What is estradiol and norgestimate?
Estradiol is a female sex hormone that is involved in the development and maintenance of
the female reproductive system.
Norgestimate is a form of progesterone. Progesterone is a female hormone important for
the regulation of ovulation and menstruation.
Estradiol and norgestimate is used to treat symptoms of menopause such as hot flashes,
and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.
Estradiol and norgestimate may also be used for other purposes not listed in this
medication guide.
What should I discuss with my healthcare provider before taking estradiol and norgestimate?
Do not take estradiol and norgestimate without first talking to your doctor if you have
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a bleeding or blood-clotting disorder;
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a history of stroke or circulation problems;
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abnormal vaginal bleeding that a doctor has not checked;
or
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any type of breast, uterine, or hormone-dependent cancer.
Before using estradiol and norgestimate, tell your doctor if you have:
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high blood pressure, angina, or heart disease;
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high cholesterol or triglycerides;
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liver disease;
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kidney disease;
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asthma;
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epilepsy or other seizure disorder;
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migraines;
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diabetes;
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depression;
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gallbladder disease;
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uterine fibroids; or
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if you have had your uterus removed (hysterectomy).
Estradiol and norgestimate increases your risk of developing
endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins
while using estradiol and norgestimate may lower this risk. If your uterus has not been removed,
your doctor may prescribe a progestin for you to take while you are using estradiol and
norgestimate.
Long-term estradiol and norgestimate treatment may increase your risk of stroke. Talk
with your doctor about your individual risks before using estradiol and norgestimate long-term.
Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine
whether you should continue this treatment.
FDA pregnancy category X. This medication can cause birth defects.
Do not
use estradiol and norgestimate if you are pregnant.
Tell your doctor right away if
you become pregnant during treatment. Use an effective form of birth control while you are
using this medication.
Estradiol and norgestimate can pass into breast milk and may harm a nursing baby.
This medication may also slow breast milk production. Do not use if you are breast-feeding a
baby.
How should I take estradiol and norgestimate?
Use this medication exactly as it was prescribed for you. Do not use the medication in
larger amounts, or use it for longer than recommended by your doctor. Follow the directions on
your prescription label.
Take this medication with a full glass of water.
This medication usually comes in a pack of pills that are different colors. In most cases,
you will take a pill of one color for three days in a row, followed by taking a pill of the other
color for the next three days. 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
medication may come with stickers to mark your weekday schedule on the pack.
Be sure to have a new pack of this medication ready to start on the day after you have
finished an entire pill pack.
Try to take estradiol and norgestimate at the same time each day.
Have yearly physical exams and examine your breasts for lumps on a monthly basis
while taking estradiol and norgestimate.
Store estradiol and norgestimate at room temperature away from moisture and heat.
What happens if I miss a dose of estradiol and norgestimate?
Take the medication as soon as you remember. If it is almost time for the next dose, skip
the missed dose and take your medicine at the next regularly scheduled time.
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 medication.
Where can I get more information about estradiol and norgestimate?
Your pharmacist has information about estradiol and norgestimate written for health professionals that you may read.
What are the possible side effects of estradiol and norgestimate?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
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chest pain or heavy feeling, pain spreading to the arm or shoulder,
nausea, sweating, general ill feeling;
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sudden numbness or weakness, especially on one side of the
body;
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sudden headache, confusion, problems with vision, speech,
or balance;
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pain or swelling in your lower leg;
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abnormal vaginal bleeding;
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pain, swelling, or tenderness in your stomach;
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jaundice (yellowing of the skin or eyes); or
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a lump in your breast.
Less serious side effects may include:
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nausea, vomiting, loss of appetite;
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swollen breasts;
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swelling of your hands or feet;
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problems with wearing contact lenses;
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acne or skin color changes;
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migraine headaches or dizziness;
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vaginal pain, dryness, itching, or discharge;
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swelling of your ankles or feet;
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depression;
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enlargement of uterine fibroids; or
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changes in your menstrual periods, break-through bleeding.
This is not a complete list of side effects and others may occur. Tell
your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about estradiol and norgestimate?
Do not use this medication if you have any of the following conditions: a history of
stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine
cancer, or abnormal vaginal bleeding.
This medication can cause birth defects in an unborn baby. Do not use
if you are pregnant.
Use an effective form of birth control, and tell your doctor if you
become pregnant during treatment.
Estradiol and norgestimate increases your risk of developing endometrial hyperplasia, a
condition that may lead to cancer of the uterus. Taking progestins while using estradiol and
norgestimate may lower this risk. If your uterus has not been removed, your doctor may
prescribe a progestin for you to take while you are using estradiol and norgestimate.
Long-term estradiol and norgestimate treatment may increase your risk of breast cancer,
heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol
and norgestimate long-term. Your doctor should check your progress on a regular basis to
determine whether you should continue this treatment.
What should I avoid while taking estradiol and norgestimate?
There are no restrictions on food, beverages, or activity while using estradiol and
norgestimate unless your doctor has told you otherwise.
What other drugs will affect estradiol and norgestimate?
Before taking estradiol and norgestimate, tell your doctor if you are taking any of the
following medicines
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insulin or an diabetes medicine you take by mouth, such as
glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), chlorpropamide (Diabinese),
tolazamide (Tolinase), tolbutamide (Orinase), and others; or
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a blood thinner such as warfarin (Coumadin).
If you are using any of these drugs, you may not be able to use
estradiol and norgestimate or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect estradiol and norgestimate. Tell your
doctor about all the prescription and over-the-counter medications you use. This includes
vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a
new medication without telling your doctor.
What happens if I have an overdose of estradiol and norgestimate?
