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Ella

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In one study, the drug ulipristal acetate proved t"...

Ella

Ella

INDICATIONS

ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive.

DOSAGE AND ADMINISTRATION

Instruct patients to take one tablet orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.

The tablet can be taken with or without food.

If vomiting occurs within 3 hours of ella intake, consideration should be given to repeating the dose.

ella can be taken at any time during the menstrual cycle.

HOW SUPPLIED

Dosage Forms And Strengths

The ella tablet is supplied as a white to off-white, round, curved tablet containing 30 mg of ulipristal acetate and is marked “ella” on both sides.

Storage And Handling

ella (ulipristal acetate) tablet, 30 mg is supplied in a PVC-PE-PVDC-aluminum blister. The tablet is a white to off-white, round, curved tablet marked with “ella” on both sides.

NDC 52544-238-54 (1 tablet unit of use package)

Store at 20-25°C (68-77°F). [See USP controlled room temperature.]

Keep the blister in the outer carton in order to protect from light. Keep out of reach of children.

Distributed By: Watson Pharma, Inc. Parsippany, NJ 07054 USA. Manufactured By: Cenexi, 95520 Osny, France, or Laboratorios León Farma S.A., 24008 León, Spain. Revised: 04/2012

Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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