Nandrolone Decanoate 250 mg/ml

Nandrolone Decanoate 250 mg/ml (Nandrolone) · ATC A14AB01

Anabolic steroid · long-acting ester

Each 1 ml contains Nandrolone Decanoate 250 mg in a sterile oil carrier.

For the full list of excipients, see section 6.1.

Solution for injection in a single-use glass ampoule for deep intramuscular use.

Therapeutic indications

Anabolic therapy as an adjunct in selected catabolic states, as determined by a physician.

Posology and method of administration

Deep intramuscular injection as directed by a physician. Not for intravenous use. Rotate injection sites. Dose and interval are individualised by the prescriber.

Contraindications

Known hypersensitivity to the active substance or excipients. Known or suspected carcinoma of the prostate or male breast. Not for use in women, in pregnancy or while breastfeeding. Use with caution in cardiac, renal or hepatic impairment.

Special warnings and precautions for use

Keep out of the reach and sight of children. Contains a substance prohibited in sport (WADA).

Interaction with other medicinal products

Vitamin K antagonists (warfarin, acenocoumarol)

Nandrolone potentiates the anticoagulant effect, in part through reduced synthesis of clotting factors and displacement from protein binding; INR may rise markedly and requires close monitoring with anticoagulant dose reduction determined by the prescriber.

Insulin and oral antidiabetic agents

Anabolic steroids improve insulin sensitivity and glucose tolerance, which can precipitate hypoglycaemia in treated diabetic patients; glycaemic monitoring and antidiabetic dose review are required.

Corticosteroids and corticotrophin

Additive sodium and water retention, increasing the risk of oedema and hypertension, particularly in patients with cardiac or renal impairment.

5-alpha reductase inhibitors (finasteride, dutasteride)

Because 5-alpha reduction of nandrolone yields a LESS potent metabolite, blockade of the enzyme does not reduce and may increase androgenic exposure in skin, scalp and prostate — the opposite of the effect expected with testosterone.

Hepatotoxic medicinal products and alcohol

Additive hepatic injury; concomitant use warrants monitoring of liver function tests.

Erythropoiesis-stimulating agents

Additive stimulation of erythropoiesis with increased risk of polycythaemia and hyperviscosity; haematocrit should be monitored.

Use in special populations

Pregnancy and breastfeeding

Contraindicated. Androgens cross the placenta and may cause virilisation of a female foetus; nandrolone's long depot half-life means exposure persists well beyond the last dose. Excretion in breast milk and effects on the breastfed infant have not been established, and breastfeeding should be discontinued.

Paediatric population

Not recommended in children and adolescents. Androgens accelerate epiphyseal maturation and may cause premature closure of the epiphyses with irreversible loss of adult height, as well as precocious virilisation. Where use is unavoidable, skeletal maturation should be monitored radiologically.

Elderly

Use with particular caution. Older men are at increased risk of benign prostatic hyperplasia and occult prostate carcinoma, of fluid retention and of polycythaemia. Prostate examination, prostate-specific antigen and haematocrit should be assessed before and during treatment.

Renal impairment

Use with caution. Sodium and water retention may precipitate or worsen oedema and hypertension. Nandrolone has historically been used in the anaemia of chronic renal failure, but treatment requires monitoring of fluid balance, blood pressure and haematocrit, at doses determined by the prescriber.

Hepatic impairment

Contraindicated in severe hepatic impairment. Although the injectable non-17-alpha-alkylated ester carries a lower hepatotoxic burden than oral alkylated androgens, hepatic metabolism is the principal clearance route and impaired function prolongs exposure; liver function should be monitored.

Athletes

Nandrolone is an exogenous anabolic androgenic steroid prohibited at all times, in and out of competition, under class S1.1 of the WADA Prohibited List. Its urinary metabolite 19-norandrosterone is the analytical target and, because of the decanoate depot, may exceed the applicable reporting threshold for many months after a single administration — detection windows of up to 12 to 18 months have been documented. Use of this product will result in an adverse analytical finding.

Undesirable effects

Endocrine

Suppression of endogenous testosterone, luteinising hormone and follicle-stimulating hormone; impaired glucose tolerance; sodium and water retention; suppression of thyroxine-binding globulin with altered total T4 and T3 values

Reproductive system and breast

Oligospermia and reduced fertility, testicular atrophy, reduced libido and erectile dysfunction (progestogen-mediated as well as gonadotrophin-mediated), gynaecomastia; in women, virilisation with hirsutism, deepening of the voice, clitoral enlargement and menstrual irregularity, some of which may be irreversible

Cardiovascular

Hypertension, fluid retention and peripheral oedema, left ventricular hypertrophy with prolonged exposure, adverse effect on the atherogenic risk profile

Hepatobiliary

Elevated transaminases; cholestasis and jaundice reported with androgen therapy, although less frequent with non-17-alpha-alkylated esters such as this one

Blood and lymphatic system

Increased haemoglobin and haematocrit, polycythaemia; alterations in coagulation factors and potentiation of anticoagulant effect

Investigations

Marked reduction in high-density lipoprotein cholesterol with increased low-density lipoprotein cholesterol; suppressed sex hormone-binding globulin; raised haematocrit

Psychiatric

Mood lability, irritability and aggression, insomnia, anxiety; depressed mood, particularly during withdrawal after prolonged administration

General and injection site

Injection site pain, induration, erythema and sterile abscess formation; acne, seborrhoea, and increased body hair; muscle cramp

Overdose

Acute overdose with a long-acting oily depot is unlikely to produce immediate toxicity; the clinical picture is one of exaggerated and prolonged pharmacological effect — fluid retention, hypertension, polycythaemia, virilisation in women and pronounced gonadotrophin suppression — persisting for weeks because the depot cannot be removed once injected. There is no specific antidote. Management is symptomatic and supportive, with monitoring of blood pressure, haematocrit and liver function until serum concentrations fall.

