Ethinyl Estradiol Norelgestromin

Follow all directions on your prescription label. Do not use more skin patches or wear them for longer than recommended by your doctor. You will apply your first patch on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

Place the patch on your skin and press it into place firmly for 10 seconds. Make sure the edges stick well. You will wear the patch for a full week.

Apply the patch to clean, dry skin on any of these areas: the outside of your upper arm, your stomach, your buttocks, or your upper back. Do not apply the patch to skin that is broken or irritated, or to a skin area that may be rubbed by tight clothing (such as a waistband).

Remove the patch and apply a new one on the same day each week for three weeks in a row. At the end of the third week, remove the patch and do not apply a new one for 7 full days. Your period should start during this time Do not allow more than 7 days to pass before starting your next 3-week patch cycle..

Check your patch every day to make sure it is sticking well. If a patch comes loose or falls off, throw it away and apply a new one. You may need to use back-up birth control, such as condoms or a spermicide, if a patch has been off for more than 24 hours. Follow your doctor's instructions.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.

While using ethinyl estradiol and norelgestromin transdermal, you will need to visit your doctor regularly.

After removing a skin patch fold it in half, sticky side in, and throw it away in a place where children and pets cannot get to it. Do not flush a used patch down the toilet.

Store the skin patches at room temperature away from moisture and heat. Do not freeze or refrigerate. Keep each patch in its foil pouch until you are ready to apply it.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

If you forget to change your patch at the end of the week, change it as soon as you remember. If it has been 24 hours or longer since your scheduled patch change, apply a new patch and start the cycle over (3 weeks wearing a weekly patch,1 week off). Do not use extra patches to make up the missed dose.

Missing a dose increases your risk of becoming pregnant and you may need to use back-up birth control. Follow the weekly patch schedule closely.

Norelgestromin/ethinyl estradiol is a prescription medication used to prevent pregnancy. It contains two medications, norelgestromin and ethinyl estradiol, which belong to a group of drugs called hormonal contraceptives. These hormones prevent pregnancy by stopping ovulation and by altering cervical mucus and the lining of the uterus.

This medication comes in the form of a skin patch to be placed on the skin each week for the first 3 weeks of the menstrual cycle.

Common side effects include nausea, breast discomfort, and headache.

Norelgestromin/ethinyl estradiol is a prescription skin patch used to prevent pregnancy in women.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ethinyl Estradiol & Norelgestromin is part of the drug class:

• Combination Progesterone and Estrogen Contraceptives

Hormonal contraceptives may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures so your doctor may need to adjust the dose. Some medicines and herbal products may make your hormonal contraceptive less effective, including:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

Blood levels of estrogen from this hormonal contraceptive may be increased if you take certain medicines or drink grapefruit juice. Also, your hormonal contraceptive may make some other medicines less effective. As with all prescription products, you should notify your doctor of any other medications and herbal products you are taking or plan to take. You may need to use a barrier contraceptive when you take medicines or products that can make hormonal contraceptives less effective.

You should discuss this possible increased risk with your healthcare professional before using norelgestromin/ethinyl estradiol.

Also talk to your healthcare professional about using norelgestromin/ethinyl estradiol if:

• you smoke
• you are recovering from the birth of a baby
• you are recovering from a second trimester miscarriage or abortion
• you are breastfeeding
• you weigh 198 pounds or more
• you are taking any other medications

Also, tell your healthcare professional if you have or have had:

• Breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram
• A family history of breast cancer
• Diabetes
• Elevated cholesterol or triglycerides
• High blood pressure
• Migraine or other headaches or epilepsy
• Depression
• Gallbladder disease
• Liver disease
• Heart disease
• Kidney disease
• Scanty or irregular menstrual periods

If you have any of these conditions you should be checked often by your healthcare professional if you use the contraceptive patch.

You should not use this medication if you are pregnant or think you may be pregnant. However norelgestromin/ethinyl estradiol is not known to cause birth defects when used by accident during pregnancy.

WARNINGS: 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 norelgestromin/ethinyl estradiol, 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 norelgestromin/ethinyl estradiol 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 norelgestromin/ethinyl estradiol.

Pharmacokinetic Profile of Ethinyl Estradiol

The pharmacokinetic (PK) profile for the norelgestromin/ethinyl estradiol 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 norelgestromin/ethinyl estradiol 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 norelgestromin/ethinyl estradiol. 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 norelgestromin/ethinyl estradiol 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.