Ulipristal acetate is the generic equivalent of the brand-name drug Ella. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Ulipristal acetate through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure [see Dosage and Administration (2.1) ] . Ella is not intended for routine use as a contraceptive. Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Ella is not intended for routine use as a contraceptive. ( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (≥ 5%) in the clinical trials were headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%) and dizziness (5%). ( 6 )To report SUSPECTED ADVERSE REACTIONS, contact HRA Pharma America Inc., at 844-994-0329 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a dr…
Drug Interactions
7 DRUG INTERACTIONS Several in vivo drug interaction studies have shown that ella is predominantly metabolized by CYP3A4. Drugs or herbal products that induce CYP3A4 decrease the effectiveness of ella . ( 7.1 ) Initiation of progestin-containing contraceptives may impair the ability of ella to delay ovulation. ( 7.1 ) 7.1 Changes in Emergency Contraceptive Effectiveness Associated with Co-Administration of Other Products CYP3A inducers Drugs or herbal products that induce CYP3A4 decrease the pla…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Take one tablet orally as soon as possible, within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. Take with or without food. Take at any time during the menstrual cycle. ( 2.1 ) After ella use, initiate or resume hormonal contraception no sooner than 5 days after the intake of ella and use a reliable barrier method until the next menstrual period. ( 2.2 ) If vomiting occurs within 3 hours of taking ella , consider repea…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved patient Labeling (Patient Information). Administration Instructions Instruct patients to take ella as soon as possible and not more than 120 hours after unprotected intercourse or a known or suspected contraceptive failure. Advise patients to contact their healthcare provider immediately in case of vomiting within 3 hours of taking the tablet, to discuss whether to take another tablet. Advise patients that after using ella , a reliable barrier method of contraception should be used for all subsequent acts of intercou…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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