Description
Primobolan Tablets
Strength: 25 mg
Molecular Formula: C22H3203
Molecular Weight: 344.495 g/mol
Active Ingredient: Methenolone acetate
CAS number: 434-05-9
Dosage Form: Tablet
Route: Oral
Market Status: Prescription
Company: Hilma Biocare
DESCRIPTION
Primobolan (Methenolone acetate) is a synthetic, orally active anabolic-androgenic steroid
and dihydrotestosterone (DHT) derivative. It can be used for the treatment of bone marrow
disease and anemia. Methenolone acetate is known for its higher therapeutic efficiency and
lower hepatic toxicity compared with its 17 alpha- alkylated analogs. Methenolone cannot
aromatase 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 acts upon the androgen receptor stimulating
anabolism through increased nitrogen retention and protein synthesis in muscle tissue.
Methenolone acetate 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 muscular
atrophy associated with extensive surgery, infections, long term hospitalization, or severe
trauma. To compensate for protein catabolism consequent to corticosteroid therapy.
DOSAGE AND ADMINISTRATION
Adult male: 50 -75 mg per day, Adult females: 25 – 50 mg per day for a duration of 4 to 6
weeks. It is not recommended to exceed the dosage of 100 – 150 mg per day for adult
males.
ADVERSE REACTIONS
Male: Gynecomastia, increased frequency of erections, azoospermia, priapism,
oligospermia, prostatic hypertrophy,increased risk of prostate carcinoma.
Skin and Appendages: Hirsutism, pattern baldness and acne.
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
examina- tlon 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
Primobolan (Methenolone Acetate) 25 mg uncoated tablets, 50 tablets in the bottle.
STORAGE
Store in a cool dry place between 15 -25°C. Protect from light.
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