Testosterone Cyp 200mg/ml Mdv 10ml

Manufacturer HIKMA /WEST-WARD 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 1979
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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, the main male hormone. It's given as an injection into a muscle to treat conditions in men where the body doesn't make enough natural testosterone (low T). It helps restore normal testosterone levels, which can improve symptoms like low energy, low sex drive, and muscle weakness.
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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. 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 use if it appears cloudy, is 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 in a dry place. Do not freeze. Keep the medication in its original container and avoid storing 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 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 to support overall health and muscle mass.
  • Report any significant mood changes, aggression, or irritability to your doctor.
  • Discuss any concerns about fertility, as testosterone therapy can suppress sperm production.
  • Avoid sharing needles or vials.
  • Store medication at room temperature, away from light and moisture.

Dosing & Administration

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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 intramuscularly every 2 to 4 weeks, adjusted based on clinical response and serum testosterone levels. Initial dose often 50-200 mg every 2-4 weeks.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: For delayed puberty in males: 50 to 200 mg intramuscularly every 2 to 4 weeks for a limited duration (e.g., 4-6 months). Use with caution and only when benefits outweigh risks.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but monitor for fluid retention.
Moderate: No specific dose adjustment recommended, but monitor for fluid retention.
Severe: Use with caution; monitor for fluid retention and potential exacerbation of renal issues. No specific dose adjustment guidelines.
Dialysis: Not available

Hepatic Impairment:

Mild: Use with caution; monitor liver function tests.
Moderate: Use with caution; monitor liver function tests. May require dose reduction or discontinuation if liver function deteriorates.
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 the androgen testosterone. Testosterone is the primary endogenous androgen, responsible for the development and maintenance of male primary and secondary sexual characteristics. It acts by binding to androgen receptors in target tissues, leading to gene transcription and protein synthesis, mediating its anabolic and androgenic effects.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (after IM administration, as it bypasses first-pass metabolism)
Tmax: Approximately 6-9 days (for testosterone levels after IM injection of cypionate)
FoodEffect: Not applicable (IM administration)

Distribution:

Vd: Approximately 1 L/kg
ProteinBinding: Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration: Limited (some penetration, but active transport mechanisms exist)

Elimination:

HalfLife: Approximately 8 days (for testosterone cypionate ester release from depot); terminal half-life of testosterone itself is much shorter (10-100 minutes)
Clearance: Approximately 10 mL/min/kg
ExcretionRoute: Mainly urine (90%, as conjugates of testosterone and its metabolites), feces (6%)
Unchanged: <6% (of testosterone in urine)
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Pharmacodynamics

OnsetOfAction: Gradual, over several days to weeks, as testosterone is slowly released from the ester.
PeakEffect: Peak serum testosterone levels typically occur 6-9 days after a single IM injection.
DurationOfAction: Approximately 2-4 weeks (due to slow release from the cypionate ester depot)

Safety & Warnings

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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. If a VTE is suspected, discontinue testosterone therapy and initiate appropriate workup and management. Cardiovascular Risk: An increased risk of major adverse cardiovascular events (MACE) including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death has been reported in some studies with testosterone use. Secondary Exposure: Virilization in children and women has been reported following secondary exposure to testosterone gel. Patients should be advised to strictly adhere to recommended instructions for use and to ensure that the application site is covered to prevent secondary exposure.
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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
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
Skin color changes
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

Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Headache
Acne
Diarrhea
Mood swings
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 in ankles, feet, or hands (fluid retention)
  • Difficulty breathing, especially during sleep (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 DVT)
  • Sudden chest pain, cough, or shortness of breath (signs of PE)
  • Yellowing of skin or eyes, dark urine, severe nausea/vomiting (signs of liver problems)
  • Frequent or difficult urination, changes in urine stream (signs of prostate issues)
  • Breast tenderness or enlargement
  • Unexplained 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. Be sure to describe the allergic reaction you experienced.
If you are a male with breast or prostate cancer.
If you have a history of certain health conditions, including heart disease, kidney disease, or liver disease.
If you are a female who is pregnant, plans to become pregnant, or is breastfeeding. Please note that this medication is not approved for use in pregnant or breastfeeding women. If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential risks and benefits.

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

Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter medications, natural products, and vitamins.
Discuss your health problems with your doctor to ensure it is safe to take this medication.
* Do not start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
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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, 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
Regular blood work and other lab tests are crucial while taking this medication. Follow your doctor's instructions for lab test scheduling.

Interference with Lab Tests
This medication may affect certain lab test results. 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 this risk with your doctor.

