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a technique [18:94% (mainly HDL-cholesterol, alpha-1-acid glycoprotein, albumin). 1 10 Elimination Metabolism In vitro data indicate metabolism is predominantly mediated by CYP3A4 in the liver to mono-demethylated (active) and di-demethylated (inactive) metabolites. 1 8 Half-life About 32 hours. 1 14 Stability Storage Oral Tablets 20 25 C. 1 Protect from light. 1 Actions Exhibits antagonist activity at progesterone receptors and inhibits progesterone from binding to its receptors; also possesses partial agonist activity at progesterone receptors. 1 7 9 11 14 Contraceptive effects may involve inhibition or delay of ovulation, inhibition of follicular growth or rupture, and/or alteration of the endometrium possibly affecting implantation. 1 4 10 11 12 13 At recommended doses for postcoital contraception, no clinically important effects on the endometrium. 2 14 Advice to Patients Importance of reading the patient information (medication guide) provided by the manufacturer before initiating therapy. 1 Importance of administering as soon as possible and not >120 hours after unprotected intercourse or known or suspected contraceptive failure. 1 Importance of women informing a clinician if pregnancy is known or suspected. 1 Do not use for termination of existing pregnancy. 1 Importance of women informing a clinician if vomiting occurs within 3 hours of administration and to discuss the need for a repeat dose. 1 Importance of advising women to seek medical attention if severe lower abdominal pain occurs 3 5 weeks after administration to rule out possibility of ectopic pregnancy. 1 Importance of women contacting a clinician if menstruation delayed >1 week beyond the expected date to rule out possibility of pregnancy. 1 Importance of advising women not to use the drug routinely for contraception and not to repeat use within the same menstrual cycle. 1 Importance of informing women that ulipristal may reduce the efficacy of other hormonal contraceptives and to use reliable barrier contraceptives (e.g., condom with spermicide) for subsequent acts of intercourse within the same menstrual cycle. 1 5 Importance of advising women not to use the drug while breast-feeding. 1 Importance of advising women that ulipristal is not effective in all cases; drug may be less effective in women with body mass index >30 kg/m 2 . 1 Importance of informing women that ulipristal does not protect against HIV-infection (AIDS) or other STDs. 1 Importance of women informing a clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses. 1 Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Ulipristal Acetate Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets 30 mg ella Watson AHFS DI Essentials. Copyright 2017, Selected Revisions June 21, 2011. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Watson Pharma. ella (ulipristal acetate) tablets prescribing information. Morristown, NJ; 2010 Aug. 2. Glasier AF, Cameron ST, Fine PM et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet . 2010; 375:555-62. [PubMed 20116841] 3. Fine P, Mathé H, Ginde S et al. Ulipristal acetate taken 48-120 hours after intercourse for emergency contraception. Obstet Gynecol . 2010; 115:257-63. [PubMed 20093897] 4. Brache V, Cochon L, Jesam C et al. Immediate pre-ovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod . 2010; 25:2256-63. [PubMed 20634186] 5. American Academy of Pediatrics Committee on Adolescence. Emergency contraception. Pediatrics . 2005; 116:1026-35. [PubMed 16147972] 6. Creinin MD, Schlaff W, Archer DF et al. Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Obstet Gynecol . 2006; 108:1089-97. [PubMed 17077229] 7. Attardi BJ, Burgenson J, Hild SA et al. In vitro antiprogestational/antiglucocorticoid activity and progestin and glucocorticoid receptor binding of the putative metabolites and synthetic derivatives of CDB-2914, CDB-4124, and mifepristone. J Steroid Biochem Mol Biol . 2004; 88:277-88. [PubMed 15120421] 8. Blithe DL, Nieman LK, Blye RP et al. Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. Steroids . 2003; 68:1013-7. [PubMed 14667994] 9. Chabbert-Buffet N, Meduri G, Bouchard P et al. Selective progesterone receptor modulators and progesterone antagonists: mechanisms of action and clinical applications. Hum Reprod Update . 2005 May-Jun; 11:293-307. 10. Gainer EE, Ulmann A. Pharmacologic properties of CDB(VA)-2914. Steroids . 2003; 68:1005-11. [PubMed 14667993] 11. Passaro MD, Piquion J, Mullen N et al. Luteal phase dose-response relationships of the antiprogestin CDB-2914 in normally cycling women. Hum Reprod . 2003; 18:1820-7. [PubMed 12923133] 12. Stratton P, Hartog B, Hajizadeh N et al. A single mid-follicular dose of CDB-2914, a new antiprogestin, inhibits folliculogenesis and endometrial differentiation in normally cycling women. Hum Reprod . 2000; 15:1092-9. [PubMed 10783359] 13. Stratton P, Levens ED, Hartog B et al. Endometrial effects of a single early luteal dose of the selective progesterone receptor modulator CDB-2914. Fertil Steril . 2010; 93:2035-41. [PubMed 19200989] 14. Gemzell-Danielsson K, Rabe T. Emergency contraception. J Reproduktionsmed Endokrinol . 2010; 7 (Sonderheft 1): 73-77. 15. Glasier A. Emergency postcoital contraception. N Engl J Med . 1997; 337:1058-64. [PubMed 9321535] 16. . Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Task Force on Postovulatory Methods of Fertility Regulation. Lancet . 1998; 352:428-33. [PubMed 9708750] 17. von Hertzen H, Piaggio G, Ding J et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. Lancet . 2002; 360:1803-10. [PubMed 12480356] 18. Hild SA, Reel JR, Hoffman LH et al. CDB-2914: anti-progestational/anti-glucocorticoid profile and post-coital anti-fertility activity in rats and rabbits. Hum Reprod . 2000; 15:822-9. [PubMed 10739827] Next Interactions Print this page Add to My Med List More about ulipristal Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 88 Reviews Add your own review/rating Drug class: progesterone receptor modulators Consumer resources Ulipristal Ulipristal Tablets (Ella) Ulipristal (Advanced Reading) Professional resources Ulipristal (Wolters Kluwer) Other brands: ella Related treatment guides Uterine Fibroids Birth Control Emergency Contraception] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Progesterone receptor modulators Related Drugs Emergency Contraception levonorgestrel , Plan B , Plan B One-Step , ulipristal , ethinyl estradiol / levonorgestrel , ella , Aftera , Next Choice , My Way , EContra EZ , More... Ulipristal Rating 88 User Reviews 7.2 /10 88 User Reviews 7.2 Rate it! even though


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