Rapid Combo 150 mg/ml

Rapid Combo 150 mg/ml (Drostanolone, testosterone and trenbolone (as drostanolone propionate, testosterone propionate and trenbolone acetate))

Anabolic–androgenic steroid · short-ester blend

Each 1 ml contains Drostanolone Propionate 50 mg, Testosterone Propionate 50 mg and Trenbolone Acetate 50 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

Combined anabolic–androgenic therapy with a rapid onset from short-acting esters, 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

Coumarin anticoagulants

Anabolic androgenic steroids depress the synthesis of vitamin K-dependent clotting factors and increase sensitivity to oral anticoagulants; the multi-agent androgen load in this preparation makes a clinically significant rise in INR and bleeding risk more likely, requiring close monitoring.

Insulin and oral antidiabetic agents

Androgen and anabolic steroid exposure alters glucose handling: insulin sensitivity may initially improve with a risk of hypoglycaemia, while sustained high-dose exposure — particularly to the non-aromatisable components — can worsen insulin resistance and glycaemic control, so antidiabetic therapy requires review by the prescriber.

Hepatotoxic and nephrotoxic medicinal products

Concurrent use with agents that burden the liver or kidney may compound the hepatic enzyme elevation and renal effects associated with this combination; hepatic and renal function should be monitored.

Dopamine antagonists (antipsychotics, metoclopramide, domperidone)

The progestogenic activity of the trenbolone component can contribute to prolactin-related effects, and concomitant prolactin-raising drugs may compound gynaecomastia, galactorrhoea and sexual dysfunction.

Aromatase inhibitors and oestrogen receptor antagonists

These agents modify only the oestrogenic consequences of the testosterone propionate component; drostanolone and trenbolone are not aromatised, so oestrogen-directed treatment does not attenuate their androgenic, progestogenic or metabolic effects, while further lowering oestradiol may aggravate the adverse lipid and bone profile.

Use in special populations

Pregnancy and breastfeeding

Contraindicated. All three components are potent androgens capable of virilising a female foetus, and 19-nor derivatives additionally carry progestogenic activity; pregnancy must be excluded and effective contraception used. Breastfeeding is contraindicated during treatment and until the actives and their metabolites have been eliminated.

Women

Not recommended. The combination causes rapid and often irreversible virilisation — deepening of the voice, hirsutism, clitoral hypertrophy, male-pattern hair loss — and menstrual disturbance; the trenbolone component in particular produces virilising effects at low exposure and these may not resolve after discontinuation.

Paediatric population

Contraindicated in children and adolescents. Anabolic androgenic steroids accelerate skeletal maturation and cause premature epiphyseal closure with permanent loss of adult height, together with precocious virilisation and permanent suppression of the developing hypothalamic-pituitary-gonadal axis.

Cardiovascular, renal and hepatic impairment

Contraindicated in severe hepatic insufficiency and used only under specialist supervision, if at all, in patients with hypertension, ischaemic heart disease, cardiac failure or renal impairment, since the combination adversely affects blood pressure, lipids, haematocrit and renal function. Baseline and periodic monitoring of lipids, haematocrit, renal and hepatic function is required.

Elderly

Not recommended. Older patients have a greater burden of prostatic, cardiovascular and cerebrovascular disease, and the combination's effects on blood pressure, haematocrit and lipids amplify that risk; prostate assessment including prostate-specific antigen should precede any androgen exposure.

Athletes

Testosterone, drostanolone and trenbolone are all exogenous anabolic androgenic steroids prohibited in sport at all times, in and out of competition, under class S1.1 of the WADA Prohibited List. Trenbolone and drostanolone metabolites are readily identified by gas chromatography-mass spectrometry and remain detectable in urine for a prolonged period after the last administration, and exogenous testosterone is identified by steroid-profile and carbon isotope ratio analysis. Use by any athlete subject to anti-doping regulation will result in an adverse analytical finding.

