Ortho Evra (Norelgestromin, Ethinyl Estradiol) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 7, 2012

Ortho Evra

Birth Control (Types and Options) »

Introduction to birth control types and options

If a woman is sexually active and she is fertile — physically able to become pregnant — she needs to ask herself, "Do I want to become pregnant now?" If her answer is "No," she must use some method of birth control (contraception).

If a woman does not want to get pregnant at this point in her life, does she plan to become pregnant in the future? Soon? Much later? Never? Her answers to these questions can determine the method of birth control that she and her male sexual partner use — now and in the future.

There are a number of different ways to describe birth control. Terms include contraception, pregnancy prevention, fertility control, and family planning. But no matter what the process is called, sexually active people can choose from a plethora of methods to reduce the possibility of their becoming pregnant. Nevertheless, no method of birth control av...

Read the Birth Control (Types and Options) article »

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Ortho Evra User Reviews >>

Ortho Evra

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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 oral contraceptives containing 30-35 mcg of ethinyl estradiol (EE) and either levonorgestrel or norgestimate was assessed in four U.S. case-control studies using electronic healthcare claims data. The odds ratios ranged from 1.2 to 2.2; one of the studies found a statistically significant increased 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.

DRUG DESCRIPTION

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:

Norelgestromin Structural Formula Illustration

Ethinyl estradiol Structural Formula Illustration

Molecular weight, norelgestromin: 327.47
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 headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
chest pain or heavy feeling, pain spreading to the arm or...

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