Testosterone Cyp 100mg/ml Mdv 10ml

Manufacturer EUGIA US LLC 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 receptor agonist
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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's given by injection to replace testosterone in men who don't produce enough of it naturally. It helps with symptoms like low energy, low sex drive, and loss of muscle mass.
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How to Use This Medicine

Proper Administration of This Medication

To ensure safe and effective use, follow your doctor's instructions carefully. Read all accompanying information and adhere to the guidelines provided. This medication is administered via injection into a muscle. If you will be self-administering the injection, your doctor or nurse will provide personalized instruction on the proper technique.

Before administering the injection, wash your hands thoroughly. It is essential to identify the correct injection site. 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 administer 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 the medication.

After use, dispose of needles and syringes in a designated needle/sharp disposal box. Never reuse needles or other equipment. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult with your doctor or pharmacist.

Storage and Disposal

Store this medication at room temperature, avoiding freezing. Keep it in the original container, protected from light, and in a dry location. Do not store in a bathroom.

Missed Dose Instructions

If you miss a dose, administer it as soon as you remember. However, if the missed dose is near the time of 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

  • Maintain a healthy diet and regular exercise routine.
  • Report any new or worsening symptoms to your doctor promptly.
  • Do not share this medication with others.
  • Keep all appointments for blood tests and follow-up visits.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypogonadism: 50-400 mg IM every 2-4 weeks
Dose Range: 50 - 400 mg

Condition-Specific Dosing:

Male Hypogonadism: 50-400 mg IM every 2-4 weeks, adjusted based on clinical response and serum testosterone levels.
Delayed Puberty (Male): 50-200 mg IM every 2-4 weeks for a limited duration (e.g., 4-6 months).
Metastatic Breast Cancer (Female): 200-400 mg IM every 2-4 weeks (palliative use, rarely used now).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for routine use; see 'Delayed Puberty (Male)' under adult conditions for specific cases.
Adolescent: See 'Delayed Puberty (Male)' under adult conditions.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, monitor for fluid retention.
Moderate: No specific dose adjustment recommended, monitor for fluid retention.
Severe: Use with caution; monitor for fluid retention and electrolyte disturbances. Not well studied.
Dialysis: Not well studied; use with caution and close monitoring.

Hepatic Impairment:

Mild: Use with caution; monitor liver function tests.
Moderate: Use with caution; monitor liver function tests. May exacerbate hepatic dysfunction.
Severe: Contraindicated in severe hepatic impairment due to potential for cholestatic hepatitis and liver tumors.

Pharmacology

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Mechanism of Action

Testosterone cypionate is an ester of testosterone, a naturally occurring androgen. It is converted to testosterone in vivo. Testosterone acts by binding to androgen receptors in target tissues (e.g., prostate, seminal vesicles, epididymis, skeletal muscle, bone, kidney, liver, central nervous system, skin, hair follicles). This binding leads to gene transcription and protein synthesis, promoting 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, beard, chest); laryngeal enlargement; vocal cord thickening; alterations in body musculature; and fat distribution. It also affects erythropoiesis, bone density, and lipid metabolism.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (IM injection, 100% bioavailability from injection site)
Tmax: Approximately 6-8 hours (for testosterone after hydrolysis of ester)
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: Limited (testosterone can cross the blood-brain barrier, but cypionate ester does not)

Elimination:

HalfLife: Approximately 8 days (for testosterone cypionate ester, due to slow release from oil depot); 10-100 minutes (for testosterone itself)
Clearance: Approximately 13.1 mL/min/kg (for testosterone)
ExcretionRoute: Approximately 90% renal (as metabolites), 6% fecal (as metabolites)
Unchanged: Less than 1% (of testosterone)
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Pharmacodynamics

OnsetOfAction: Weeks to months for full therapeutic effect (e.g., muscle mass, libido, mood)
PeakEffect: Variable, depends on dosing interval and individual response; peak serum testosterone levels typically occur within 24-48 hours post-injection, but clinical effects are cumulative.
DurationOfAction: Approximately 2-4 weeks (due to slow release from oil depot)
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

