Brand Names: Ortho Evra
Generic Name: ethinyl estradiol and norelgestromin (transdermal) (Pronunciation: EH thi nil ESS tra DYE ol and nor ell JESS tro min)
- What is ethinyl estradiol and norelgestromin (Ortho Evra)?
- What are the possible side effects of this medication (Ortho Evra)?
- What is the most important information I should know about this medication (Ortho Evra)?
- What should I discuss with my healthcare provider before taking this medication (Ortho Evra)?
- How should I take this medication (Ortho Evra)?
- What happens if I miss a dose (Ortho Evra)?
- What happens if I overdose (Ortho Evra)?
- What should I avoid while taking this medication (Ortho Evra)?
- What other drugs will affect this medication (Ortho Evra)?
- Where can I get more information?
What is ethinyl estradiol and norelgestromin (Ortho Evra)?
Ethinyl estradiol and norelgestromin contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Ethinyl estradiol and norelgestromin are used as contraception to prevent pregnancy.
Ethinyl estradiol and norelgestromin may also be used for purposes not listed in this medication guide.
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 breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- a change in the pattern or severity of migraine headaches;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet;
- a breast lump; or
- symptoms of depression (sleep problems, weakness, tired feeling, mood changes).
Less serious side effects may include:
- mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
- breast tenderness or swelling, nipple discharge;
- freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
- changes in weight or appetite;
- problems with contact lenses;
- vaginal itching or discharge; or
- changes in your menstrual periods, decreased sex drive.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about this medication (Ortho Evra)?
Do not use this medication if you are pregnant or if you have recently had a baby.
You should not use this medication if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.
Many drugs can interact with birth control medication, and some can make it less effective. Tell your doctor about all other medications you are using.
What should I discuss with my healthcare provider before taking this medication (Ortho Evra)?
This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before using this medication.
You should not use this medication if you have:
- untreated or uncontrolled high blood pressure;
- heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);
- a blood-clotting disorder or circulation problems;
- problems with your eyes, kidneys or circulation caused by diabetes;
- a history of hormone-related cancer such as breast or uterine cancer;
- unusual vaginal bleeding that has not been checked by a doctor;
- liver disease or liver cancer;
- severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
- a history of jaundice caused by pregnancy or birth control pills; or
- if you smoke and are over 35 years old.
To make sure you can safely use this medication, tell your doctor if you have any of these other conditions:
- high blood pressure, varicose veins;
- high cholesterol or triglycerides, or if you are overweight;
- a history of depression;
- underactive thyroid;
- gallbladder disease;
- seizures or epilepsy;
- a history of irregular menstrual cycles;
- tuberculosis; or
- a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.
The hormones in this medication can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.
Your risk of serious blood clot may be higher with the use of birth control skin patches than with the use of birth control pills.
How should I take this medication (Ortho Evra)?
Use exactly as prescribed by your doctor. 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..
You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.
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.
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.
If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using this medication.
While using this medication, you will need to visit your doctor regularly.
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.
What happens if I miss a dose (Ortho Evra)?
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.
What happens if I overdose (Ortho Evra)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.
What should I avoid while taking this medication (Ortho Evra)?
Smoking can increase your risk of blood clots, stroke, or heart attack caused by this medication, especially if you are older than 35.
This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.
Avoid using creams, lotions, powders, or other medications on the skin where you apply the patch, or it may not stick to your skin.
Grapefruit and grapefruit juice may interact with ethinyl estradiol and norelgestromin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
What other drugs will affect this medication (Ortho Evra)?
Many drugs can interact with birth control medication, and some can make it less effective. Below is just a partial list of these drugs. Tell your doctor if you are using:
- acetaminophen (Tylenol) or ascorbic acid (vitamin C);
- bosentan (Tracleer);
- cyclosporine (Neoral, Sandimmune, Gengraf);
- rosuvastatin (Crestor);
- an antibiotic or tuberculosis medication;
- drugs to treat hepatitis C, HIV, or AIDS;
- phenobarbital (Solfoton) and other barbiturates;
- St. John's wort;
- theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl); or
- seizure medications.
This list is not complete and other drugs may interact with ethinyl estradiol and norelgestromin. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about ethinyl estradiol and norelgestromin.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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