NEBID ® is a testosterone undecanoate drug
THERAPEUTIC GROUP: Androgens
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications NEBID ® - Testosterone undecanoate
NEBID® is useful in treating symptoms associated with androgen deficiency present in pathological conditions such as hypogonadism, male climacteric syndrome, eunucoidism and castration.
Mechanism of action NEBID ® - Testosterone undecanoate
NEBID ® is a drug based on testosterone undecanoate, an ester of the common testosterone, characterized by the high lipophilicity that determines its long duration of action.
Assumed parenterally, more precisely intramuscularly, testosterone undecanoate is subject to the activity of different serum esterases, which split testosterone from undecaoic acid, saving it from the effect of the first liver passage, thus contributing only after 24 hours to increase in plasma concentrations of this hormone.
Linked to plasma proteins, testosterone reaches various tissues, where:
- Exerts anabolic effect: increasing protein synthesis levels, improving bone neodeposition processes, supporting hematopoiesis with a significant increase in hemoglobin and the number of erythrocytes;
- It maintains sexual libido and sexual abilities high;
- It induces skeletal and cartilaginous variations, important both in the growth phase and in the appearance of some male secondary sexual characteristics, such as the lowering of the tone of voice;
- It modulates motivational and emotional aspects.
Once its action is over, testosterone undergoes an intense hepatic and extrahepatic metabolism, being eliminated mainly through the urine and minimally with the faeces.
Studies carried out and clinical efficacy
1. NEBID IN THE HYPOGONADISM IPOGONADOTRPO
Study demonstrating that the administration of NEBID ® in patients with hypogonadotrophic hypogonadism may be effective and safe in inducing the development of male secondary sexual characteristics.
2. UNDECANOATE TESTOSTERONE IN THE ELDERLY
Experimentation in hypogonadic patients older than 50 years, in which the effectiveness of testosterone undecanoate was tested, in improving the complained symptomatology. The study showed that the cost / benefit ratio in this case is decidedly pending towards the benefits.
3. UNDECANOATE TESTOSTERONE AND METABOLIC SYNDROME
Testosterone intake in patients with late-onset hypogonadism and metabolic syndrome has shown that this therapy can ensure a significant improvement in body composition leading to an improvement in the various parameters related to this syndrome
Method of use and dosage
NEBID ®
Intramuscular solution for injection, 4 ml ampoules containing 1000 mg of testosterone undecanoate:
the intramuscular administration of NEBID ® should be supervised, at least for the first few times, by health personnel, in order to avoid unpleasant incidents.
The dosage, which may vary from patient to patient, must be defined by your doctor, after a careful evaluation of the patient's clinical picture and his state of health.
Generally speaking, the administration of a vial should be done every 10-14 weeks,
thus maintaining the appropriate concentrations of this hormone, without potentially harmful accumulations.
Warnings NEBID ® - Testosterone undecanoate
NEBID ® should be preceded by a careful medical examination to assess the prescriptive appropriateness and the possible presence of conditions capable of increasing the risk of side effects.
In this regard the presence of hypertension, epilepsy, cardiovascular, hepatic, renal and metabolic pathologies, histories or familiarity of prostatic and malignant pathologies, should alarm the doctor, who is obliged to inform the patient of the cost / benefit ratio of the therapy, submitting it to regular medical checks to assess the patient's psycho-physical health, therapeutic efficacy and the appearance of signs and symptoms indicative of the side effects of the therapy.
The use in prepubera age should instead take place with particular attention, given the possible deleterious effects on bone growth and on the too rapid development of the male genital organs.
PREGNANCY AND BREASTFEEDING
NEBID ® is indicated exclusively for the treatment of male diseases.
Taking testosterone undecanoate during pregnancy could seriously affect the reproductive capacity of the unborn child, inducing virilization of the fetus.
Interactions
The administration of androgens could increase the risk of:
- Hemorrhages, following the concomitant intake of anticoagulants;
- Hypoglycemia, in diabetic patients undergoing hypoglycemic therapy;
- Edema and hypertension, in the case of simultaneous intake of anti-inflammatory drugs such as cortisone drugs.
It is also useful to remember that testosterone intake could alter some laboratory parameters related to hepatic, renal, thyroid and hematopoietic function.
Contraindications NEBID ® - Testosterone undecanoate
Testosterone intake is contraindicated in case of hypersensitivity to the active substance or to one of its excipients, breast cancer, estrogen-dependent neoplasms, cancer and prostatic hypertrophy, history of hepatocarcinoma, hypercalcaemia, nephrotic syndrome, pregnancy and breastfeeding.
Undesirable effects - Side effects
Hormone replacement therapy with androgens, especially when not supported by medical needs, is often associated with the appearance of different side effects related both to the potential androgenic activity of specific metabolites and to estrogen, due to the action of aromatase.
Gastro intestinal disorders, myalgia, arthralgia, respiratory disorders, acne, gynecomastia, prostatic hypertrophy, changes in liver function, libido changes, disorders of sexual erection, oligoazoospermia, water retention and hypertension, are just some of the most frequently described side effects during androgen intake prolonged over time and at high doses.
To these we should add others linked to the particular mode of administration of NEBID ® as subcutaneous hematomas and disorders at the injection site.
Note
NEBID ® is salable only under medical prescription.
NEBID ® is an anabolic agent, therefore its use, outside of medical prescriptions on pathological grounds, is prohibited in the race and out of the race.
