Depo-Testosterone 100mg/ml Mdv 10ml
Overview
What is this medicine?
How to Use This Medicine
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via intramuscular injection. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before administering the injection, wash your hands thoroughly. It is essential to identify a suitable injection site. If you are unsure about the correct location, 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 faint yellow. If the color changes, do not use the medication.
After administering the injection, dispose of the needle in a designated needle/sharp disposal box. Do not reuse needles or other items. 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, 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, administer 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 administer two doses at the same time or take extra doses.
Lifestyle & Tips
- Administer injections exactly as prescribed by your doctor. Do not change the dose or frequency without consulting your healthcare provider.
- Rotate injection sites to prevent irritation and scarring.
- Report any new or worsening symptoms to your doctor promptly.
- Maintain a healthy lifestyle, including regular exercise and a balanced diet.
- Attend all scheduled follow-up appointments and laboratory tests.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
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 notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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 or changes in eyesight
Prolonged or frequent erections (priapism)
Urination problems, such as:
+ Trouble passing urine
+ Pain while urinating
+ 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, such as:
+ 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. 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 attention:
Headache
Acne
Diarrhea
Emotional changes
Fatigue or weakness
Sleep disturbances
* Irritation at the site of application
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult 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 leg pain/swelling (signs of blood clot)
- Changes in urination (e.g., increased frequency, difficulty urinating)
- Nausea, vomiting, yellowing of skin or eyes (jaundice), dark urine (liver problems)
- Unusual hair growth or hair loss
- Acne or oily skin
- Mood changes, aggression, or irritability
- Breast tenderness or enlargement
- Prolonged or painful erections (priapism)
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, 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. 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, discuss this with your doctor.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dosage of any medication without first consulting your doctor.
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.
Blood Pressure Monitoring
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 a history of 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 exacerbate the condition.
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 undergo blood work and other lab tests as directed by your doctor. Inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab tests.
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 cases, medications like this one have caused high calcium levels in patients with cancer. Seek medical attention immediately if you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.
Age-Related Considerations
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 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 teens, and regular growth checks may be necessary. Discuss this with your doctor.
Overdose Information
Overdose Symptoms:
- Irritability
- Nervousness
- Weight gain (due to fluid retention)
- Frequent or prolonged erections
- Acne
- Changes in libido
What to Do:
There is no specific antidote for testosterone overdose. Treatment is symptomatic and supportive. Discontinue the medication and monitor for adverse effects. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Major Interactions
- Oral anticoagulants (e.g., warfarin): May increase anticoagulant activity, leading to increased bleeding risk.
- Corticosteroids (e.g., prednisone): Concomitant use may increase the risk of edema.
Moderate Interactions
- Insulin and oral hypoglycemic agents: Testosterone may decrease blood glucose, requiring adjustment of antidiabetic medication dosage.
- Thyroid hormones: May decrease serum thyroxine-binding globulin, leading to decreased total T4 levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged.
Monitoring
Baseline Monitoring
Rationale: To confirm diagnosis of hypogonadism and establish baseline levels.
Timing: Prior to initiation of therapy
Rationale: To assess for polycythemia, a common side effect.
Timing: Prior to initiation of therapy
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 >40 years old or with risk factors)
Rationale: Testosterone therapy can affect lipid profiles.
Timing: Prior to initiation of therapy
Rationale: To assess baseline liver health, as testosterone can cause hepatic dysfunction.
Timing: Prior to initiation of therapy
Routine Monitoring
Frequency: 3-6 months after initiation, then annually or as clinically indicated. Draw midway between injections.
Target: 300-1000 ng/dL (or within normal physiological range)
Action Threshold: If consistently >1000 ng/dL, reduce dose or extend interval. If consistently <300 ng/dL, increase dose or shorten interval.
Frequency: 3-6 months after initiation, then annually.
Target: <54%
Action Threshold: If Hct >54%, temporarily discontinue therapy until Hct decreases, then reinitiate at a lower dose or extend interval. Consider phlebotomy.
Frequency: 3-6 months after initiation, then annually (in men >40 years old or with risk factors).
Target: Stable or within age-appropriate limits.
Action Threshold: Significant increase from baseline or abnormal values warrant urological evaluation.
Frequency: Annually (in men >40 years old or with risk factors).
Target: Normal findings.
Action Threshold: Abnormal findings warrant urological evaluation.
Frequency: Annually.
Target: Within normal limits.
Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.
Frequency: Periodically, especially if symptoms of hepatic dysfunction occur.
Target: Within normal limits.
Action Threshold: Significant elevations warrant investigation and potential discontinuation.
Symptom Monitoring
- Signs of virilization (e.g., deepening voice, hirsutism, clitoromegaly in females)
- Fluid retention (e.g., edema, weight gain)
- Mood changes (e.g., irritability, aggression, depression)
- Sleep apnea (worsening or new onset)
- Breast tenderness or enlargement (gynecomastia)
- Urinary symptoms (e.g., frequency, urgency, difficulty voiding)
- Skin changes (e.g., acne, oily skin)
- Injection site reactions (pain, swelling, redness)
Special Patient Groups
Pregnancy
Testosterone is contraindicated in pregnant women. It can cause virilization of the female fetus, including clitoral enlargement, abnormal vaginal development, and fusion of the labia.
Trimester-Specific Risks:
Lactation
Testosterone is 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.
Pediatric Use
Not indicated for use in children for growth promotion or to enhance athletic performance. Use in adolescents for delayed puberty should be done with extreme caution, under specialist supervision, and for limited durations due to the risk of premature epiphyseal closure (stunting growth) and virilization.
Geriatric Use
Geriatric patients may be at increased risk for prostate enlargement, prostate cancer, and cardiovascular events (e.g., heart attack, stroke, VTE) with testosterone therapy. Close monitoring of PSA, DRE, Hct, and cardiovascular status is essential.
Clinical Information
Clinical Pearls
- Testosterone cypionate is a long-acting ester, allowing for less frequent injections compared to testosterone propionate.
- Always confirm hypogonadism with at least two morning serum testosterone levels before initiating therapy.
- Monitor hematocrit closely due to the risk of polycythemia, which can increase the risk of thrombotic events.
- Educate patients on the signs and symptoms of fluid retention, sleep apnea, and potential cardiovascular events.
- Testosterone therapy is contraindicated in men with known or suspected prostate cancer or breast cancer.
- Counsel patients on the potential for mood changes, including irritability and aggression, often referred to as 'roid rage' in higher doses or abuse settings.
- Injection technique is crucial; deep intramuscular injection is required to ensure proper absorption and minimize local reactions.
Alternative Therapies
- Other testosterone formulations (e.g., testosterone enanthate, testosterone undecanoate, testosterone gels, patches, buccal tablets, pellets)
- Gonadotropin-releasing hormone (GnRH) agonists/antagonists (for prostate cancer, not hypogonadism)
- Human Chorionic Gonadotropin (hCG) (to stimulate endogenous testosterone production)
- Clomiphene citrate (off-label use to stimulate endogenous testosterone production)
- Lifestyle modifications (e.g., weight loss, exercise) for some cases of functional hypogonadism.