Nandrolone Decanoate

Package leaflet (information for patients)

Tradename
Nandrolone Decanoate

Dosage form
Solution for injection 200mg / ml.

Description
Transparent liquid of light yellow color with a weak odor.

Structure
1 ml of solution contains:
Active ingredients: Nandrolone Decanoate 200mg.
Auxiliary components: ethyl oleate.

Pharmacotherapeutic group
Anabolic / androgenic steroids.

Pharmacological properties
Pharmacological action - antitumor, androgenic, anabolic, antianemic.
It binds to specific receptor proteins on the surface of target organ cells, forms a receptor- nandrolone complex, which ensures the transport of the latter through the cell membrane into the hyaloplasm, from where it diffuses through the nuclear membrane into the cell nucleus and activates the regulator genes. Androgenic properties are to stimulate the synthesis of nucleic acids (DNA, RNA), structural proteins, enhance tissue respiration and oxidative phosphorylation in skeletal muscles with the accumulation of macroergs (ATP, creatine phosphate); increases muscle mass and reduces adipose tissue. Accelerates the growth of male genital organs and the formation of secondary sexual characteristics in the male pattern. Promotes calcification of growth zones in bones and cessation of skeletal growth. Stimulates the secretory activity of androgen-dependent glands - male reproductive (activation of the process of spermatogenesis), sebaceous; in large doses, it causes suppression of Leydig cells and reduces the synthesis of endogenous sex hormones by inhibiting the production of FSH and LH by the pituitary gland (negative feedback). The anabolic effect is manifested by the activation of reparative processes in the epithelium (integumentary and glandular), bone and muscle tissues as a result of stimulation of protein synthesis and structural components of cells. Increases the completeness of absorption of amino acids from the small intestine (against the background of a diet rich in proteins), creating a positive nitrogen balance. Stimulates the production of erythropoietin and activates anabolic processes in the bone marrow, which, with the simultaneous administration of iron preparations, is manifested by an antianemic effect. Violates the synthesis of vitamin K-dependent plasma coagulation factors (II, VII, IX, X) in the liver, changes the plasma lipid profile (increases the concentration of LDL and decreases the HDL content), enhances the reabsorption of sodium and water in the kidneys, contributing to the formation of peripheral edema. After i / m administration of 100 mg Cmax is created in 1-3 weeks. Undergoes biotransformation in the liver to form 17-ketosteroids. It is excreted mainly in the urine (over 90%) and about 6% in feces.

Indications for use
Diabetic retinopathy ; progressive muscular dystrophy; Werdnig-Hoffmann syndrome ; conditions characterized by a negative balance of Ca2 + (senile and postmenopausal osteoporosis, long-term glucocorticoid therapy); an increase in catabolic processes that deplete the body's resources (chronic infectious diseases, severe injuries, extensive surgical interventions, steroid myopathy); anemia in chronic renal failure, myelofibrosis, myelosclerosis, myeloid aplasia of the bone marrow (refractory to conventional therapy), damage to the bone marrow by metastases of malignant neoplasms, myelotoxic drugs and heavy metal salts; inoperable (with metastases) breast carcinoma in postmenopausal women or after ovariectomy ; growth retardation in children caused by a deficiency of growth hormone.

Method of administration and dosage
V / m, deep. Nandrolone decanoate : for anemia (along with iron preparations) - 100-200 mg (for women - 50-100 mg) once a week; to stimulate anabolic processes - 50-200 mg (women - 50-100 mg) 1 time in 1-4 weeks ; children 2-13 years old - 25-50 mg 1 time in 3-4 weeks. The duration of the course (with a 1-4-week interval between injections) is up to 12 weeks, the second course is 8 weeks after the last injection of the drug. Treatment is carried out against the background of a diet rich in proteins. For breast carcinoma (nandrolone phenylpropionate) - 50-100 mg once a week; the duration of the course is individual.

