DECATEST – Testosterone Decanoate 350mg/ml 5x2ml Box
PHARMACEUTICAL NAME: Testosterone DecanoateUSP
MOLECULAR STRUCTURE: C29H46O3
PROPRIETARY NAME: DECATEST
DOSAGE FORM: 350 mg/ml injection
COMPOSITION: Each ml of DECATEST contains Testosterone Decanoate 350 mg
in oily base quantity sufficient.
PHARMACOLOGICAL CLASSIFICATION: Androgenic/Anabolic steroid
Testosterone is secreted by the interstitial Leydig cell of the testes under the influence of LH from pituitary. FSH is mainly responsible for promotion of spermatogenesis in tubular cells. Testosterone is responsible for all the changes that occur in a body at puberty. It is needed for normal spermatogenesis and maturation of spermatozoa and promotes muscle building specially if aided by exercise.
Testosterone decanoate esters are less polar than free testosterone. Testosterone decanoate esters in oil administrated intramuscularly are absorbed slowly from the lipid phase, thus testosterone decanoate can be given at intervals of two to four weeks. Testosterone in plasma is 98% bound to a specific testosterone-estradiol binding globulin, and approximately 2% is free. About 90% of a dose of testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; 6% of a dose is excreted in the feaces, mostly in unconjugated form. Inactivation of testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways. In responsive tissues, the activity of testosterone appears to depend on reduction to dihydrotestosterone, which binds to cytosol receptor proteins. The steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes.
I. Treatment of hypogonadism resulting from androgenic deficiency and anemia.
II. Replacement therapy in the treatment of hypogonadism associated with anaemia and androgenic deficiency with testicular failure, accidental castration.
III. In hereditary angioneurotic oedema, infertility due to defective spermatogenesis, osteoporosis, refractory anemia, and endometriosis.
IV. To improve nitrogen balance in catabolic state. Certain types of infertility due to disorders of spermatogenesis
I. Supplementary therapy in disseminated breast carcinoma in the post menopausal period
FEMALE: Amenorrhea, menstrual irregularities, virilization including deepening of voice and ditoral enlargement.
MALE: Gynaecomastia, oligospermia at higher doses (reduction in spermatogenesis) and excessive frequency and duration of penile erection. Hirsutism, acne and male pattern baldness.
Fluid and electrolyte disturbances – Retention of water, sodium, calcium, potassium. Chloride and inorganic phosphates. Nausea, cholestatic jaundice, alterations in liver function, polycythemia acne, precocious puberty, premature epi-physeal closure, increased or decreased libido, headache, anxiety and depression.
Contraindicated in prostate and male breast carcinoma and liver and kidney dysfunction.
DECATEST should not used in patients with known hypersensitivity to testosterone or any of its excipients.
Contraindicated in infant, pregnancy, lactating mothers as testosterone supplements causes fetal harm.
In patients with breast carcinoma, hormonal therapy may cause hypercalcemia, the drug should be discontinued and appropriate measures should be taken. The androgen therapy should be discontinued and the etiology should be determined, if cholestatic hepatitis with jaundice appears or if be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. If the administration of testosterone decanoate is restarted, a lower dose should be considered. Gynaecomastia frequently develops and occasionally persists in patients being treated for hypogonadism.
The use of testosterone in women may cause symptoms of virilization such as acne vulgaris which manifests itself on the back, chest, shoulders, and arms more than on the face. Caution should be taken when administering testosterone decanoate to patients with a history of myocardial infarction or coronary artery disease as androgens may alter serum cholesterol concentrations.
Concurrent administration with following drugs shows the interaction with androgens.
Oral hypoglycemic agent and insulin: the metabolic effects of androgens may reduce the blood glucose level & insulin in diabetic patients. Corticosteroids: tendency towards oedema enhanced, use with caution in patients with hepatic or cardiac disease.
Oxyphenbutazone: It may results elevated serum levels of oxyphenbytazone. Enzyme-inducing agents may exert increasing or decreasing effects on testosterone levels. Therefore, adjustment of the dose, and/or intervals between injections may be required.
EFFECT OF ABILITY TO DRIVE AND USE MACHINES:
No research suggests the inuence on alertness and concentration.
The acute intramuscular toxicity of Testosterone is very low. Priapism in men is a
symptom of chronic overdose. If this occurs, Testosterone treatment should be
interrupted and, after disappearance of the symptom, be resumed at a lower dose.
BOX: 5 vials of 2 ml (350 mg/ml)
DOSAGE AND DIRECTIONS FOR USE:
DEPOTEST injections are only to be administered intramuscularly.
MALE: Hypogonadism: Intramuscular administration of 100 to 400 mg every 2 to 4 weeks as replacement therapy i.e. eunuchism.
FEMALE: Intramuscular administration of 200 to 400 mg every 2 to 4 weeks is recommended as supplementary therapy in disseminated therapy in breast carcinoma in post menopausal period. Women with metastatic breast carcinoma must be followed closely because androgen therapy occasionally appears to accelerate the disease.
Not to be refrigerated. Protect from light. Store in cool place below 25 °C. Keep the ampoules in the outer carton, protect from light. DECATEST should be kept out of reach of children.
Pharmed Corporation Ltd., 3361/A, Rani Bagh, Mahindra Park Rajdhani Enclave, Shakurpur, New Delhi, Delhi 110034, India, tel +919953242466, http://www.pharmed-corp.com
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