Testosterone Decanoate USP 100mg
Testosterone isocaproate BP 60mg
Testosterone phenylpropinate BP 60 mg
Testosterone propinate BP 30mg
Oil Base 250mg/1ml
Store in a dark & dry place below 25c keep out of chidren
(Testosterone Mix Injection 250mg/ml) ‘
Each ml contains:
Testosterone Decanoate BP 100 mg
Testosterone Isocaproate BP 60 mg
Testosterone Phenylpropionate BP 60 mg
Testosterone Propionate USP 30 mg
Pharmacotherapeutic group: Androgens.ATC code G03B A03
Treatment of hypogonadal men with Sustabol 250 results in a clinically signiﬁcant rise of plasma concentrations of testosterone, dihydrotestosterone, estradiol and androstenedione, as well as decrease of SHBG (Sex hormone binding globulin). Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are restored to the normal range. In hypo gonadal men, treatment with Sustabol 250 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 and increases haemoglobin and haematocrit, 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 diabeteic 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 Sustabol 250 accelerates growth and induces development of secondary sex characteristics. In female-to-male transsexuals, treatment with Sustabol 250 induces masculinisation.
Sustabol 250 contains four esters of testosterone with different durations of action. The esters are hydrolysed into the natural hormone testosterone as soon as they enter the general circulation.
A single dose of Sustabol 250 leads to an increase of total plasma testosterone with peak levels of approximately 70nmol/l (Cmax), which are reached approximately 24-48 h (tmax) after administration. Plasma testosterone levels return to the lower limit of the normal range in males in approximately 2 1 days.
In female-to-male transsexuals, a single dose of Sustabol 250 repeated ever), two weeks resulted in mean trough testosterone levels towards the upper end of the normal male range at 2, 4 and 12 months.
Testosterone displays a high (over 97%) non-specific binding to plasma proteins and sex hormone binding globulin in in vitro tests. ,
Testosterone is inetabolised to dihydrotestosterone and estradiol. which are further metabolised via the normal pathways.
Excretion mainly takes place via the urine as conjugates of etiocholanolone and androsterone.
Testosterone replacement therapy for male hypogonadism, when testosterone deﬁciency has been conﬁrmed by clinical features and biochemical tests. Testosterone administration may also be used as supportive therapy for female-to-male transsexuals.
Known or suspected carcinoma of the prostate or breast Breast-feeding.
Hypersensitivity to the active substance or to any of the excipients including arachis oil Sustabol 250 is therefore contraindicated in patients allergic to peanuts or soya.
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 Sustabol 250 before the start of treatment, at quarterly intervals for the first 12
months and yearly thereafter for the following parameters:
Digital rectal examination (DRE) of the prostate and PSA to exclude benign prostate hypeiplasia or a sulvclinicalpprostate cancer Haematocrit and haemoglobin to exclude polycythaemia
In patients receiving long~term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, 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 hypercaleaemia or hypercaiciuria may develop spontaiieously. 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 insiiﬁiciency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such cases treatment must be stopped
immediately. Patients who experienced myocardial infarction, caidiac, hepatic or renal insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk of deterioration of or reoccurrenee of disease. In such cases treatment must be stopped immediately.
Testosterone may cause a rise in blood pressure. and Sustabol 250 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 Sustabol 250 can improve glucose tolerance in diabetic patients.
Anti-coagulant therapy-Androgens in general and Sustabol 250 can enhance the anti-coagulant action of coumarin-type agents.
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.
If androgen-associated adverse reactions occur, treatment with Sustabol should be discontinued and, upon resolution of complaints, resumed with a lower dose.
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.
Misuse 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 Sustabol can interfere with anti-doping testing. The misuse of androgens to enhance ability in sports carries serious health risks and 1S to be discouraged.
Sustabol 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 Sustabol.
Sustabol 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.
Female-to-male transsexual supportive therapy:
Before initiating Sustabol for female-to-male transsexuals, specialist assessment should be undertaken, including psychiatric assessment, A
complete personal and medical history should be taken. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual. The following should be monitored:
* signs of osteoporosis,
* changes in lipid profile.
In patients with a personal or family history of breast cancer and with a personal history of endometrial cancer, careful monitoring should be
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.
In pre-pubertal children statural growth and sexual development should be monitored since androgens in general and Sustabol in high dosages may accelerate epiphyseal closure and sexual maturation.
There is limited experience on the safety and efficacy of the use of Sustabol 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.
DOSAGE AND DIRECTIONS FOR USE:
In general, the dose should be adjusted to the response of the individual patient.
Adults (incl. elderly):
Usually, one injection of lml per 3 weeks is adequate.
Safety and efficacy have not been adequately determined in children and adolescents. Pre-pubertal children treated with Sustabol should be treated with caution.
Different specialist centres have used doses varying from one injection of 1 ml every two weeks to one injection of lml every four weeks.
Method of administration
Sustabol should be administered by deep intramuscular injection.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Due to the nature of Sustabol side effects cannot be quickly reversed by discontinuing medication. Injectables in general, may cause a local
reaction at the injection site.
synonyms and related terms.
Treatment in vyom en:
Treatment with Sustabol my induce signs of virilisation in women. Symptoms of virilisation may include hoarseness, acne, hirsutism,
menstrual irregularity and alopecia.
The following undesirable effects have been reported in prepubertal children using androgens precocious sexual development, an increased
frequency of erections, phallic enlargement and premature epiphyseal closure.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the
benefit/risk balance of the medicinal product.
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.
Store below 3 0°C. Protect from light.
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