Testosterone Propionate

ACTIVE INGREDIENT

Each mL contains Testosterone Propionate 100 mg.

DESCRIPTION

Testosterone Propionate is a synthetic androstane steroid and a testosterone ester. It is an androgen hormone responsible for the development and maintenance of male characteristics. Testosterone Propionate has a shorter half-life than other testosterone esters, making it a fast-acting form of testosterone.

PHARMACOLOGICAL PROPERTIES

Mechanism of Action: Testosterone is the primary male sex hormone produced in the testicles, responsible for the development of secondary sexual characteristics in males. Testosterone Propionate is rapidly absorbed from the injection site and metabolized into active testosterone. The esterification of the 17-beta-hydroxy group slows the release of testosterone, allowing for a sustained pharmacological effect.

Testosterone has anabolic (muscle-building) effects and androgenic (virilizing) effects. It promotes nitrogen retention in muscle tissue, increases protein synthesis, and stimulates the production of red blood cells. It also aids in the maintenance of bone density, sexual function, mood, and energy.

Pharmacokinetics:

• Absorption: After intramuscular administration, Testosterone Propionate is slowly absorbed and hydrolyzed to free testosterone.

• Distribution: Testosterone binds to plasma proteins, primarily to sex hormone-binding globulin (SHBG).

• Metabolism: It is metabolized in the liver primarily to dihydrotestosterone (DHT) and other metabolites.

• Excretion: Testosterone and its metabolites are excreted in urine as conjugates of glucuronic acid and sulfuric acid.

INDICATIONS

Testosterone Propionate is indicated for:

1. Testosterone replacement therapy in male hypogonadism associated with a deficiency or absence of endogenous testosterone (primary or secondary hypogonadism).

2. Delayed puberty in males.

3. Androgen deficiency symptoms, including decreased libido, erectile dysfunction, fatigue, and depression in men with testosterone deficiency.

DOSAGE AND ADMINISTRATION

Dosage: The dosage and frequency of administration should be individualized based on the patient’s response to treatment and serum testosterone levels.

• Adult males (Hypogonadism): 25-50 mg injected intramuscularly every 2-3 days.

• Delayed puberty in males: 25-50 mg injected intramuscularly every 2-4 weeks for 4-6 months.

Dosage adjustments should be made according to serum testosterone levels and clinical response.

Administration: For intramuscular use only. Testosterone Propionate should be injected deep into the gluteal muscle. Care should be taken to avoid intravascular injection. The injection site should be rotated periodically to prevent tissue irritation.

CONTRAINDICATIONS

• Hypersensitivity to Testosterone Propionate or any component of the product.

• Males with breast carcinoma or known or suspected prostate carcinoma.

• Pregnancy (Category X) or breastfeeding.

• Patients with severe hepatic or renal impairment.

• Known or suspected history of cardiovascular 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

The most commonly reported adverse reactions include:

• Local reactions: Pain, erythema, or swelling at the injection site.

• Endocrine: Gynecomastia, testicular atrophy, changes in libido.

• Cardiovascular: Hypertension, edema, increased risk of thromboembolism.

• Metabolic: Weight gain, changes in cholesterol levels.

• Hematological: Increased red blood cell count (polycythemia).

• Psychiatric: Mood swings, aggression, depression, anxiety.

• Dermatological: Acne, hair loss (androgenic alopecia).

Rare but serious side effects include liver toxicity, jaundice, and hepatic neoplasms.

INTERACTIONS

1. Anticoagulants: Testosterone may enhance the anticoagulant effect of warfarin. Prothrombin time and INR should be monitored more frequently.

2. Corticosteroids and Adrenocorticotropic Hormone (ACTH): Concomitant use with corticosteroids may increase the risk of fluid retention, particularly in patients with cardiovascular or renal conditions.

3. Insulin: Testosterone may alter insulin sensitivity. Diabetic patients may require adjustments to their anti-diabetic therapy.

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 may include priapism (prolonged erection), polycythemia, and fluid retention. In case of overdose, discontinue treatment and provide symptomatic care. Serum testosterone levels 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 Propionate is available in vials containing 10 mL of solution (100 mg of Testosterone Propionate per mL).

MANUFACTURER

Oxydine Metabolics Switzerland

Oxydine.org
Hi@Oxydine.org