Testosterone Cypionate 10ml

TESTOSTERONE CYPIONATE 250

TESTOSTERONE CYPIONATE 250 is used in replacement therapy in condi_xfffe_tions associated with deficiency of endogenous testosterone. It is an oil based

injectable, designed to release testosterone slowly from the injection site. Once

administered, serum concentrations of this hormone will rise for several days, and

remain markedly elevated for approximately two weeks. For medical purposes

this is the most widely prescribed testosterone used regularly to treat cases of

hypogonadism and other disorders related to androgen deficiency. As with all tes_xfffe_tosterone products it has a strong anabolic activity, with a pronounced androgenic

component. Significant gains in strength and muscle tissue as well a noticeable

increase in libido.

TESTOSTERONE CYPIONATE 250 is approved for the following uses:

Testosterone replacement therapy in conditions associated with a testosterone

deficiency such as:

primary hypogonadism

hypogonadotropic hypogonadism

delayed puberty

Treatment of metastatic mammary cancer in women

Chemical: Testosterone Cypionate 250mg/ml

Molecular Formula: C27H40O3

Molecular Weight: 412.61

Prescription Medicine

Testosterone Cypionate USP 250 mg

Oil base q.s.

DESCRIPTION

Testosterone Cypionate 250 Injection provides testosterone cypionate, a derivative

of the primary endogenous androgen testosterone.

INDICATIONS

Males

Testosterone Cypionate Injection is indicated for replacement therapy in conditions

associated with a deficiency or absence of endogenous testosterone.

Primary hypogonadism : Testicular failure due to cryptorchidism, bilateral torsion,

orchitis, vanishing testis syndrome, or orchidectomy.

Hypogonadotropic hypogonadism : Idiopathic gonadotropin or luteinizing hormone

– releasing hormone (LHRH) deficiency, or pituitary – hypothalamic injury from

tumors, trauma, or radiation.

Delayed Puberty : Testosterone Cypionate Injection may be used to stimulate

puberty in carefully selected males with clearly delayed puberty.

Females

Metastatic mammary cancer: Testosterone Cypionate Injection may be used

secondarily in women with advancing inoperable metastatic mammary cancer who

are one to five years postmenopausal. It has also been used in premenopausal

women who have benefited from oophorectomy and are considered to have a

hormone-responsive tumor.

CLINICAL PHARMACOLOGY

Endogenous androgens are responsible for the normal growth and development of

the male sex organs and for maintenance of secondary sex characteristics. These

effects include growth and maturation of prostate, seminal vesicles, penis and

scrotum; development of male hair distribution,such as beard, pubic, chest, and

auxillary hair; laryngeal enlargement; vocal chord thickening; alterations in body

musculature; and fat distribution.

Androgens are responsible for the growth spurt of adolescence and for the eventu_xfffe_al 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

growth process. Androgens have been reported to stimulate the production of red

blood cells by enhancing the production of erythropoeitic stimulating factor. During

exogenous administration of androgens, endogenous testosterone release is

inhibited through feedback inhibition of pituitary luteinizing hormone (LH).

ADVERSE REACTIONS

Endocrine and Urogenital, Female: The most common side effects of androgen

therapy are amenorrhea and other menstrual irregularities, inihibition of gonad_xfffe_otropin secretion, and virilization, including deepening of the voice and clitoral

enlargement.

Male : Gynecomastia, and excessive frequency and duration of penile erections.

Oligospermia may occur at high dosages.

Skin and Appendages : Hirsutism, male pattern baldness and acne.

Fluid and electrolyte Disturbances : Retention of sodium, chloride, water, potassi_xfffe_um, calcium, and inorganic phosphates.

Gastrointestinal : Nausea, cholestatic jaundice, alterations in liver function tests;

rarely, hepatocellular neoplasms, peliosis hepatitis. Hematologic : Suppression of

cloning factors IL, V, VII, and X; bleeding in-patients on concominant anti-coagu_xfffe_lant therapy.

