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Ortho Evra®

Brand Name: Ortho Evra
Active Ingredient:   norelgestromin/ethinyl estradiol
Strength(s): 150 mcg and 20 mcg 
Dosage Form(s):   Patch
Company Name:    Ortho-McNeil
Availability:         Prescription only
*Date Approved by the FDA:   November 20, 2001
*Approval by FDA does not mean that the drug is available for consumers at this time




What is Ortho Evra used for?

Ortho Evra is a contraceptive (birth control) skin patch used to prevent pregnancy. It is a combination hormonal contraceptive because it contains two hormones, estrogen and progestin. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 

Who should not take Ortho Evra?

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from the use of hormonal birth control methods. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use hormonal birth control methods should not smoke. 

Ortho Evra should not be used by women who have: 

  • a history of heart attack or stroke 
  • blood clots in the legs, lungs (pulmonary embolism), or eyes 
  • a history of blood clots in the deep veins of the legs 
  • chest pain 
  • known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina 
  • unexplained vaginal bleeding 
  •  yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives 
  • liver tumor (benign or cancerous) 
  • known or suspected pregnancy 
  • severe high blood pressure 
  • diabetes with complications of the kidneys, eyes, nerves, or blood vessels 
  • an allergy to Ortho Evra or to any of its ingredients 

General Precautions with Ortho Evra:

For the majority of women, Ortho Evra can be used safely. But some women are at high risk of developing certain serious diseases that can be life threatening or may cause temporary or permanent disability or death. The risks associated with using Ortho Evra increase significantly if you: 

  • smoke 
  • have high blood pressure, diabetes, or high cholesterol 
  • have or have had clotting disorders, heart attack, stroke, chest pain (angina pectoris), and cancer of the breast or reproductive organs, jaundice, or malignant or benign liver tumors

Ortho Evra may be less effective in women weighing more than 198 pounds. 

What should I tell my health care provider?

Tell your health care provider: 

  • about all your medical conditions 
  • if you smoke cigarettes 
  • about all the medications you take, including prescription and nonprescription medications, vitamins, and herbal supplements. Some medicines can affect Ortho Evra and make it less effective.

What are some possible side effects of Ortho Evra? (This is NOT a complete list of side effects reported with Ortho Evra. Your health care provider can discuss with you a more complete list of side effects.)

Some common side effects with combination hormonal contraceptives like Ortho Evra are: 

  • breast tenderness and enlargement 
  • headache 
  • nausea 
  • menstrual changes 
  • abdominal cramps and bloating 
  • vaginal discharge 

Ortho Evra may also cause skin irritation at the application site. 

For more detailed information about Ortho Evra, ask your health care provider and pharmacist.

http://www.fda.gov/cder/foi/nda/2001/021-180_Ortho%20EVRA_prntlbl.pdf    Link to Ortho Evra's Labeling 

Posted: 11/22/02; Revised 8/8/2003

 

Back to Drug Side Effects


source: FDA


last update: December 2004





This information is not intended to be a substitute for professional medical advice. You should not use this material to diagnose or treat a health condition or disease without consulting with your healthcare provider.
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