ulipristal

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Protein Binding: >94%.

Metabolism/Excretion: Mostly metabolized by CYP3A4 enzyme system; one metabolite (monodemethyl-ulispristal) pharmacologically active.

Half-Life: Ulipristal—32 hr; monodemethyl-ulispristal—27 hr.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK‡	DURATION
PO	unknown	Ulipristal—0.9 hr; monodemethyl-ulispristal—1 hr	unknown

‡Blood level.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

OB: Pregnancy or termination of existing pregnancy;
Lactation: Not recommended during breastfeeding.

Use Cautiously in:

Repeated use; regular contraception should be continued/instituted and additional method should be used during current cycle.

Adv. Reactions/Side Effects ⬆ ⬇

GI: abdominal pain, nausea

GU: altered menstrual cycle, dysmenorrhea

Neuro: headache, dizziness, fatigue

Interactions ⬆ ⬇

Drug-drug:

Effectiveness may be ↓ by CYP3A4 inducers, including barbiturates, bosentan, carbamazepine, oxcarbazepine, phenytoin, topiramate, felbamate, rifampin; avoid concomitant use.
Effects may be ↑ CYP3A4 inhibitor including itraconazole and ketoconazole.
May ↑ levels of P-glycoprotein substrates, including dabigatran and digoxin.
Efficacy of hormonal contraceptives may be ↓ during current cycle.

Drug-Natural Products:

Effectiveness may be ↓ by St. John's wort.

Route/Dosage ⬆ ⬇

PO (Adults ): One tablet as soon as possible within 120 hr (5 days) after unprotected intercourse or known/suspected contraceptive failure. If vomiting occurs within 3 hr dose may be repeated.

Availability ⬆ ⬇

Tablet: 5 mg; 30 mg

Assessment ⬆ ⬇

Exclude the possibility of pregnancy on the basis or history and/or physical exam or a pregnancy test before administering ulipristal.

Implementation ⬆ ⬇

PO: Administer 1 tablet as soon as possible within 120 hrs (5 days) after unprotected intercourse or a known or suspected contraceptive failure. May be taken without regard to food. If vomiting occurs within 3 hrs of dose, may repeat. May be taken at any time during the menstrual cycle.
- Ulipristal may be less effective in women with a body mass index >30 kg/m².

Patient/Family Teaching ⬆ ⬇

Instruct patient to take ulipristal as directed. Advise patient that they should not take ulipristal if they know or suspect they are pregnant or if breastfeeding; ulipristal is not for use to end an existing pregnancy. Advise patient to contact health care professional if they vomit within 3 hrs after taking ulipristal. Instruct patient to read Patient Information pamphlet before taking ulipristal.
Ulipristal may delay next expected menses. Advise patient to notify health care professional and consider the possibility of pregnancy if their period is delayed by more than 1 wk beyond the expected date after taking ulipristal.
Inform patient that ulipristal is not to be used as a routine form of contraception or to be used repeatedly within the same menstrual cycle.
Advise patient that ulipristal does not protect against HIV infection and other sexually transmitted infections.
Advise patient to notify health care professional if severe lower abdominal pain occurs 3–5 wks after taking ulipristal to be evaluated for an ectopic pregnancy.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Rep: Inform patient that ulipristal may reduce the effectiveness of hormonal contraceptives. Advise patient to use a non-hormonal contraceptive until the next menstrual period. Advise patient to wait at least 5 days after taking ulipristal to resume taking hormonal contraceptive. Advise female patients to avoid breastfeeding if taking ulipristal.

Evaluation/Desired Outcomes ⬆ ⬇

Prevention of pregnancy.

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Code ⬆

NDC Code

50090- A-S Medication Solutions
- 50090-2835- Ella
  - 50090-2835-0- 1 BLISTER PACK in 1 CARTON (50090-2835-0) > 1 TABLET in 1 BLISTER PACK

50102- Afaxys Pharma LLC
- 50102-911- Ella
  - 50102-911-01- 1 BLISTER PACK in 1 CARTON (50102-911-01) > 1 TABLET in 1 BLISTER PACK

53002- RPK Pharmaceuticals, Inc.
- 53002-1630- Ella
  - 53002-1630-1- 1 TABLET in 1 DOSE PACK (53002-1630-1)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