Depo-Testosterone 200mg/ml Mdv 10ml

Manufacturer PFIZER Active Ingredient Testosterone Cypionate Injection(tes TOS ter one) Pronunciation tes-TOS-ter-own SIP-ee-oh-nate
It is used to treat low testosterone levels.
đŸˇī¸
Drug Class
Androgen
đŸ§Ŧ
Pharmacologic Class
Androgen receptor agonist
🤰
Pregnancy Category
Category X
✅
FDA Approved
Jul 1953
âš–ī¸
DEA Schedule
Schedule III

Overview

â„šī¸

What is this medicine?

Depo-Testosterone is a medication that contains testosterone, a natural male hormone. It is given as an injection into a muscle, usually every 2 to 4 weeks. It's used to treat men who have low testosterone levels (hypogonadism) due to certain medical conditions. It helps restore normal testosterone levels, which can improve symptoms like low energy, low sex drive, and muscle weakness.
📋

How to Use This Medicine

Taking Your 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're unsure, consult your doctor.

Important Administration Guidelines

Do not inject into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Check the solution before use; do not use if it appears cloudy, is leaking, or contains particles. The solution should be colorless to a faint yellow; if the color changes, do not use it.

Disposal and Storage

Dispose of used needles in a designated needle/sharp disposal box. Never reuse needles or other items. When the box is full, follow local regulations for disposal. If you have questions, consult your doctor or pharmacist.
Store the medication at room temperature, away from light, and in a dry place. Do not store it in the bathroom or freeze it. Keep the medication in its original container.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's 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

  • Maintain a healthy diet and regular exercise routine to support overall health and muscle mass.
  • Report any new or worsening symptoms, especially swelling in legs, chest pain, or difficulty breathing, immediately.
  • Do not share this medication with others, as it is a controlled substance and can be harmful if misused.
  • Keep all appointments for blood tests and doctor visits to monitor your treatment and check for side effects.

Dosing & Administration

đŸ‘¨â€âš•ī¸

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.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (use generally contraindicated due to risk of premature epiphyseal closure)
Adolescent: Limited use in specific cases of delayed puberty, under strict medical supervision, typically 50-200 mg IM every 2-4 weeks for a limited duration. Close monitoring of bone age is essential.
âš•ī¸

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: Considerations: Use with caution, monitor for fluid retention and electrolyte imbalances. No specific dose adjustment guidelines.

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: Use with caution; may exacerbate fluid retention and liver dysfunction. No specific dose adjustment guidelines.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Testosterone is an endogenous androgen. Testosterone cypionate is an ester of testosterone, which is converted to testosterone in the body. Testosterone acts by binding to androgen receptors in target tissues, where it promotes the development and maintenance of male primary and secondary sexual characteristics. It also has anabolic effects, promoting protein synthesis and bone growth.
📊

Pharmacokinetics

Absorption:

Bioavailability: 100% (after IM injection, as the ester is fully hydrolyzed to testosterone)
Tmax: Approximately 6-9 days (for testosterone cypionate after IM injection)
FoodEffect: Not applicable (IM injection)

Distribution:

Vd: Approximately 1 L/kg (for testosterone)
ProteinBinding: Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration: Yes (testosterone can cross the blood-brain barrier)

Elimination:

HalfLife: Approximately 8 days (for testosterone cypionate ester)
Clearance: Approximately 13.2 mL/min/kg (for testosterone)
ExcretionRoute: Urine (approximately 90%), Feces (approximately 10%)
Unchanged: Less than 6% (of testosterone excreted unchanged in urine)
âąī¸

Pharmacodynamics

OnsetOfAction: Gradual (effects typically seen over weeks to months)
PeakEffect: Weeks to months (for full therapeutic effect)
DurationOfAction: Approximately 2-4 weeks (due to slow release from the cypionate ester)

Safety & Warnings

âš ī¸

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 immediately. Cardiovascular Risk: An increased risk of major adverse cardiovascular events (MACE) including myocardial infarction, stroke, and cardiovascular death, has been reported in some studies with testosterone use. Consider patient's cardiovascular risk factors before initiating therapy. Abuse Potential: Testosterone cypionate is a Schedule III controlled substance. Abuse of testosterone, alone or in combination with other anabolic androgenic steroids, is associated with serious cardiovascular and psychiatric adverse reactions.
âš ī¸

