Retabolil

General characteristics. Structure:

For injections contains in 1 ml of Solutio oleosa:
Active agent – Nandrolonum деканоат 50,00 mg
Excipients – benzyl alcohol, isopropanol, sunflower oil (for injections).

Pharmacological properties:

Pharmacodynamics. Retabolil is to synthetic derivatives of testosterone, anabolic drug of the prolonged action (depot drug). Stimulates synthesis of protein in an organism, causes a delay of nitrogen, calcium, sodium, potassium, chlorides and phosphorus that leads to increase in muscle bulk and acceleration of growth of bones, a water delay in an organism. Has low androgenic activity.

Pharmacokinetics. Nandrolonum деканоат it is slowly released from the place of an injection in a blood stream with an elimination half-life of 6 days. In blood ether is quickly hydrolyzed in Nandrolonum with an elimination half-life less than 1 hour. In general, the elimination half-life for the combined process of hydrolysis, distribution and removal of Nandrolonum from plasma makes 4,3 h. Nandrolonum is metabolized in a liver. The metabolites removed by kidneys are 19-norandrosteron, 19-noretiokholanon and 19-norepiandrosteron. Data on pharmacological activity of these metabolites are unknown.

Indications to use:

- Osteoporosis of various genesis;
- cachexia of various etiology;
- disturbance of protein metabolism, increase in the catabolic processes exhausting organism resources (burns, injuries, surgeries, radiation therapy, serious infectious diseases);
- operations, radiation therapy, serious infectious diseases
- disturbance of protein metabolism after serious burns, injuries, surgeries, radiation therapy, at serious infectious diseases;
- the progressing muscular dystrophy;
- amyotrophy the spinal progressing Verdniga-Goffmanna;
- a glomerulonephritis, a program hemodialysis at patients with a chronic renal failure.

Route of administration and doses:

The drug is administered deeply intramusculary. The dose of drug is defined individually. The average single dose for adults makes 25-50 mg each 3-4 weeks. At a heavy renal failure, including with uraemia, the dose makes 50 mg weekly.
To children Retabolil each 3-4 weeks appoint in a dose 400 mkg/kg of body weight.

Features of use:

For achievement of optimum therapeutic effect against the background of therapy by Retabolil the patient has to receive with is deprived adequate amount of proteins, fats, carbohydrates, vitamins, mineral substances.
At use of Retabolil in high doses at pubertal age perhaps premature closing of regions of growth and suspension of growth. Acceleration of epiphyseal growth of tubular bones can be noted at children both during treatment, and 6 months later after the termination of administration of drug.
For control of a condition of epiphyseal regions of growth of tubular bones at children and teenagers their X-ray inspection is recommended each 6 months.
During treatment it is necessary to carry out by Retabolil careful control in eye pressure.

 In the course of treatment systematic control of concentration in blood of calcium ions, cholesterol (especially at patients with the accompanying pathology of cardiovascular system), a hematocrit, hemoglobin, concentration of serumal phosphorus is necessary.
In certain cases against the background of use of drug disturbances of indicators of some functional hepatic trials are observed. Therefore each 4 weeks it is necessary to control function of a liver.
Retabolil can cause increase in tolerance to glucose in patients with a diabetes mellitus, thereby reducing the need for insulin or peroral hypoglycemic means.
At emergence of disturbances of a menstrual cycle and/or emergence of signs of virilescence treatment should be stopped.
To apply strictly on doctor's orders in order to avoid complications.
Before the beginning and during treatment by drug it is necessary to carry out rectal control of the size of a prostate.

Abuse of the medicines containing Nandrolonum (at use of high doses as anabolic means) can cause endocrine, metabolic and mental disorders.
Use of anabolic steroids for the purpose of stimulation of athletic qualities can do serious harm to health and is inadmissible!
Retabolil solution under the influence of cold can become, muddy. In this case before use the ampoule with drug needs to be heated to dissolution of crystals.

