Ethinyl Estradiol / Norelgestromin

Ethinyl estradiol / norelgestromin is a combined hormonal contraceptive patch with one supported use.

• Prevention of pregnancy in women with a BMI under 30 kg/m² for whom a combined hormonal contraceptive is appropriate (Xulane, Zafemy, Gwyn Lo and the generic norelgestromin and ethinyl estradiol patch).
• Xulane, Zafemy and the generic patch may be less effective in women who weigh 198 lbs (90 kg) or more.

The patch delivers an estrogen (ethinyl estradiol) and a progestin (norelgestromin) through the skin. Together they suppress the hormones that drive ovulation, so an egg is usually not released. They also thicken cervical mucus, making it harder for sperm to enter the uterus, and alter the uterine lining, making implantation less likely.

This patch is applied to the skin. It follows a 28-day cycle with a new patch each week for 3 weeks, then a patch-free week 4, when withdrawal bleeding is expected.

• Apply each new patch on the same day of the week (your “Patch Change Day”).
• Wear only one patch at a time.
• Place it on the upper outer arm, abdomen, buttock or back.
• Do not cut, damage or alter the patch. This may reduce its effectiveness.
• Do not go more than 7 days without a patch between cycles.

If you start after the first 24 hours of your period, use non-hormonal backup contraception for the first 7 days of the first cycle. Follow your prescriber's and the label's instructions.

Many people have mild side effects, especially early on.

The biggest risks are blood clots, heart attack and stroke. They are higher in women who smoke, are over 35, or have high blood pressure, abnormal cholesterol, diabetes or obesity. The patch is contraindicated in women over 35 who smoke and in women with a BMI of 30 or higher.

• Stop the patch if a clot occurs or you have sudden vision changes.
• Stop it at least 4 weeks before and through 2 weeks after major surgery, if feasible.
• Stop it if jaundice develops.
• Blood pressure can rise, so it needs monitoring.
• It may slightly raise the risk of gallbladder disease.
• Women with diabetes or prediabetes need careful monitoring.
• Evaluate new or worsening headaches.
• Tell your doctor about unexpected bleeding or missed periods.

Some medicines can change how well the patch works, or the patch can change how they work.

• Enzyme inducers such as carbamazepine, phenytoin, rifampin, topiramate and St. John's wort can lower hormone levels, so use backup contraception.
• Ombitasvir/paritaprevir/ritonavir hepatitis C regimens can raise liver enzymes and must not be combined with it.
• Some HIV medicines can raise or lower hormone levels.
• Colesevelam lowers estrogen levels, so separate doses by 4 or more hours.
• Lamotrigine levels may drop, risking less seizure control.
• Thyroid and corticosteroid replacement doses may need to increase.
• Antifungals such as itraconazole or fluconazole, and grapefruit juice, may raise hormone levels.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

• Do not use if your BMI is 30 or higher, or if you are over 35 and smoke.
• Avoid if you have a history of blood clots, stroke, coronary artery disease, uncontrolled high blood pressure, or migraine with aura.
• Avoid with liver disease or liver tumors, breast cancer, or undiagnosed abnormal uterine bleeding.
• Do not use during pregnancy.
• Breastfeeding is not recommended, as estrogen can reduce milk supply.
• It is not for use before the first period or after menopause.
• Steroid hormones may be poorly processed with impaired liver function. Kidney function has not been studied with Xulane.

Too much may cause nausea and vomiting, and withdrawal bleeding may occur. If an overdose is suspected, all patches should be removed and symptoms treated.

The hormones in the patch suppress the body's natural reproductive hormone signals during use. In one trial, FSH, LH and estradiol levels were suppressed during treatment. They returned to near baseline within 6 weeks after stopping.

The patch continuously delivers hormones through the skin, and levels plateau about 48 hours after the first application. Steady state is reached within 2 weeks. Absorption is therapeutically equivalent across the buttock, upper outer arm, abdomen and upper torso (excluding breast), though slightly lower from the abdomen. Because the hormones bypass the gut and liver at first, the “first pass” effect of pills does not occur. After the patch is removed, hormone levels drop to very low or unmeasurable within 3 days. Heat exposure such as a sauna or whirlpool can increase estrogen exposure.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) . Store patches in their protective pouches. store in the refrigerator or freezer.