Testosterone Blend

ACTIVE INGREDIENT

Each mL contains:

• Testosterone Phenylpropionate 65 mg
• Testosterone Cypionate 135 mg
• Testosterone Decanoate 200 mg

DESCRIPTION

Testosterone Blend 400 mg is a combination of three testosterone esters—Testosterone Phenylpropionate, Testosterone Cypionate, and Testosterone Decanoate. This blend is designed to provide both a rapid and sustained release of testosterone following intramuscular injection. It is used primarily in testosterone replacement therapy for males with conditions associated with primary or secondary hypogonadism.

PHARMACOLOGICAL PROPERTIES

Mechanism of Action: Testosterone Blend 400 mg is a combination of short- and long-acting testosterone esters. After intramuscular administration, the esters are slowly hydrolyzed into free testosterone, which exerts its effects by binding to androgen receptors, promoting the development of male sexual characteristics, muscle growth, and bone density.

Pharmacokinetics:

• Absorption: Testosterone esters are absorbed at different rates, with Phenylpropionate being the fastest, followed by Cypionate, and Decanoate providing a prolonged release.
• Distribution: Testosterone is highly bound to sex hormone-binding globulin (SHBG) and albumin.
• Metabolism: Testosterone is converted in peripheral tissues into its active forms—dihydrotestosterone (DHT) and estradiol.
• Excretion: Testosterone is excreted mainly in the urine as inactive metabolites.

INDICATIONS

Testosterone Blend 400 mg is indicated for:

1. Testosterone replacement therapy in adult males 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 of Testosterone Blend 400 mg must be individualized according to the patient’s serum testosterone levels and clinical response. Typical doses range from 400 mg every 2 to 4 weeks.

• Hypogonadism in adult males: 400 mg intramuscularly every 3 to 4 weeks.
• Delayed puberty in males: 100-200 mg every 3 to 4 weeks for 4-6 months, adjusted based on individual response.

Testosterone levels should be monitored to ensure they remain within the target range.

Administration: Administer intramuscularly. Inject deeply into the gluteal muscle. Rotate injection sites to prevent local irritation and fibrosis. Do not inject intravenously.

CONTRAINDICATIONS

• Hypersensitivity to any of the testosterone esters or excipients.

• Men with known or suspected prostate or breast carcinoma.
• Women who are pregnant or breastfeeding (Pregnancy Category X).
• Patients with severe hepatic, renal, or cardiovascular disease.
• Patients with a history of thromboembolic events or significant cardiac disease.

WARNINGS AND PRECAUTIONS

1. Cardiovascular Risks: Testosterone replacement therapy has been associated with an increased risk of cardiovascular events including heart attack, stroke, and thromboembolism. Use with caution in patients with cardiovascular disease.

2. Prostate Health: Testosterone may stimulate the growth of prostate tissue, particularly in older men, increasing the risk of benign prostatic hyperplasia (BPH) or prostate cancer. Monitor prostate health regularly.

3. Hematological Effects: Testosterone can increase red blood cell production, leading to polycythemia (high red blood cell count). Monitor hematocrit regularly and adjust dosage if necessary.

4. Fluid Retention: Androgens may cause water retention, which could exacerbate conditions like heart failure or kidney disease. Monitor patients with a history of fluid retention closely.

5. Hepatic Effects: Prolonged use of high doses of androgens has been associated with hepatotoxicity, including hepatic tumors and peliosis hepatis. Regular liver function tests are recommended for patients on long-term therapy.

6. Misuse and Abuse: Testosterone and anabolic steroids can be abused, leading to severe psychiatric and physical health consequences, including cardiovascular and liver damage. Testosterone Blend 400 mg should only be used for medically approved indications.

ADVERSE REACTIONS

Common adverse reactions:

• Local: Pain, swelling, and irritation at the injection site.
• Dermatological: Acne, oily skin, hirsutism, alopecia.
• Endocrine: Gynecomastia, testicular atrophy, decreased sperm count.
• Psychiatric: Mood swings, aggression, depression.
• Cardiovascular: Hypertension, increased risk of thromboembolism.
• Hematological: Polycythemia, increased hemoglobin and hematocrit.
• Gastrointestinal: Nausea, vomiting, changes in liver enzymes.

Rare but serious adverse effects:

• Hepatotoxicity, hepatic neoplasms, and peliosis hepatis (with prolonged use).
• Serious cardiovascular events such as myocardial infarction and stroke.

INTERACTIONS

1. Anticoagulants: Testosterone may enhance the anticoagulant effect of warfarin and other oral anticoagulants. Monitor INR and prothrombin time regularly.

2. Corticosteroids and ACTH: Concomitant use may increase the risk of fluid retention and worsen conditions like heart failure.

3. Antidiabetic medications: Testosterone can affect blood glucose levels and may require adjustments to insulin or oral antidiabetic agents.

USE IN SPECIFIC POPULATIONS

Pregnancy and Lactation: Testosterone Blend 400 mg is contraindicated in women who are pregnant or breastfeeding. It may cause fetal harm or masculinization of the female fetus if used during pregnancy.

Pediatric Use: Testosterone should only be used in adolescents with caution to avoid premature epiphyseal closure and to ensure proper monitoring of growth.

Geriatric Use: Older patients treated with testosterone may be at increased risk for prostate hypertrophy or cancer. Prostate evaluation is recommended prior to and during treatment.

OVERDOSAGE

Symptoms of overdose may include priapism (prolonged erections), fluid retention, polycythemia, and electrolyte disturbances. In case of overdose, discontinue testosterone administration and provide symptomatic treatment.

STORAGE

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

PACKAGING

Testosterone Blend 400 mg is supplied in vials containing 1 mL of solution (400 mg/mL).

MANUFACTURER

Oxydine Metabolics Switzerland

Oxydine.org
Hi@Oxydine.org