Testosterone Oil Base

ACTIVE INGREDIENT

Each mL contains:

• Testosterone Base 100 mg

DESCRIPTION

Testosterone Oil Base 100 mg is an injectable solution containing free testosterone (non-esterified) suspended in an oil base. This formulation provides a moderately fast release of testosterone after intramuscular injection, making it useful for testosterone replacement therapy (TRT) in males with low or absent testosterone levels. The oil base allows for a slightly prolonged release compared to aqueous suspension, though still faster than esterified testosterone forms like enanthate or cypionate.

PHARMACOLOGICAL PROPERTIES

Mechanism of Action: Testosterone is the primary male sex hormone responsible for the development of male reproductive organs and secondary sexual characteristics. It promotes muscle mass, bone density, and the synthesis of proteins. Testosterone Oil Base delivers testosterone quickly after administration, causing a prompt rise in testosterone levels, which can be beneficial in situations requiring rapid onset of action.

Pharmacokinetics:

• Absorption: Testosterone Oil Base is absorbed more gradually compared to aqueous suspension due to the oil base, but faster than esterified forms.
• Distribution: Testosterone is highly bound to plasma proteins, mainly sex hormone-binding globulin (SHBG).
• Metabolism: Testosterone is metabolized in the liver to active metabolites such as dihydrotestosterone (DHT) and estradiol.
• Excretion: Metabolites are primarily excreted via the urine.

INDICATIONS

Testosterone Oil Base 100 mg is indicated for:

1. Testosterone replacement therapy in male adults with primary or secondary hypogonadism (congenital or acquired).
2. Short-term testosterone therapy requiring fast onset of action, such as in cases of hypogonadism where rapid normalization of testosterone levels is needed.
3. Treatment of delayed puberty in males.

DOSAGE AND ADMINISTRATION

Dosage: The dosage must be tailored to the individual patient based on serum testosterone levels, clinical response, and side effects. Typical dosing is:

• Hypogonadism in adult males: 100 mg administered intramuscularly once or twice a week.
• Delayed puberty in males: Dosages typically range from 25–50 mg administered intramuscularly every 2–4 weeks, depending on the clinical response.

Administration: Administer intramuscularly. Deep intramuscular injection into the gluteal muscle is recommended. Rotate injection sites to prevent local irritation or tissue damage. Avoid intravenous administration.

CONTRAINDICATIONS

• Known hypersensitivity to testosterone or any of the ingredients in the formulation.

• Known or suspected prostate or breast cancer in males.

• Pregnancy or breastfeeding (Pregnancy Category X).

• Severe hepatic, renal, or cardiovascular disease.

• Patients with a history of thromboembolic disorders or uncontrolled heart disease.

WARNINGS AND PRECAUTIONS

1. Cardiovascular Risks: Testosterone therapy may increase the risk of serious cardiovascular events such as myocardial infarction, stroke, or venous thromboembolism, especially in older patients. Caution is advised in those with cardiovascular conditions.

2. Prostate Health: Testosterone replacement may increase prostate size, leading to or worsening benign prostatic hyperplasia (BPH). Regular monitoring of prostate-specific antigen (PSA) and prostate health is advised during therapy, especially in older men.

3. Polycythemia: Testosterone can stimulate erythropoiesis, increasing the risk of polycythemia. Hematocrit levels should be monitored periodically to detect an excessive increase in red blood cell counts.

4. Fluid Retention: Testosterone therapy can cause fluid retention, leading to complications in patients with heart failure, renal insufficiency, or hypertension. Regular monitoring for signs of edema is recommended.

5. Hepatic Effects: Testosterone may be associated with liver dysfunction, including elevated liver enzymes. Monitoring of liver function tests is recommended in patients on long-term therapy.

6. Misuse and Abuse: Testosterone has potential for abuse, particularly by athletes and bodybuilders, which can lead to serious adverse effects such as liver damage, cardiovascular complications, and psychiatric issues.

ADVERSE REACTIONS

Common adverse reactions:

• Local reactions: Pain, swelling, and redness at the injection site.
• Dermatological effects: Acne, oily skin, increased hair growth (hirsutism), hair loss.
• Endocrine effects: Gynecomastia, decreased sperm production, testicular atrophy, changes in libido.
• Cardiovascular: Hypertension, risk of blood clots.
• Hematological: Polycythemia.
• Psychiatric: Mood swings, irritability, aggression, depression, or anxiety.

Serious adverse reactions:

• Hepatic dysfunction (e.g., liver enzyme abnormalities, jaundice).
• Cardiovascular events, including myocardial infarction or stroke.
• Worsening of BPH or increased risk of prostate cancer.

INTERACTIONS

1. Anticoagulants: Testosterone may enhance the effects of anticoagulants, such as warfarin. Regular monitoring of blood clotting parameters is recommended.

2. Insulin and Antidiabetics: Testosterone can reduce blood glucose levels, potentially altering the required dosage of insulin or oral hypoglycemics.

3. Corticosteroids: Concomitant use with corticosteroids may increase the risk of fluid retention, particularly in patients with heart disease or kidney dysfunction.

USE IN SPECIFIC POPULATIONS

Pregnancy and Lactation: Testosterone is contraindicated during pregnancy and lactation due to the risk of virilization of the female fetus. It is classified as Pregnancy Category X.

Pediatric Use: Caution is advised when administering testosterone to pediatric patients as it may cause premature closure of the growth plates and stunt height growth.

Geriatric Use: Older males receiving testosterone therapy should be monitored for prostate health and cardiovascular risks.

OVERDOSAGE

Overdose of testosterone may result in priapism (persistent painful erection), polycythemia, or excessive fluid retention. In the event of overdose, discontinue testosterone therapy and provide supportive care. No specific antidote is available.

STORAGE

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

PACKAGING

Testosterone Oil Base 100 mg is supplied in 10 mL vials containing 100 mg of testosterone in an oil base.

MANUFACTURER

Oxydine Metabolics Switzerland

Oxydine.org
Hi@Oxydine.org