DESCRIPTION
STAVIS 50 is an aqueous suspension of the C17 a-alkylated steroid
stanozolol, an oral
androgen derived from dihydrotestosterone. STAVIS 50 acts on
androgen receptors to
promote anabolism through increased nitrogen retention and
protein synthesis in muscle
tissue. STAVIS 50 75 is a strong anabolic substance with androgenic
action. Stanozolol
does not convert to estrogen and therefore does not produce
typical estrogen mediated side
effects such as water retention. While chemically identical
to oral stanozolol, Stanol-AQ is
injected IM eliminating the first pass of liver metabolism
of its oral counterpart reducing
stress on the liver. Stanozolol reduces SHBG increasing free
testosterone levels.
CLINICAL PHARMACOLOGY
Anabolic steroids are synthetic derivatives of the natural
steroid testosterone. Stanozolol has
been demonstrated to increase LDL and decrease HDL with
serum lipid values returning to
baseline after cessation of use. Hereditary angioedema (HAE)
is an autosomal dominant
disorder caused by a deficient or nonfunctional C1 esterase
inhibitor (C1 INH) and is
clinically characterized by episodes of swelling of the
face, extremities, genitalia, bowel wall,
and upper respiratory tract. In small clinical studies,
stanozolol was effective in controlling
the frequency and severity of attacks of angioedema and in increasing
serum levels of C1
INH and C4. Stanozolol is not effective in stopping HAE
attacks while they are underway. The
effect of stanozolol on increasing serum levels of C1 INH
and C4 may be related to an
increase in protein anabolism.
INDICATIONS
Hereditary Angioedema: for prophylactic use to decrease
frequency and severity of attacks
of angioedema.
Muscle Anabolism: for adjunctive therapy in patients for
weight gain following severe
muscular atrophy associated with extensive surgery, chronic
infections, long term
hospitalization, or severe trauma.
Corticosteroid Atrophy: to reduce muscle wasting during
prolonged corticosteroid use.
CONTRAINDICATIONS
Not for use in female patients due to risk of virilization
and fetal harm.
Male patients with known or suspected carcinoma of the
breast, prostate, or testis.
Patients with hypercalcaemia as anabolic steroids may
stimulate osteolytic bone resorption.
Patients with cardiovascular disorders, renal or hepatic
impairment, epilepsy, migraines, or
diabetes mellitus.
Nephrosis or the nephrotic phase of nephritis.
STORAGE
WARNING
PRECAUTIONS
Anabolic steroids may cause suppression of clotting factors
II, V, VII and X and an increase in
prothrombin time.
Anabolic steroids may increase sensitivity to
anticoagulants. Dosage of anticoagulants may
have to be decreased in order to maintain the prothrombin
time at the desired therapeutic
level.
Oral hypoglycemic dosage may need adjustment in diabetic
patients who receive anabolic
steroids.
Patients should be monitored for hepatotoxicity and
jaundicing.
ADVERSE REACTIONS
Hepatic: Cholestatic jaundice with rarely, hepatic necrosis
and death. Hepatocellular
neoplasms and peliosis hepatis have been reported in
association with long term
androgenic anabolic steroid use. Reversible changes in liver
function tests also occur
including increased bromsulphalein (BSP) retention and
increases in serum bilirubin,
glutamic oxaloacetic transaminase (SGOT), and alkaline
phosphatase.
Genitourinary System (post pubertal men): Inhibition of
testicular functions, testicular
atrophy, and oligospermia, impotence, chronic priapism,
epididymitis and bladder irritability.
Genitourinary System (Women): Clitoral enlargement,
menstrual irregularities.
In both sexes: increased or decreased libido.
CNS: Habituation, excitation, insomnia, and depression.
Hematologic: Bleeding in patients on concomitant
anticoagulant therapy.
Hair: Hirsutism and male pattern baldness in those
genetically predisposed.
Other: Acne, oily skin, electrolytic retention, reversible
changes in serum lipids.
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
Muscle anabolism: 50 – 100mg injected IM every 2 days for a
duration of 4 weeks.
Hereditary angioedema: as prescribed by physician.
The use of anabolic steroids is associated with serious
adverse reactions. Such reactions
are often dose dependent. Physicians are urged to treat
patients with the lowest possible
effective dose.
PRESENTATION
STAVIS 50 (50mg/ml) – 10 ampules of 1ml each
COMPOSITION | |
Each ml contains: | |
Stanozolol Suspension | 50 mg |