Norgestimate & Ethinyl Estradiol

Norgestimate/ethinyl estradiol is a prescription oral contraceptive used to prevent pregnancy. Oral contraceptives are also known as "birth control pills."

Norgestimate/ethinyl estradiol can also be used to treat moderate acne in females at least 15 years old who have started to have menstrual periods.

Norgestimate/ethinyl estradiol does not protect against HIV infection or other sexually-transmitted diseases and is not intended for use in emergency contraception.

Norgestimate/ethinyl estradiol contains two hormones, norgestimate 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 tablet form. It is taken once daily, with or without food.

Common side effects of norgestimate/ethinyl estradiol include nausea, breast tenderness, and vaginal bleeding between menstrual periods.

Norgestimate/ethinyl estradiol may cause dizziness and blurred vision. Do not drive or operate heavy machinery until you know how norgestimate/ethinyl estradiol affects you.

Norgestimate/ethinyl estradiol is a prescription oral contraceptive used to prevent pregnancy. Oral contraceptives are also known as "birth control pills."

Norgestimate/ethinyl estradiol can also be used to treat moderate acne in females at least 15 years old who have started to have menstrual periods.

Norgestimate/ethinyl estradiol does not protect against HIV infection or other sexually-transmitted diseases and is not intended for use in emergency contraception.

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

Norgestimate & Ethinyl Estradiol may be found in some form under the following brand names:

• Estarylla

• MonoNessa

• Ortho Tri-Cyclen

• Ortho Tri-Cyclen Lo

• Ortho-Cyclen

• Previfem

• Sprintec

• Tri-Estarylla

• Tri-Previfem

• Tri-Sprintec

• TriNessa

Serious side effects have been reported with norgestimate/ethinyl estradiol. See the "Norgestimate & Ethinyl Estradiol Precautions" section.

Common side effects of norgestimate/ethinyl estradiol include:

• nausea
• vomiting
• diarrhea
• constipation
• gingivitis
• changes in appetite
• brown or black patches on skin
• acne
• unusual hair growth
• spotting or bleeding between menstrual periods
• changes in menstrual flow
• painful or missed periods
• swelling of the fingers or ankles
• breast tenderness, enlargement, or discharge
• vaginal discharge
• swelling or irritation of the vagina
• weight changes
• difficulty wearing contact lenses

​This is not a complete list of norgestimate/ethinyl estradiol side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• acetaminophen (APAP, Tylenol)
• antibiotics such as ampicillin (Principen), clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Erythrocin), isoniazid (INH, Nydrazid), metronidazole (Flagyl),minocycline (Dynacin, Minocin), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane), and tetracycline (Sumycin)
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• antifungals such as griseofulvin (Fulvicin, Grifulvin, Grisactin), fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral)
• atorvastatin (Lipitor)
• clofibrate (Atromid-S)
• cyclosporine (Neoral, Sandimmune)
• bosentan (Tracleer)
• cimetidine (Tagamet)
• danazol (Danocrine)
• delavirdine (Rescriptor)
• diltiazem (Cardizem, Dilacor, Tiazac)
• fluoxetine (Prozac, Sarafem, in Symbyax)
• HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir)
• medications for seizures such as carbamazepine (Tegretol), felbamate (Felbatol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), primidone (Mysoline), and topiramate (Topamax)
• modafinil (Provigil)
• morphine (Kadian, MS Contin, MSIR, others)
• nefazodone
• rifampin (Rimactane, in Rifadin, in Rifater)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone), and prednisolone (Prelone)
• temazepam (Restoril)
• theophylline (Theobid, Theo-Dur)
• thyroid medication such as levothyroxine (Levothroid, Levoxyl, Synthroid)
• verapamil (Calan, Covera, Isoptin, Verelan)
• vitamin C
• zafirlukast (Accolate)
• St. John's Wort

This is not a complete list of ethinyl estradiol interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with norgestimate/ethinyl estradiol including:

• Blood clots, heart attack and stroke.Tell your healthcare provider right away if you have some or all of the following symptoms:
  • shortness of breath
  • sharp or crushing chest pain
  • weakness or numbness in an arm or leg
  • slurring of speech
  • coughing of blood
  • pain in the calf
  • sudden severe headache or vomiting
  • dizziness or fainting
• Hypertension (high blood pressure). Have your blood pressure monitored by your doctor closely if taking norgestimate/ethinyl estradiol, especially if you have a history of hypertension or are taking medications to treat hypertension.
• Lipid disorders. Women who are being treated for hyperlipidemia (high blood fat/cholesterol) should be monitored closely, as steroids can elevate lipid levels.
• Breast, ovarian, or uterine cancer. Tell your healthcare provider right away if you detect a lump in the breast or experience new abdominal pain.
• Liver problems. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • severe pain or tenderness in the stomach area
  • yellowing of the skin or eyeballs
• Severe depression. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • difficulty sleeping
  • weakness, lack of energy, fatigue
  • change in mood
• Eye conditions.Tell your healthcare provider right away if you have some or all of the following symptoms:
  • unexplained partial or complete loss of vision
  • double vision
  • bulging of the eyes
• Severe migraine headaches. Tell your healthcare provider right away if you experience recurrent or persistent headaches.

