Testosterone Cyp 200mg/ml Sdv 1ml

Manufacturer PERRIGO Active Ingredient Testosterone Cypionate Injection(tes TOS ter one) Pronunciation tes TOS ter one SIP ee oh nate
It is used to treat low testosterone levels.
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Drug Class
Androgen
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Pharmacologic Class
Androgen; Sex Hormone
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Pregnancy Category
Category X
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FDA Approved
Jul 1951
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DEA Schedule
Schedule III

Overview

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What is this medicine?

Testosterone cypionate is a man-made form of testosterone, a natural male hormone. It is given by injection into a muscle to treat conditions in men where the body does not make enough testosterone (hypogonadism). It helps with male characteristics like muscle mass, bone density, and sexual function.
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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 and syringes 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, away from light and moisture. Keep it in its original container and avoid storing it in a bathroom. Do not freeze the medication.

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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Administer injections exactly as prescribed by your doctor. Do not inject more frequently or in larger amounts than directed.
  • Do not share your medication with others.
  • Report any new or worsening symptoms to your doctor, especially swelling in ankles/feet, difficulty breathing, chest pain, or changes in urination.
  • Maintain a healthy lifestyle, including diet and exercise, as advised by your healthcare provider.
  • Keep all appointments for blood tests and physical exams to monitor your treatment and check for side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: 50-400 mg IM every 2-4 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. Initial dose often 200 mg every 2 weeks or 100 mg weekly.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (contraindicated due to risk of premature epiphyseal closure)
Adolescent: For delayed puberty in males: 50-200 mg IM every 2-4 weeks for 4-6 months. Discontinue if no response or if epiphyseal closure occurs.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution due to potential for fluid retention.
Severe: No specific adjustment recommended, use with caution due to potential for fluid retention.
Dialysis: Considerations: Use with caution; monitor for fluid retention and electrolyte imbalances.

Hepatic Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: Use with caution; monitor liver function tests. May exacerbate hepatic dysfunction.
Severe: Use with caution; monitor liver function tests. May exacerbate hepatic dysfunction.
Confidence: Medium

Pharmacology

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Mechanism of Action

Testosterone is an endogenous androgen. Testosterone cypionate is an ester of testosterone that is slowly released from the injection site. Testosterone and its active metabolite, dihydrotestosterone (DHT), bind to androgen receptors in target tissues (e.g., prostate, seminal vesicles, epididymis, skin, hair follicles, muscle, bone), stimulating 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 (pubic, axillary, chest, beard); laryngeal enlargement; vocal cord thickening; alterations in body musculature; and fat distribution. It also affects erythropoiesis, bone density, and mood.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IM injection)
Tmax: Approximately 3-10 days after IM injection (for testosterone levels)
FoodEffect: Not applicable (IM injection)

Distribution:

Vd: Approximately 1 L/kg
ProteinBinding: Approximately 98% (to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration: Limited (some penetration, but active metabolites like DHT are more potent in CNS)

Elimination:

HalfLife: Approximately 8 days (for the cypionate ester, leading to sustained release)
Clearance: Not readily quantifiable due to sustained release from depot
ExcretionRoute: Primarily renal (approximately 90% as metabolites), fecal (approximately 6%)
Unchanged: <6% (renal)
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Pharmacodynamics

OnsetOfAction: Weeks to months for full therapeutic effect (e.g., muscle mass, libido)
PeakEffect: Peak serum testosterone levels typically occur 3-10 days post-injection, but clinical effects are gradual.
DurationOfAction: Approximately 2-4 weeks (due to slow release from the oil depot)
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

WARNING: ABUSE POTENTIAL. Testosterone cypionate 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 who abuse testosterone may present with symptoms of addiction, including tolerance and drug-seeking behavior. Serious venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), has been reported in patients using testosterone products. Evaluate patients with symptoms of VTE for DVT or PE.
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Side Effects

Serious Side Effects: Seek Medical Help 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 attention 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 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 only minor 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.
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Seek Immediate Medical Attention If You Experience:

  • Swelling of the ankles, feet, or body (fluid retention)
  • Difficulty breathing, especially at night (may indicate sleep apnea or heart issues)
  • Chest pain, shortness of breath, or pain radiating to the arm (signs of heart attack or blood clot)
  • Pain, swelling, or redness in a leg (signs of a blood clot)
  • Yellowing of the skin or eyes, dark urine, or light-colored stools (signs of liver problems)
  • Frequent or difficult urination, changes in urine stream (signs of prostate enlargement)
  • New or worsening acne or oily skin
  • Increased body hair or male pattern baldness
  • Voice deepening
  • Enlargement of breasts (gynecomastia)
  • Mood changes, irritability, aggression, or depression
  • Priapism (prolonged, painful erection)
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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 allergic reaction 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 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 options 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 you determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

Important Warnings and Cautions for Patients Taking This Medication

If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.