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 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 experience 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 of ankles, feet, or hands (fluid retention)
  • Difficulty breathing, especially at night (sleep apnea)
  • Chest pain, shortness of breath, or pain radiating to arm/jaw (signs of heart attack)
  • Sudden weakness or numbness on one side of the body, sudden severe headache, vision changes (signs of stroke)
  • Pain, swelling, or redness in a leg (signs of deep vein thrombosis)
  • Yellowing of skin or eyes (jaundice), dark urine, severe stomach pain (signs of liver problems)
  • Frequent or difficult urination, changes in urine stream (prostate issues)
  • Unusual hair growth or acne (in women or children exposed to the medication)
  • Mood changes, aggression, or irritability
📋

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 a female who is pregnant, plans to become pregnant, or is breastfeeding. This medication is not approved for use in pregnant or breastfeeding women, so it is crucial to discuss this with your doctor.

Additionally, this medication may interact with other medications or health conditions. Therefore, it is vital to:

Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor to ensure it is safe to take this medication.
* Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
âš ī¸

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.

Diabetes Management
If you have high blood sugar (diabetes), you will need to closely monitor your blood sugar levels while taking this medication.

Prostate Cancer Risk
There may be an increased risk of prostate cancer associated with this medication. Discuss this risk with your doctor.

Enlarged Prostate
If you have an enlarged prostate, your symptoms may worsen while taking this medication. Contact your doctor if you experience any changes.

Blood Pressure Monitoring
High blood pressure has been reported in patients taking this medication. Have your blood pressure checked regularly as advised by your doctor. Elevated blood pressure can increase the risk of heart attack, stroke, or death from heart disease. If you have high blood pressure or heart disease, discuss this with your doctor.

Sleep Apnea
If you have sleep apnea, consult with your doctor, as this medication may worsen sleep apnea in some individuals.

Cholesterol and Triglyceride Levels
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood. Discuss this with your doctor.

Lab Tests and Monitoring
Regularly have your blood work and other lab tests checked as directed by your doctor. This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this medication.

Blood Clots
Blood clots have been reported in patients taking this medication. If you have a history of blood clots, inform your doctor.

Anabolic Steroid Abuse
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 problems, stroke, liver problems, and mental or mood disorders. Discuss the risks with your doctor.

High Calcium Levels
In some individuals with cancer, high calcium levels have been reported with medications like this one. Seek medical attention immediately if you experience symptoms of high calcium levels, such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.

Elderly Patients
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Low Testosterone Treatment
This medication is not approved for treating low testosterone levels caused by aging. Discuss this with your doctor.

Male Fertility
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 teens, and 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. Overdose symptoms are usually managed by discontinuing the medication and providing supportive care. Call 1-800-222-1222 for poison control.

Drug Interactions

🔴

Major Interactions

  • Oral anticoagulants (e.g., warfarin): May increase anticoagulant effect, leading to increased risk of bleeding. Requires close INR monitoring and dose adjustment of anticoagulant.
  • Corticosteroids: Concomitant use may increase the risk of fluid retention and edema, especially in patients with cardiac, hepatic, or renal disease.
🟡

Moderate Interactions

  • Insulin and oral hypoglycemic agents: Testosterone may improve glucose tolerance and decrease insulin requirements in diabetic patients. Monitor blood glucose and adjust antidiabetic medication dose.
  • Adrenocorticotropic hormone (ACTH): Similar to corticosteroids, may increase fluid retention.
đŸŸĸ

Minor Interactions

  • Thyroid hormones: May decrease serum concentrations of thyroxine-binding globulin, leading to decreased total T4 levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Serum Testosterone (total and free)

Rationale: To confirm diagnosis of hypogonadism and establish baseline levels.

Timing: Prior to initiation of therapy

Hematocrit (Hct) and Hemoglobin (Hgb)

Rationale: Testosterone can stimulate erythropoiesis, leading to polycythemia.

Timing: Prior to initiation of therapy

Prostate-Specific Antigen (PSA)

Rationale: To screen for prostate cancer and benign prostatic hyperplasia (BPH), as testosterone can stimulate prostate growth.