Testosterone cypionate injection is indicated for replacement therapy in males with conditions associated with symptoms of deficiency or absence of endogenous testosterone. Androgens, including testosterone cypionate, may increase the risk of cardiovascular events and venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients should be informed of this potential risk. Abuse of testosterone, alone or with other anabolic androgenic steroids, is associated with serious adverse reactions, including cardiovascular and psychiatric events. If abuse is suspected, check for signs of abuse and dependence.
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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. 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
+ 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 while sleeping
Excessive daytime sleepiness
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Changes in skin color
Changes in testicle size or shape
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Trouble speaking or swallowing
Liver problems, which can be life-threatening. Seek medical attention immediately if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Headache
Acne
Diarrhea
Emotional changes
Fatigue or weakness
Sleep disturbances
* Irritation at the application site

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 in ankles, feet, or hands (fluid retention)
  • Difficulty breathing, especially at night or with exertion
  • 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, slurred speech (signs of stroke)
  • Pain, swelling, or redness in a leg (signs of blood clot)
  • Yellowing of skin or eyes, dark urine, severe stomach pain (signs of liver problems)
  • Frequent or difficult urination, changes in urine stream (signs of prostate issues)
  • Mood changes, aggression, or depression
  • Unexplained weight gain or rapid weight gain
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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, 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 pregnant, plan to become pregnant, or are breastfeeding. This medication is not approved for use in these situations, so it is crucial to discuss your options 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 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 avoid potential interactions or complications.
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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 in your symptoms.

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, consult with your doctor.

Sleep Apnea
If you have sleep apnea, discuss your condition with your doctor, as this medication may worsen sleep apnea in some cases.

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 your lipid profiles with your doctor.

Laboratory Tests
Regularly have your blood work and other laboratory tests checked as directed by your doctor. Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain laboratory test results.

Blood Clots
Blood clots have been reported in patients taking this medication. If you have a history of blood clots, inform your doctor and discuss the risks associated with this medication.

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

High Calcium Levels
In some cases, medications like this one have caused high calcium levels in patients with cancer. If you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, contact your doctor immediately.

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

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

Male Fertility
High doses of this medication may affect sperm production in males and potentially impact fertility. If you have concerns, discuss them with your doctor.

Pediatric Use
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, and regular growth checks may be necessary. Consult with your doctor.
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Overdose Information

Overdose Symptoms:

  • Fluid retention (edema)
  • Polycythemia (excess red blood cells, leading to symptoms like headache, dizziness, fatigue)
  • Mood disturbances (irritability, aggression)
  • Priapism (prolonged, painful erection)
  • Gastrointestinal disturbances (nausea, vomiting)

What to Do:

There is no specific antidote for testosterone overdose. Treatment is symptomatic and supportive. Discontinue the medication and manage symptoms. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Major Interactions

  • Anticoagulants (e.g., Warfarin): Increased risk of bleeding due to enhanced anticoagulant effect.
  • Corticosteroids: Increased risk of fluid retention and edema.
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Moderate Interactions

  • Insulin and Oral Hypoglycemics: May decrease blood glucose, requiring dose adjustment of antidiabetic agents.
  • 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.
  • Cyclosporine: Potential for increased cyclosporine levels.

Monitoring

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Baseline Monitoring

Serum Testosterone (total and free)

Rationale: To confirm diagnosis of hypogonadism and establish baseline for treatment efficacy.

Timing: Prior to initiation of therapy

Hematocrit (Hct) and Hemoglobin (Hb)

Rationale: To assess for polycythemia, a common side effect.

Timing: Prior to initiation of therapy

Prostate-Specific Antigen (PSA)

Rationale: To screen for prostate cancer, as testosterone can stimulate prostate growth.

Timing: Prior to initiation of therapy (in males over 40 or with risk factors)

Lipid Panel (Total Cholesterol, HDL, LDL, Triglycerides)

Rationale: Testosterone can affect lipid profiles.