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

Special Considerations for Older Adults
If you are 65 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 this 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 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.
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Overdose Information

Overdose Symptoms:

  • Priapism (prolonged, painful erection)
  • Exaggerated androgenic effects (e.g., severe acne, increased body hair)
  • Fluid retention
  • Irritability or aggression

What to Do:

Seek immediate medical attention. Management is supportive, often involving discontinuation of the drug and symptomatic treatment. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Anticoagulants (e.g., warfarin): May increase anticoagulant effects, leading to increased bleeding risk.
  • Corticosteroids (e.g., prednisone): Concomitant use may increase fluid retention and edema.
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Moderate Interactions

  • Insulin and oral hypoglycemics: Testosterone may decrease blood glucose, requiring adjustment of antidiabetic medication.
  • Thyroid hormones: May decrease levels of thyroid-binding globulin, leading to increased free thyroid hormone levels (clinical significance usually minimal).
  • Immunosuppressants (e.g., cyclosporine): Potential for increased cyclosporine levels.
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Minor Interactions

  • Diuretics: May enhance fluid retention when used with testosterone.

Monitoring

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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: To assess for polycythemia, a common side effect.

Timing: Before initiation of therapy

Prostate-Specific Antigen (PSA)

Rationale: To screen for prostate cancer and benign prostatic hyperplasia (BPH) before initiating therapy in men over 40.

Timing: Before initiation of therapy

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

Rationale: Testosterone therapy can 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

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Routine Monitoring

Serum Testosterone (total)

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

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

Action Threshold: Levels consistently above or below target range may require dose adjustment.

Hematocrit (Hct)

Frequency: 3-6 months after initiation, then annually

Target: <54%

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

Prostate-Specific Antigen (PSA)

Frequency: 3-6 months after initiation, then annually (for men >40 years)

Target: Stable or within normal limits for age.

Action Threshold: Significant increase in PSA (>1.4 ng/mL from baseline or >4 ng/mL total) or abnormal digital rectal exam (DRE) warrants urological evaluation.

Lipid Panel

Frequency: Annually

Target: Within normal limits; monitor for adverse changes.

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

Liver Function Tests (LFTs)

Frequency: Periodically, especially if symptoms of liver dysfunction occur or in patients with pre-existing liver conditions.

Target: Within normal limits.

Action Threshold: Elevated LFTs may require dose adjustment or discontinuation.

Bone Mineral Density (BMD)

Frequency: Baseline and periodically (e.g., every 1-2 years) for patients with osteoporosis or at high risk.

Target: Stable or improving.

Action Threshold: Significant decline may require further evaluation.

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Symptom Monitoring

  • Signs of fluid retention (edema, weight gain)
  • Changes in mood or behavior (irritability, aggression, depression)
  • Sleep apnea (worsening or new onset)
  • Breast tenderness or enlargement (gynecomastia)
  • Skin changes (acne, oily skin)
  • Urinary symptoms (difficulty urinating, frequency, urgency) - indicative of BPH progression
  • Signs of liver dysfunction (jaundice, dark urine, persistent nausea/vomiting)
  • Symptoms of deep vein thrombosis (DVT) or pulmonary embolism (PE) (leg pain/swelling, chest pain, shortness of breath)
  • Symptoms of cardiovascular events (chest pain, shortness of breath, weakness on one side of body)

Special Patient Groups

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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.
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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 infant, 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: L5 (Contraindicated - significant documented hazard to infant)
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Pediatric Use

Safety and efficacy not established in children under 12 years of age. Use in adolescents for delayed puberty should be done with extreme caution and only when clearly indicated, due to potential for premature epiphyseal closure and virilization. Bone age should be monitored.

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Geriatric Use

Older men may be at increased risk for prostate enlargement and prostate cancer. Increased monitoring for prostate-related adverse events and cardiovascular events is recommended. Lower starting doses and slower titration may be considered.

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 common choice for replacement therapy.
  • Always administer intramuscularly (IM) into a large muscle (e.g., gluteal muscle, thigh). Do not administer intravenously.
  • Patients should be educated on the signs and symptoms of polycythemia, fluid retention, and potential cardiovascular events.
  • Regular monitoring of hematocrit is crucial due to the risk of polycythemia, which can increase the risk of thrombotic events.
  • PSA and DRE monitoring are essential in older men to screen for prostate cancer and BPH.
  • Testosterone therapy can suppress spermatogenesis and may impair fertility; this should be discussed with patients of reproductive age.
  • Counsel patients on the risk of secondary exposure to women and children, especially with topical testosterone products (though less relevant for IM injection, proper disposal of needles/syringes is important).
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Alternative Therapies

  • Testosterone enanthate (IM injection)
  • Testosterone undecanoate (IM injection, oral capsule)
  • Testosterone gel (topical)
  • Testosterone solution (topical)
  • Testosterone transdermal patch
  • Testosterone buccal system
  • Testosterone pellets (subcutaneous implant)
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Cost & Coverage

Average Cost: $50 - $200 per 10ml 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'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, including the amount taken and the time it happened, to ensure you receive the best possible care.