Side effects:

At use of the drug Retabolil according to the recommended dosing mode, manifestation of by-effects is usually improbable. At prolonged use or in case of abuse of drug the following side effects can appear:
At patients of both sexes: nausea, vomiting, loss of appetite, an abdominal pain, burning sensation in language, an abnormal liver function with jaundice, гепатонекроз (dark kcal, vomiting with blood impurity, a headache, feeling of discomfort, an unpleasant hepatic smell from a mouth), a hepatocellular carcinoma, пелиоз a liver (appetite loss, dark urine, decolouration a calla, a small tortoiseshell, a dot or makulezny hemorrhagic enanthesis and mucous membranes of an oral cavity and a nose), cholestatic hepatitis (yellow coloring of scleras and skin, pain in right hypochondrium, dark urine, decolouration a calla), diarrhea, feeling of overflow in a stomach, a meteorism, strengthening or decrease in a libido, an acne (especially at women and at boys of pubertal age).

The delay of nitrogen, sodium and water in an organism, peripheral hypostases, strengthening of vascularization of integuments, a hypercalcemia can be observed (especially at motionless patients and at women with metastasises of a breast cancer).
Progressing of atherosclerosis (increase in concentration of lipoproteins of low density – LPNP and decrease in concentration of lipoproteins of high density – LPVP), an iron deficiency anemia, a leukemoid syndrome (a leukosis, long tubular bone pains, hypocoagulation with tendency to bleedings), increase in secretion of sebaceous glands, a fever, spasms, a sleep disorder.
Suppression of secretion of gonadotropic hormones.

At women: virilescence symptoms (hirsutism, alopecia, irreversible decrease in a timbre of a voice, dis-and amenorrhea, suppression of function of ovaries, increase in a clitoris, steroid eels, fat skin), hypercalcemia (nausea, vomiting, increased fatigue).
At men: in the prepubertatny period – a virilism (acne rash, increase in a penis, a priapism, formation of secondary sexual characteristics), an idnopatichesky hyperpegmentation of skin, delay or the termination of growth (calcification of epiphyseal growth zones of tubular bones); in the post-pubertal period – irritation of a bladder (increase in frequency of desires), a mastodynia, a gynecomastia, a priapism, an oligospermatism, decrease in sexual function; advanced age – a hyperplasia and/or a carcinoma of a prostate.

Interaction with other medicines:

With care it is necessary to appoint Retabolil against the background of use of antiagregant and anticoagulants of indirect action (strengthening of their action is possible), hypoglycemic drugs (strengthening of their hypoglycemic effect is possible).
Retabolil can be applied in a combination therapy with glucocorticosteroids, tuberculostatic and cytostatic drugs.
Weakens effects of somatotropic hormone and its derivatives (accelerates a mineralization of epiphyseal regions of growth of tubular bones). Glucocorticosteroids and mineralokortikoida, corticotropin, sodium the containing medicines and the food rich with sodium strengthen (mutually) a liquid delay in an organism, increase risk of development of hypostases, increase expressiveness of acne rashes.
Co-administration with gepatotoksichny medicines increases risk of an abnormal liver function.

Contraindications:

- Hypersensitivity to any of drug components;
- pregnancy, lactation;
- nephrotic syndrome;
- prostate cancer;
- acute or chronic prostatitis;
- cancer of chest gland at men;
- severe damages of a liver, a liver failure at oncological patients or metastasises in a liver;
- a breast cancer (with metastasises in the presence of a hypercalcemia);
- a hypercalcemia (including in the anamnesis).

Overdose:

There are no data on overdose.
Symptoms: strengthening of the side effects described above.
Treatment: symptomatic. There is no specific antidote.

Storage conditions:

List B. At a temperature of 15-25 °C, in the place protected from light. To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

Solution for intramuscular introduction (oil) 50 mg/ml.
1 ml of solution for the intramuscular introduction (oil) containing 50 mg of Nandrolonum of a dekanoat in an ampoule from colourless glass of 1 hydrolytic class with a point for a break of blue color. 1 ampoule in the plastic pallet. 1 plastic pallet together with the application instruction in a cardboard pack.