Timing: Prior to initiation of therapy

Liver Function Tests (LFTs)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver conditions.

Timing: Prior to initiation of therapy

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Routine Monitoring

Serum Testosterone (total and free)

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

Target: Generally mid-normal range (e.g., 300-1000 ng/dL), measured midway between injections.

Action Threshold: Levels consistently above target range may require dose reduction; levels consistently below target range may require dose increase.

Hematocrit (Hct) and Hemoglobin (Hb)

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

Target: Hct < 54%

Action Threshold: If Hct > 54%, consider dose reduction, temporary cessation, or phlebotomy.

Prostate-Specific Antigen (PSA)

Frequency: 3-6 months after initiation, then annually (in males over 40 or with risk factors)

Target: Age-dependent, typically < 4 ng/mL

Action Threshold: Significant increase from baseline or abnormal values warrant further urological evaluation.

Digital Rectal Exam (DRE)

Frequency: Annually (in males over 40 or with risk factors)

Target: Normal prostate exam

Action Threshold: Abnormal findings warrant further urological evaluation.

Lipid Panel

Frequency: Annually or as clinically indicated

Target: Within normal limits for cardiovascular risk

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

Blood Pressure

Frequency: Regularly

Target: Normal limits

Action Threshold: Monitor for hypertension, especially with fluid retention.

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Symptom Monitoring

  • Fluid retention (edema, weight gain)
  • Mood changes (irritability, aggression, depression)
  • Sleep apnea (worsening or new onset)
  • Urinary symptoms (difficulty urinating, increased frequency, nocturia)
  • Breast tenderness or enlargement (gynecomastia)
  • Skin changes (acne, oily skin)
  • Hair loss (male pattern baldness)
  • Signs of deep vein thrombosis (DVT) or pulmonary embolism (PE) (e.g., leg pain/swelling, shortness of breath, chest pain)
  • Signs of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of body, slurred speech)

Special Patient Groups

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Pregnancy

Contraindicated in pregnant women. Testosterone can cause virilization of the female fetus (e.g., clitoral enlargement, abnormal vaginal development).

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. Testosterone is excreted in breast milk and can cause serious adverse reactions in the nursing infant, including virilization.

Infant Risk: High risk of virilization (e.g., clitoral enlargement, hirsutism) and potential for other endocrine disruptions in the infant.
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Pediatric Use

Not indicated for use in children for general purposes. Use in adolescent males for delayed puberty should be carefully considered and monitored due to potential for premature epiphyseal closure (stunting growth) and accelerated sexual development. Not for use in female pediatric patients.

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Geriatric Use

Older males may be at increased risk for prostate enlargement (BPH) and prostate cancer. 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 appropriate.

Clinical Information

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Clinical Pearls

  • Testosterone cypionate is a long-acting ester, allowing for less frequent injections compared to testosterone propionate.
  • Injections should be given deep into the gluteal muscle to minimize local reactions.
  • Patients should be educated on the signs and symptoms of polycythemia, fluid retention, and potential cardiovascular/thromboembolic events.
  • Regular monitoring of testosterone levels, Hct, and PSA is crucial for safe and effective therapy.
  • Testosterone therapy is not recommended for age-related decline in testosterone without clear symptoms of hypogonadism and confirmed low testosterone levels.
  • Counsel patients on the potential for abuse and the serious adverse effects associated with supraphysiologic doses.
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Alternative Therapies

  • Testosterone enanthate (another long-acting injectable ester)
  • Testosterone undecanoate (oral, injectable)
  • Testosterone gels (e.g., AndroGel, Testim, Fortesta)
  • Testosterone patches (e.g., Androderm)
  • Testosterone buccal system (Striant)
  • Testosterone pellets (Testopel)
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Cost & Coverage

Average Cost: Varies widely, typically $50-$200 per 10ml vial (100mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic), Tier 3 (Brand)
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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 overdose, including the medication taken, the amount, and the time it occurred.