Ethinyl Estradiol and Norgestimate, Oral

What are other names for this medicine?

Type of medicine: contraceptive (birth control)

Generic and brand names: ethinyl estradiol and norgestimate, oral; Ortho Tri-Cyclen 21; Ortho Tri-Cyclen 28; Ortho-Cyclen 21; Ortho-Cyclen 28; Ovral 21; Ovral 28

What is this medicine used for?

This medicine (commonly called birth control pills) is used to prevent pregnancy. Your health care provider may prescribe this medicine for other reasons as well. Birth control pills are available in many types and brands.

What should my health care provider know before I take this medicine?

You should not use this product if you have:

• an allergy to any hormones
• blood clots in your legs, lungs, or eyes (now or in the past)
• diabetes
• disease of the heart valves
• gallbladder or kidney disease
• headaches along with symptoms such as vomiting, double vision, unsteadiness, weakness, or personality changes
• heart attack or stroke (now or in the past)
• high blood pressure or high cholesterol
• known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina (now or in the past)
• liver disease
• unexplained vaginal bleeding
• yellowing of the eyes or skin (jaundice) during pregnancy or during past use of birth control pills
• recently had a long period of bedrest after major surgery or a broken bone in a cast.

Females of childbearing age: DO NOT use this product if you are pregnant or breast-feeding because it can harm the baby.

How do I take it?

Take this medicine exactly as prescribed by your health care provider on the schedule prescribed. Take it at the same time each day. Use the special packaging to keep track of doses. Read the information sheet that comes in the medicine package for more information.

If you miss a dose at your normal time, take it as soon as you remember. If you do not remember until the next day, take 2 tablets that day. If you miss 2 doses in a row, take 2 tablets a day for the next 2 days, then go back to your regular schedule. If you miss 3 doses in a row, ask your health care provider what to do. Use another form of birth control until your next period.

What should I watch out for?

Depending on the type of pill prescribed for you, your health care provider may recommend that you use a second method of birth control during the first month you are taking this medicine.

If you need surgery or dental work, tell the health care provider or dentist you are using this medicine.

If you need any lab tests, tell your health care provider you are using this medicine. Birth control hormones may change some blood test results.

Diabetics: If you are taking insulin or another medicine for diabetes, talk to your health care provider because your dosage of diabetes medicine may need to be changed.

Other medicines may reduce the effectiveness of this medicine. Tell all health care providers who treat you that you are taking this medicine. You may need to use another method of birth control if the health care provider prescribes a medicine that might reduce the effectiveness of the birth control pills.

Smoking while you take this medicine increases your risk of side effects. The risk increases with age and the number of cigarettes smoked a day. Talk to your health care provider about ways to quit smoking.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your health care provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your health care provider right away. If you are unable to reach your health care provider right away, get emergency medical care or call 911 for help):

• allergic reaction (hives, itching, rash, tightness in your chest, trouble breathing)
• sharp chest pain, coughing blood, or sudden shortness of breath
• sudden severe headache or vomiting, dizziness or fainting, problems with vision or speech, weakness, or numbness in an arm or leg
• sudden partial or complete loss of vision.

Serious (report these to your health care provider right away):

• yellowing of the skin or whites of the eyes (jaundice), especially with fever, tiredness, loss of appetite, dark urine, or light-colored bowel movements
• pain in the calf
• severe pain, swelling, or tenderness in the abdomen
• breast lumps or tenderness
• irregular vaginal bleeding or spotting that happens in more than 1 menstrual cycle or lasts for more than a few days
• swelling of your hands or ankles
• trouble sleeping, weakness, lack of energy, fatigue, or depression.

Other: Vaginal or urinary infection, vaginal discharge, weight gain, nausea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your health care provider if you are taking:

• acetaminophen (Tylenol)
• antibiotics such as griseofulvin (Fulvicin, Grisactin, Gris-Peg), penicillin, ampicillin (Omnipen, Totacillin, Polycillin, Principen, Unasyn), amoxicillin (Amoxil, Trimox, Wymox, Augmentin), cloxacillin (Cloxapen), dicloxacillin (Dynapen, Dycill, Pathocil), oxacillin (Bactocill), penicillin VK (Beepen-VK, PenVee K, Veetids), demeclocycline (Declomycin), doxycycline (Vibramycin, Vibra-Tabs, Doryx, Doxychel), minocycline (Minocin, Vectrin), oxytetracycline (Terramycin), and tetracycline (Achromycin V, Sumycin, Panmycin, Tetracyn)
• anticonvulsants such as carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), topiramate (Topamax), ethotoin (Peganone), fosphenytoin (Cerebyx), and mephenytoin (Mesantoin)
• ascorbic acid (vitamin C)
• atorvastatin (Lipitor)
• barbiturates such as phenobarbital, amobarbital (Amytal), butabarbital (Butisol), pentobarbital (Nembutal), and secobarbital (Seconal)
• benzodiazepines such as alprazolam (Xanax), chlorazepate (Tranxene, Gen-Xene), chlordiazepoxide (Librium, Libritabs), diazepam (Valium), lorazepam (Ativan), oxazepam (Serax), temazepam (Restoril), and triazolam (Halcion)
• beta blockers such as atenolol (Tenormin), acebutolol (Sectral), esmolol (Brevibloc), carteolol (Cartrol), betaxolol (Kerlone), bisoprolol (Zebeta), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), propranolol (Inderal), timolol (Blocadren), and sotalol (Betapace)
• blood thinners such as warfarin (Coumadin)
• caffeine
• chloramphenicol (Chloromycetin)
• corticosteroids such as betamethasone (Celestone), cortisone (Cortone), dexamethasone (Hexadrol, Decadron), hydrocortisone (Hydrocortone, Cortef), methylprednisolone (Medrol), prednisone (Meticorten, Deltasone, Orasone), and prednisolone (Delta-Cortef, Prelone)
• cyclosporine (Sandimmune, Neoral, SangCya)
• isoniazid (Nydrazid, Laniazid)
• medicines to treat HIV such as amprenavir (Agenerase), indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, Kaletra)
• morphine
• neomycin (Mycifradin, Neo-fradin, Neo-Tabs)
• nitrofurantoin (Furadantin, Macrobid, Macrodantin)
• phenylbutazone (Butazolidin)
• primidone (Mysoline)
• rifampin (Rifadin, Rimactane)
• salicylic acid
• St. John's wort
• sulfonamides such as sulfadiazine, sulfamethoxazole (Gantanol), sulfamethizole (Thiosulfil Forte), and sulfasalazine (Azulfidine)
• theophylline
• triamcinolone (Aristocort, Kenacort)
• tricyclic antidepressants such as amitriptyline (Elavil), nortriptyline (Aventyl, Pamelor), imipramine (Tofranil), and doxepin (Sinequan)
• vitamins.

Keep a list of all your medicines (prescription, nonprescription, supplements, natural remedies, and vitamins) with you. Be sure that you tell all health care providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your health care provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.