Nandrolone Phenylpropionate 100 mg/ml

Nandrolone Phenylpropionate 100 mg/ml (Nandrolone) · ATC A14AB01

Anabolic steroid · short-acting ester

Each 1 ml contains Nandrolone Phenylpropionate 100 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 where a short-acting nandrolone ester is preferred, 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)

Potentiation of anticoagulation with a rise in INR and bleeding risk; the shorter ester produces faster onset and offset of this interaction, so INR should be checked after both initiation and discontinuation.

Insulin and oral antidiabetic agents

Increased insulin sensitivity may lower blood glucose and precipitate hypoglycaemia; antidiabetic requirements should be reassessed by the prescriber.

Corticosteroids and corticotrophin

Additive sodium retention and oedema formation, with increased risk in patients with cardiac, hepatic or renal disease.

Ciclosporin and other narrow-therapeutic-index immunosuppressants

Androgens have been reported to reduce hepatic clearance of ciclosporin, raising plasma concentrations and nephrotoxicity risk; concentration monitoring is advised.

5-alpha reductase inhibitors (finasteride, dutasteride)

Of no benefit for androgenic side effects with this agent and potentially counterproductive, since 5-alpha reduction of nandrolone generates a less potent, not a more potent, metabolite.

Use in special populations

Pregnancy and breastfeeding

Contraindicated. Nandrolone is teratogenic with respect to sexual differentiation and may virilise a female foetus. Women of childbearing potential should use effective contraception; the shorter ester shortens but does not remove the washout requirement. Breastfeeding should be discontinued during treatment.

Paediatric population

Not recommended. Risk of premature epiphyseal closure and permanent reduction in attained adult height, together with precocious virilisation. If administration cannot be avoided, bone age should be monitored at regular intervals.

Elderly

Caution is required. Increased susceptibility to fluid retention, hypertension, polycythaemia and to stimulation of pre-existing prostatic hyperplasia or occult carcinoma; prostate assessment and haematocrit monitoring are recommended before and during treatment.

Renal impairment

Caution. Fluid and sodium retention may aggravate oedema and hypertension; the more frequent dosing schedule of the short ester gives less time for fluid balance to stabilise between doses, and monitoring of weight, blood pressure and electrolytes is advised.

Hepatic impairment

Contraindicated in severe hepatic impairment; caution in mild to moderate impairment, where reduced metabolic clearance prolongs exposure. Periodic liver function testing is recommended, particularly with concomitant hepatotoxic agents or alcohol.

Athletes

Prohibited at all times under class S1.1 of the WADA Prohibited List as an exogenous anabolic androgenic steroid. Detection is by urinary 19-norandrosterone; although clearance is faster than for the decanoate, the metabolite remains detectable above the applicable reporting threshold for weeks to months after the last injection, and use will result in an adverse analytical finding.

Undesirable effects

General and injection site

Injection site pain, induration, erythema and swelling — reported more frequently than with long esters because of the shorter dosing interval and the greater number of injections required; sterile abscess and local fibrosis with repeated injection at one site

Endocrine

Suppression of endogenous testosterone and gonadotrophins; reduced sex hormone-binding globulin; impaired glucose tolerance; sodium and water retention

Reproductive system and breast

Reduced libido and erectile dysfunction, oligospermia, testicular atrophy, gynaecomastia; in women, virilisation with hirsutism, voice deepening, clitoromegaly and amenorrhoea, potentially irreversible

Cardiovascular

Hypertension, peripheral oedema, unfavourable shift in atherogenic risk, left ventricular hypertrophy with prolonged use

Investigations

Reduction in high-density lipoprotein cholesterol with elevation of low-density lipoprotein cholesterol, raised haemoglobin and haematocrit, elevated transaminases, altered thyroid function test values through suppression of thyroxine-binding globulin

Skin and subcutaneous tissue

Acne, seborrhoea, oily skin, increased body hair; androgenetic alopecia less frequently than with testosterone owing to the weaker 5-alpha-reduced metabolite

Psychiatric

Irritability, aggression, mood lability, insomnia; depressed mood on withdrawal

Hepatobiliary

Transient transaminase elevation; cholestatic jaundice reported uncommonly with parenteral androgen esters

Overdose

Because the phenylpropionate ester clears comparatively quickly, features of overdose — oedema, hypertension, virilisation in women, marked gonadotrophin suppression and polycythaemia — are correspondingly shorter-lived than with a long-acting nandrolone depot, though still measured in days rather than hours. No specific antidote exists. Treatment consists of withdrawal of the product and symptomatic supportive care, with monitoring of blood pressure, fluid balance, haematocrit and hepatic function.

Pharmacodynamic properties

Pharmacotherapeutic group: anabolic steroids, 19-nortestosterone derivatives (ATC A14AB01). The active moiety liberated from this ester is nandrolone, the same 19-nortestosterone agonist as in the decanoate presentation; the phenylpropionate ester alters delivery, not mechanism. Nandrolone binds the nuclear androgen receptor with affinity comparable to testosterone and drives transcription of genes controlling myofibrillar protein synthesis, positive nitrogen balance, erythropoiesis and bone mineral matrix, while suppressing hypothalamic-pituitary gonadotrophin secretion. Its distinguishing feature within the androgen class is that 5-alpha reduction produces 5-alpha-dihydronandrolone, a WEAKER androgen-receptor ligand than the parent compound, so androgenic effect is dampened in 5-alpha reductase-rich tissues. Aromatisation to estradiol proceeds at roughly one-fifth the rate seen with testosterone, and nandrolone retains meaningful progesterone-receptor agonism, an activity that contributes to suppression of libido and to breast tissue effects independently of oestrogen.

Pharmacokinetic properties

The 3-phenylpropionate is a shorter, less lipophilic ester than the decanoate and is therefore released from the intramuscular oil depot considerably faster. Serum nandrolone rises within about 24 to 48 hours of injection and falls with an apparent half-life of approximately 2.5 to 3 days, giving a shorter, higher-amplitude exposure profile and requiring more frequent administration at intervals set by the prescriber. Hydrolysis of the ester by plasma and tissue esterases yields free nandrolone, which is extensively protein-bound, principally to albumin, with weaker sex hormone-binding globulin affinity than testosterone. Hepatic metabolism proceeds by 5-alpha reduction to 5-alpha-dihydronandrolone and by weak aromatisation to estradiol, with terminal metabolites 19-norandrosterone and 19-noretiocholanolone conjugated and excreted in urine. Because the depot empties faster, both accumulation on repeated dosing and washout after discontinuation are more rapid than with the decanoate ester.

List of excipients

Benzyl alcohol 50 mg (co-solvent and antimicrobial preservative), refined oil carrier of vegetable origin q.s. to 1 ml. The headspace is overlaid with nitrogen. At this strength the active substance dissolves fully in the oil carrier, so no benzyl benzoate co-solvent and no added antioxidant are required. All excipients comply with the current Ph. Eur. / USP–NF monographs.

Excipient warnings

This medicinal product contains 50 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. Use with caution in patients with hepatic or renal impairment because of the risk of accumulation and 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. Withdraw and administer the dose immediately after opening; no in-use shelf life has been established and any unused portion must be discarded. Do not retain a part-used ampoule for a later injection.

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 the dose has been withdrawn. 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

05012345678906

Serial

4471 6650 0983 27

LOT

NP2606F

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.