DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Ella (Ulipristal Acetate) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Several in vivo drug interaction studies have shown that ella is predominantly metabolized by CYP3A4.

Changes in Emergency Contraceptive Effectiveness Associated with Co-Administration of Other Products

Drugs or herbal products that induce CYP3A4 decrease the plasma concentrations of ella, and may decrease its effectiveness [see Warnings and Precautions (5.4​) and Pharmacokinetics ]. Avoid co-administration of ella and drugs or herbal products such as:

  • barbiturates
  • bosentan
  • carbamazepine
  • felbamate
  • griseofulvin
  • oxcarbazepine
  • phenytoin
  • rifampin
  • St. John’s Wort
  • topiramate

Increase in Plasma Concentrations of ella Associated with Co-Administered Drugs

CYP3A4 inhibitors such as itraconazole or ketoconazole increase plasma concentrations of ella [see Pharmacokinetics].

Effects of ella on Co-Administered Drugs

In vitro studies demonstrated that ella does not induce or inhibit the activity of cytochrome P450 enzymes.

P-glycoprotein (P-gp) transporters: In vitro data indicate that ulipristal may be an inhibitor of P-gp at clinically relevant concentrations. Thus, co-administration of ulipristal acetate and P-gp substrates (e.g., dabigatran etexilate, digoxin) may increase the concentration of P-gp substrates. In vivo data suggest that ulipristal acetate 10 mg does not affect P-gp transporters. However, there was no in vivo drug interaction study between ulipristal acetate 30 mg and P-gp transporters [see Pharmacokinetics (12.3)].

OVERDOSAGE

Experience with ulipristal acetate overdose is limited. In a clinical study, single doses equivalent to up to 4 times ella were administered to a limited number of subjects without any adverse reactions.

CONTRAINDICATIONS

ella is contraindicated for use in the case of known or suspected pregnancy. The risks to a fetus when ella is administered to a pregnant woman are unknown. If this drug is inadvertently used during pregnancy, the woman should be apprised of the potential hazard to the fetus. [See Use in Specific Populations (8.1 ).]

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017