DESCRIPTION

PRIMAVIS 100 is a dihydrotestosterone derived anabolic
steroid. PRIMAVIS 100 contains

methenolone enanthate, a long-acting methenolone ester
producing a rapid onset of serum

methenolone with a continued duration of action of 5 to 7
days after IM injection. PRIMAVIS

100 is moderately anabolic with limited androgenic
properties. Methenolone cannot

aromatize to estrogen, reducing estrogenic side effects, and
has a favorable safety profile

among anabolic agents.

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). Methenolone is a
dihydrotestosterone derivative which cannot

be aromatized to estrogen and which acts upon the androgen
receptor stimulating

anabolism through increased nitrogen retention and protein
synthesis in muscle tissue.

Methenolone enanthate in a single dose pharmacokinetic study
has demonstrated a mean

elimination half-life of 6 days.

INDICATIONS

As an alternate or adjunctive therapy in patients for the
promotion of weight gain following

weight loss and/or muscular atrophy associated with
extensive surgery, chronic infections,

long term hospitalization, or severe trauma. To compensate
for protein catabolism

consequent to corticosteroid therapy.

DOSAGE AND ADMINISTRATION

Adult male: 100 – 200mg injected IM every 3 – 5 days for a
duration of 8 to 12 weeks.

ADVERSE REACTIONS

Male: Gynecomastia, increased frequency of erections,
azospermia, priapism,

oligospermia, prostatic hypertrophy,increased risk of prostate
carcinoma.

Skin and Appendages: Hirsutism, 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: Increased or decreased libido, headache,
anxiety, depression, and

generalized paresthesia.

Metabolic: Reduced glucose tolerance and inhibition of
gonadotrophin secretion.

Other: Serum lipid changes, hypercalcaemia, hypertension,
oedema, and potentiation of

sleep apnea.

CONTRAINDICATIONS

Patients with diagnosed or suspected carcinoma of the
prostate, breast, or testis.

Patients with diagnosed or suspected female breast carcinoma
with hypercalcemia as

androgenic agents may increase osteolytic bone resorption.

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.

Hypersensitivity to this product or any of its ingredients.

Patients with pre-existing cardiac, renal, and/or hepatic
disease.

Discontinue treatment upon signs of jaundicing or
hepatotoxicity.

PRECAUTIONS

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.

Patients on oral anticoagulant therapy require close
monitoring especially when androgens

are started or stopped.

Diabetics: androgens may alter the metabolism of oral
hypoglycemic agents or may change

insulin sensitivity in patients with diabetes mellitus which
may require adjustment of dosage

of insulin and other hypoglycemic drugs.

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.

DRUG INTERACTIONS

Oral hypoglycemic agents: may inhibit the metabolism of oral
hypoglycemic agents which

may require adjustment of dosage.

Anticoagulants: Patients on anticoagulants should be
carefully monitored during anabolic

steroid therapy as anabolic steroids may increase
sensitivity to oral anticoagulants. Patients

should be monitored regularly during anabolic steroid
therapy, particularly during initiation

and termination of therapy.

PRESENTATION

PRIMAVIS 100(100mg/ml )- 10 ampules of 1ml each.

COMPOSITION
Each ml contains:
Metenolone Enanthate	100 mg