Pharmacodynamic properties

Pharmacotherapeutic group: anabolic steroids, 19-nortestosterone derivatives (ATC A14AB01). Nandrolone is 19-nortestosterone: testosterone lacking the C19 methyl group, a modification that raises the ratio of anabolic to androgenic activity. It acts as an agonist at the nuclear androgen receptor, for which its affinity is comparable to or slightly greater than that of testosterone; the ligand-receptor complex binds androgen response elements and increases transcription of genes governing skeletal muscle protein synthesis, nitrogen retention and erythropoiesis, and suppresses hypothalamic-pituitary gonadotrophin release. The class difference is metabolic rather than receptor-level: 5-alpha reductase converts nandrolone to 5-alpha-dihydronandrolone, a metabolite of LOWER androgen-receptor potency than the parent, so androgenic expression is attenuated in 5-alpha reductase-rich tissue (scalp, skin, prostate) rather than amplified as with testosterone. Aromatisation to estradiol occurs but is weak, of the order of one-fifth the rate observed with testosterone; nandrolone additionally possesses appreciable progesterone-receptor agonism, which contributes to gonadotrophin suppression and to progestogen-mediated effects on breast tissue and sexual function.

Pharmacokinetic properties

The decanoate ester is essentially inactive until hydrolysed; after deep intramuscular injection the oily depot is the rate-limiting compartment, releasing esterified drug slowly into the circulation where non-specific tissue and plasma esterases liberate free nandrolone. Serum nandrolone rises over approximately 24 to 48 hours and then declines with an apparent terminal half-life of the order of 6 to 12 days, reflecting depot release rather than clearance of the parent steroid, whose own half-life is only a few hours. Nandrolone is extensively bound to plasma proteins, chiefly albumin, with lower affinity for sex hormone-binding globulin than testosterone. Metabolism is hepatic and includes 5-alpha reduction to 5-alpha-dihydronandrolone and weak aromatisation to estradiol, with onward conversion to 19-norandrosterone and 19-noretiocholanolone; these are conjugated as glucuronides and sulfates and excreted predominantly in urine. Steady state is approached only after repeated administration at the prescribed interval, and washout after the last dose is correspondingly protracted.

List of excipients

Benzyl alcohol 100 mg (co-solvent and antimicrobial preservative), butylated hydroxytoluene 0.15 mg (antioxidant), refined oil carrier of vegetable origin q.s. to 1 ml. The headspace is overlaid with nitrogen. All excipients comply with the current Ph. Eur. / USP–NF monographs; no colourants and no chelating agents are used.

Excipient warnings

This medicinal product contains 100 mg benzyl alcohol in each 1 ml. Benzyl alcohol may cause allergic reactions. It must not be given to premature or newborn infants and may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old. Large volumes should be used with caution, and only if necessary, in patients with hepatic or renal impairment and in pregnancy or breast-feeding, because of the risk of accumulation and toxicity (metabolic acidosis). The product also contains a refined oil carrier of vegetable origin; it must not be used in patients with a known hypersensitivity to vegetable oils.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. As an oil-based solution it is not miscible with aqueous injections or infusion fluids and must not be diluted.

Shelf life

36 months from the date of manufacture in the unopened container. Do not use after the expiry date (EXP) printed on the ampoule and the carton.

After first opening

Single-dose ampoule — for immediate use only. Inspect the solution visually before administration; use only if it is clear, free from visible particles and the ampoule is intact. Once the ampoule has been opened, the dose must be withdrawn and administered immediately; no in-use shelf life has been established and any residual solution must be discarded. Do not retain a part-used ampoule.

Storage

Store below 25 °C. Protect from light. Do not freeze. Keep ampoules in the outer carton until use.

Container

Colourless (transparent) or amber Type I glass ampoule (Ph. Eur. / USP Type I borosilicate), one-point-cut, containing 1 ml of sterile oil solution for injection, sealed under a nitrogen overlay. Pack size: 10 ampoules × 1 ml in a serialised outer carton with the package leaflet; the carton bears a GS1 DataMatrix, a human-readable serial and a scratch-off verification code. Primary packaging is sourced and controlled to ISO 15378.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. The ampoule is for single use: discard the opened ampoule and any residual solution immediately after withdrawal of the dose. Glass ampoules, needles and syringes must be placed directly into an approved puncture-resistant sharps container and must not be recapped or returned to the carton.

Pack

10 Ampoules × 1 ml

GTIN

05012345678905

Serial

1190 4482 7714 55

LOT

ND2510E

MFG

06 / 2026

EXP

06 / 2029

Every carton carries a GS1 DataMatrix and a verification code; a pack can be checked at ergopharm.net/verify.

Ergopharm Advanced Research Centre, Tandalja, Vadodara, Gujarat 390012, India. For Export Only.

Report a suspected adverse reaction or quality defect to pv@ergopharm.net.