Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
mesterolone, Quantity: 25 mg
Bayer Australia Ltd
Mesterolone
Tablet, uncoated
Excipient Ingredients: propyl hydroxybenzoate; lactose monohydrate; povidone; magnesium stearate; methyl hydroxybenzoate; maize starch
Oral
50 tablets
(S4) Prescription Only Medicine
Hypogonadism - Androgen replacement for male hypogonadism, where there is androgen deficiency confirmed by clinical and biochemical testing (see 'Precautions' and 'Dosage and Administration').
Visual Identification: round white scored tablets marked with "AX" inside a hexagon; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2007-06-20
PROVIRON ® CMI 1 PROVIRON ® (PRO·VAI·RON) _mesterolone _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Proviron. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Proviron against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PROVIRON IS USED FOR Proviron is used to replace testosterone in men with hypogonadism. Male hypogonadism is a condition when the body does not produce enough testosterone. Testosterone is a natural male hormone, known as an androgen, which controls normal sexual development in men. Testosterone is essential for the development and maintenance of the male reproductive organs as well as other male characteristics, such as hair growth, deep voice, sexual drive, muscle mass and body fat distribution. Proviron is for use in male patients only. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU USE PROVIRON _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PROVIRON IF YOU HAVE AN ALLERGY TO: • mesterolone, the active ingredient in Proviron • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE PROVIRON IF YOU HAVE: prostate cancer previous or existing liver tumours male breast cancer high blood calcium levels DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK AND BLISTER. The expiry date is printed on the carton and on each blister after “EXP” (e.g. Read the complete document
PRODUCT INFORMATION PROVIRON ® NAME OF THE MEDICINE Mesterolone is a white to yellowish crystalline powder and is practically insoluble in water. The chemical name for mesterolone is 17 beta-Hydroxy-1 alpha-methyl-5 alpha- androstan-3-one and has the following structural formula: O CH 3 CH 3 OH H H H CH 3 H Molecular formula C 20 H 32 O 2 Molecular weight 304.47 Melting point 205 - 211 ° C CAS Number 001424-00-6 DESCRIPTION Proviron is a hormonal preparation and contains 25 mg mesterolone. Each small white tablet contains mesterolone 25 mg and the excipients: lactose, starch-maize, povidone, methyl hydroxybenzoate, propyl hydroxybenzoate and magnesium stearate. PHARMACOLOGY PHARMACODYNAMICS 1 Mesterolone (Proviron) has androgenic properties. Early studies suggested oral mesterolone did not usually suppress gonadotrophins or endogenous testosterone production. A later single dose study suggests there may be a central suppression effect at doses of 75-100 mg daily. PHARMACOKINETICS Following oral ingestion mesterolone is rapidly absorbed. In a study in 18 men the intake of Proviron 25 mg generated maximum serum drug levels of 3.1 ± 1.1 ng/mL after 1.6 ± 0.6 hours. Thereafter, drug levels in serum decrease with a terminal half-life of 12 - 13 hours. Mesterolone is bound to serum proteins by 98 %. Binding to albumin accounts for 40 % and binding to SHBG (sex hormone binding globulin) to 58 %. Mesterolone is rapidly metabolised. The metabolic clearance rate from serum accounts for 4.4 ± 1.6 mL·min -1 ·kg -1 . Renal excretion of unchanged drug has not been detected. In a study of C14 labelled mesterolone in two men, up to 2% of mesterolone was excreted as the conjugated form in the urine. The main metabolite has been identified as 1 α -methyl-androsterone, which - in conjugated form - accounts for 55 - 70 % of renally excreted metabolites. The ratio of conjugated main metabolite glucuronide to sulfate detected in urine was about 12:1. As a further metabolite 1 α -methyl-5 α -androstane-3 α ,17 β -diol has b Read the complete document