Generic
Ulipristal Acetate
10 brands available in the market
At a glance
Ulipristal Acetate is a selective progesterone receptor modulator used to treat uterine fibroids. It reduces symptoms like vaginal bleeding, prolonged periods, and lower back pain. It is also used for emergency contraception.
Description
Ulipristal Acetate is a selective progesterone receptor modulator with antagonistic and partial agonistic effects. When taken immediately before ovulation, it postpones follicular rupture. The primary mechanism for emergency contraception is inhibition or delay of ovulation; however, alterations to the endometrium may also occur.
Indications
- Uterine fibroids
- Emergency contraception
Therapeutic class
Selective Progesterone Receptor Modulator
Pharmacological class
Selective Progesterone Receptor Modulator
Pharmacology
Ulipristal Acetate is a selective progesterone receptor modulator with antagonistic and partial agonistic effects. When taken immediately before ovulation, it postpones follicular rupture. The primary mechanism of action for emergency contraception is inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also occur.
Mechanism of action
Modulates progesterone receptors, delaying ovulation and reducing fibroid size.
Dosage
Adult Dose (Oral):
- Emergency contraception: One tablet as soon as possible within 120 hours (5 days) after unprotected intercourse or contraceptive failure
- Uterine fibroids: 5 mg once daily for up to 3 months; this 3-month course can be repeated once; re-treatment should start during the second menstruation following the first course; treatment should always be started during the first week of menstruation
- If a dose is missed, take as soon as possible; if missed by >12 hours, skip the missed dose and resume the usual dosing schedule
Administration
- May be taken with or without food
- Swallow whole; do not chew, crush or break
- Take at the same time each day
Missed dose
If you miss a dose, take it as soon as possible; if missed by >12 hours, skip the missed dose and resume the usual dosing schedule; do not double the dose.
Side effects
Common Side Effects:
- Absence of menstrual periods
- Headache
- Endometrial hyperplasia
Precautions & warnings
- May affect ability to drive
- Dizziness, drowsiness, blurred vision, or loss of concentration may occur; do not drive if these symptoms occur
- Menstrual bleeding considerably reduces or stops within the first 10 days of treatment; notify doctor if heavy bleeding continues
- Periods usually start again within four weeks of stopping
- May make hormonal contraceptives less effective; use reliable barrier contraceptive
- Routine blood tests may be needed to assess liver function
- Inform doctor if yellowing of skin/eye, dark urine, or stomach pain occurs
Contraindications
- Known or suspected pregnancy
- Hypersensitivity to ulipristal acetate or any excipients
- Genital bleeding of unknown aetiology or for reasons other than uterine fibroids
- Uterine, cervical, ovarian or breast cancer
- Breastfeeding
Drug interactions
- Concomitant administration of progestagen-containing products is not recommended
- Concomitant use with potent CYP3A4 inducers (rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, primidone, St John's wort, efavirenz, nevirapine, long-term use of ritonavir) is not recommended
Food interactions
It is not known whether it is safe to consume alcohol with Ulipristal Acetate; consult your doctor.
Use in pregnancy
Use in Pregnancy: Highly unsafe; studies show significant harmful effects to the developing baby; consult your doctor.
Pregnancy Category: X — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably safe; limited human data suggests no significant risk; consult your doctor.
Pediatric use
Safety and efficacy not established in children
Geriatric use
No overall differences in safety or effectiveness in elderly
Renal / hepatic impairment
Renal Impairment: Limited information; consult your doctor
Hepatic Impairment: Limited information; consult your doctor
Overdose effects
Symptoms: Absence of menstrual periods, headache, endometrial hyperplasia.
Treatment: Supportive care.
Storage conditions
Store in a cool and dry place; keep out of reach of children.