Side effects
In men and women, the progression of atherosclerosis (an increase in the concentration of LDL and a decrease in the concentration of HDL), iron deficiency anemia, peripheral edema, dyspeptic disorders (pain in the abdomen and epigastric region, nausea, vomiting), impaired liver function with jaundice, leukemia-like syndrome (changes in leukocytic formula, pain in long bones), hypocoagulation with a tendency to bleeding, hepatonecrosis (dark stools, vomiting with blood, headache, discomfort, respiratory failure), hepatocellular carcinoma, hepatic purpura (dark urine, discoloration, stool, urticaria or macular hemorrhagic rash on the skin and mucous membranes, pharyngitis or tonsillitis), cholestatic hepatitis (yellow staining of the sclera and skin, pain in the right hypochondrium, dark-colored urine, discolored stools). In women, virilism (enlargement of the clitoris, coarsening of the voice, dys - and amenorrhea, male hair growth), hypercalcemia (depression of the central nervous system, nausea, vomiting, fatigue). In men: in the prepubertal period - virilism (acne, enlarged penis, priapism, formation of secondary sexual characteristics), idiopathic hyperpigmentation of the skin, slowing or cessation of growth (calcification of the epiphyseal growth zones of tubular bones); in the postpubertal period - bladder irritation (increased frequency of urge), breast hardening, gynecomastia, priapism, in old age - hypertrophy and / or carcinoma of the prostate gland.

Contraindication
Hypersensitivity, prostate cancer, malignant breast tumors in men, breast carcinoma in women with hypercalcemia (able to activate osteoclasts and cause bone resorption), pregnancy (has embryotoxicity, fetotoxicity, can cause musculinization of the female fetus); acute and chronic liver diseases, incl. alcoholic lesions; nephritis, nephrotic syndrome, breastfeeding.

Overdose
Symptoms: hepatotoxicity and intoxication. During intoxication, sweating, nausea, and vomiting may occur. These symptoms can be eliminated by reducing the dose.
Treatment: in case of signs of poisoning, induce vomiting or gastric lavage, prescribe activated charcoal and a laxative, and consult a doctor.
Intoxication and hepatotoxicity are more likely in elderly patients and especially in young children (therapeutic overdose or accidental intoxication can be very dangerous for them).

Precautions
To achieve the optimal therapeutic effect during the treatment period, the patient should receive adequate amounts of proteins, fats, carbohydrates, vitamins, and minerals with food.
When using nandrolone in high doses at puberty, premature closure of growth zones and growth arrest are possible. Acceleration of the epiphyseal growth of tubular bones can be observed in children both during treatment and 6 months after discontinuation of nandrolone.
To monitor the condition of the epiphyseal growth zones of tubular bones in children and adolescents, it is recommended to conduct an X-ray examination every 6 months.
During treatment with nandrolone, intraocular pressure should be carefully monitored.
In the course of treatment, systematic monitoring of the concentration of calcium ions, cholesterol in the blood (especially in patients with concomitant pathology of the cardiovascular system), hematocrit, hemoglobin, and serum phosphorus concentration is necessary.
In some cases, against the background of the use of nandrolone, violations of the indicators of some functional liver tests are observed. Therefore, liver function should be monitored every 4 weeks.

Interaction with other medicinal products
With caution, nandrolone should be prescribed against the background of the use of antiplatelet agents and anticoagulants of indirect action (their effect may be enhanced), hypoglycemic drugs (their hypoglycemic effect may be enhanced).
Nandrolone can be used in combination therapy with GCS, tuberculostatic and cytostatic drugs.
Attenuates the effects of growth hormone and its derivatives (accelerates mineralization epiphyseal 's tubular bone growth areas).
GCS and mineralocorticoids, corticotropin, sodium-containing drugs and foods rich in sodium, increase (mutually) fluid retention in the body, increase the risk of edema, and increase the severity of acne.
Simultaneous administration with gspatotoxic drugs increases the risk of liver dysfunction.

Special instructions
In diabetic patients, nandrolone can cause an increase in glucose tolerance, thereby reducing the need for insulin or oral hypoglycemic agents.
If menstrual irregularities occur and / or signs of virilization appear, treatment should be discontinued.
Before and during treatment with the drug, it is necessary to carry out rectal control of the size of the prostate gland.
The use of anabolic steroids to stimulate athletic performance can be severely harmful and unacceptable.

Pregnancy and elbowing
This drug should not be used during pregnancy and lactation.
During pregnancy, the drug can cause virilization in female fetuses.
During breastfeeding, it is not known how anabolic steroids are excreted in breast milk. In accordance with the adverse reactions that may occur in infants, it is necessary to decide whether to stop breastfeeding or stop taking the drug.

Influence on the ability to drive vehicles and work with mechanisms
Does not affect.

Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life
3 years. Do not use after the expiration date printed on the package.

Vacation conditions
On prescription.

Packaging
The solution is in 1 ml glass ampoules. Each ampoule is fixed in a plastic clip for 5 ampoules. 5 ampoules are packed in a cardboard box in a fixer together with an enclosed leaflet