Testosterone Cyp 200mg/ml Mdv 10ml
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
- Testosterone Cyp 200mg/ml Sdv 1ml
- Testosterone Cyp 200mg/ml Mdv 10ml
- Testosterone Cyp 200mg/ml Mdv 10ml
- Testosterone Enan 200mg/ml Mdv 5ml
- Testosterone Cyp 100mg/ml Mdv 10ml
- Testosterone 1%(50mg)gel 5gm Pkt
- Testosterone 1% (12.5mg/1.25gm)pump
- Testosterone 1%(50mg) Gel 5gm Udt
- Testosterone 10mg/act Gel(120pumps)
- Testosterone 1% Gel(25mg)30x2.5gm
- Testosterone 1%(50mg) Gel 5gm Pk
- Testosterone 30mg/act Solution
- Testosterone 30mg/act Topsolution
- Testosterone 1.62% Gel (60 Pumps)
- Testosterone 10mg/act Gel(120pumps)
- Testosterone 30mg/act Solution
- Testosterone 1.62% Gel (60 Pumps)
- Testosterone 1.62%(20.25mg/1.25gm)
- Testosterone 1%(50mg) Gel 5gm Pk
- Testosterone 1.62%(40.5mg/2.5gm)pkt
- Testosterone 1.62%(20.25mg/1.25gm)
- Testosterone Cyp 100mg/ml Mdv 10ml
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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.
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.
Minor Interactions
- Diuretics: May enhance fluid retention when used with testosterone.
Monitoring
Baseline Monitoring
Rationale: To confirm diagnosis of hypogonadism and establish baseline levels.
Timing: Before initiation of therapy
Rationale: To assess for polycythemia, a common side effect.
Timing: Before initiation of therapy
Rationale: To screen for prostate cancer and benign prostatic hyperplasia (BPH) before initiating therapy in men over 40.
Timing: Before initiation of therapy
Rationale: Testosterone therapy can affect lipid profiles.
Timing: Before initiation of therapy
Rationale: To assess baseline liver function, especially in patients with pre-existing hepatic conditions.
Timing: Before initiation of therapy
Routine Monitoring
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.
Frequency: 3-6 months after initiation, then annually
Target: <54%
Action Threshold: If Hct >54%, reduce dose, temporarily discontinue, or consider phlebotomy.
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.
Frequency: Annually
Target: Within normal limits; monitor for adverse changes.
Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.
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.
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.
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
Pregnancy
Contraindicated in pregnant women. Testosterone can cause virilization of the female fetus.
Trimester-Specific Risks:
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.
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.
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
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).
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)