Nebido - instructions for use, reviews, analogs and forms of release (injections in ampoules for injections of 250 mg and 1000 mg on the basis of the hormone of testosterone) drugs for the treatment of testicular hypofunction and in bodybuilding in adults, children and in pregnancy

In this article, you can read the instructions for using the drug Nebido. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Nebido in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Nebido in the presence of existing structural analogues. Use to treat hypofunction of the testicles and in bodybuilding in adults, children, as well as during pregnancy and lactation.Composition of a hormone drug based on testosterone.

Nebido androgen. Testosterone undecanoate (the active substance of the drug Nebido) is the ester of natural androgen, testosterone. The active form, testosterone, is formed as a result of the cleavage of the side chain.

Testosterone is a male sex hormone possessing the entire spectrum of biological activity necessary for the formation and maintenance of androgenic functions. It is synthesized mainly in testicles and, to a lesser extent, in the adrenal cortex. Provides the formation of male characteristics during intrauterine development, in early childhood; in the period of puberty - the development of male genital organs and secondary sexual characteristics. Subsequently, testosterone provides maintenance of the male phenotype and androgen-dependent functions (for example, spermatogenesis, sex glands).

Insufficient secretion of testosterone leads to male hypogonadism, which is characterized by low concentrations of testosterone in the serum. Symptoms associated with male hypogonadism include, but are not limited to, erectile dysfunction, decreased sexual desire, fatigue, depressive moods,absence, underdevelopment or regression of secondary sexual characteristics, as well as an increased risk of osteoporosis. Exogenous androgens are prescribed to increase inadequate levels of endogenous testosterone and reduce symptoms of hypogonadism.

Depending on the target organ, the action of testosterone is mainly androgenic (for example, the prostate gland, seminal vesicles, epididymis) or protein-anabolic (muscle, bone, hematopoietic system, kidney, liver).

The action of testosterone in some organs is manifested after the peripheral conversion of testosterone to estradiol, which then binds to estrogen receptors in the nuclei of target cells (for example, the pituitary, adipose tissue, brain, bones and testicular cells of Leydig).

In men suffering from hypogonadism, the use of androgens reduces the body fat mass, increases the body's lean body mass, and also prevents the loss of bone tissue. Androgens can improve sexual function, and also have a positive psychotropic effect, improving mood.

Composition

Testosterone undecanoate + excipients.

Pharmacokinetics

After intramuscular injection of the oil solution, Nebido is gradually released from the depot and almost completely cleaved by serum esterases to testosterone and undecanoic acid. An increase in serum testosterone concentrations relative to the baseline may be determined the day after the injection. In the male serum, binding to proteins (GSPA and albumin) is about 98%. Only the free fraction of testosterone is considered biologically active. Testosterone, formed from testosterone undecanoate as a result of cleavage of the ester bond, is metabolized and excreted from the body in the same ways as endogenous testosterone. Undecanoic acid is metabolized by p-oxidation in the same way as other aliphatic carboxylic acids. Testosterone is significantly metabolized in the liver and beyond. After the administration of labeled testosterone, about 90% of radioactivity is detected in the urine as glucuronide and sulfate acid conjugates, and 6% after passage of the enterohepatic circulation is detected in the stool. Urine-specific foods include androsterone and etiocholanolone.

Indications

• testosterone deficiency in primary and secondary hypogonadism in men (testosterone replacement therapy for testicular hypo-function or hypopituitarism).

Forms of release

Solution for intramuscular injection (injections in injectable ampoules) 250 mg in 1 ml (4 ml or 1000 mg in 1 ampoule solution).

Instructions for use and how to use them

Injection of Nebido in a dose of 1 g of testosterone undecanoate (1 ampoule) is performed once every 10-14 weeks. At this injection frequency, a sufficient level of testosterone is maintained, and no cumulation of the substance takes place.

The drug is administered intramuscularly immediately after opening the ampoule. Injections should be made very slowly. Nebido can only be entered strictly in / m. Care must be taken to ensure that the product does not enter the blood vessel.

Before starting treatment, determine the amount of testosterone in the serum. The first interval between injections can be reduced, but should be at least 6 weeks.

At the end of the interval between injections, it is recommended to measure testosterone concentration in serum. If its level is lower than normal, this fact may indicate a need to reduce the interval between injections.At high concentrations, the feasibility of increasing this interval should be considered. The interval between injections should remain within the recommended range of 10-14 weeks.

Available limited data do not indicate the need for dose adjustment in elderly patients.

