Retabolil - instructions for use, dose, side effects, contraindications

Active substanceNandroloneNandrolone

Similar drugsTo uncover

Retabolil

solution w / m

GEDEON RICHTER, OJSC Hungary

Dosage form: & nbsp

solution for intramuscular administration (oily)

Composition:

In 1 ml of oily solution for injection contains:

Active substance - Nandrolone decanoate 50.00 mg

Excipients - benzyl alcohol, isopropanol, sunflower oil (for injection).

Description:

Greenish-yellow transparent oil solution with a characteristic odor, free from mechanical inclusions.

Pharmacotherapeutic group:anabolic steroid.

ATX: & nbsp

A.14.A.B.01 Nandrolone

Pharmacodynamics:

Retabolil is a synthetic derivative of testosterone, an anabolic drug of prolonged action (depot preparation). Stimulates the synthesis of protein in the body, causes a delay in nitrogen, calcium, sodium, potassium, chlorides and phosphorus, which leads to an increase in muscle mass and accelerated bone growth, water retention in the body. Has low androgenic activity.

Pharmacokinetics:Nandrolone decanoate is slowly released from the injection site into the bloodstream with a zero-elimination period of 6 days. In the blood, the ether rapidly hydrolyzes in nandrolone with a zero-elimination period of less than 1 hour. In general, the half-life for the combined process of hydrolysis, distribution and removal of nandrolone from plasma is 4.3 h. Nandrolone is metabolized in the liver.Metabolites excreted by the kidneys are 19-norandrosterone, 19-norethiocholanone and 19-norepiadrosterone. Data on the pharmacological activity of these metabolites are unknown.

Indications:

- Osteoporosis of various genesis;

- cachexia of various etiologies;

- violation of protein metabolism, increased catabolic processes, depleting body resources (burns, trauma, surgery, radiation therapy, severe infectious diseases);

- operations, radiotherapy, severe infectious diseases

- violation of protein metabolism after severe burns, injuries, surgical operations, radiation therapy, with severe infectious diseases;

- progressive muscular dystrophy;

- amyotrophy spinal progressive Werdnig-Hoffmann;

- glomerulomephritis, program hemodialysis in patients with chronic renal insufficiency;

Contraindications:

- Hypersensitivity to any of the components of the drug;

- pregnancy, lactation;

- nephrotic syndrome;

- prostate cancer;

- acute or chronic prostatitis;

- breast cancer in men;

- severe liver damage, liver failure in cancer patients or metastasis in the liver;

- Breast cancer (with metastases if available hypercalcemiaand);

- hypercalcemia (including in the anamnesis).

Carefully:

cardiac, hepatic and renal insufficiency, arterial hypertension, severe atherosclerosis, myocardial infarction (including history), cerebral circulation disorder, diabetes mellitus, prostatic hypertrophy, migraine, epilepsy, history of glaucoma (anabolic steroids cause sodium and liquid retention in the organism), elderly age, convulsions (including in the anamnesis).

In connection with androgenic activity of women and children, the drug is prescribed in the event that the expected effect of therapy exceeds the possible risk.

Pregnancy and lactation:contraindicated

Dosing and Administration:

The drug is administered intramuscularly. The dose of the drug is determined individually. The average single dose for adults is 25-50 mg every 3-4 weeks. In severe renal failure, including uremia, the dose is 50 mg weekly.

To children Retabolil is prescribed in a dose of 400 mkg / kg of body weight every 3-4 weeks.

Side effects:

When using Retabolil according to the recommended dosing regimen, the appearance of side effects is usually unlikely.With prolonged use or in case of abuse of the drug, the following side effects may appear:

In patients of both sexes; nausea, vomiting, loss of appetite, abdominal pain, burning sensation in the tongue, dysfunction of the liver with jaundice, hepatonecrosis (dark feces, vomiting with blood, headache, discomfort, unpleasant hepatic smell from the mouth), hepatocellular carcinoma, liver pelitis (loss of appetite, dark urine, fecal decolorization, urticaria, spot or macular haemorrhagic rashes on the skin and mucous membranes of the oral cavity and nose), cholestatic hepatitis (yellow staining of sclera and skin, pain in the right hypochondrium, dark urine, impotence echivanie stool), diarrhea, feeling of fullness in the stomach, flatulence, increased or decreased libido, acne (especially in women and boys puberty). There may be a delay in nitrogen, sodium and water in the body, peripheral edema, increased vascularization of the skin, hypercalcemia (especially in immobile patients and in women with metastases of breast cancer). Progression of atherosclerosis (an increase in the concentration of low density lipoproteins - LDL and a decrease in the concentration of high-density lipoproteins - LH1VG1), iron deficiency anemia,leukemoid syndrome (leukemia, pain in long tubular bones, gi on coagulation with a tendency to bleeding), increased secretion of sebaceous glands, chills, convulsions, sleep disturbance.