Undesirable effects

Endocrine and reproductive system

Rapid and profound suppression of LH, FSH and endogenous testosterone, testicular atrophy, azoospermia and prolonged impairment of fertility, loss of libido and erectile dysfunction during and after use, gynaecomastia (from aromatisation of the testosterone component and from the progestogenic activity of trenbolone), galactorrhoea, marked virilisation and irreversible voice change in women

Cardiovascular and metabolism

Severe deterioration of the lipid profile with pronounced suppression of HDL-cholesterol, hypertension, left ventricular hypertrophy and impaired diastolic function, insulin resistance; the non-aromatisable components are associated with particularly marked lipid changes

Blood and lymphatic system

Erythrocytosis with raised haemoglobin and haematocrit, increased blood viscosity, thromboembolic events

Renal and urinary

Reduced urine volume with darkening of the urine, increased serum creatinine, worsening of pre-existing renal impairment; nephrotoxicity has been associated with high-dose trenbolone exposure

Hepatobiliary

Elevation of transaminases and bilirubin, cholestasis; peliosis hepatis and hepatic tumours have been reported after prolonged high-dose anabolic steroid exposure

Psychiatric and nervous system

Aggression and hostility, irritability, anxiety, emotional lability and hypomanic symptoms, marked insomnia, night sweats, headache; depression, anhedonia and steroid withdrawal syndrome on discontinuation

Respiratory, thoracic and mediastinal

Acute cough, chest tightness and dyspnoea occurring within seconds to minutes of injection (consistent with pulmonary oil microembolism), reduced exercise tolerance and breathlessness on exertion, sleep-disordered breathing

Skin and subcutaneous tissue, and injection site

Severe acne including acne conglobata, seborrhoea, hyperhidrosis, androgenetic alopecia; injection-site pain, erythema and induration, which is prominent with a three-ester short-chain oil solution, and sterile abscess formation

Overdose

Acute overdose is unlikely to be immediately life-threatening, but the combined androgen load may produce pronounced hypertension, erythrocytosis, fluid retention, insomnia, agitation and aggression, and, with the trenbolone component, sweating, dark urine and rising creatinine; effects persist for several days after exposure because all three actives are depot esters. There is no specific antidote and no reversal agent; management is withdrawal of the product together with symptomatic and supportive care, including monitoring of blood pressure, haematocrit, renal and hepatic function and mental state, and venesection if erythrocytosis is severe. Haemodialysis does not enhance elimination of the extensively protein-bound components.

Pharmacodynamic properties

The preparation is a fixed combination of three short-ester anabolic androgenic steroids — drostanolone propionate 50 mg, testosterone propionate 50 mg and trenbolone acetate 50 mg per ml — with complementary but distinct receptor pharmacology; all three are ester prodrugs acting through the nuclear androgen receptor after hydrolysis. Testosterone, released from the propionate ester, is the reference androgen and is the only component subject to aromatisation to oestradiol and to 5-alpha reduction to dihydrotestosterone. Drostanolone is 2-alpha-methyl-dihydrotestosterone, already 5-alpha reduced and therefore not a substrate for aromatase or for 5-alpha reductase; it binds the androgen receptor with high affinity, is strongly bound by sex hormone-binding globulin and exerts a weak anti-oestrogenic action, which historically underlay its use in advanced breast carcinoma. Trenbolone is a 19-nortestosterone (estrane) derivative with markedly higher androgen receptor affinity than testosterone that is not aromatised, is not converted to a weaker 5-alpha reduced metabolite, and additionally binds the progesterone and glucocorticoid receptors, giving progestogenic activity and an anti-glucocorticoid effect; the combined androgenic load produces profound and rapid suppression of hypothalamic-pituitary gonadotrophin secretion and of endogenous testicular steroidogenesis.