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 associated with this medication. Discuss this with your doctor.
If you have an enlarged prostate, your symptoms may worsen while taking this medication. Contact your doctor if you experience any changes.
High blood pressure has been reported in patients taking this medication. Follow your doctor's instructions for regular blood pressure checks.
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, consult your doctor.
If you have sleep apnea, discuss your condition with your doctor, as this medication may worsen sleep apnea in some individuals.

Cardiovascular and Metabolic Risks

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.
Regular blood work and lab tests are crucial to monitor your health while taking this medication.
Inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab tests.

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 cardiovascular issues, stroke, liver damage, and mental or mood disorders. Discuss this with your doctor.

Additional Warnings

High calcium levels have been reported in some patients 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.

Special Considerations

Large doses of this medication may affect sperm production in males and potentially impact fertility. If you have concerns, discuss this with your doctor.
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.
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Overdose Information

Overdose Symptoms:

  • Symptoms of overdose are generally an exaggeration of known side effects, such as severe fluid retention, polycythemia, or mood disturbances (irritability, aggression).
  • There is no specific antidote for testosterone overdose.

What to Do:

Seek immediate medical attention. Management is supportive and symptomatic. Discontinue the medication and monitor vital signs and laboratory parameters (e.g., hematocrit, electrolytes). Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Oral Anticoagulants (e.g., Warfarin): May increase anticoagulant effect, leading to increased risk of bleeding. Mechanism: Decreased clotting factor synthesis and/or increased catabolism of clotting factors. Close INR monitoring required.
  • Corticosteroids: Concomitant use may increase the risk of edema, especially in patients with cardiac, renal, or hepatic disease. Mechanism: Additive fluid retention.
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Moderate Interactions

  • Insulin and Oral Hypoglycemics: May decrease blood glucose levels and insulin requirements in diabetic patients. Mechanism: Testosterone may improve insulin sensitivity. Monitor blood glucose.
  • Cyclosporine: May increase cyclosporine levels. Mechanism: Unclear, possibly affecting metabolism or excretion. Monitor cyclosporine levels.
  • Thyroid Hormones: May decrease serum concentrations of thyroxine-binding globulin, resulting in decreased total T4 levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged. Clinical significance is usually minimal, but monitor thyroid function if symptoms arise.

Monitoring

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Baseline Monitoring

Serum Testosterone (Total and Free)

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

Timing: Prior to initiation of therapy (preferably morning samples, two separate measurements)

Hematocrit (Hct) and Hemoglobin (Hb)

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 in men >40 years old or with risk factors.

Timing: Prior to initiation of therapy

Digital Rectal Exam (DRE)

Rationale: To screen for prostate abnormalities in men >40 years old or with risk factors.

Timing: Prior to initiation of therapy

Lipid Profile

Rationale: Testosterone therapy may affect lipid levels.

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

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Routine Monitoring

Serum Testosterone (Total)

Frequency: 3-6 months after initiation, then annually or as clinically indicated. Sample drawn midway between injections.

Target: Trough levels in the mid-normal range (e.g., 300-1000 ng/dL)

Action Threshold: If consistently above normal range, reduce dose or frequency. If consistently below normal range, increase dose or frequency.

Hematocrit (Hct)

Frequency: 3-6 months after initiation, then annually. More frequently if Hct is rising.

Target: <54%

Action Threshold: If Hct >54%, temporarily discontinue therapy until Hct decreases, then restart at a lower dose or consider phlebotomy.

Prostate-Specific Antigen (PSA) and Digital Rectal Exam (DRE)

Frequency: Annually in men >40 years old or with risk factors for prostate cancer. More frequently if abnormalities detected.

