Ulipristal Acetate is indicated for emergency contraception within 120 hours (5 days) after unprotected sexual intercourse or contraceptive failure.
Ulipristal Acetate [For emergency contraception]
Generic MedicineDescription
Ulipristal Acetate 30 mg tablet is an emergency contraceptive pill used to prevent unintended pregnancy. It is a Selective Progesterone Receptor Modulator (SPRM). The tablet is intended for oral administration. Inactive ingredients include lactose monohydrate, povidone K-30, croscarmellose sodium, and magnesium stearate.
Pharmacology
Ulipristal Acetate is an orally active synthetic SPRM that binds with high affinity to human progesterone receptors. Its primary mechanism of action is inhibition or delay of ovulation. Studies show that even when taken shortly before ovulation, it may delay follicular rupture in some women.
Dosage Administration
One 30 mg tablet must be taken as soon as possible but no later than 120 hours of unprotected intercourse or contraceptive failure, with or without food. If vomiting occurs within 3 hours of intake, then another tablet needed to be taken. Ulipristal Acetate can be taken at any time of menstrual cycle
Interactions
Ulipristal Acetate may interact with drugs such as barbiturates, carbamazepine, phenobarbital, rifampicin, itraconazole, and ketoconazole, which can alter its effectiveness.
Contraindications
Ulipristal Acetate is contraindicated in patients with hypersensitivity to the active substance and in confirmed or suspected pregnancy.
Side Effects
Common side effects include headache, nausea, abdominal pain, dysmenorrhea, fatigue, dizziness, and breast tenderness.
Pregnancy & Lactation
Ulipristal Acetate is contraindicated during existing or suspected pregnancy. It is excreted into breast milk; therefore, breastfeeding is not recommended for one week after administration. Limited data are available regarding fetal or newborn exposure.
Precautions & Warnings
Existing Pregnancy: Ulipristal Acetate is not intended for termination of an existing pregnancy.
Ectopic Pregnancy: Previous ectopic pregnancy is not a contraindication.
Repeated Use: This medicine is intended for occasional emergency contraception and should not replace regular contraceptive methods. Repeated use within the same menstrual cycle is not recommended.
Fertility Following Use: Fertility may return rapidly after treatment; therefore, barrier contraception such as condoms should be used for subsequent intercourse.
Effect on Menstrual Cycle: Menstruation may occur earlier or later than expected. If menstruation is delayed by more than one week, pregnancy testing is recommended. Intermenstrual bleeding may occur in some women.
Special Populations
Children and Adolescents: Limited safety and efficacy data are available in females under 18 years of age.
Hepatic Impairment: No studies have evaluated the effect of liver disease on Ulipristal Acetate.
Renal Impairment: No studies have evaluated the effect of kidney disease on Ulipristal Acetate.
Overdose Effects
Experience with overdose is limited. In clinical studies, doses up to four times the recommended amount were administered without significant adverse reactions.
Therapeutic Class
Drugs acting on the uterus, Emergency Contraceptive Pill
Storage Conditions
Store in a cool and dry place, protected from sunlight. Do not freeze. Keep out of the reach of children.
Common Questions
What is Ulipristal Acetate [For emergency contraception] for?
What does Ulipristal Acetate do?
What are the side effects of Ulipristal Acetate?
What happens if you take too much Ulipristal Acetate?
Can Ulipristal Acetate be taken during pregnancy?