your doctor.
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, 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.
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, consult your doctor.
If you have sleep apnea, discuss this with your doctor, as this medication may worsen sleep apnea in some individuals.
Potential Side Effects and Risks
Treatment with this medication may lead to increased cholesterol and triglyceride levels; the impact of these changes on heart health is unknown. Discuss this with your doctor.
Regular blood work and lab tests are necessary, as this medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication.
Blood clots have been reported with this medication; if you have a history of blood clots, inform your doctor.
This medication is an anabolic steroid, which can be abused and misused, leading to dependence and severe health problems, including heart or blood vessel problems, stroke, liver problems, and mental or mood disorders. Discuss the risks with your doctor.
Special Considerations
High calcium levels have been reported in some individuals with cancer taking medications like this one. Seek medical attention immediately 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 this with your doctor.
Large doses of this medication may affect sperm production in males and potentially impact fertility. If you have concerns, discuss this with your doctor.
Pediatric Patients
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 adolescents; regular growth checks may be necessary. Discuss this with your doctor.
Overdose Information
Overdose Symptoms:
- Priapism (prolonged, painful erection)
- Fluid retention (edema)
- Polycythemia (excess red blood cells, leading to symptoms like headache, dizziness, fatigue)
- Mood disturbances (irritability, aggression)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For general overdose information, contact a poison control center at 1-800-222-1222. Treatment is generally supportive and may involve discontinuing the medication or reducing the dose.
Drug Interactions
Major Interactions
- Anticoagulants (e.g., warfarin): May increase anticoagulant effect, leading to increased risk of bleeding. Close monitoring of INR/PT is required.
- Corticosteroids: Concomitant use may increase the risk of fluid retention and edema.
Moderate Interactions
- Insulin and Oral Hypoglycemics: Testosterone may decrease blood glucose levels, potentially requiring a reduction in insulin or oral hypoglycemic dosage.
- Adrenocorticotropic Hormone (ACTH): May increase fluid retention.
Monitoring
Baseline Monitoring
Serum Testosterone (total and free)
Rationale: To confirm diagnosis of hypogonadism and establish baseline levels.
Timing: Before initiation of therapy
Hematocrit (Hct) and Hemoglobin (Hgb)
Rationale: Testosterone can stimulate erythropoiesis, leading to polycythemia.
Timing: Before initiation of therapy
Prostate-Specific Antigen (PSA)
Rationale: To screen for prostate cancer and establish baseline, as testosterone can stimulate prostate growth.
Timing: Before initiation of therapy (in men âĨ40 years old)
Digital Rectal Exam (DRE)
Rationale: To screen for prostate abnormalities.
Timing: Before initiation of therapy (in men âĨ40 years old)
Lipid Panel
Rationale: Testosterone therapy may affect lipid profiles.
Timing: Before initiation of therapy
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function, especially in patients with pre-existing hepatic conditions.
Timing: Before initiation of therapy
Routine Monitoring
Serum Testosterone (total and free)
Frequency: 3-6 months after initiation, then annually or as clinically indicated
Target: Trough levels (just before next injection) should be within the normal physiologic range (e.g., 300-1000 ng/dL)
Action Threshold: Levels consistently above or below target range; adjust dose or frequency.
Hematocrit (Hct) and Hemoglobin (Hgb)
Frequency: 3-6 months after initiation, then annually
Target: Hct <54%
Action Threshold: Hct âĨ54%; consider dose reduction, temporary cessation, or phlebotomy.
Prostate-Specific Antigen (PSA) and Digital Rectal Exam (DRE)
Frequency: 3-6 months after initiation, then annually (in men âĨ40 years old)
Target: Stable or within normal limits for age
Action Threshold: Significant increase in PSA (>0.4 ng/mL/year or >2 ng/mL above baseline) or abnormal DRE; refer to urologist.
Lipid Panel
Frequency: Annually
Target: Within normal limits
Action Threshold: Significant adverse changes; consider lipid-lowering therapy or re-evaluation of testosterone therapy.
Liver Function Tests (LFTs)
Frequency: Periodically, especially if symptoms of liver dysfunction occur
Target: Within normal limits
Action Threshold: Elevated LFTs; investigate cause, consider dose adjustment or discontinuation.
Blood Pressure and Weight
Frequency: At each visit
Target: Within normal limits
Action Threshold: Significant increase; investigate for fluid retention or other cardiovascular risks.
Symptom Monitoring
- Signs of fluid retention (edema, weight gain)
- Mood changes (irritability, aggression, depression)
- Sleep apnea (worsening or new onset)
- Breast tenderness or enlargement (gynecomastia)
- Urinary symptoms (difficulty urinating, frequency, urgency)
- Skin changes (acne, oily skin)
- Hair loss (male pattern baldness)
- Signs of liver dysfunction (jaundice, dark urine, persistent nausea/vomiting)
Special Patient Groups
Pregnancy
Testosterone cypionate is contraindicated in pregnant women. It can cause virilization of the female fetus, including clitoral enlargement, abnormal vaginal development, and fusion of the labia.
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 cypionate is not recommended for use in breastfeeding women. It is unknown if testosterone is excreted in human milk, but due to the potential for serious adverse reactions in the infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for serious adverse effects, including virilization, in the breastfed infant.
Pediatric Use
Testosterone cypionate is contraindicated in pediatric patients for growth promotion due to the risk of premature epiphyseal closure and virilization. Safety and efficacy have not been established in pediatric patients.
Geriatric Use
Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostate carcinoma. Close monitoring of PSA and DRE is essential. They may also be at increased risk for cardiovascular events and fluid retention. Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Testosterone cypionate is a long-acting ester, allowing for less frequent intramuscular injections compared to testosterone propionate.
- Always administer IM injections deep into the gluteal muscle to minimize local reactions.
- Patients should be educated on the signs and symptoms of polycythemia (e.g., headache, dizziness, fatigue) and fluid retention.
- Regular monitoring of testosterone levels, Hct, PSA, and lipids is crucial for safe and effective therapy.
- Consider the potential for abuse and diversion, and counsel patients accordingly.
- Patients with a history of prostate cancer or breast cancer are generally contraindicated for testosterone therapy.
Alternative Therapies
- Testosterone enanthate (IM injection)
- Testosterone undecanoate (IM injection or oral)
- Testosterone gels (e.g., AndroGel, Testim, Fortesta)
- Testosterone patches (e.g., Androderm)
- Testosterone buccal system (Striant)
- Testosterone pellets (Testopel)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200+ per 1ml vial (200mg/ml)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization for hypogonadism diagnosis)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.