Target: Age-specific normal ranges for PSA; no palpable abnormalities on DRE.

Action Threshold: Significant increase in PSA or abnormal DRE warrants urological evaluation.

Lipid Profile

Frequency: Annually

Target: Normal ranges for LDL, HDL, triglycerides

Action Threshold: Significant adverse changes may require dose adjustment or lipid-lowering therapy.

Liver Function Tests (LFTs)

Frequency: Periodically, especially in patients with pre-existing hepatic impairment or symptoms of liver dysfunction.

Target: Normal ranges

Action Threshold: Significant elevations warrant investigation and potential discontinuation.

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Symptom Monitoring

  • Signs of virilization (e.g., acne, hirsutism, voice deepening, clitoral enlargement in females)
  • Fluid retention (e.g., edema, weight gain)
  • Symptoms of benign prostatic hyperplasia (BPH) (e.g., urinary frequency, urgency, nocturia, decreased stream)
  • Breast tenderness or gynecomastia
  • Mood changes, irritability, aggression
  • Sleep apnea (new onset or worsening)
  • Signs of venous thromboembolism (e.g., leg pain, swelling, shortness of breath, chest pain)
  • Cardiovascular symptoms (e.g., chest pain, shortness of breath, signs of heart failure)
  • Injection site reactions (pain, swelling, redness)

Special Patient Groups

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Pregnancy

Contraindicated in pregnant women. Testosterone can cause virilization of the female fetus, including clitoral enlargement, abnormal vaginal development, and fusion of the labia. There is insufficient data on the risk of major birth defects or miscarriage.

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.
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Lactation

Contraindicated in breastfeeding women. It is unknown if testosterone is excreted in human milk. However, due to the potential for serious adverse reactions in the breastfed infant, including virilization, and the potential for adverse effects on milk production, testosterone cypionate is contraindicated during lactation.

Infant Risk: L5 (Contraindicated - high risk of adverse effects to infant)
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Pediatric Use

Contraindicated in children due to the risk of premature epiphyseal closure (stunting growth) and precocious puberty. Use in adolescent males for delayed puberty should be carefully considered and monitored due to the risk of accelerated bone maturation and virilization.

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Geriatric Use

Use with caution in elderly males. They may be at increased risk for developing benign prostatic hyperplasia (BPH) and prostate cancer. Increased monitoring for prostate-related adverse events, cardiovascular events, and fluid retention is recommended.

Clinical Information

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Clinical Pearls

  • Testosterone cypionate is a long-acting ester, providing stable testosterone levels over 2-4 weeks, making it a convenient option for IM administration.
  • Always confirm hypogonadism with at least two morning serum testosterone measurements before initiating therapy.
  • Monitor hematocrit closely, as polycythemia is a common dose-limiting side effect. If Hct >54%, consider dose reduction or temporary discontinuation.
  • Regular prostate monitoring (PSA and DRE) is crucial in men over 40 or with risk factors, as testosterone therapy may accelerate growth of pre-existing prostate cancer.
  • Educate patients about the signs of fluid retention, cardiovascular events, and venous thromboembolism, as these are serious potential side effects.
  • Testosterone is a Schedule III controlled substance due to its potential for abuse, particularly by athletes and bodybuilders. Prescribe and store with appropriate caution.
  • Counsel patients that clinical effects (e.g., libido, energy, muscle mass) may take several weeks to months to become apparent.
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Alternative Therapies

  • Other injectable testosterone esters (e.g., Testosterone Enanthate, Testosterone Undecanoate)
  • Transdermal testosterone gels/solutions (e.g., AndroGel, Testim, Fortesta, Axiron)
  • Transdermal testosterone patches (e.g., Androderm)
  • Testosterone buccal system (Striant)
  • Testosterone nasal gel (Natesto)
  • Testosterone subcutaneous pellets (Testopel)
  • Oral testosterone undecanoate (Jatenzo, Kyzatrex, Tlando)
  • Gonadotropin-releasing hormone (GnRH) agonists/antagonists (for central hypogonadism, though not direct testosterone replacement)
  • Human Chorionic Gonadotropin (hCG) (stimulates endogenous testosterone production)
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Cost & Coverage

Average Cost: $50 - $200 per 1ml vial (200mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.