Ella

Ella

ulipristal

Manufacturer:

Hyphens

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ulipristal acetate
Indications/Uses
Emergency contraception w/in 120 hr (5 days) of unprotected sexual intercourse or contraceptive failure.
Dosage/Direction for Use
1 tab taken not later than 120 hr (5 days) after unprotected intercourse or contraceptive failure. May be taken at any moment during the menstrual cycle. Another tab should be taken if vomiting occurs w/in 3 hr of intake.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Not as replacement for regular contraceptive method. Not recommended in women w/ severe asthma treated by oral glucocorticoid. Not recommended w/ levonorgestrel-containing emergency contraceptive & CYP3A4 inducers eg, barbiturates, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, St. John's wort, rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine & ritonavir (long-term use). Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not recommended in severe hepatic impairment. Women of childbearing potential should use effective contraception until next menstruation. Not to be taken by women of childbearing potential & not intended for use during pregnancy. Not recommended for 1 wk during lactation.
Adverse Reactions
Mood disorders; headache, dizziness; nausea, abdominal pain & discomfort, vomiting; myalgia, back pain; dysmenorrhea, pelvic pain, breast tenderness; fatigue.
Drug Interactions
Decreased efficacy w/ CYP3A4 inducers eg, barbiturates, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, St. John's wort, rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine. Increased Cmax & AUC w/ potent & moderate CYP3A4 inhibitor. Reduced plasma conc w/ ritonavir. Lowered mean Cmax, delayed Tmax & higher mean AUC w/ proton pump inhibitors. Reduced contraceptive action of combined hormonal contraceptives & progesterone-only contraception. Not recommended w/ levonorgestrel-containing emergency contraceptive.
MIMS Class
ATC Classification
G03AD02 - ulipristal ; Belongs to the class of emergency contraceptives. Used as systemic contraceptives.
Presentation/Packing
Form
Ella tab 30 mg
Packing/Price
1's
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