Testosterone Cypionate

ACTIVE INGREDIENT

Each mL contains 250 mg of Testosterone Cypionate.

DESCRIPTION

Testosterone Cypionate is a synthetic androgen, used for testosterone replacement therapy in males with conditions associated with primary or secondary hypogonadism. The cypionate ester allows for a slower release of testosterone from the injection site and a longer duration of action compared to other testosterone esters.

PHARMACOLOGICAL PROPERTIES

Mechanism of Action: Testosterone Cypionate is hydrolyzed to testosterone after injection. Testosterone acts on androgen receptors, promoting the development and maintenance of male sexual characteristics, muscle mass, and bone density. It has both androgenic (responsible for male characteristics) and anabolic (tissue-building) effects.

Pharmacokinetics:

• Absorption: Slowly absorbed from the intramuscular site over several days.
• Distribution: Circulates bound to sex hormone-binding globulin (SHBG) and albumin.
• Metabolism: Metabolized in the liver, primarily into dihydrotestosterone (DHT) and estradiol.
• Excretion: Mainly excreted in the urine as conjugates of testosterone metabolites.

INDICATIONS

Testosterone Cypionate is indicated for:

1. Testosterone replacement therapy in adult men with primary or secondary hypogonadism (congenital or acquired).
2. Treatment of delayed puberty in males.
3. Hormone therapy for transgender men (female-to-male).

DOSAGE AND ADMINISTRATION

Dosage: The dosage and frequency of administration depend on the individual patient’s condition, testosterone serum levels, and clinical response.

• Adult males (Hypogonadism): 50-400 mg intramuscularly every 2-4 weeks, depending on the patient’s testosterone levels.
• Delayed puberty in males: 50-200 mg every 2-4 weeks for 4-6 months, based on individual response.

Testosterone serum levels should be measured periodically to ensure proper dosage adjustments.

Administration: For intramuscular injection only. Administer deep into the gluteal muscle. Take care to avoid intravascular injection. Rotate injection sites to prevent local irritation.

CONTRAINDICATIONS

• Hypersensitivity to Testosterone Cypionate or any excipients.

• Men with known or suspected prostate or breast carcinoma.

• Women who are pregnant or breastfeeding (Pregnancy Category X).

• Patients with severe hepatic or renal impairment.

• Those with a history of cardiovascular events or risk of thromboembolic disorders.

WARNINGS AND PRECAUTIONS

1. Cardiovascular Effects: Testosterone therapy may increase the risk of cardiovascular events such as heart attack, stroke, and venous thromboembolism. Patients with a history of cardiovascular disease should be monitored closely during therapy.

2. Prostate Health: Monitor prostate health regularly during testosterone therapy, especially in elderly men, as testosterone may promote the growth of prostate tissue.

3. Polycythemia: Testosterone can increase red blood cell production, leading to an elevated hematocrit level. Regular monitoring of hematocrit is recommended to reduce the risk of complications.

4. Fluid Retention: Androgens, including testosterone, may cause fluid retention and exacerbate conditions like heart failure, especially when used with corticosteroids.

5. Hepatic Effects: High doses or long-term use of testosterone can cause hepatic adverse effects. Liver function tests should be performed periodically.

6. Misuse and Abuse: Testosterone and other anabolic steroids can be abused, particularly by athletes, leading to serious cardiovascular, psychiatric, and reproductive side effects.

ADVERSE REACTIONS

Common adverse reactions include:

• Injection site reactions: Pain, swelling, and erythema at the injection site.
• Endocrine effects: Gynecomastia, testicular atrophy, reduced spermatogenesis.
• Dermatological effects: Acne, oily skin, hair loss (alopecia).
• Psychiatric effects: Mood swings, depression, anxiety, or increased aggression.
• Cardiovascular effects: Increased blood pressure, risk of thromboembolism, edema.
• Hematological effects: Polycythemia, elevated hemoglobin and hematocrit.

Rare but serious adverse effects include hepatic dysfunction, liver tumors, and liver cancer with long-term use.

INTERACTIONS

1. Oral Anticoagulants: Testosterone may potentiate the effects of oral anticoagulants such as warfarin, leading to an increased risk of bleeding. Close monitoring of prothrombin time or INR is recommended.

2. Corticosteroids and ACTH: Concomitant use with testosterone may increase the risk of fluid retention and heart failure.

3. Insulin and Oral Antidiabetic Agents: Testosterone may alter insulin sensitivity and glucose metabolism, requiring dose adjustments of antidiabetic medications.

USE IN SPECIFIC POPULATIONS

• Pregnancy and Lactation: Testosterone Cypionate is contraindicated during pregnancy and breastfeeding. It may cause masculinization of the female fetus if administered during pregnancy.

• Pediatric Use: Use in boys for delayed puberty should be closely monitored to avoid premature epiphyseal closure.
• Geriatric Use: Elderly men using testosterone may have an increased risk of developing prostate hypertrophy or prostate cancer. Prostate screening is recommended before and during treatment.

OVERDOSAGE

Symptoms of overdose may include priapism (prolonged erections), electrolyte imbalance, and excessive red blood cell production (polycythemia). Treatment of overdose should include discontinuation of the drug and symptomatic management. Blood tests should be monitored.

STORAGE

Store below 25°C (77°F). Protect from light. Do not refrigerate or freeze. Keep out of reach of children.

PACKAGING

Testosterone Cypionate 250 mg is supplied in vials containing 10 mL of solution (250 mg of Testosterone Cypionate per mL).

MANUFACTURER

Oxydine Metabolics Switzerland

Oxydine.org
Hi@Oxydine.org