ulipristal

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ulipristal

(u-li-priss-tal) ,

Ella

(trade name)

Classification

Therapeutic: contraceptive hormones
Pharmacologic: progesterone agonists antagonists
Pregnancy Category: X

Indications

Prevention of pregnancy following unprotected intercourse or known/suspected contraceptive failure; not intended for routine use.

Action

Binds to progesterone receptors.
Delays follicular rupture, thereby inhibiting/delaying ovulation. Changes in endometrial environment may also contribute to action.

Therapeutic effects

Prevention of pregnancy.

Pharmacokinetics

Absorption: Well absorbed following oral administration.
Distribution: Unknown.
Protein Binding: >94%.
Metabolism and 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

ROUTEONSETPEAK†DURATION
POunknownUlipristal—0.9 hr; monodemethyl-ulispristal—1 hrunknown
†Blood level.

Contraindications/Precautions

Contraindicated in: 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.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • dizziness
  • fatigue

Gastrointestinal

  • abdominal pain (most frequent)
  • nausea (most frequent)

Genitourinary

  • altered menstrual cycle
  • dysmenorrhea

Interactions

Drug-Drug interaction

Effectiveness may be ↓ by CYP3A4 inducers, including barbiturates, bosentan, carbamazepine, oxcarbazepine, phenytoin, topiramate, felbamate, rifampin.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.Effectiveness may be ↓ by St. John's wort.

Route/Dosage

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

Availability

Tablet: 30 mg

Nursing implications

Nursing assessment

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

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Oral: 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; 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.
  • Inform patient that ulipristal may reduce the effectiveness of hormonal contraceptives. Advise patient to use a non-hormonal contraceptive during that menstrual cycle.
  • Advise patient to notify health care professional and consider the possibility of pregnancy of 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.
  • Advise female patients to avoid breastfeeding if taking ulipristal.

Evaluation/Desired Outcomes

  • Prevention of pregnancy.