Undecanoato De Testosterona｜Male Hypogonadism

Undecanoato De Testosterona Application Scope

• Treatment of male hypogonadism (primary or secondary) confirmed by clinical and biochemical evidence of testosterone deficiency.
• Not approved for age-related hypogonadism or use in women.

 

Undecanoato De Testosterona Characteristics

Ingredients:

• Active: Testosterone undecanoate (TU).
• Excipients: Castor oil, benzyl benzoate (in injectable formulations), propylene glycol laurate (in oral capsules).

Properties:

• Prodrug of testosterone, metabolized to active testosterone and DHT.
• Bioidentical hormone, mimicking endogenous testosterone.

Specification:

• Oral: 40 mg capsules (e.g., Andriol, Jatenzo).
• Injectable: 250 mg/mL (e.g., Nebido, Aveed), 1000 mg/4 mL vials.

Packaging Specification:

• Oral: 30 or 60 capsules per pack.
• Injectable: Single-use ampoules/vials.

Storage:

• Oral: Room temperature (avoid light and moisture).
• Injectable: Store below 25°C; do not freeze.

Expiry Date:

• Oral: Up to 3 years (new formulations).
• Injectable: Check manufacturer’s label (typically 2–3 years).

Executive Standard:

• Complies with pharmacopeial standards (e.g., USP, EP).

Approval Number:

• Varies by country (e.g., FDA approval for Aveed in 2014).

Date of Revision:

• Updated formulations (e.g., stable castor oil-based injectables) introduced in the 2000s.

Manufacturer:

• Oral: Organon (Andriol), Clarus Therapeutics (Jatenzo).
• Injectable: Bayer (Nebido), Endo Pharmaceuticals (Aveed).

Guidelines For The Use Of Undecanoato De Testosterona

Dosage and Administration:

• Oral: 40–240 mg/day (divided into 2–3 doses), taken with fatty meals to enhance absorption.
• Injectable:
  • Initial: 1000 mg IM, repeated after 6 weeks.
  • Maintenance: 1000 mg every 10–14 weeks.

Adverse Reactions:

• Common: Acne, hypertension, increased libido, voice deepening, injection-site pain.
• Serious: Anaphylaxis (rare, linked to benzyl benzoate in injectables), polycythemia, liver enzyme elevation.

Contraindications:

• Prostate/breast cancer, liver tumors, hypersensitivity to TU or excipients.

Precautions:

• Monitor: Hematocrit, PSA, lipid profile, liver function.
• Avoid in severe cardiac, renal, or hepatic disease due to fluid retention risks.

Undecanoato De Testosterona Interactions

Drug Interactions:

• Anticoagulants: Increased bleeding risk (e.g., warfarin).
• Insulin: May alter glucose control.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.