Estradiol and norgestimate

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor at once if you have any unusual vaginal bleeding while using this medicine.

Estradiol and norgestimate usually comes in a pack of pills that are different colors. In most cases you will take a pill of one color for 3 days in a row, and then take a pill of the other color for the next 3 days in a row. This cycle is then repeated throughout your treatment.

Each time you start a new pack, start with the first tablet in the first row of pills. Your medicine may come with stickers to mark your weekday schedule on the pack.

Be sure to have a new pack of this medicine ready to start on the day after you have finished an entire pill pack.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using estradiol and norgestimate. Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.

If you need surgery or medical tests or if you will be on 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 estradiol and norgestimate.

Store at room temperature away from moisture and heat.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss 2 doses in a row, take the next tablet in order and keep taking only one pill per day. Call your doctor if you miss more than 2 doses of this medicine.

Usual Adult Dose for Atrophic Urethritis:

1 tablet orally once a day.

Usual Adult Dose for Atrophic Vaginitis:

1 tablet orally once a day.

Usual Adult Dose for Postmenopausal Symptoms:

1 tablet orally once a day.

Usual Adult Dose for Prevention of Osteoporosis:

1 tablet orally once a day. In addition to hormonal therapy, adequate calcium intake is important for postmenopausal women who require treatment or prevention of osteoporosis. The average diet of older American women contains 400 to 600 mg of calcium per day. A suggested optimal intake is 1500 mg per day. If dietary intake is insufficient to achieve 1500 mg per day, supplementation may be useful in women who have no contraindication to calcium supplementation.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Shortness of breath.
• Coughing up blood.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Very bad headache.
• Very upset stomach or throwing up.
• Very bad dizziness or passing out.
• Change in eyesight.
• Bulging eyes.
• Change in how contact lenses feel in the eyes.
• A lump in the breast, breast soreness, or nipple discharge.
• Breast pain.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Low mood (depression).
• Memory problems or loss.
• Swelling in hands or feet.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

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• Estradiol and NGM
• Norgestimate and Estradiol
• Ortho Prefest

Osteoporosis prevention: Prevention of osteoporosis

Vasomotor symptoms associated with menopause: Treatment of moderate to severe vasomotor symptoms

Vulvar and vaginal atrophy associated with menopause: Treatment of moderate to severe symptoms of vulvar and vaginal atrophy

Limitations of use: For use in women with a uterus. When used solely for the treatment of vulvar and vaginal atrophy, topical vaginal products should be considered. When used for the prevention of osteoporosis, use only in women at significant risk; consider use of nonestrogen medications

Reduced response to metyrapone test.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Hair loss.
• Upset stomach or throwing up.
• Cramps.
• Bloating.
• Tender breasts.
• Enlarged breasts.
• Vaginal bleeding or spotting.
• This drug may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

1 tablet orally once a day. In addition to hormonal therapy, adequate calcium intake is important for postmenopausal women who require treatment or prevention of osteoporosis. The average diet of older American women contains 400 to 600 mg of calcium per day. A suggested optimal intake is 1500 mg per day. If dietary intake is insufficient to achieve 1500 mg per day, supplementation may be useful in women who have no contraindication to calcium supplementation.