"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Serious ill effects have not been reported following accidental ingestion of large doses of hormonal contraceptives. Overdosage may cause nausea and vomiting, and withdrawal bleeding may occur in females. Given the nature and design of the ORTHO EVRA®patch, it is unlikely that overdosage will occur. Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. In case of suspected overdose, all ORTHO EVRA® patches should be removed and symptomatic treatment given.
ORTHO EVRA® should not be used in women who currently have the following conditions:
- Thrombophlebitis, thromboembolic disorders
- A past history of deep vein thrombophlebitis or thromboembolic disorders
- Known thrombophilic conditions
- Cerebrovascular or coronary artery disease (current or past history)
- Valvular heart disease with complications103
- Persistent blood pressure values of ≥160 mm Hg systolic or ≥100 mg Hg diastolic103,112
- Diabetes with vascular involvement103
- Headaches with focal neurological symptoms
- Major surgery with prolonged immobilization
- Known or suspected carcinoma of the breast or personal history of breast cancer
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
- Acute or chronic hepatocellular disease with abnormal liver function103
- Hepatic adenomas or carcinomas
- Known or suspected pregnancy
- Hypersensitivity to any component of this product
1. Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
103. Improving access to quality care in family planning: Medical eligibility criteria for contraceptive use. Geneva, WHO, Family and Reproductive Health, 1996 (WHO/FRH/FPP/96.9).
112. Chobanian et al. Seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension 2003;42;1206-1252.
Last reviewed on RxList: 10/10/2012
This monograph has been modified to include the generic and brand name in many instances.
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