
Utal5 mg
Square Pharmaceuticals PLC.
Ulipristal Acetate [For uterine fibroids] is a selective progesterone receptor modulator (SPRM) indicated in premenopausal women for the intermittent or pre-operative treatment of moderate-to-severe…
Ulipristal Acetate [For uterine fibroids] is a selective progesterone receptor modulator (SPRM) indicated in premenopausal women for the intermittent or pre-operative treatment of moderate-to-severe signs and symptoms of uterine fibroids (leiomyomas), such as heavy or prolonged menstrual bleeding, pelvic pain/pressure, and fibroid-related anemia.
Note: This bracketed indication of Ulipristal Acetate [For uterine fibroids] is distinct from the separate emergency-contraception use and dosing of ulipristal acetate, which is not covered by this entry.
Treatment with Ulipristal Acetate [For uterine fibroids] should be initiated and supervised by a physician experienced in the diagnosis and treatment of uterine fibroids, with pregnancy excluded before starting.
| Indication | Dose | Duration |
|---|---|---|
| Pre-operative treatment | One 5 mg tablet by mouth once daily, started within the first week of the menstrual cycle | Up to 3 months, single course |
| Intermittent treatment (surgery not appropriate/failed) | One 5 mg tablet once daily, started within the first week of each menstrual cycle | Repeated courses of up to 3 months each, separated by a treatment-free interval (allowing a menstrual bleed) between courses, with mandatory liver monitoring between courses |
Tablets may be taken with or without food. If a dose is missed, it should be taken as soon as possible; if more than 12 hours late, the missed dose should be skipped and the next tablet taken at the usual time. Ulipristal Acetate [For uterine fibroids] is not intended for continuous, uninterrupted long-term use outside a defined treatment-and-monitoring plan (see Precautions and Warnings).
Reported adverse effects with Ulipristal Acetate [For uterine fibroids] include:
Ulipristal Acetate [For uterine fibroids] is contraindicated in patients with:
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