Desogestrel/ethinyl estradiol (By mouth)

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to desogestrel or ethinyl estradiol. You should not use this medicine if you are pregnant or if you have liver disease or heart disease. You should not use this medicine if you have a chest pain, heart rhythm problems, blood vessel disorder, or if you have unusual vaginal bleeding. You should not use this medicine if you have cancer of the breast, liver, or uterus. Do not use this medicine if you have ever had a heart attack, stroke, or history of blood clots. Do not use this medicine if you have had jaundice (yellowing of your skin or the whites of your eyes) from pregnancy or birth control pills.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• There are many other drugs that you should not use together with this medicine. This includes medicine for seizures (such as phenobarbital, topiramate, carbamazepine, phenytoin, Luminal®, Topamax®, Tegretol®, or Dilantin®), phenylbutazone (Butazolidin®), medicine to treat infections (such as rifampin), nonprescription (over-the-counter) medicines, and herbal products (such as St. John's Wort). Make sure your doctor knows about all other medicines you are using.

Warnings While Using This Medicine

• Make sure your doctor knows if you are breastfeeding, or if you have recently been pregnant. Tell your doctor if you have liver disease, kidney disease, gallbladder disease, high blood pressure, high cholesterol, diabetes, breast lumps, a history of depression, or a family history of breast cancer.
• This medicine can cause serious side effects such as heart attacks or stroke. Your chances for a stroke are higher if you have certain health problems (such as migraine headaches), or are overweight. Your chances for a stroke are also higher if you plan to use this medicine for several years. Cigarette smoking will increase the risk for serious side effects, especially if you are over 35 years old.
• Your risk of having blood clots is higher if you use this medicine for a long time, and may continue for several years after stop using this medicine.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• This medicine will not protect you from getting HIV, AIDS, or other sexually transmitted diseases. Talk with your doctor if this is a concern for you.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Breast lump.
• Dark-colored urine, or yellowing of your skin or the whites of your eyes.
• Darkening of the skin, especially the face.
• Heavy vaginal bleeding, or a missed, late, or irregular period.
• Pain in your chest, lower leg (calf), or stomach.
• Sudden or severe headache, problems with vision, speech, or walking.
• Sudden shortness of breath.
• Swelling in your hands, feet, or ankles.

If you notice these less serious side effects, talk with your doctor:

• Breast tenderness or discharge.
• Contact lens discomfort.
• Light bleeding, spotting, or vaginal discharge between periods.
• Loss of appetite.
• Mild nausea, vomiting, or stomach cramps.
• Unusual mood changes.

Introduction

Desogestrel (des-oh-JES-trel), Ethinyl Estradiol (ETH-i-nil es-tra-DYE-ol)

Used to prevent pregnancy. This medicine is an oral contraceptive (birth control pill).

Brand Name(s)

Kariva, Apri, Mircette, Velivet, Desogen, Reclipsen, Ortho-Cept, Cyclessa, Caziant, Azurette, Viorele, Emoquette

There may be other brand names for this medicine.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Unless your doctor tells you to use a different schedule, start taking this medicine on the first Sunday after your menstrual period starts. If your period starts on a Sunday, start taking this medicine on that day. Then continue taking one pill each day in the order they appear in the package.
• It is best to take your pill at the same time every day.

If a dose is missed:

• This medicine needs to be taken every day on a fixed schedule. If you miss a dose or forget to take your medicine, take it as soon as you can. Then take your next pill at the regular time. This means you may take two pills in one day.
• If you miss two or more pills in a row, see your patient instructions or call your doctor or pharmacist.
• You could become pregnant if you have sex on the days when you miss pills or during the first seven days after you restart your pills. To keep from getting pregnant, use another form of birth control. Other forms include condoms, a diaphragm, or a contraceptive foam or jelly.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088