Turnibol 10 is a 17-alpha alkylated anabolic steroid for oral use. It promotes anabolism through androgen receptor activity and is strongly anabolic and moderately androgenic. When taken in clinical doses, it produces potent increases in strength and moderate increases in muscle mass. In short term clinical trials, it has been well tolerated in healthy male subjects during 6 weeks of treatment.
Anabolic steroids are synthetic derivatives of testosterone. Certain clinical effects and adverse reactions demonstrate the androgenic properties of these drugs. 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 larger doses, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH).
In a single dose pharmacokinetic study of Chlorodehydromethyltestosterone, 10mg administered orally to healthy males reached maximum serum levels in 3 hours. It is subject to first pass hepatic deactivation rapidly with a strong dominance of bioactive metabolites over the parent drug within a few hours. Prior to reaching serum maxima, orally dosed subjects exhibited significant variations in serum absorption levels linked to variations in enterohepatic circulation as demonstrated by radiographic label tracing. In a study involving IV administration of Turnibol 10, the terminal half-life of the parent molecule was found to be 16-hours. Given the lack of consensus on the bioactivity of its metabolites and the predominance of metabolites over the parent drug after oral administration a clinically useful biological half-life remains unclear. Turnibol has demonstrated an affinity for SHBG introducing competition for testosterone binding, thereby yielding increased plasma levels of unbound testosterone.
INDICATION AND USAGE
Turnibol 10 is indicated 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. Turnibol 10 is indicated to compensate for protein catabolism consequent to corticosteroid therapy.The physician and patient must consider the risks of therapy versus the potential benefits.
Patients with known hypersensitivity to any ingredients in this product.
Patients with known or suspected carcinomas of the breast, testis, or prostate.
Patients with severe heart disease, liver disease, or kidney disease or with a history of epilepsy.
Products containing androgens should not be used in women as they may cause virilization and fetal harm.
Patients with nephrosis or the nephrotic phase of nephritis. Patients with hypercalcemia.
Patients with pre-existing cardiac, renal, and/or hepatic disease.
Elevated liver enzymes and in rare cases hepatic liver dysfunction may occur. Periodic liver function tests should be conducted given the association of 17-alpha-alkylated androgens with hepatotoxicity and treatment discontinued if patient presents with signs of hepatotoxicity or jaundicing.
Edema may be increased in patients on concurrent adrenal cortical steroid or ACTH therapy.
Androgenic anabolic steroids have been associated with changes in serum lipids, generally with decreases in high-density lipoprotein (HDL) concentration and increases in low-density lipoprotein (LDL) concentration, a profile known to be associated with increased risk of atherosclerosis and associated risk of coronary artery disease. Thus caution should be used when administering these drugs to patients with a history of myocardial infarction or coronary artery disease.
Anabolic steroids may reduce clotting factors II, V, VII, and X, and may increase pro-thrombin time (PT). Patients should be instructed to report any use of warfarin or other oral anticoagulant therapy and any irregular bleeding.
Male patients receiving androgenic anabolic steroid therapy may be at an increased risk of prostate hypertrophy.
Oral hypoglycemic agents: may inhibit the metabolism of these 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.
Diabetics: androgens may alter the metabolism of oral hypoglycemic agents or may change insulin sensitivity inpatients with diabetes mellitus which may require adjustment of dosage of insulin and other hypoglycemic drugs.
Male: Gynecomastia, excessive frequency and duration of penile erections, priapism, 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 anti-coagulant therapy.
Nervous System: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
Metabolic: Reduced glucose tolerance, changes in creatinine clearance.
Other: Serum lipid changes, polycythemia, hypercalcaemia, hypertension, and potentiation of sleep apnea.
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 males: 10 - 30mg taken orally per day in divided doses for a duration of 4 to 6 weeks.
10mg uncoated tablets: 100 tablets per bottle.
Protect from light. Store at 15-25oC.
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