Country: বাংলাদেশ
ভাষা: ইংরেজি
সূত্র: DGDA (Directorate General of Drug Administration)
Elagolix
Nuvista Pharma Ltd
Elagolix
150 mg
Tablet
Each ELAGOX Pack contains 28 Tablets, among these 21 tablets are light yellow color tablet film coated which contains Drospirenone USP 3.0 mg & Ethinylestradiol USP 0.03 mg and remaining 7 white colored round tablets are without API. DESCRIPTIONS ELAGOX contains two active ingredients, Ethinylestradiol and Drospirenone. Ethinylestradiol is a synthetic version of oestrogen and Drospirenone is a synthetic form of progesterone. The hormonal components of ELAGOX inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms, which may contribute to the effectiveness of ELAGOX as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation). Drospirenone has antimineralocorticoid activity, counteracting oestrogen related sodium retention. In combination with Ethinylestradiol, Drospirenone displays a favourable lipid profile with an increase in high-density lipoprotein HDL. Drospirenone exerts antiandrogenic activity and does not counteract the Ethinylestradiol-related sex hormone binding globulin (SHBG) increase which is useful for binding and inactivating the endogenous androgens. PHARMACOKINETICS ABSORPTION The absolute bioavailability of DRSP is about 76%. The absolute bioavailability of EE is approximately 40%. The absolute bioavailability of ELAGOX tablet, has not been evaluated. Serum concentrations of DRSP and EE reached peak levels within 1-2 hours after administration of Drospirenone & ethinyl estradiol tablets. FOOD EFFECT The rate of absorption of DRSP and EE following single administration of a formulation slower under fed (high fat meal). DISTRIBUTION DRSP and EE serum concentrations decline in two phases. The apparent volume of distribution of DRSP does not bind to sex hormone binding globulin (SHBG) or corticosteroid binding globulin (CBG) but binds about 97% to other serum proteins. EE is reported to be highly but non-specifically bound to serum albumin (approxi- matel সম্পূর্ণ নথি পড়ুন