Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
Drospirenone; Oestradiol hemihydrate; oestradiol
Bayer Australia Ltd
Medicine Registered
ANGELIQ ® 1/2 CMI 1 CONSUMER MEDICINE INFORMATION ANGELIQ 1/2 _oestradiol and drospirenone _ WARNING The Women’s Health Initiative (WHI) trial examined the health benefits and risks of combined _oestrogen plus progestogen_ therapy (n=16,608) and _oestrogen-alone_ therapy (n=10,739) in postmenopausal women aged 50 to 79 years. The _oestrogen plus progestogen_ arm of the WHI trial indicated an increased risk of _myocardial infarction (MI), stroke, invasive breast cancer, pulmonary embolism and deep vein _ _thrombosis _in postmenopausal women receiving treatment with combined conjugated equine oestrogens (CEE, 0.625 mg/day) and medroxyprogesterone acetate (MPA, 2.5 mg/day) for 5.2 years compared to those receiving placebo. The _oestrogen-alone_ arm of the WHI trial indicated an increased risk of_ stroke and deep vein _ _thrombosis _in hysterectomised women treated with CEE-alone (0.625 mg/day) for 6.8 years compared to those receiving placebo. Other doses of oral conjugated oestrogens with medroxyprogesterone acetate, and other combinations and dosage forms of oestrogens and progestogens were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Therefore, the following should be given serious consideration at the time of prescribing: • Oestrogens with or without progestogens should not be prescribed for primary or secondary prevention of cardiovascular diseases. • Oestrogens with or without progestogens should be prescribed at the lowest effective dose for the approved indication. • Oestrogens with or without progestogens should be prescribed for the shortest period possible for the approved indication. • For the prevention of osteoporosis, oestrogen treatment should be considered in light of other available therapies. ANGELIQ ® 1/2 CMI Izlasiet visu dokumentu
121206 ANGELIQ 1/2 PI Page 1 of 20 PRODUCT INFORMATION ANGELIQ ® 1/2 NAME OF THE MEDICINE ANGELIQ 1/2 is an HRT preparation containing the oestrogen oestradiol and the progestogen drospirenone. Each red film-coated tablet contains: oestradiol 1.0 mg, drospirenone 2.0 mg. Oestradiol is oestra-1,3,5(10)-triene-3, 17 -diol, the major estrogenic hormone produced by the human ovary and has the following chemical structure: CH 3 OH O H H H H Chemical formula: C 18 H 24 O 2 Molecular weight: 281.4 CAS No: 50-28-2 Drospirenone is a progestogen. The chemical name for drospirenone is 6 , 7, 15, 16- Dimethylene-3-oxo-17 -pregn-4-ene-21, 17-carbolactone and has the following chemical structure: O O CH 3 H 3 C O H H H Chemical formula: C 24 H 30 O 3 Molecular weight: 366.50 CAS No: 67392-87-4 DESCRIPTION Oestradiol exists mostly as the hemihydrate, which is a non hygroscopic, stable solid. Oestradiol is a white to almost white, crystalline powder and is practically insoluble in water. The melting point is between 173 and 180 C. Drospirenone is a white to off-white crystalline powder. It is freely soluble in methylene chloride, soluble in acetone, methanol, sparingly soluble in ethylacetate and ethanol 96% (v/v) and 121206 ANGELIQ 1/2 PI Page 2 of 20 practically insoluble in hexane and water. ANGELIQ 1/2 tablets contain the following excipients: Lactose, maize starch, pregelatinised maize starch, povidone 25 000, magnesium stearate, hypromellose, macrogol 6000, purified talc, titanium dioxide and iron oxide red. PHARMACOLOGY PHARMACODYNAMIC PROPERTIES ANGELIQ 1/2 contains 17 -oestradiol, which is chemically and biologically identical to endogenous human oestradiol, and the synthetic progestogen, drospirenone. 17 -oestradiol provides hormone replacement during and after the climacteric. The addition of drospirenon Izlasiet visu dokumentu