Uses
What is transdermal norelgestromin/ethinyl estradiol used for?
Transdermal norelgestromin/ethinyl estradiol is a combination birth control patch (contraceptive) used to prevent pregnancy in women who have a body mass index (BMI) less than 30 kg/m2. Transdermal norelgestromin/ethinyl estradiol contains 2 types of hormones: norelgestromin (a progestin) and ethinyl estradiol (an estrogen).
Transdermal norelgestromin/ethinyl estradiol may be less effective in preventing pregnancy in women who are over 198 pounds (90 kg).
Transdermal norelgestromin/ethinyl estradiol may also be used for other conditions as determined by your healthcare provider.
How does transdermal norelgestromin/ethinyl estradiol work (mechanism of action)?
Transdermal norelgestromin/ethinyl estradiol works for pregnancy prevention in a few ways. Transdermal norelgestromin/ethinyl estradiol stops ovulation, changes your cervical mucus which prevents sperm cells from entering your uterus, and causes changes in the tissue that lines the uterus (endometrium) which reduces the chances of a fertilized egg implanting in your uterus.
How is transdermal norelgestromin/ethinyl estradiol supplied (dosage forms)?
Transdermal norelgestromin/ethinyl estradiol is available as Onsura, Xulane, Zafemy, and generic norelgestromin/ethinyl estradiol in the following dosage forms that are applied to the skin.
150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol transdermal patch
How should I store transdermal norelgestromin/ethinyl estradiol?
Transdermal norelgestromin/ethinyl estradiol should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C), for shorter periods of time, such as when transporting it. Store in a cool, dry place. Do not refrigerate or freeze. Store patches in the protective pouches.
Side Effects
What are the most common side effects of transdermal norelgestromin/ethinyl estradiol?
The most common side effects of transdermal norelgestromin/ethinyl estradiol are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Breast issues (breast discomfort, breast pain, breasts becoming bigger)
- Nausea
- Vomiting
- Headache
- Skin irritation at the application site (redness, pain, swelling, itching, or rash)
- Stomach pain
- Painful or irregular periods
- Spotting or bleeding between periods
- Unusual changes in mood or anxiety
There may be other side effects of transdermal norelgestromin/ethinyl estradiol that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of transdermal norelgestromin/ethinyl estradiol?
While less common, the most serious side effects of transdermal norelgestromin/ethinyl estradiol are described below, along with what to do if they happen.
Severe Allergic Reactions. Transdermal norelgestromin/ethinyl estradiol may cause allergic reactions, which can be serious. Stop using transdermal norelgestromin/ethinyl estradiol and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Blood Clots. Transdermal norelgestromin/ethinyl estradiol may cause blood clots in your veins or arteries and could cause venous thromboembolism (VTE), stroke, heart attack, or a blood clot in the lungs (pulmonary embolism). Stop using transdermal norelgestromin/ethinyl estradiol and get emergency help right away if you have any of the following signs of blood clots.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
- Pain, swelling, or tenderness in your arm or leg
- Vision loss
- Bulging eyes
- Double vision
Increased Blood Pressure (Hypertension). Transdermal norelgestromin/ethinyl estradiol may increase your blood pressure or make it worse if you have a history of high blood pressure. Stop using transdermal norelgestromin/ethinyl estradiol and call your healthcare provider if your blood pressure increases significantly while using this medicine.
If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, stop using transdermal norelgestromin/ethinyl estradiol and get medical attention right away. Increases in blood pressure may not be noticeable but look out for any of the following symptoms of severely high blood pressure.
- Sudden severe headache
- Chest pain
- Dizziness or confusion
- Trouble breathing
- Nausea/vomiting
- Blurry or other changes to vision
- Anxiety
- Buzzing in the ears
- Nosebleed
- Feeling of skipped heart beats
Jaundice. Transdermal norelgestromin/ethinyl estradiol may cause changes to your liver function, which could cause jaundice. Stop using transdermal norelgestromin/ethinyl estradiol and call your healthcare provider right away if your skin or the whites of your eyes turn yellowish in color, as this may be a symptom of jaundice.
