Trenbolone Acetate 100 mg/ml

Trenbolone Acetate 100 mg/ml (Trenbolone)

Anabolic–androgenic steroid · short-acting ester

Each 1 ml contains Trenbolone Acetate 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 ester is preferred, under close medical supervision.

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)

Anabolic androgenic steroids potentiate the anticoagulant response, raising INR and bleeding risk; frequent INR monitoring is required on initiation and withdrawal.

Corticosteroids

Trenbolone's antagonism at the glucocorticoid receptor may blunt the therapeutic effect of corticosteroid therapy; conversely, sodium retention from both agents may be additive with respect to oedema and hypertension.

Insulin and oral antidiabetic agents

Altered glucose handling with potential for hypoglycaemia; glycaemic monitoring and reassessment of antidiabetic dose are required.

Aromatase inhibitors and selective oestrogen receptor modulators

Pharmacologically without benefit against trenbolone-related breast symptoms, which are progestogenic in origin; concurrent aromatase inhibition further lowers an already suppressed estradiol and may worsen arthralgia, dyslipidaemia, low mood and loss of libido.

Hepatotoxic medicinal products and alcohol

Additive potential for hepatic injury; liver function tests should be monitored during concomitant use.

Use in special populations

Pregnancy and breastfeeding

Contraindicated. Trenbolone is a potent androgen and progestogen with a high potential to virilise a female foetus and to disturb pregnancy maintenance. Effective contraception is required in women of childbearing potential, and breastfeeding must be discontinued.

Paediatric population

Contraindicated. The potency of this agent makes premature epiphyseal closure, irreversible loss of adult height and precocious virilisation particularly likely; there are no data supporting use in children or adolescents.

Elderly

Not recommended. The cardiovascular burden — hypertension, tachycardia, reduced aerobic capacity and severe HDL suppression — is poorly tolerated with advancing age, and prostatic tissue effects add further risk. If use is unavoidable, cardiovascular and prostatic assessment should precede and accompany treatment.

Renal impairment

Contraindicated in significant renal impairment. Reports of altered renal function markers and dark urine during trenbolone exposure, together with sodium retention and hypertension, make deterioration of renal function a realistic concern; renal function and blood pressure should be monitored.

Hepatic impairment

Contraindicated in severe hepatic impairment. Hepatic metabolism is the principal route of elimination, and impaired function prolongs exposure to a highly potent androgen; periodic liver function testing is recommended in all treated patients.

Athletes

Trenbolone is an exogenous anabolic androgenic steroid prohibited at all times, in and out of competition, under class S1.1 of the WADA Prohibited List. Detection is based on the urinary metabolites epitrenbolone and trendione, which remain identifiable for a prolonged period after the last dose despite the short ester; use will result in an adverse analytical finding.

Undesirable effects

Endocrine

Profound and rapid suppression of luteinising hormone, follicle-stimulating hormone and endogenous testosterone; hyperprolactinaemia and progestogen-mediated effects; suppression of serum estradiol to subphysiological concentrations, since no aromatisation occurs to replace it

Cardiovascular

Hypertension, tachycardia and palpitations, marked reduction in exercise tolerance and aerobic capacity, left ventricular hypertrophy; pronounced adverse change in the atherogenic lipid profile

Respiratory, thoracic and mediastinal

Transient severe cough, chest tightness and dyspnoea occurring within seconds to minutes of intramuscular injection and resolving spontaneously; exertional breathlessness during treatment

Psychiatric

Insomnia, irritability, aggression and hostility, anxiety, restlessness and mood lability, reported more prominently than with other androgens

General and injection site

Profuse night sweats, injection site pain and induration; the frequent injection interval demanded by the short ester increases cumulative local reactions

Reproductive system and breast

Loss of libido and erectile dysfunction, oligospermia, testicular atrophy; gynaecomastia mediated by progesterone-receptor activity and hyperprolactinaemia rather than by oestrogen; virilisation in women, potentially irreversible

Renal and urinary

Dark-coloured urine, reported alterations in renal function markers and reduced creatinine clearance with prolonged high exposure

Investigations and hepatobiliary

Steep fall in high-density lipoprotein cholesterol, elevated haematocrit, raised transaminases and rarely cholestasis

Overdose

Overdose presents as exaggerated pharmacological effect — tachycardia, hypertension, profuse sweating, insomnia, agitation and dyspnoea — rather than as a distinct toxidrome, and with the short acetate ester these features decline over a few days after the last administration. No specific antidote is available. Management is symptomatic and supportive, with cardiovascular monitoring and correction of fluid and electrolyte disturbance as required.

Pharmacodynamic properties

Pharmacotherapeutic group: anabolic steroids, 19-nortestosterone (estrene) derivatives. Trenbolone is 17-beta-hydroxyestra-4,9,11-trien-3-one, a 19-nortestosterone bearing additional double bonds at positions 9 and 11. This triene configuration confers two defining properties: the molecule is not a substrate for aromatase and therefore does NOT convert to estradiol, and it is a poor substrate for 5-alpha reductase, so its activity is not modulated by that enzyme in the way testosterone's is. Its affinity for the androgen receptor is several-fold that of testosterone, producing potent stimulation of muscle protein synthesis and nitrogen retention. Trenbolone additionally binds the progesterone receptor with high affinity, acting as a progestogen, and interacts with the glucocorticoid receptor, where it exerts an antiglucocorticoid, anticatabolic effect by opposing cortisol-mediated protein breakdown. The absence of oestrogenic conversion combined with strong progestogenic activity gives a hormonal profile quite unlike that of testosterone or nandrolone.

Pharmacokinetic properties

The acetate is a short two-carbon ester giving rapid liberation of free trenbolone from the intramuscular oil depot by plasma and tissue esterases. Serum concentrations peak within roughly 24 hours and decline with an apparent half-life of the order of 2 to 3 days, so that a short administration interval is required to maintain steady exposure; unesterified trenbolone itself has a half-life of only a few hours. Trenbolone is highly bound to plasma proteins, principally albumin, with negligible affinity for sex hormone-binding globulin. Metabolism is hepatic and yields 17-alpha-trenbolone (epitrenbolone) and trendione (trenbolone-17-one), which are conjugated as glucuronides and sulfates and excreted in urine and faeces. Neither estradiol nor a less potent 5-alpha-reduced metabolite is formed in any meaningful quantity.

List of excipients

Benzyl alcohol 20 mg (antimicrobial preservative and co-solvent), butylated hydroxytoluene 0.10 mg (antioxidant, protecting the oxidation-sensitive trienone system of the active substance), refined oil carrier of vegetable origin q.s. to 1 ml. Compounding, filtration and filling are carried out under nitrogen. All excipients comply with the current Ph. Eur. / USP–NF monographs; no benzyl benzoate co-solvent is required at 100 mg/ml.

Excipient warnings

This medicinal product contains 20 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. The product also contains butylated hydroxytoluene, which may cause local skin reactions or irritation of the eyes and mucous membranes, and 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. A slight yellow colour is characteristic of the active substance. Withdraw and administer the dose immediately after opening; 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. Keep the ampoules in the outer carton in order to protect them from light.

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

05012345678912

Serial

5523 8890 1147 63

LOT

TA2612L

MFG

12 / 2026

EXP

12 / 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.