Timing: Prior to initiation of therapy (in men â‰Ĩ40 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, though IM testosterone is less hepatotoxic than oral forms.

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Serum Testosterone (total)

Frequency: 3-6 months after initiation, then annually or as clinically indicated

Target: Trough levels (just before next dose) should be in the mid-normal range (e.g., 300-1000 ng/dL)

Action Threshold: If levels are consistently above or below target range, adjust dose or frequency.

Hematocrit (Hct)

Frequency: 3-6 months after initiation, then annually

Target: <54%

Action Threshold: If Hct >54%, reduce dose, discontinue therapy temporarily, or consider phlebotomy.

Prostate-Specific Antigen (PSA)

Frequency: 3-6 months after initiation, then annually (in men â‰Ĩ40 years old or with risk factors)

Target: Stable or within normal limits for age

Action Threshold: Significant increase from baseline or age-specific normal range, or abnormal digital rectal exam (DRE), warrants urological evaluation.

Lipid Panel

Frequency: Annually

Target: Within normal limits

Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.

Bone Mineral Density (BMD)

Frequency: Periodically, especially in men with osteoporosis at baseline

Target: Improvement or stabilization

Action Threshold: Not applicable for dose adjustment, but for overall management.

đŸ‘ī¸

Symptom Monitoring

  • Signs of virilization (e.g., acne, hirsutism, voice deepening, clitoromegaly in females)
  • Fluid retention (e.g., edema, weight gain)
  • Mood changes (e.g., irritability, aggression)
  • Sleep apnea (new onset or worsening)
  • Breast tenderness or gynecomastia
  • Urinary symptoms (e.g., frequency, urgency, difficulty urinating)
  • Signs of cardiovascular events (e.g., chest pain, shortness of breath, leg swelling)
  • Signs of venous thromboembolism (e.g., pain, swelling, warmth in leg)

Special Patient Groups

🤰

Pregnancy

Contraindicated in pregnant women. Testosterone can cause virilization of the female fetus.

Trimester-Specific Risks:

First Trimester: High risk of virilization of female fetus (e.g., clitoral enlargement, abnormal external genitalia).
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, including virilization, 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 (e.g., acne, hirsutism, clitoromegaly) and potential for other serious adverse effects.
đŸ‘ļ

Pediatric Use

Generally not recommended for use in pediatric patients due to the risk of premature epiphyseal closure (stunting growth) and accelerated sexual development. If used for specific indications (e.g., delayed puberty), close monitoring of bone age and growth is essential. Contraindicated in infants and young children.

👴

Geriatric Use

Use with caution in elderly men. Increased risk of benign prostatic hyperplasia (BPH) and prostate cancer. Higher incidence of cardiovascular events and fluid retention. Close monitoring of PSA, Hct, and cardiovascular status is crucial.

Clinical Information

💎

Clinical Pearls

  • Testosterone cypionate is a long-acting ester, allowing for less frequent injections compared to testosterone propionate.
  • Always administer intramuscularly (IM) into the gluteal muscle. Do not administer intravenously.
  • 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, and PSA is critical for safe and effective therapy.
  • Counsel patients on the potential for mood changes, including irritability and aggression, and the importance of reporting these.
  • Due to its Schedule III classification, proper storage and handling are required to prevent diversion and abuse.
🔄

Alternative Therapies

  • Testosterone enanthate (IM injection)
  • Testosterone undecanoate (IM injection or oral capsule)
  • Testosterone gels (e.g., AndroGel, Testim, Fortesta)
  • Testosterone patches (e.g., Androderm)
  • Testosterone buccal system (Striant)
  • Testosterone pellets (Testopel)
  • Human Chorionic Gonadotropin (hCG) (for secondary hypogonadism, to stimulate endogenous testosterone production)
  • Clomiphene citrate (off-label for secondary hypogonadism, to stimulate endogenous testosterone production)
💰

Cost & Coverage

Average Cost: $50 - $200 per 10ml vial (200mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand), Tier 1 (for generic)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. 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 this 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, including the amount taken and the time it happened, to ensure you receive the best possible care.