Headache/Migraine. Stop using transdermal norelgestromin/ethinyl estradiol and call your healthcare provider right away if you develop new headaches/migraines that keep coming back or cause you a lot of pain.
Depression. Transdermal norelgestromin/ethinyl estradiol may cause changes in mood, including depression. Stop using transdermal norelgestromin/ethinyl estradiol and call your healthcare provider right away if you have new or increased feelings of anxiety, depression, or other unusual changes in mood or behavior.
Warnings & Precautions
Who should not use transdermal norelgestromin/ethinyl estradiol?
Allergies to Ingredients. People who are allergic to any of the following should not use transdermal norelgestromin/ethinyl estradiol.
- Norelgestromin
- Ethinyl estradiol
- Xulane
- Zafemy
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in the specific norelgestromin/ethinyl estradiol products they stock.
Drug Interactions. Transdermal norelgestromin/ethinyl estradiol should not be used while you are using certain other medicines. Before using transdermal norelgestromin/ethinyl estradiol, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Do not use transdermal norelgestromin/ethinyl estradiol if you are pregnant. If you become pregnant, contact your healthcare professional right away. See the Pregnancy section for more details.
Smoking. Transdermal norelgestromin/ethinyl estradiol should not be used if you are 35 years of age or older and if you smoke, as this can increase your chances of having blood clots.
History of Blood Clots. Transdermal norelgestromin/ethinyl estradiol should not be used if you currently have or have had a history of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, heart attack, or have blood clots/blood vessel damage from diabetes.
Blood and Blood Vessel Problems. Transdermal norelgestromin/ethinyl estradiol should not be used if you have a condition that makes your blood more prone to getting blood clots (hypercoagulation). Transdermal norelgestromin/ethinyl estradiol should not be used if you have plaque buildup in your blood vessels (coronary artery disease) or if you have a condition that affects the blood flow to your brain (cerebrovascular disease). Transdermal norelgestromin/ethinyl estradiol should not be used if you have a condition that affects your blood vessels (vascular disease) and diabetes.
Heart Problems. Transdermal norelgestromin/ethinyl estradiol should not be used if you currently have or have had a history of heart rhythm problems (such as atrial fibrillation) or heart valve problems, as this may increase your chances of having a blood clot.
Increased Blood Pressure (Hypertension). Transdermal norelgestromin/ethinyl estradiol should not be used if you have high blood pressure that is not controlled or high blood pressure with a condition that affects your blood vessels (vascular disease).
Headaches/Migraines. Transdermal norelgestromin/ethinyl estradiol should not be used if you have migraines with vision or hearing changes, muscle weakness, tingling, or affects your ability to speak (aura) or certain types of headaches. Transdermal norelgestromin/ethinyl estradiol should not be used if you are 35 or older with migraine headaches (with or without aura). If there is a concern about your headaches, your healthcare provider may do tests to determine if you are able to use this medicine.
Liver Problems. Transdermal norelgestromin/ethinyl estradiol should not be used if your liver is not working as well as it should be or if you have tumors in your liver. If there is a concern about the health of your liver, your healthcare provider may do tests to determine if it is working well enough to use this medicine.
Spotting. Transdermal norelgestromin/ethinyl estradiol should not be used if you are bleeding between your monthly periods without any specific causes. Tell your healthcare provider if you are bleeding between your monthly periods while on transdermal norelgestromin/ethinyl estradiol. Your healthcare provider will find out why this is happening and may do tests to determine if you are able to use this medicine.
Breast Cancer or Hormone-Sensitive Cancer. Transdermal norelgestromin/ethinyl estradiol should not be used if you have or have had breast cancer or other estrogen- or progestin-sensitive cancer.
Body Mass Index. Transdermal norelgestromin/ethinyl estradiol should not be used if you have a body mass index (BMI) of 30 kg/m2 or more, as your risk for developing blood clots may be higher.
