Ulipristal

Ulipristal is an emergency contraceptive used to prevent pregnancy after having sex without using a condom or other effective birth control method. Ulipristal is not to be used as a regular form of daily, weekly, or  monthly birth control. Ulipristal should not be used to terminate an existing pregnancy.

• Ulipristal is available under various brand names: Ella

Common side effects of Ulipristal include:

• headache.
• dizziness, tired feeling.
• nausea, stomach pain; or
• menstrual pain.

Serious side effects of Ulipristal include:

• hives. 
• difficult breathing. 
• swelling of the face, lips, tongue, or throat.
• severe pain in the lower stomach (especially on only one side) 3 to 5 weeks after using ulipristal.

Rare side effects of Ulipristal include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 30 mg (Ella, Logilia)

Emergency contraception: 

Adult dosage

• Oral: 30 mg as soon as possible, but within 120 hours (5 days) of unprotected intercourse or contraceptive failure.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ulipristal has severe interactions with the following drugs:
  • ketoconazole
  • levoketoconazole
• Ulipristal has serious interactions with at least 43 other drugs.
• Ulipristal has moderate interactions with at least 31 other drugs.
• Ulipristal has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Confirmed pregnancy
• Allergic to Ulipristal
• Menopausal woman
• Premenarche.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ulipristal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ulipristal?”

Cautions

• Ulipristal is not to be used as a regular form of daily, weekly, or monthly birth control.
• ULIPRISTAL SHOULD NOT BE USED TO TERMINATE AN EXISTING PREGNANCY.
• You should wait at least 5 days after taking ulipristal before you start using hormonal birth control (birth control pills, injections, implants, skin patches, vaginal rings). Both ulipristal and hormonal birth control may be less effective when used at the same time. You may need to use a barrier form of birth control until your hormonal birth control takes effect.
• Ulipristal will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Pregnancy and Lactation

• Ulipristal can harm an unborn baby or cause birth defects. Do not use emergency contraception if you are already pregnant or think you might be pregnant.
• Contraceptives
  • After use of ulipristal, a reliable barrier method of contraception should be used with subsequent acts of intercourse until the next menstrual period
  • Progestin-containing contraceptives may impair ability of ulipristal to delay ovulation; after using ulipristal, if a woman wishes to initiate hormonal contraception as a regular method, she can do so, no sooner than 5 days after intake of ulipristal and she should use a reliable barrier method until next menstrual period
  • If a woman used ulipristal due to a known or suspected failure of her hormonal contraception refer to the hormonal contraceptive’s prescribing information for instructions on what to do
• Lactation
  • You should not breastfeed while using this Ulipristal.
  • The drug and its active metabolite, monodemethyl-ulipristal acetate, are present in human milk in small amounts; based on levels of drug and active metabolite measured in breastmilk, a fully breastfed child would receive a weight-adjusted dosage of approximately 0.8% of ulipristal acetate and monodemethyl-ulipristal acetate on Day 1 of drug administration and an approximate total of 1% of maternal dose over a 5-day period after drug administration; there is no information on effects on breastfed child or on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition