Testoko P 100

COMPOSITION:

Each ml contains: Testosterone Propionate 100 mg
Oil Base........q.s.

DESCRIPTION:

Testosterone Propionate is an esterified derivative of the primary endogenous androgen testosterone for intramuscular use. In bioactive form, androgens have a 17-beta-hydroxy group, the esterification of which produces esters of testosterone which undergo hydrolysis in vivo; producing a delayed release of the bioactive testosterone.

CLINICAL PHARMACOLOGY:

Endogenous androgens such as testosterone are responsible for the development and growth of the male sexual organs and post-adolescent secondary sex characteristics. Androgen effects include but are not limited to the maturation of the penis, scrotum, prostate, seminal tubules, laryngeal enlargement, vocal cord thickening, changes in muscle mass and fat distribution, and the development and distribution of male hair (facial, pubic, chest, back, axillary). Androgens have been linked to increased protein anabolism and consequent decreased protein catabolism. Androgens are responsible for the growth spurt of adolescence and the aromatization of androgens to estrogens for the eventual termination of linear growth, which is brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates but may cause a disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Androgens have been reported to stimulate the production of red blood cells by enhancing the production of erythropoietin stimulating factor. Androgens may suppress gonadotrophic function of the pituitary. During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). With large doses, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).

INDICATION AND USAGE:

Males: Androgen Replacement Therapy: Testosterone is indicated for androgen replacement therapy in conditions associated with deficiency or absence of endogenous testosterone. Primary hypogonadism: Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchiectomy. Females: Metastatic mammary cancer:T estosterone Injection may be used secondarily in women with advancing inoperable metastatic mammary cancer who are one to five years post-menopausal. It has also been used in pre-menopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor.

CONTRAINDICATIONS:

Diagnosed or suspected carcinoma of the male breast or prostate. Women who are pregnant or may become pregnant because of possible masculinization of the fetus. When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. This virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. Patients with a history of hypersensitivity to testosterone or any of its components. Patients with serious renal, cardiac, or hepatic dysfunction.

WARNINGS:

This product can be used only by healthy adults over 18 years old. Carefully read directions before using this product. Consult your physician before using this product if you are taking any prescription or over the counter drugs or supplements. KEEP AWAY FROM CHILDREN.

SIDE EFFECTS:

Males: Frequent or persistent penile erections and increases in the appearance of acne vulgaris. Females: Hoarseness of the voice, acne, changes in menstrual periods, or more facial hair.

DOSAGE AND ADMINISTRATION:

Adult male:100 mg injected intramuscularly (IM) 2 to 3 times per week.

STORAGE:

Do not refrigerate or freeze. Do not store above 30 C. Protect from direct sunlight.

PACKAGE:

10 x 1 ml Ampoule