What should I know about transdermal norelgestromin/ethinyl estradiol before using it?
Read the Instructions for Use when using transdermal norelgestromin/ethinyl estradiol. Talk to your healthcare provider about backup contraception options (condoms, spermicide).
Transdermal norelgestromin/ethinyl estradiol does not protect against human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or other sexually transmitted infections (STIs).
Your periods may be irregular, lighter and/or shorter than usual while you are using transdermal norelgestromin/ethinyl estradiol. If you miss your period and have not used transdermal norelgestromin/ethinyl estradiol as directed, call your healthcare provider right away.
Do not cut the patch. Wear 1 patch at a time. Apply the patch right away once you take it out from the protective pouch.
When you are ready to throw your patch away, remove the patch from your skin, fold the sticky sides of the patch together, put it in a sturdy child-proof container, and throw the container in the trash. Do not flush patches down the toilet.
Do not use transdermal norelgestromin/ethinyl estradiol unless it has been prescribed to you by a healthcare provider. Use it as prescribed.
Do not share transdermal norelgestromin/ethinyl estradiol with other people, even if they have the same condition as you. It may harm them.
Keep transdermal norelgestromin/ethinyl estradiol out of the reach of children.
Do not use transdermal norelgestromin/ethinyl estradiol if you smoke and are 35 years of age or older. Smoking while using transdermal norelgestromin/ethinyl estradiol can increase your chances of having heart and blood vessel problems, which can include blood clots, heart attack, or stroke. Your risk increases as you get older and the number of cigarettes you smoke.
What should I tell my healthcare provider before using transdermal norelgestromin/ethinyl estradiol?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if transdermal norelgestromin/ethinyl estradiol is right for you.
In particular, make sure that you discuss any of the following.
Major Surgeries. Talk to your healthcare provider about any upcoming surgeries. Using transdermal norelgestromin/ethinyl estradiol may increase your risk of blood clots after surgery. Your healthcare provider may stop transdermal norelgestromin/ethinyl estradiol if you are about to have major surgery and may not start you on it right away after your surgery. If your healthcare provider decides to stop transdermal norelgestromin/ethinyl estradiol because of an upcoming surgery, your healthcare provider will talk to you about other forms of contraception to use during that time.
Gallbladder Problems. Talk to your healthcare provider if you have gallbladder problems, as this may worsen while using transdermal norelgestromin/ethinyl estradiol. Tell your healthcare provider if you previously had a condition called cholestasis (slowed flow of bile from the liver) while you were pregnant, as this may increase your chances of having cholestasis again when using transdermal norelgestromin/ethinyl estradiol. Cholestasis can cause your skin or the whites of your eyes to turn yellowish (jaundice).
Angioedema. Talk to your healthcare provider if you have a condition called hereditary angioedema that leads to swelling in different parts of your body including your lips, face, tongue, or throat. Using transdermal norelgestromin/ethinyl estradiol may increase your chances of having angioedema or make your angioedema symptoms worse if you have a history of angioedema.
Skin Issues. Talk to your healthcare provider if you have had a condition that led to dark patches of skin around your forehead, nose, cheeks, and around your mouth, especially during pregnancy (chloasma) as this may increase your chances of having chloasma while using transdermal norelgestromin/ethinyl estradiol.
Depression. Talk to your healthcare provider if you have a history of depression. Using transdermal norelgestromin/ethinyl estradiol may worsen depression.
Diabetes. Tell your healthcare provider if you have prediabetes or diabetes. Transdermal norelgestromin/ethinyl estradiol may increase your blood sugar.
High Triglycerides. Tell your healthcare provider if you have high triglyceride levels or you have a family history of high triglyceride levels. Transdermal norelgestromin/ethinyl estradiol may increase your triglyceride levels, which may increase your chances of having pancreatitis. Your healthcare provider will decide if you should take transdermal norelgestromin/ethinyl estradiol.
