Testosterone Enanthate

ACTIVE INGREDIENT

Each mL contains Testosterone Enanthate 250 mg.

DESCRIPTION

Testosterone Enanthate is a long-acting ester of testosterone, an androgen hormone responsible for the development and maintenance of male characteristics. This ester allows for slower absorption and a prolonged release of testosterone into the bloodstream, making it ideal for testosterone replacement therapy with less frequent dosing than other forms of testosterone.

PHARMACOLOGICAL PROPERTIES

Mechanism of Action: Testosterone is the primary male sex hormone involved in the development of male reproductive tissues and secondary sexual characteristics such as muscle mass and body hair. Testosterone Enanthate is slowly absorbed from the injection site and hydrolyzed into testosterone in the body. It binds to androgen receptors, which leads to the transcriptional activation of specific genes that result in its anabolic and androgenic effects.

Testosterone has anabolic effects such as promoting nitrogen retention, enhancing muscle protein synthesis, and increasing red blood cell production. It also maintains bone density, energy levels, and libido.

Pharmacokinetics:

• Absorption: Testosterone Enanthate is slowly absorbed following intramuscular injection.
• Distribution: Testosterone binds to plasma proteins such as sex hormone-binding globulin (SHBG) and albumin.
• Metabolism: It is metabolized in the liver primarily to dihydrotestosterone (DHT) and estradiol.
• Excretion: Testosterone and its metabolites are excreted primarily in the urine as conjugates of glucuronic acid and sulfuric acid.

INDICATIONS

Testosterone Enanthate is indicated for:

1. Testosterone replacement therapy in male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.
2. Treatment of delayed puberty in males.
3. Testosterone therapy for male androgen deficiency symptoms, such as erectile dysfunction, low libido, and reduced energy levels, due to a lack of endogenous testosterone production.

DOSAGE AND ADMINISTRATION

Dosage: The dosage should be individualized based on the patient’s needs, testosterone serum levels, and clinical response.

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

Adjust dosage based on periodic measurement of serum testosterone and the patient’s response.

Administration: For intramuscular use only. Inject deep into the gluteal muscle. Avoid intravascular injection. Rotate injection sites regularly to minimize local reactions.

CONTRAINDICATIONS

• Hypersensitivity to Testosterone Enanthate or any other ingredient in the formulation.

• Men with known or suspected prostate or breast cancer.

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

• Patients with severe hepatic or renal impairment.

• History of severe cardiovascular, cerebrovascular, or thromboembolic disease.

WARNINGS AND PRECAUTIONS

1. Cardiovascular Effects: Testosterone therapy may increase the risk of cardiovascular events such as myocardial infarction and stroke. Patients with a history of cardiovascular disease or risk factors (e.g., smoking, obesity, diabetes) should be monitored closely.

2. Prostate Cancer: Testosterone therapy may accelerate the progression of subclinical prostate cancer. Screening for prostate cancer is recommended before initiating treatment.

3. Liver Toxicity: Testosterone may cause hepatic adverse effects, including hepatocellular carcinoma. Regular liver function tests are recommended.

4. Polycythemia: Testosterone therapy may increase red blood cell mass. Hematocrit should be monitored regularly to prevent polycythemia, which can increase the risk of thrombosis.

5. Endocrine and Metabolic Disorders: Testosterone therapy may cause hypercalcemia in immobilized patients. In patients with diabetes, changes in insulin sensitivity may occur, requiring dose adjustments of insulin or other anti-diabetic medications.

6. Misuse and Abuse: Androgens may be abused for their anabolic effects. Abuse of testosterone can lead to serious adverse cardiovascular, psychiatric, and reproductive consequences.

ADVERSE REACTIONS

Common adverse effects include:

• Injection site reactions: Pain, erythema, or swelling at the injection site.
• Endocrine effects: Gynecomastia, testicular atrophy, decreased spermatogenesis.
• Cardiovascular effects: Edema, increased blood pressure, increased risk of cardiovascular events.
• Dermatologic effects: Acne, oily skin, alopecia (hair loss).
• Psychiatric effects: Mood swings, aggression, depression, or anxiety.
• Hematological effects: Polycythemia (increased red blood cell count).

Serious but less common adverse effects include liver toxicity, jaundice, and hepatocellular carcinoma.

INTERACTIONS

1. Anticoagulants: Testosterone may increase the effects of oral anticoagulants such as warfarin, requiring more frequent monitoring of prothrombin time and INR.

2. Corticosteroids or ACTH: Concomitant use with testosterone can increase the risk of fluid retention, especially in patients with pre-existing cardiovascular or renal disease.

3. Insulin and Oral Hypoglycemic Agents: Testosterone may reduce insulin sensitivity, and adjustments to the dose of insulin or other antidiabetic medications may be required in diabetic patients.

USE IN SPECIFIC POPULATIONS

• Pregnancy and Lactation: Testosterone is contraindicated in pregnancy. It may cause fetal harm.

• Pediatric Use: Testosterone should not be used in pediatric patients, except in cases of delayed puberty, and should be used cautiously.

• Geriatric Use: Elderly men treated with testosterone may have an increased risk of prostate enlargement or cancer.

OVERDOSAGE

Symptoms of overdose include priapism (prolonged erections), polycythemia, and electrolyte imbalances. In cases of overdose, treatment should be symptomatic and supportive, including monitoring of serum testosterone levels.

STORAGE

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

PACKAGING

Testosterone Enanthate is available in vials containing 10mL of solution (250 mg of Testosterone Enanthate per mL).

MANUFACTURER

Oxydine Metabolics Switzerland

Oxydine.org
Hi@Oxydine.org