Ella

Ella

ulipristal

Manufacturer:

Hyphens

Distributor:

Pan-Malayan
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
Concomitant use w/ a levonorgestrel-containing emergency contraceptive. Women w/ severe asthma insufficiently controlled by oral glucocorticoid. Not a replacement for regular contraceptive method. Repeated administration w/in the same menstrual cycle is not advisable. Severe hepatic impairment. Concomitant use w/ CYP3A4 inducers (eg, rifampicin, phenytoin, phenobarb, carbamazepine, efavirenz, fosphenytoin, nevirapine, oxcarbazepine, primidone, rifabutine, St. John's wort). Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or use machines. Not recommended during lactation for 1 wk.
Adverse Reactions
Mood disorders; headache, dizziness; nausea, abdominal pain/discomfort, vomiting; myalgia, back pain; dysmenorrhea, pelvic pain, breast tenderness; fatigue.
Drug Interactions
Increased Cmax & AUC w/ potent & a moderate CYP3A4 inhibitor. Reduced plasma conc w/ ritonavir. Lower mean Cmax, delayed Tmax & higher AUC w/ proton pump inhibitors. Reduced plasma conc w/ CYP3A4 inducers (eg, rifampicin, phenytoin, phenobarb, carbamazepine, efavirenz, fosphenytoin, nevirapine, oxcarbazepine, primidone, rifabutine, St. John's wort). Reduced contraceptive action of combined hormonal contraceptives & progestogen-only contraception.
MIMS Class
Oral Contraceptives
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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