Pregnancy. Do not use transdermal norelgestromin/ethinyl estradiol and tell your healthcare provider if you are or plan to become pregnant. If you become pregnant, stop using transdermal norelgestromin/ethinyl estradiol right away and contact your healthcare provider.
Breastfeeding. Transdermal norelgestromin/ethinyl estradiol passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Transdermal norelgestromin/ethinyl estradiol may decrease the amount of breast milk you make. Your healthcare provider will advise you if you should use transdermal norelgestromin/ethinyl estradiol while breastfeeding.
Interactions
Does transdermal norelgestromin/ethinyl estradiol interact with foods or drinks?
Eating grapefruit or drinking grapefruit juice using transdermal norelgestromin/ethinyl estradiol can increase the level of ethinyl estradiol in your body. Talk to your healthcare provider if you eat grapefruit or drink grapefruit juice. Your healthcare provider will advise you if you can eat grapefruit/drink grapefruit juice while using transdermal norelgestromin/ethinyl estradiol
There are no known interactions between transdermal norelgestromin/ethinyl estradiol and alcohol.
Does transdermal norelgestromin/ethinyl estradiol interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Some other medicines may alter the blood levels of transdermal norelgestromin/ethinyl estradiol, and vice versa. This may cause transdermal norelgestromin/ethinyl estradiol to not work as well, may cause bleeding between your monthly periods, or higher than normal levels of hormones in your body. Tell your healthcare provider about all medicines that you take or have recently taken.
In particular, make sure that you discuss if you are using any of the following before using transdermal norelgestromin/ethinyl estradiol.
- A medicine for HIV, AIDS, or hepatitis C
- Phenytoin (Dilantin, Phenytek, and others), felbamate, oxcarbazepine, rufinamide, or lamotrigine which are medicines to control seizures
- A barbiturate, such as phenobarbital, butalbital, or primidone which is a medicine that may be used to treat insomnia, migraines, or seizures
- Carbamazepine (Tegretol, Carbatrol, and others), which is a medicine used to control seizures and treat nerve pain
- Bosentan, which is a medicine used to treat a condition called pulmonary arterial hypertension (PAH)
- Griseofulvin, itraconazole, fluconazole, ketoconazole, or voriconazole which are medicines used to treat certain types of fungus infections
- Topiramate, which is a medicine used to control seizures and to prevent migraine headaches
- Rifabutin, which is a medicine used to treat certain bacterial infections in people with human immunodeficiency virus (HIV)
- Aprepitant, which is a medicine used to prevent nausea and vomiting caused by chemotherapy
- St. John’s wort, which is a supplement that may be used to treat depression
- Atorvastatin, rosuvastatin, colesevelam, or clofibric acid, which are medicines used for high cholesterol
- Vitamin C (ascorbic acid) which is a medicine used to treat/prevent low vitamin C levels
- Acetaminophen (Tylenol), which is used to treat pain and fever
- Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine to suppress your immune system
- Prednisolone, which is a medicine used for certain inflammatory conditions
- Theophylline, which is a medicine used to treat asthma and other lung problems
- Tizanidine (Zanaflex), which is a muscle relaxant
- Morphine, which is used to treat pain
- Temazepam, which is a medicine used for sleeping problems (insomina)
- A thyroid medicine, such as levothyroxine, which is used to raise thyroid hormone levels
This may not be a complete list of medicines that can interact with transdermal norelgestromin/ethinyl estradiol. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much transdermal norelgestromin/ethinyl estradiol?
If you or someone else has used too much transdermal norelgestromin/ethinyl estradiol, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of transdermal norelgestromin/ethinyl estradiol?
Transdermal norelgestromin/ethinyl estradiol may not work as it should if you forget to remove and replace the patch. Follow the Instructions for Use on how to use transdermal norelgestromin/ethinyl estradiol if you forget to remove and replace the patch, as this can change depending on which week you forgot to replace the patch.
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