Ulipristal Acetate [For uterine fibroids]
Generic Details
Generic Name
Ulipristal Acetate
Other Names
- Ella
- Esmya
Drug Class
- Selective progesterone receptor modulator (SPRM)
Chemical Formula
C28H32ClNO4
Molecular Weight
475.01 g/mol
Mechanism of Action
- Blocks the effects of progesterone on the uterus
Indications
- Treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age
Common Dosage Forms
- Tablet
Typical Dosage
- 5 mg once daily for up to 3 months
Pediatric Dosage
- Not established
Geriatric Dosage
- Use with caution
Side Effects
- Headache
- Hot flashes
- Nausea
- Muscle pain
- Fatigue
Contraindications
- Pregnancy
- Severe liver impairment
Pregnancy Category
- Category X - Contraindicated in pregnancy
Lactation Safety
- Limited data, caution advised
Drug Interactions
- Strong CYP3A4 inducers
- Hormonal contraceptives
Overdose Symptoms
- Nausea
- Vomiting
Antidote for Overdose
- Symptomatic and supportive treatment
Storage Conditions
- Store at room temperature away from moisture and heat
Pharmacokinetics
- Absorption: Well absorbed
- Distribution: High distribution volume
- Metabolism: Metabolized in the liver
- Excretion: Excreted in urine and feces
Precautions
- Hepatic impairment
- Cardiovascular risk factors
Warnings
- Increased risk of hepatotoxicity
- Embryo-fetal toxicity