Side effect

• acne or acne;
• increase in hematocrit;
• increase in the number of red blood cells;
• increased hemoglobin levels;
• hypersensitivity;
• increase in body weight;
• increased appetite;
• hypercholesterolemia;
• depression;
• insomnia;
• aggressiveness;
• irritability;
• headache;
• migraine;
• tremor;
• tides;
• hypertension;
• dizziness;
• bronchitis;
• sinusitis;
• cough;
• dyspnea;
• diarrhea;
• nausea;
• alopecia (baldness);
• rash;
• itching;
• anaphylactic reactions;
• dry skin;
• pain in the limbs;
• muscle spasms;
• muscular tension;
• myalgia;
• retention of urine;
• benign prostatic hyperplasia;
• prostatitis;
• increased libido;
• decreased libido;
• pain in the testicles;
• pain in the mammary gland;
• compaction in the mammary gland;
• gynecomastia;
• increased fatigue;
• asthenia;
• night sweats;
• pain, discomfort, itching, swelling, bruising, irritation at the injection site.

Long-term or high-dose therapy with testosterone can sometimes lead to increased frequency of fluid retention in the body and edema.

Contraindications

• androgen-dependent carcinoma of the prostate;
• androgen-dependent breast carcinoma in men;
• hypercalcemia associated with malignant tumors;
• a liver tumor at present or in the anamnesis;
• hypersensitivity to the active substance or any of the auxiliary components of the drug.

Application in pregnancy and lactation

Nebido is not used in women.

Use in children

Clinical trials Nebido involving children or adolescents under the age of 18 has not been carried out to date.

Because clinical studies have not been conducted in men under the age of 18, Nebido is not intended for children and adolescents.

The use of testosterone for the treatment of children, along with masculinization, can cause the growth and maturation of bone tissue to accelerate, as well as premature closure of the epiphyseal growth zone, which will result in a decrease in the final growth. Perhaps the appearance of common acne.

Application in elderly patients

With the use of androgens in the treatment of elderly patients, the risk of developing prostatic hyperplasia may increase. Despite the lack of evidence that androgens can cause prostate carcinoma, they can contribute to the growth of the existing carcinoma. Therefore, before starting treatment with drugs containing testosterone, prostate cancer should be excluded.

special instructions

With the use of androgens in the treatment of elderly patients, the risk of developing prostatic hyperplasia may increase. Despite the lack of evidence that androgens can cause prostate carcinoma, they can contribute to the growth of the existing carcinoma. Therefore, before starting treatment with drugs containing testosterone, prostate cancer should be excluded.

As a preventive measure, regular examinations of the prostate gland are recommended.

Patients on long-term androgen therapy are advised to periodically monitor hemoglobin and hematocrit to identify cases of polycythemia.

Against the background of the use of sex steroids, which include testosterone, benign and, more rarely, malignant liver tumors that could lead to intraabdominal bleeding have been observed. If the treatment with Nebido develops severe pain in the upper abdomen, the liver is enlarged, or there are signs of intra-abdominal bleeding, then in case of differential diagnosis, the probability of a liver tumor should be taken into account.

The use of the drug in bodybuilding to build muscle mass is questionable due to a wide range of side effects. At the moment it is forbidden and is regarded as the use of doping.

Caution should be exercised in patients prone to edema, as androgen therapy may delay the excretion of sodium ions.

The existing sleep apnea syndrome may worsen.

Androgens are not used to enhance muscle development in healthy subjects, nor to increase physical ability.

Substitution testosterone therapy can reversibly reduce spermatogenesis.

Like all oily solutions, Nebido should be injected / m and very slowly to avoid pulmonary artery microembolism with an oil solution of the drug that can manifest itself with symptoms such as coughing, shortness of breath, malaise, hyperhidrosis, chest pain, dizziness, paresthesia or fainting. These reactions can develop during or immediately after injection and are reversible. Treatment, as a rule, supporting, for example, the introduction of additional oxygen.

Safety data from preclinical studies

The use of Nebido can lead to virilization of the female fetus at some stages of development. However, the results of studies for embryotoxic and, in particular, teratogenic effects, do not indicate the likelihood of further deterioration in organ development.

Impact on the ability to drive vehicles and manage mechanisms

Nebido does not affect the ability to drive and work with mechanisms that require increased attention.

Drug Interactions

Drugs affecting testosterone

Possible interaction with drugs that induce microsomal enzymes (eg, barbiturates), which can lead to an increase in testosterone clearance.

Influence of androgens on other drugs

Androgens can cause an increase in the concentration of oxyphenbutazone in the serum.

Testosterone and its derivatives can increase the activity of oral anticoagulants, which may lead to the need for dose adjustment. Regardless of this fact, as a general rule, restrictions should always be observed regarding intramuscular injections to patients with acquired or hereditary blood coagulation disorders.

Under the influence of androgens, hypoglycemic effects of insulin may increase. You may need to reduce the dose of hypoglycemic drug.

Since compatibility studies have not been conducted, this drug should not be confused with other drugs.

Analogues of the drug Nebido

Structural analogs for the active substance:

• Andriol;
• Androgel;
• Testosterone propionate.

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