DESCRIPTION

DROSTAVIS 100 is a synthetic derivative of
dihydrotestosterone, producing an anabolic

effect and promoting protein synthesis as well as creating
positive nitrogen balance in

humans. Since it is a derivative of dihydrotestosterone,
drostanolone does not aromatize to

estrogens. DROSTAVIS 100 and Drostan 150 have significant
anabolic and androgenic

properties promoting an increase in strength and growth of
muscle tissue while acting as an

estrogen antagonist. The combination of a short-acting
propionate ester with a long-acting

enanthate ester produces rapid increases in serum
drostanolone levels with a sustained

duration of 5-8 days.

CLINICAL PHARMACOLOGY

Anabolic steroids are synthetic derivatives of testosterone.
Certain clinical effects and

adverse reactions demonstrate the androgenic properties of
these drugs. Complete

dissociation of anabolic and androgenic effects has not been
achieved. The actions of

anabolic steroids are thus similar to those of male sex
hormones. Anabolic steroids

suppress the gonadotropic functions of the pituitary and may
exert a direct effect upon the

testes. During exogenous administration of anabolic
androgens, endogenous testosterone

release is inhibited through inhibition of pituitary
luteinizing hormone (LH). At large doses,

spermatogenesis may be suppressed through feedback
inhibition of pituitary folliclestimulating hormone (FSH).

Drostanolone attaches to androgen receptors; increasing
nitrogen retention and protein

synthesis. Drostanolone acts on DHT modulated pathways as
well. Drostanolone is a potent

estrogen antagonist and does not aromatize to estrogen,
limiting expression of side effects

often linked to estrogen such as water retention,
gynecomastia, and some types of high

blood pressure. Drostanolone undergoes hepatic metabolism
with a half-life of 2-3 days

after separation of the ester.

INDICATIONS

To rapidly restore muscle tissue atrophied during recovery
from a traumatic injury.

To offset muscle catabolism in patients with a wasting
syndrome.

To treat certain types of anemia which are non-responsive to
first line agents.

Oestrogen antagonist in treatment of breast cancer.

CONTRAINDICATIONS

Not indicated for women, children, or the elderly.

Women who are pregnant or may become pregnant because of
possible masculinization of

the fetus.

Patients with nephrosis or the nephrotic phase of nephritis.
Patients with hypercalcemia.

Patients suffering from testicular cancer, prostate cancer,
breast cancer, liver damage,

kidney damage, stroke, high blood pressure, heart disease or
respiratory problems.

PRECAUTIONS

Elevated liver enzymes and in rare cases hepatic liver
dysfunction may occur. Periodic liver

function should be monitored for changes including serum
bilirubin, AST, ALT, and AP.

Edema may be increased in patients on concurrent adrenal
cortical steroid or ACTH therapy.

Anabolic steroid hormones may increase low-density
lipoproteins (LDL) and decrease high

density lipoproteins (HDL).Lipids levels generally return to
normal upon discontinuation of

treatment.

Anabolic steroids may reduce clotting factors II, V, VII,
and X, and may increase prothrombin time (PT). Patients should be instructed to
report any use of warfarin and any

irregular bleeding.

ADVERSE REACTIONS

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

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

Fluid/electrolyte Disturbances: Retention of sodium,
chloride, water, potassium, calcium,

and inorganic phosphates.

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

hepatocellular neoplasms, peliosis hepatitis, hepatic
adenomas, and cholestatic hepatitis.

Hematologic: Suppression of clotting factors II, V, VII,
& X; bleeding in patients on anticoagulant therapy.

Nervous System: Changes in libido, aggression, headache,
anxiety, depression, and

generalized paresthesia.

Metabolic: reduced glucose tolerance, increased creatinine
clearance, and inhibition of

gonadotrophin secretion.

Other: Serum lipid changes, hypercalcaemia, hypertension,
oedema, priapism, and

potentiation of sleep apnea.

PATIENT MONITORING

Serum Cholesterol, HDL, LDL, TG. Hemoglobin and Hematocrit,
Hepatic function tests –

AST/ALT

Prostatic specific antigen – PSA, Testosterone: total, free,
and bioavailable.

Dihydrotestosterone & Estradiol

Male patients over 40 should undergo a digital rectal
examination and evaluate PSA prior to

androgen use.

Periodic evaluations of the prostate should continue while
on androgen therapy, especially in

patients with difficulty

in urination or with changes in voiding habits.

DOSAGE AND ADMINISTRATION

Adult male: 100 – 150mg injected IM every 3-5 days for
duration of 4-8 weeks.

PRESENTATION

DROSTAVIS 100 (100mg/ml) – 10 ampules of 1ml each