INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo DEPO-TESTOSTERONE™ 100 mg Injection
SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

DEPO-TESTOSTERONE™ 100 mg Injection

COMPOSITION:
Each mL contains 100 mg testosterone cypionate with benzyl alcohol 0,9% m/v as preservative.

PHARMACOLOGICAL CLASSIFICATIONS:
Category A 21.7 (Male sex hormones)

PHARMACOLOGICAL ACTION:
In the eunuch and eunuchoid male, androgens act to stimulate and maintain the secondary sexual characteristics associated with the adult male. Androgens influence closure of the epiphyseal lines in males and some females, administration of androgens reduces urinary excretion of nitrogen, sodium, potassium, chloride, phosphorus and water.

INDICATIONS:
Based on a review by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the indications for certain androgens as follows:
Effective - In the male:
1. Eunuchism, eunuchoidism, deficiency after castration.
2. Male climacteric symptoms when these are secondary to androgen deficiency.
3. Oligospermia.
Probably Effective - In the female or male:
1. Postmenopausal or senile osteoporosis. Androgens are without value as a primary therapy, but may be of value as adjunctive therapy. Equal or greater consideration should be given to diet, calcium balance, physiotherapy, and good general health-promoting measures.
Final classification of the less-than-effective indications requires further investigation.

CONTRA-INDICATIONS:
Carcinoma of the male breast.
Carcinoma known or suspected of the prostate.
Cardiac, hepatic or renal decompensation.
Hypercalcaemia.
Liver function impairment.
Prepubertal males.
Pregnancy.

DOSAGE AND DIRECTIONS FOR USE:
DEPO-TESTOSTERONE is for intramuscular use only. Dosage will vary depending upon the individual, the condition being treated, its severity, and prior androgen therapy. Because of the protracted action of DEPO-TESTOSTERONE injections more frequently than every two weeks are seldom required.
Eunuchism; Eunuchoidism - For complete replacement in eunuchs and eunuchoid patients, the usual dose of DEPO-TESTOSTERONE is 200 to 400 mg injected at intervals of three to four weeks. It is usually preferable to begin treatment with full therapeutic doses, which are later adjusted to individual requirements. Priapism is a sign of excessive dosage and is an indication for temporary withdrawal of androgen therapy.
Impotence due to Testicular Deficiency; Male Climacteric - DEPO-TESTOSTERONE may be given every three to four weeks in doses ranging from 200 to 400 mg.
Oligospermia - To stimulate spermatogenesis when trial androgen therapy is indicated in subfertile males with oligospermia, recommended dosage of DEPO-TESTOSTERONE is: (1) 100 to 200 mg every three to six weeks for development and maintenance of testicular function; (2) 200 mg each week for six to ten weeks for suppression which may then be followed by rebound spermatogenesis following discontinuance of the injection.
Anabolic Effect; Osteoporosis - The dosage of DEPO-TESTOSTERONE for anabolic effect should be adjusted according to age, sex, and the condition of the individual patient. In the majority of cases, the dose will range from 200 to 400 mg injected every three to four weeks. In addition, an adequate diet should be provided and prolonged immobilization avoided whenever possible.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Hypercalcaemia may occur in immobilized patients, and in patients with breast cancer. In patients with cancer this may indicate progression of bony metastasis. If this occurs the drug should be discontinued. Testosterone propionate must not be used interchangeably with testosterone cypionate, enanthate or phenylacetate due to the difference in duration of action.
Do not give intravenously.
Watch female patients closely for signs of virilization. Some effects such as voice changes may not be reversible when the drug is stopped.
Due to the prolonged action of this drug, it should be administered with caution to patients with organic heart disease of debilitation.
Patients with cardiac, renal or hepatic derangement may retain sodium and water thus forming oedema.
Priapism or excessive sexual stimulation may develop. Oligospermia and reduced ejaculatory volume may occur after prolonged administration or excessive dosage. Hypersensitivity and gynecomastia may occur.
When any of these effects appear the androgen should be stopped and if restarted, a lower dosage should be utilized.
The PBI may increase during androgen therapy without clinical significance.
Acne Priapism
Decreased ejaculatory volume Hypercalcaemia (especially in immobile patients
Gynecomastia and those with metastatic breast carcinoma)
Oedema Local irritation
Hypersensitivity, including skin
manifestations and anaphylactiod reactions		 Virilization in females

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment should be symptomatic and supportive.

IDENTIFICATION:
A pale yellow oily solution.

PRESENTATION:
DEPO-TESTOSTERONE 100 mg is available in 1 mL and 10 mL vials.

STORAGE INSTRUCTIONS:
Store at room temperature (15°C - 30°C)
Keep out of reach of children

REFERENCE NUMBER:
G 2989 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Ltd.,
Alphen West G,
George Street
Midrand 1685,
R.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
30.8.76

™ = Trade Mark

New addition to this site: February 2005
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005