Esmya

Esmya

ulipristal

Manufacturer:

Cenexi

Distributor:

Zuellig Pharma

Marketer:

Zuellig Pharma
Concise Prescribing Info
Contents
Ulipristal acetate
Indications/Uses
Pre-op & intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Dosage/Direction for Use
1 tab once daily for up to 3 mth. Start during 1st wk of menstruation. Start retreatment courses at the earliest during 2nd menstruation following 1st treatment course completion. Repeated intermittent treatment Up to 4 intermittent courses.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Genital bleeding of unknown aetiology or for reasons other than uterine fibroids. Uterine, cervical, ovarian or breast cancer. Pregnancy & lactation.
Special Precautions
Not recommended in women w/ severe asthma uncontrolled by oral glucocorticoids. Endometrial changes. Reduction in menstrual blood loss or amenorrhea. Not recommended w/ concomitant use of progestagen-only pills, progestagen-releasing IUD or combined OC pills & co-administration w/ moderate (eg, erythromycin, grapefruit juice, verapamil) or potent (eg, ketoconazole, ritonavir, nefazodone, itraconazole, telithromycin, clarithromycin) CYP3A4 inhibitors & potent CYP3A4 inducers (eg, rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarb, primidone, St. John's wort, efavirenz, nevirapine, long-term use of ritonavir). May affect ability to drive & use machines. Not recommended in severe renal & moderate or severe hepatic impairment. Childn.
Adverse Reactions
Amenorrhea, endometrial thickening. Headache; vertigo; abdominal pain, nausea; acne; musculoskeletal pain; hot flush, pelvic pain, ovarian cyst, breast tenderness/pain; fatigue; increased wt.
Drug Interactions
Reduced efficacy w/ hormonal contraceptives. Increased Cmax & AUC by moderate or potent CYP3A4 inhibitors. Decreased Cmax & AUC w/ potent CYP3A4 inducers. P-gp substrates eg, dabigatran etexilate, digoxin, fexofenadine.
ATC Classification
G03XB02 - ulipristal ; Belongs to the class of antiprogestogens.
Presentation/Packing
Form
Esmya tab 5 mg
Packing/Price
28's
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