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Product Information Leaflet

 

Gonadon-250 Injection

 

Composition:

 

Each mL contains :

 

Testosterone Propionate BP 30mg

 

Testosterone Phenylpropionate BP 60 mg

 

Testosterone Isocaproate BP 60 mg

 

Testosterone Deeanoate BP 100 mg

 

Description:

 

Testosterone Propionate is 3_oxoandrost-4-en- 1 7ß-yl propionate.

 

Testosterone Phenylpropionate is 3_oxoandrost-4-en-17ß-yl 3_phenylpropionate. Testosterone isocaproate is 3_oxoandrost_4_en_17ß_y14_methylpcntanoate. Testosterone decanoate is 3_oxoandrost-4-en-17ß-yl-deeanoate.

 

Gonadon -250 are androgenic preparations for intra-muscular administration respectively containing 4 different esters of the natural hormone testosterone. Testosterone Propionate, Testosterone Phenylpropionate, Testosterone Isoeaproate and Testosterone Decanoatc are prepared synthetically from plant origins. They are fatty acid esters of the naturally occurring androgen testosterone.

 

Pharmacology:

Pharmacodynamic properties: Testosterone is the principal endogenous hormone essential for normal growth and development of the male sex organs and male secondary sex characteristics. During adult life testosterone is essential for the functioning of the testes and accessory structures, and for the maintenance of libido, sense of well-being, erectile potency, prostate and seminal vesicle function. Treatment of hypo gonadal males with Gonadon results in a clinically significant rise of plasma, concentrations of testosterone, dihydrotestostcrone and androstenedione, as well as a decrease of SHBG (sex hormone binding globulin). in males with primary (hypergonadotropic) hypogonadism treatment with Gonadon results in a normalisation of pituitary function. Treatment of female to male transsexuals with Gonadon results in a clinically significant rise of plasma testosterone levels, a decrease of LH and FSH levels and a decrease in SHBG level.

 

Pharmacokinetic properties: Gonadon contains a number of esters of testosterone with different duration of action. The esters are hydrolysed into the natural hormone testosterone as soon as they enter the general circulation. A single dose of Gouadon -250 leads to an increase of total plasma testosterone with peak-levels of approximately 70 nmoi/L (Cmax), which are reached approximately 24-48 h (max) after administration. Plasma testosterone levels return to the lower limit of the normal range in males in approximately 21 days. Testosterone is metabolised via the normal pathways. Excretion mainly takes place via the urine as conjugates of etiocholanolone and androsterone.

 

Indications:

Androgen replacement therapy for confirmed testosterone deficiency in males.

 

Contra- indications :

 

* Known or suspected prostatic or mammary carcinoma.

* Hypercalcaemia and/or hypercalciuria.

* Hypersensitivity to one of the excipients.

 

Precautions:

 

• If androgen-associated adverse reactions occur. treatment should be interrupted and, after disappearance of the symptoms, be resumed at a lower dosage.

 

• Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be monitored, since androgens may occasionally induce salt and fluid retention.

• Androgens should be used cautiously in prepubertal boys to avoid prematurc epiphyseal closure or precocious sexual development.

 

• Risk of developing prostatic hypertrophy and prostatic carcinoma may be increased

in geriatric patients receiving androgens.

 

• lschacmic heart disease as androgens may produce hypercholesterolaemia.

 

• Urethral obstruction in patients with benign prostatic hypertrophy receiving

testosterone.

 

In prepubertal boys androgens may cause accelerated bone maturation without compensatory gain in linear growth. This may compromise adult stature; younger the patient, higher. The risk. Effect on bone maturation should be monitored by assessing bone

age of wrist and hand every 6 months.

 

Interactions with other medicaments and other forms of interaction:

 

Androgens may improve glucose tolerance and thereby in diabetic patients decrease the need for insulin or other antidiabetic drugs. May potentiate the effects of cyclosporins and increase risk of nephrotoxicity. Gonadon may interfere with a number of clinical laboratory tests eg. those for glucose tolerance and thyroid function, suppression of clotting factors II,V, VII and X.A decrease in protein-bound iodine (PBl) may occur, but this has no clinical significance.

Enzyme inducing agents may exist increasing or decreasing effects of testosterone levels,

therefore adjustment of the dose of Gonad on may be required.

 

Anticoagulants: C-17 substituted derivatives of testosterone have been reported to decrease the anticoagulant requirements. Patients receiving oral anticoagulants require dose monitoring especially when androgens are started or stopped. However. this

interaction has not been reported for Gonadon to date.

 

Adverse Reactions:

Gonadon has a small number of adverse reactions associated with it, as detailed:

Skin and appendages disorders: Rare: Pruritus, flushing of the skin .

Musculo-skeletal System disorders: Rare: Myalgia

Central and peripheral Nervous System disorders: Rare: Dizziness, headache

Gastro-intestinal System disorders: Rare: Abdominal pain

Urinary System disorders: Rare: Micturition disorders

Body as a whole-general disorders: Rare: fever, malaise

Application site disorders: Rare: injectionsitereaction

 

The following adverse reactions have been associated with androgen therapy in general:

• Priapism and other signs of excessive sexual stimulation.

• In prepubertal boys, precocious sexual development, an increased frequency of

erections, phallic enlargement and premature epiphyseal closure.

Oligospermia and decreased ejaculatory volume.

• Water and salt retention.

Nausea, acne, gynecomastia, increased or decreased libido, jaundice, flushing of skin.

Dosage and Administration:

In general, dosage should be adjusted according to the response of the individual patient.

Usually, one injection of 1 mL per three weeks is adequate for Gonadon '250'.

Usually, one injection of 1 mL per two weeks is adequate for Gonadon' 1 001•

Gonadon should be administered by deep intramuscular injection.

 

Overdosage:

There are no specific recmmnendations for the management of overdosage with

Gonadon.

 

Storage:

Store below 25°C. protect from light.

Presentation: 1 ml Amber colour glass ampoule 10 such ampoule in a plastic tray individually mono cartooned and such 10 mono cartons in printed box (10x 10).