Sustanon

A clear, pale yellow solution.
Sustanon 250 is a solution in oil. Each ampoule contains 1 ml arachis oil containing the following active substances: 30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate, 100 mg testosterone decanoate.
All four compounds are esters of the natural hormone testosterone. The total amount of testosterone per ml is 176 mg.
Excipients/Inactive Ingredients: Arachis oil, Benzyl alcohol.

Pharmacotherapeutic group: Androgens. ATC code: G03B A03.
Pharmacology: Pharmacodynamics: Treatment of hypogonadal men with Sustanon results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone, estradiol and androstenedione, as well as a decrease of SHBG (sex hormone binding globulin). Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are restored to the normal range. In hypogonadal men, treatment with Sustanon results in an improvement of testosterone deficiency symptoms. Moreover, treatment increases bone mineral density and lean body mass, and decreases body fat mass. Treatment also improves sexual function, including libido and erectile function. Treatment decreases serum LDL-C, HDL-C and triglycerides, increases hemoglobin and hematocrit, which may lead to polycythaemia. No clinically relevant changes in liver enzymes and PSA have been reported. Testosterone also produces systemic effects, such as increasing the retention of sodium, potassium and chloride leading to an increase in water retention. Treatment may result in an increase in prostate size and worsening of lower urinary tract symptoms, but no adverse effects on prostate symptoms have been observed. In hypogonadal diabetic patients, improvement of insulin sensitivity and/or reduction in blood glucose have been reported with the use of androgens. In boys with constitutional delay of growth and puberty, treatment with Sustanon accelerates growth and induces development of secondary sex characteristics. In female-to-male transsexuals, treatment with Sustanon induces masculinization.
Pharmacokinetics: Sustanon contains four esters of testosterone with different durations of action. The esters are hydrolyzed into the natural hormone testosterone as soon as they enter the general circulation.
Absorption: A single dose of Sustanon leads to an increase of total plasma testosterone with peak levels of approximately 70 nmol/l (C_max), which are reached approximately 24-48 h (t_max) after administration. Plasma testosterone levels return to the lower limit of the normal range in males in approximately 21 days.
In female-to-male transsexuals, a single dose of Sustanon repeated every two weeks resulted in mean trough testosterone levels towards the upper end of the normal male range at 2, 4 and 12 months.
Distribution: Testosterone displays a high (over 97%) non-specific binding to plasma proteins and sex hormone binding globulin in in vitro tests.
Biotransformation: Testosterone is metabolized to dihydrotestosterone and estradiol, which are further metabolized via the normal pathways.
Elimination: Excretion mainly takes place via the urine as conjugates of etiocholanolone and androsterone.
Toxicology: Preclinical safety data: Preclinical data with androgens in general reveal no hazard for humans. The use of androgens in different species has been demonstrated to result in virilisation of the external genitals of female foetuses.

Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Posology: In general, the dose should be adjusted to the response of the individual patient.
Adults (incl. elderly): Usually, one injection of 1 ml per 3 weeks is adequate.
Paediatric population: Safety and efficacy have not been adequately determined in children and adolescents. Pre-pubertal children treated with Sustanon should be treated with caution (see Precautions).
Method of administration: Sustanon should be administered by deep intramuscular injection.

The acute toxicity of testosterone is low.
If symptoms of chronic overdose occur (e.g. Polycythaemia, priapism) treatment should be discontinued and after disappearance of the symptoms, be resumed at lower dosage.

Known or suspected carcinoma of the prostate or breast (see Precautions).
Hypersensitivity to the active substance or to any of the excipients listed in Description, including arachis oil. Sustanon is therefore contraindicated in patients allergic to peanuts or soya (see Precautions).
Use in Pregnancy & Lactation: Pregnancy (see Use in Pregnancy & Lactation).
Breast-feeding.