Nervous System : Increased or decreased libido, headache, anxiety, depression,

and generalized paresthesia.

Metabolic : Increased serum cholesterol. Miscellaneous : Rarely, anaphylactoid

reactions; inflammation and pain at injection site.

DRUG INTERACTIONS

When administered concurrently, the following drugs may interact with andro_xfffe_gens, such as methandrostenolone, have been reported to decrease the antoco_xfffe_agulant requirement. Patients receiving oral anticoagulant therapy require close

monitoring especially when androgens are started or stopped.

Antidiabetic agents, oral or insulin.

Cyclosporine

Hepatotoxic medications, other human growth hormone (somatrem or somatro_xfffe_pin)

CONTRAINDICATIONS

Androgens are contraindicated in men with carcinomas of the breast or with

known or suspected carcinomas of the prostate and in women who are or may

become pregnant.

When administered to pregnant women, androgens cause virilization of the exter_xfffe_nal genitalia of the female fetus. This virilization includes clitoromegaly, abnormal

vaginal development, and fusion of genital folds to form a scrotal-like structure.

This preparation is also contraindicated in patients with a history of hypersensi_xfffe_tivity to any of its components. Patients with a severe heart disease, liver disease

and kidney disease.

PRECAUTIONS

General: Women should be observed for signs of virilization.

Because androgens may alter serum cholesterol concentration, caution should

be used when administering these drugs to patients with a history of myocardial

infarction or coronary artery disease.

All patients : Any nausea, vomiting, changes in skin color or ankle swelling.

PATIENT MONITORING

Bone age determinations

Cholesterol and/or HDL and LDL

Hemoglobin and Hematocrit determinations

Hepatic function determinations

Prostatic acid phosphatase and prostatic specific antigen

Testosterone, total, serum

For treatment of breast carcinoma

Alkaline phosphatase, serum values and physical examination and x-rays of

known or suspected metastases

Calcium

For gender change androgen therapy

LH (Luteinizing hormone)

ALT [SGPT] (Alkaline aminotransferase)

For pediatrics

Androgens should be used with caution in children and adolescents who are still

growing because of possible premature epiphyseal closure in males and females,

precocious sexual development in prepubertal males, or virilization in females.

Skeletal maturation should be monitored at 6-month intervals by an x-ray of the

hand and wrist.

For geriatrics

Treatment of male patients over the age of approximately 50 years with androgens

should be preceded by a thorough examination of the prostate and baseline

measurement of prostatespecific antigen serum concentration since androgens

may cause increased risk of prostatic hypertrophy or may stimulate the growth of

occult prostatic carcinoma. Periodic evaluation of prostate function should also be

performed during the course of therapy.

DOSAGE AND ADMINISTRATION

In males with delayed puberty: Various dosage regimens have been used; some

call for lower dosages initially with gradual increases as puberty progresses, with

or without a decrease to maintenance levels. Other regimens call for higher dosage to induce pubertal changes and lower dosage for maintenance after puberty.

The chronological and skeletal ages must be taken into consideration, both in

determining the initial dose and in adjusting the dose.

Dosage is within the range of 50 to 200 mg every 2 to 4 weeks for a limited duration, for example, 4 to 6 months. X-rays should be taken at appropriate intervals to

determine the amount of bone maturation and skeletal development (see INDICATIONS AND USAGE AND WARNINGS).

Palliation of inoperable mammary cancer in woman: A dosage of 200 to 400 mg

every 2 to 4 weeks is recommended. Women with metastatic breast carcinoma

must be followed closely because androgen therapy occassionally appears to

accelerate the disease.

PRESENTATION

250 mg/ml, 1 x 10 ml vials

STORAGE

Store in a cool dry place (< 25 ºC)

Protect from light.

Warming and rotating the vial between the palms of the hands will redissolve any

crystals that may have been formed during storage at low temperatures.

Manufactured by: Primus Ray Laboratories