Ethinyl estradiol and norethindrone (HRT)

Ethinyl estradiol is a type of estrogen. Estrogen is a female sex hormone that is important for many functions in the body.

Norethindrone is a type of progesterone. Progesterone is a female hormone that plays a key role in regulating ovulation and menstruation.

Ethinyl estradiol and norethindrone (HRT) is a combination medicine used to treat menopause symptoms like hot flashes, vaginal dryness, burning, and irritation. It is also used to help prevent osteoporosis.

Ethinyl estradiol and norethindrone may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Try to take this medicine at the same time each day.

Ethinyl estradiol and norethindrone may increase your risk of developing a condition that can lead to uterine cancer. To help lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding right away.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using ethinyl estradiol and norethindrone.

Store at room temperature away from moisture and heat.

You should not use this medicine if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant.

This medicine may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Ethinyl estradiol and norethindrone should not be used to prevent heart disease, stroke, or dementia.

You should not use ethinyl estradiol and norethindrone if you are allergic to ethinyl estradiol or norethindrone, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease;
• a bleeding disorder;
• a history of heart attack, stroke, or blood clot; or
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Ethinyl estradiol and norethindrone should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

Tell your doctor if you have ever had:

• heart disease;
• liver problems, or jaundice caused by pregnancy or taking hormones;
• kidney disease;
• hereditary angioedema (an immune system disorder);
• bone cancer;
• lupus;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• gallbladder disease;
• endometriosis or uterine fibroid tumors;
• a thyroid disorder; or
• high or low levels of calcium in your blood.

Using ethinyl estradiol and norethindrone may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

This medicine can slow breast milk production. Tell your doctor if you are breast-feeding.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

ethinyl estradiol and norethindrone may cause serious side effects. Stop using ethinyl estradiol and norethindrone and call your doctor immediately if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• swelling or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes);
• unusual vaginal bleeding, pelvic pain;
• a breast lump;
• memory problems, confusion, unusual behavior; or
• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects of ethinyl estradiol and norethindrone may include:

• stomach pain;
• bloating, swelling, weight gain;
• breast pain;
• light vaginal bleeding or spotting;
• thinning scalp hair; or
• headache.

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.

Usual Adult Dose for Contraception:

1 tablet orally once a dayComments: To be taken at the same time each day.

Usual Adult Dose for Postmenopausal Symptoms:

1 tablet orally once a dayComments: Not all preparations are indicated for the treatment of vasomotor symptoms due to menopause; the manufacturer product information should be consulted.Use: For the treatment of moderate to severe vasomotor symptoms due to menopause

Usual Adult Dose for Acne:

1 tablet orally once a dayComments: Not all preparations are indicated for the treatment of acne; the manufacturer product information should be consulted.Use: For the treatment of moderate acne vulgaris in females with no known contraindications to oral contraceptive therapy and who have achieved menarche and are unresponsive to topical anti-acne medications

Usual Adult Dose for Prevention of Osteoporosis:

1 tablet orally once a dayComments:-Not all preparations are indicated for the prevention of postmenopausal osteoporosis; the manufacturer product information should be consulted.-When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.Use: For the prevention of postmenopausal osteoporosis

Usual Pediatric Dose for Contraception:

1 tablet orally once a dayComments: To be taken at the same time each day.

Usual Pediatric Dose for Acne:

15 years or older: 1 tablet orally once a dayComments:-Not all preparations are indicated for the treatment of acne; the manufacturer product information should be consulted.-Use should be reserved for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 monthsUse: For the treatment of moderate acne vulgaris in females at least 15 years of age with no known contraindications to oral contraceptive therapy and who have achieved menarche and are unresponsive to topical anti-acne medications

Take the medicine as soon as possible, but if it’s nearly time for your next dose, skip the missed dose. Do not take two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Symptoms of overdose may include nausea, vomiting, or vaginal bleeding.

Do not smoke. It can significantly raise your risk of blood clots, stroke, or heart attack while taking ethinyl estradiol and norethindrone.

Grapefruit may interact with ethinyl estradiol and norethindrone and cause unwanted side effects. Avoid using grapefruit products.

Sometimes, it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medications work.

Other drugs may affect ethinyl estradiol and norethindrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all the medicines you are currently taking and any new medicine you begin or stop using.