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Ortho Evra

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Ortho Evra

ORTHO EVRA
(norelgestromin /ethinyl estradiol) Transdermal System

WARNING

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 AND PRECAUTIONS].

Pharmacokinetic (PK) Profile of Ethinyl Estradiol (EE)

The PK profile for the ORTHO EVRA patch is different from the PK profile for oral contraceptives in that it has a higher steady state concentrations and a lower peak concentration. Area under the time-concentration curve (AUC) and average concentration at steady state (Css) for EE are approximately 60% higher in women using ORTHO EVRA compared with women using an oral contraceptive containing 35 mcg of EE. In contrast, the peak concentration (Cmax) for EE is 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 VTE [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

DRUG DESCRIPTION

ORTHO EVRA is a combination transdermal contraceptive system with a contact surface area of 20 cm². It contains 6 mg NGMN and 0.75 mg 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 the Cmax is lower than those produced by an oral contraceptive containing NGM 250 mcg / EE 35 mcg. [see BOXED WARNING and CLINICAL PHARMACOLOGY].

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, NGMN and EE. 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:

ORTHO EVRA (norelgestromin /ethinyl estradiol transdermal system) Structural Formula Illustration

Molecular weight, NGMN: 327.47

Molecular weight, EE: 296.41

Chemical name for NGMN: 18, 19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,3-oxime,(17α)

Chemical name for EE: 19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol,(17α)

What are the possible side effects of this medication (Ortho Evra)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult 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 and 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;
  • sudden cough, wheezing, rapid...

Read All Potential Side Effects and See Pictures of Ortho Evra »

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 ethinyl estradiol or norelgestromin; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), high cholesterol or triglyceride (blood fat) levels, depression, diabetes, gallbladder problems,...

Read All Potential Precautions of Ortho Evra »

Last reviewed on RxList: 7/12/2013
This monograph has been modified to include the generic and brand name in many instances.

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Ortho Evra - User Reviews

Ortho Evra User Reviews

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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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