Pharmacokinetic properties

All three actives are short esters dissolved in an oily vehicle; after deep intramuscular injection they are released from the depot and hydrolysed by non-specific esterases, giving a rapid rise in plasma concentrations of the parent steroids with maxima generally within 12 to 48 hours. The apparent half-lives are release-limited and differ modestly between components: testosterone propionate approximately 20 hours, drostanolone propionate approximately 2 days and trenbolone acetate approximately 2 to 3 days, so the combination behaves as a fast-onset, short-duration preparation requiring frequent administration at intervals determined by the prescriber. Plasma protein binding differs by component — testosterone and drostanolone are extensively bound to sex hormone-binding globulin and albumin (of the order of 98 %), whereas trenbolone has low affinity for sex hormone-binding globulin and circulates largely albumin bound. Metabolism is hepatic: testosterone via 5-alpha reduction, aromatisation (CYP19A1) and oxidation to 17-ketosteroids; drostanolone by 3-alpha and 3-beta hydroxysteroid dehydrogenase and 17-oxidation; trenbolone to 17-alpha-trenbolone and trendione. Metabolites are conjugated as glucuronides and sulphates and excreted predominantly in urine, with a significant faecal component for the trenbolone metabolites, which remain detectable in urine for a prolonged period.

List of excipients

Refined oil carrier (vehicle for injection); benzyl benzoate 100 mg per 1 ml (co-solvent); benzyl alcohol 50 mg per 1 ml (co-solvent and antimicrobial preservative); butylated hydroxytoluene 0.1 mg per 1 ml (antioxidant); nitrogen (headspace overlay). The benzyl benzoate holds three different short esters in a single phase at a combined 150 mg/ml; the antioxidant and nitrogen overlay protect the oxidation-sensitive trienone structure of trenbolone acetate, which also accounts for the characteristic yellow colour of the solution.

Excipient warnings

This medicinal product contains 50 mg benzyl alcohol and 100 mg benzyl benzoate in each 1 ml ampoule. Benzyl alcohol may cause allergic reactions and, with benzyl benzoate, local irritation and pain at the injection site. Benzyl alcohol must not be administered to premature babies or neonates because of the risk of severe adverse reactions including "gasping syndrome". Patients who are pregnant or breastfeeding, and patients with hepatic or renal impairment, should be assessed by the prescriber, since benzyl alcohol may accumulate and cause metabolic acidosis. The product also contains butylated hydroxytoluene, which may cause local skin reactions and irritation of the eyes and mucous membranes. As an oil solution it must not be given to patients with known hypersensitivity to the oil carrier.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. It must not be diluted or combined in one syringe with aqueous injections or with other oil solutions, since altering the co-solvent ratio may precipitate one or more of the three esters.

Shelf life

36 months from the date of manufacture in the unopened container, protected from light. Do not use after the expiry date stated on the ampoule and carton, which refers to the last day of that month.

After first opening

For single use only. Open the ampoule immediately before administration, withdraw the full contents and inject in one operation; discard any residue and never retain an opened ampoule. From a microbiological point of view, the product should be used immediately, and prompt use also limits exposure of the solution to air and light. The solution is a clear yellow to amber oil; a deepening of colour on brief exposure to light is expected, but the product must not be used if it is cloudy, has separated, or contains visible particles.

Storage

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

Container

1 ml of solution in a 1 ml one-point-cut ampoule of Type I neutral borosilicate glass (Ph. Eur. 3.2.1 / USP <660>), amber or clear according to the presentation, flame-sealed under a nitrogen overlay; clear-glass presentations are protected from light by the outer carton, which must be retained until use. Ten ampoules in a moulded tray within a serialised outer carton with the package leaflet, the carton bearing a GS1 DataMatrix encoding GTIN, serial, lot and expiry, a human-readable serial and a scratch-off verification code. Pack size: 10 ampoules × 1 ml. Not all pack presentations may be marketed in every territory.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Opened ampoules, residual oil solution, needles and syringes must be placed immediately into an approved sharps container for glass and needles; do not discard with domestic waste or into wastewater. Spilled solution should be absorbed and the area cleaned, avoiding skin contact.

Pack

10 Ampoules × 1 ml

GTIN

05012345678907

Serial

6650 3320 7741 07

LOT

RC2607G

MFG

07 / 2026

EXP

07 / 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.