Suppression of the secretion of gonadotropic hormones.

Among women: symptoms of virilization (hirsutism, alopecia, irreversible decrease in the tone of voice, dis- and amenorrhea, suppression of ovarian function, clitoris enlargement, steroid acne, oily skin), hypercalcemia (nausea, vomiting, fatigue).

In men: in the non-pubertal period - virilism (acne, penis enlargement, priapism, the formation of secondary sexual characteristics), idiopathic hyperpigmentation of the skin, slowing or stopping growth (calcification of epiphyseal growth zones of tubular bones); in the post-pubertal period - irritation of the bladder (increased frequency of urge), mastodynia, gynecomastia, priapism, oligospermia, decreased sexual function; advanced age - hyperplasia and / or carcinoma of the prostate.

Overdose:

There is no information about an overdose.

Symptoms: increased side effects described above.

Treatment: symptomatic. There is no specific antidote.

Interaction:

With caution should prescribe Retabolil against the backdrop of the use of antiaggregants and anticoagulants of indirect action (possibly increasing their effect), hypoglycemic drugs (possibly increasing their hypoglycemic effect). Retabolil can be used in combination therapy with glucocorticosteroids, tuberculostatic and cytostatic drugs.

Weakens the effects of growth hormone and its derivatives (accelerates the mineralization of epiphyseal growth zones of tubular bones). Glucocorticosteroids and mineralocorticoids, kortnkotropin, sodium containing medicines and foods rich in sodium, enhance (mutually) the retention of fluid in the body, increase the risk of edema, increase the severity of acne eruptions. Simultaneous administration with gspatotoksicnymi drugs increases the risk of impaired liver function.

Special instructions:

To achieve the optimal therapeutic effect against Retabolil therapy, the patient should receive with the adequate amount of proteins, fats, carbohydrates, vitamins, minerals.

With the use of Rstabolil in high doses at pubertal age, premature closure of growth zones and growth retardation are possible. Acceleration of epiphyseal growth of tubular bones can be noted in children both during treatment and 6 months after discontinuation of the drug.

To monitor the condition of epiphyseal growth zones of tubular bones in children and adolescents, it is recommended that they be radiolabelled every 6 months.

During treatment with Retabolil, careful monitoring should be carried out within the eye pressure.

In the course of treatment, a systematic control of the concentration of calcium, cholesterol (especially in patients with concomitant cardiovascular pathology), hematocrit, hemoglobin, serum phosphorus concentration is necessary in the blood.

In some cases, against the background of the use of the drug, there are violations of the indices of some functional liver samples. Therefore, every 4 weeks, liver function should be monitored.

In patients with diabetes, Retabolil can cause an increase in glucose tolerance, thereby reducing the need for insulin or oral hypoglycemic agents.

If there is a violation of the menstrual cycle and / or signs of virilization, treatment should be discontinued.

Use strictly according to the doctor's prescription to avoid complications.

Before and during the treatment with the drug, rectal control of the size of the prostate gland is necessary.

Abuse of medicinal products containing nandrolone (when using high doses as an anabolic agent) can cause endocrine, metabolic and mental disorders.

The use of anabolic steroids for the purpose of stimulating athletic qualities can cause serious damage to health and is unacceptable!

Retabolil solution under the influence of cold can become turbid. In this case, before use, the ampoule with the preparation must be heated to dissolve the crystals.

Effect on the ability to drive transp. cf. and fur:does not affect the ability to manage motor vehicles and perform work associated with a high risk of injury.

Form release / dosage:

Solution for intramuscular administration (oily) 50 mg / ml.

1 ml of solution for intramuscular administration (oily) containing 50 mg of nandrolone decanoate,in an ampoule of colorless glass 1 hydrolytic class with a point for the break in blue. 1 ampoule in a plastic pallet. 1 plastic pallet together with instructions for use in a cardboard bundle.

Packaging:ampoules (1) -tacks of cardboard
ampoules (1) -packing contour plastic (pallets)

Storage conditions:

List B. At a temperature of] 5-25 ° C, in a place protected from light. Keep out of the reach of children!

Shelf life:

5 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014823 / 01

Date of registration:26.12.2008

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER, Ltd. Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp19.02.2010

Illustrated instructions

Instructions

Retabolil (Retabolil)