Medical examination: Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.
Physicians should consider monitoring patients receiving Sustanon before the start of treatment, at quarterly intervals for the first 12months and yearly thereafter for the following parameters: digital rectal examination (DRE) of the prostate and PSA to exclude benign prostate hyperplasia or a sub-clinical prostate cancer (see Contraindications), hematocrit and hemoglobin to exclude polycythaemia.
In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: hemoglobin and hematocrit liver function tests and lipid profile.
Conditions that need supervision: Patients, especially the elderly, with the following conditions should be monitored for: Tumours: Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcaemia or hypercalciuria may develop spontaneously, also during androgen therapy. The latter can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia or hypercalciuria should first be treated appropriately and after restoration of normal calcium levels, hormone therapy can be resumed.
Pre-existing conditions: In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterized by edema with or without congestive cardiac failure. In such a cases, treatment must be stopped immediately. Patients who experienced myocardial infarction, cardiac-, hepatic- or renal insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk of deterioration of or reoccurrence of disease. In such cases treatment must be stopped immediately.
Testosterone may cause a rise in blood pressure and Sustanon should be used with caution in men with hypertension.
Epilepsy or Migraine: (or a history of these conditions), since androgens may occasionally induce fluid and sodium retention.
Diabetes mellitus: Androgens in general and Sustanon can improve glucose tolerance in diabetic patients (see Interactions).
Anti-coagulant therapy: Androgens in general and Sustanon can enhance anticoagulant action of coumarin-type agents (see also Interactions).
Sleep apnoea: Caution should be applied when treating men with sleep apnoea. There have been reports that testosterone can cause or exacerbate pre-existing sleep apnoea. However, there is a lack of evidence regarding the safety of testosterone in men with the condition. Good clinical judgment and caution should be employed in patients with risk factors such as adiposity or chronic lung diseases.
Adverse events: If androgen-associated adverse reactions occur (see Adverse Reactions), treatment with Sustanon should be discontinued and upon resolution of the complaints resumed with lower dosages.
Virilisation: Patients should be informed about the potential occurrence of signs of virilisation. In particular, singers and women with speech professions should be informed about the risk of deepening of the voice. The voice changes may be irreversible.
If signs of virilisation develop, the risk/benefit ratio has to be newly assessed with the individual patient.
(Mis)use in sports: Patients who participate in competitions governed by the World Anti-Doping Agency (WADA) should consult the WADA-code before using this product as Sustanon can interfere with anti-doping testing. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.
Drug abuse and dependence: Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication(s) and in combination with other anabolic androgenic steroids. Abuse of testosterone and other anabolic androgenic steroids can lead to serious adverse reactions including: cardiovascular (with fatal outcomes in some cases), hepatic and/or psychiatric events. Testosterone abuse may result in dependence and withdrawal symptoms upon significant dose reduction or abrupt discontinuation of use. The abuse of testosterone and other anabolic androgenic steroids carries serious health risks and is to be discouraged.
Excipients: Sustanon contains Arachis oil (peanut oil) and should not be taken/applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Sustanon (see Contraindications).
Sustanon contains 100 mg benzyl alcohol per ml solution and must not be given to premature babies or neonates. Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
In patients with a personal or family history of breast cancer and with a personal history of endometrial cancer, careful monitoring should be undertaken.
Subject to specialist advice, hysterectomy and bilateral oophorectomy should be considered after 18-24 months of testosterone treatment, to reduce the possible increased risk of endometrial and ovarian cancer.
Continued surveillance is required to detect osteoporosis in patients who have undergone oophorectomy, as testosterone may not fully reverse the decline in bone density in these patients.
Continued surveillance is required to detect endometrial and ovarian cancer in patients on long term treatment who have not proceeded to hysterectomy and bilateral oophorectomy.
Clotting disorders: Testosterone should be used with caution in patients with thrombophilia or risk factors for venous thromboembolism (VTE), as there have been post-marketing studies and reports of thrombotic events (e.g. deep-vein thrombosis, pulmonary embolism, ocular thrombosis) in these patients during testosterone therapy. In thrombophilic patients, VTE cases have been reported even under anticoagulation treatment, therefore continuing testosterone treatment after first thrombotic event should be carefully evaluated. In case of treatment continuation, further measures should be taken to minimise the individual VTE risk.
Effects on ability to drive and use machines: Sustanon has no influence on the ability to drive and use machines.
Use in Children: In pre-pubertal children statural growth and sexual development should be monitored since androgens in general and Sustanon in high dosages may accelerate epiphyseal closure and sexual maturation.
Use in the Elderly: There is limited experience on the safety and efficacy of the use of Sustanon in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.

Sustanon is contra-indicated in women who are pregnant (see Contraindications).
Pregnancy: There are no adequate data for the use of Sustanon in pregnant women. In view of the risk of virilisation of the foetus, Sustanon should not be used during pregnancy (see Contraindications). Treatment with Sustanon should be discontinued when pregnancy occurs.
Breastfeeding: There are no adequate data for the use of Sustanon during lactation. Therefore, Sustanon should not be used during lactation.
Fertility: In men treatment with androgens can lead to fertility disorders by repressing sperm-formation (see Adverse Reactions).
In women treatment with androgens can lead to an infrequent or repressed menstrual cycle (see Adverse Reactions).

Due to the nature of Sustanon side effects cannot be quickly reversed by discontinuing medication. Injectables in general, may cause a local reaction at the injection site.
The following adverse reactions have been associated with androgen therapy in general. All adverse reactions are listed by system organ class and frequency; common (>1/100 to <1/10) and not known (cannot be estimated from the available data). (See table.)

Click on icon to see table/diagram/image

Enzyme-inducing agents may decrease and enzyme-inhibiting drugs may increase testosterone levels. Therefore, adjustment of the dose of Sustanon may be required.
Insulin and other anti-diabetic medicines: Androgens may improve glucose tolerance and decrease the need for insulin or other anti-diabetic medicines in diabetic patients (see Precautions).
Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during Sustanon treatment.
Anti-coagulant therapy: High doses of androgens may enhance the anticoagulant action of coumarin type agents (see Precautions). Therefore, close monitoring of prothrombin time and if necessary a dose reduction of the anti-coagulant is required during therapy.
ACTH or Corticosteroids: The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation therefore these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to edema (see Precautions).
Laboratory test interactions: Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Incompatibilities: Not applicable.

Do not refrigerate or freeze.
Store in original package in order to protect from light.

Androgens & Related Synthetic Drugs

G03BA03 - testosterone ; Belongs to the class of 3-oxoandrosten (4) derivative androgens used in androgenic hormone preparations.

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