Norgestimate/ethinyl estradiol does not protect against HIV infection or other sexually-transmitted diseases.

Do not take norgestimate/ethinyl estradiol if you:

• are allergic to norgestimate/ethinyl estradiol or to any of its ingredients
• have a history of heart attack or stroke
• have blood clots in the legs, lungs, or eyes
• have a history of blood clots in the deep veins of your legs
• have chest pain (angina pectoris)
• have or have had cerebral vascular or coronary artery disease
• have disease of the heart valves with complications
• have severe hypertension (very high blood pressure)
• have diabetes with blood vessel involvement
• have headaches with focal neurological symptoms (movement disorders affecting a specific region of the body, such as the left arm or right leg)
• have had a major surgery requiring a long period of inactivity
• have, may have, or have had cancer of the breast
• have cancer of the lining of the uterus or other estrogen-dependent cancer
• have undiagnosed abnormal genital bleeding
• have jaundice (yellowing of the skin or eyes)
• have liver disease with abnormal liver function
• have tumors of the liver
• are or may be pregnant

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of norgestimate/ethinyl estradiol, there are no specific foods that you must exclude from your diet when taking this medication.

Before taking norgestimate/ethinyl estradiol, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have or have ever had blood clots in your legs, lungs, or eyes
• have thrombophilia (condition in which the blood clots easily)
• have coronary artery disease (clogged blood vessels leading to the heart)
• have cerebrovascular disease (clogging or weakening of the blood vessels within the brain or leading to the brain)
• have had a stroke or mini-stroke
• have an irregular heartbeat
• have had a heart attack
• have had chest pain
• have diabetes
• have severe or migraine headaches
• have high blood pressure
• have breast cancer or have ever had problems with your breasts or have a family history of breast cancer
• have cancer of the lining of the uterus, cervix, or vagina
• have liver cancer, liver tumors, or other types of liver disease
• have yellowing of the skin or eyes during pregnancy or while you were using hormonal contraceptives (birth control pills, patches, rings, implants, or injections)
• have unexplained abnormal vaginal bleeding
• have adrenal insufficiency (condition in which the body does not produce enough of certain natural substances needed for important functions such as blood pressure)
• have kidney disease
• have recently had surgery or have been unable to move around for any reason.
• have high blood cholesterol or fats
• have asthma
• have had toxemia (high blood pressure during pregnancy)
• have or have had seizures
• have or have had depression
• have gallbladder disease
• have jaundice (yellowing of the skin or eyes)
• experience excessive weight gain and fluid retention (bloating) during the menstrual cycle

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Norgestimate/ethinyl estradiol falls into category X. This medication should not be used during pregnancy as it has the potential to cause miscarriage.

Tell your doctor if you are breastfeeding or plan to breastfeed.

You should not take norgestimate/ethinyl estradiol if you are breastfeeding. It may be excreted in your breast milk and may harm your nursing child.

Take norgestimate/ethinyl estradiol exactly as prescribed.

Norgestimate/ethinyl estradiol comes in a blister card and tablet dispenser containing 28 tablets: 21 "active" tablets (white, light blue, and blue) and 7 "reminder" tablets (green). One tablet should be taken by mouth at the same time daily. It can be taken with or without food. The tablets are taken in the order shown on the packaging, starting with the first white pill on the first day of menstruation. When all 28 tablets have been taken, a new package should be started the following day.

When starting norgestimate/ethinyl estradiol, use another method of birth control for at least the first 7 days of using norgestimate/ethinyl estradiol.

If you miss an active tablet during weeks 1, 2, or 3, the tablet should be taken as soon as you remember. If you miss 2 active tablets in a row during week 1 or week 2, you should take 2 tablets the day you remember and 2 tablets the next day, and then continue taking one tablet daily. If you miss 2 active tablets in a row during week 3 or miss 3 or more active tablets in a row, you should throw away the rest of the pack and start a new pack that same day. You should use a back-up method of birth control if you have sex in the 7 days after missing a dose.

If you miss any of the 7 reminder tablets during week 4, throw away the pill you missed and continue taking 1 pill each day until the pack is empty.

Take norgestimate/ethinyl estradiol exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Norgestimate/ethinyl estradiol comes in a blister card containing 28 tablets:

• 7 white tablets containing 0.180 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 light blue tablets containing 0.215 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 blue tablets containing 0.250 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 green tablets containing no active drug

Norgestimate/ethinyl estradiol also comes in a blister card containing 28 tablets:

• 21 blue tablets containing 0.250 mg norgestimate and 0.035 mg ethinyl estradiol
• 7 green tablets containing no active drug

One tablet should be taken by mouth at the same time each day in the order indicated on the packaging.

If you take too much norgestimate/ethinyl estradiol,  call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

Ifnorgestimate/ethinyl estradiol is administred by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store norgestimate/ethinyl estradiol at room temperature between 59° and 86°F (15° and 30°C).
• Protect this medication from light.
• Keep this and all medicines out of the reach of children.

Warnings: Cardiovascular Risk Associated with Smoking

Cigarette smoking increases the risk of serious cardiovascular events from combination oral 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, combination oral contraceptives, including norgestimate/ethinyl estradiol, should not be used by women who are over 35 years of age and smoke.