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(norelgestromin / ethinyl estradiol) Transdermal System
CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING, RISK OF VENOUS THROMBOEMBOLISM, AND PHARMACOKINETIC PROFILE OF ETHINYL ESTRADIOL
Cigarette Smoking and Serious Cardiovascular Risks
Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, hormonal contraceptives, including ORTHO EVRA®, should not be used by women who are over 35 years of age and smoke.
Risk of Venous Thromboembolism
The risk of venous thromboembolism (VTE) among women aged 15-44 who used the ORTHO EVRA®patch compared to women who used several different oral contraceptives was assessed in five U.S. epidemiologic studies using electronic healthcare claims data. The relative risk estimates ranged from 1.2 to 2.2; one of the studies found a statistically significant increased relative risk of VTE for current users of ORTHO EVRA® (see WARNINGS - Table 5).
Pharmacokinetic Profile of Ethinyl Estradiol
The pharmacokinetic (PK) profile for the ORTHO EVRA® patch is different from the PK profile for oral contraceptives in that it has higher steady state concentrations and lower peak concentrations. Area under the time-concentration curve (AUC) and average concentration at steady state for ethinyl estradiol (EE) are approximately 60% higher in women using ORTHO EVRA®compared with women using an oral contraceptive containing 35 mcg of EE. In contrast, peak concentrations for EE are approximately 25% lower in women using ORTHO EVRA®. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using ORTHO EVRA® compared with women using oral contraceptives containing 30-35 mcg of EE. Increased estrogen exposure may increase the risk of adverse events, including venous thromboembolism. (See WARNINGS and CLINICAL PHARMACOLOGY, Transdermal versus Oral Contraceptives.)
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
ORTHO EVRA® is a combination transdermal contraceptive patch with a contact surface area of 20 cm². It contains 6.00 mg norelgestromin (NGMN) and 0.75 mg ethinyl estradiol (EE). Systemic exposures (as measured by area under the curve [AUC] and steady state concentration [Css]) of NGMN and EE during use of ORTHO EVRA®are higher and peak concentrations (Cmax) are lower than those produced by an oral contraceptive containing norgestimate 250 mcg / EE 35 mcg. (See BOLDED WARNING; CLINICAL PHARMACOLOGY, Transdermal versus Oral Contraceptives).
ORTHO EVRA® is a thin, matrix-type transdermal contraceptive patch consisting of three layers. The backing layer is composed of a beige flexible film consisting of a low-density pigmented polyethylene outer layer and a polyester inner layer. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric and lauryl lactate as inactive components. The active components in this layer are the hormones, norelgestromin and ethinyl estradiol. The third layer is the release liner, which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyethylene terephthalate (PET) film with a polydimethylsiloxane coating on the side that is in contact with the middle adhesive layer.
The outside of the backing layer is heat-stamped “ORTHO EVRA®.”
The structural formulas of the components are:
Molecular weight, ethinyl estradiol: 296.41
Chemical name for norelgestromin: 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,3-oxime,(17α)
Chemical name for ethinyl estradiol: 19-Norpregna-1,3,5(10)-trien-20-yne-3,17diol,(17α)
What are the possible side effects of ethinyl estradiol and norelgestromin (Ortho Evra)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using the patches and call your doctor at once if you have any of these serious side effects:
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- a change in...
What are the precautions when taking norelgestromin, ethinyl estradiol transdermal (Ortho Evra)?
See also Warning section.
Before using this medication patch, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), severe high blood pressure, abnormal breast exam, breathing problems (e.g., asthma), cancer (especially endometrial or breast cancer), blood clotting disorders (such as protein C or protein S deficiency),...
Last reviewed on RxList: 10/10/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Ortho Evra Information
Ortho Evra - User Reviews
Ortho Evra User Reviews
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