SUSTAMIX – Testosterone Blend Mix 300mg/ml 5x2ml Box
PHARMACEUTICAL NAME:
Testosterone propionate,
Testosterone isocaproate,
Testosterone phenylpropionate,
Testosterone decanoate
EMPIRICAL FORMULA (base): C19H2802
COMPOSITION:
SUSTAMIX is a blend of different testosterone esters (4 of them):
Each ml contains :300mg
Testosterone propionate – ++
Testosterone phenylpropionate – ++
Testosterone isocaproate – ++
Testosterone decanoate – ++
in oily base quantity sufficient.
DOSAGE FORM:
300 mg/1 ml injection
PHARMACOLOGICAL CLASSIFICATION:
Androgenic/Anabolic steroid
DESCRIPTION:
SUSTAMIX injection contains testosterone esters. These are derivatives of the naturally occurring male hormone testosterone. They are converted in the body to testosterone. Testosterone is produced by the testicles and is the main hormone essential for normal growth and development of the male sex organs and male sexual characteristics.
The natural production of testosterone is controlled by gonadotrophins, which are released from the pituitary gland in the brain. During adult life, testosterone is essential for the functioning of the testes and accessory structures, the maintenance of libido, sense of well being, erectile potency and the functioning of the prostate gland. It also has functions in the skin, muscles, skeleton, kidney, liver, bonemarrow and central nervous system. Low levels of testosterone can cause decreased sex drive, impotence, infertility due to decreased sperm production, decreased mental and physical activity, fatigue and weakening of bones. Testosterone is given as replacement therapy when natural testosterone levels fall too low, causing symptoms such as those above.
PHARMACOKINETIC PROPERTIES:
SUSTAMIX contains four esters of testosterone with different duration of action. The esters are hydrolyzed into natural hormone testosterone as they enter the circulation system. A single dose of SUSTAMIX leads to increased plasma testosterone levels after administration. The levels of plasma testosterone returns to lower limit of the normal range in 21 days approx.
INDICATIONS:
– Replacement therapy of low testosterone levels in men.
– Male menopause symptoms such as decreased sex drive.
– Prevention and treatment of osteoporosis in men with low testosterone levels
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side Effects: The following are some of the side effects that are known to be associated with SUSTAMIX: high blood pressure (hypertension), breast pain, enlargement of the breasts, swelling caused by fluid retention (oedema), hair loss, acne, depression, hostility, nervousness, prostate problems, prolonged painful erection of the penis.
SUSTAMIX increased sexual desire, premature closure of the ends of bones, causing stunted growth when used in young boys. In female-to-male transsexuals additional possible side effects are: weight gain, loss of bone mineral density (osteoporosis), increased risk of endometrial and ovarian cancer. Ongoing monitoring and supervision is required to detect signs of osteoporosis, endometrial and ovarian cancer.
SPECIAL PRECAUTIONS:
Androgens should be used with caution in people with Renal / Hepatic impairment, epilepsy, migraine, cancer of the bone, diabetes, since androgens may ocassionally induce salt and fluid retention.
Androgens should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. A decrease in protein bound iodine (PBI) may occur, but this has no clinical significance.
CONTRAINDICATIONS:
Prostatic carcinoma, male breast cancer, cardiac failure, pregnancy and lactation. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
WARNING:
Consult a doctor, if you experience symptoms such as frequent or persistent erections, irritability, nervousness or weight gain after starting treatment with this medicine, as these suggest your testosterone levels are too high and your dose may need adjusting. Regular blood tests to monitor red blood cells, liver function and prostate specific antigen (PSA) levels. Testosterone can increase the growth of prostate cancers and benign enlargement of the prostate. The use of steroids may influence the results of certain laboratory tests.
DRUG INTERACTIONS:
SUSTAMIX may increase the anti-blood-clotting effects of anticoagulants such as warfarin, nicoumalone and phenindione. If testosterone is used in combination with corticosteroids such as dexamethasone, there may be a greater chance of fluid retention and oedema. This combination of medicines should be used with caution in people with heart, liver or kidney disease. Enzyme-inducing agents may exert increasing or decreasing effects on testosterone levels.
PACKAGING: BOX:
5 vials of 2 ml (300 mg/ml)
DOSAGE AND DIRECTIONS FOR USE:
SUSTAMIX injection is called a depot injection
Generally dosage should be adjusted according to the response of the individual patient.
Usually, one injection of 1 ml per four weeks is adequate.
SUSTAMIX should be administered by deep intramuscular injection.
STORAGE:
Not to be refrigerated. Protect from light. Store incool place below 25 °C. Keep the ampoules in the outer carton, protect from light. SUSTAMIX should be kept out of reach of children.
MARKETED BY:
Pharmed Corporation Ltd., 3361/A, Rani Bagh, Mahindra Park Rajdhani Enclave, Shakurpur, New Delhi, Delhi 110034, India tel +919953242466, http://www.pharmed-corp.com
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
04.2020
