Estradiol is a form of estrogen. Estrogen is a female sex hormone that is involved in the
development and maintenance of the female reproductive system.
Norethindrone is a form of progesterone. Progesterone is a female hormone important for
the regulation of ovulation and menstruation.
Together, estradiol and norethindrone are used to treat the symptoms of menopause such
as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating
("hot flashes" or "hot flushes"); to treat vulvar and vaginal changes (itching, burning, dryness in
or around the vagina, difficulty or burning with urination) caused by menopause; and to replace
estrogen in conditions such as hypogonadism, removal of the ovaries, or primary ovarian failure
that result in a lack of estrogen. Estradiol and norethindrone is also used to prevent thinning of
the bones (osteoporosis).
Estradiol and norethindrone may also be used for purposes other than those listed in this
medication guide.
What should I discuss with my healthcare provider before taking estradiol and norethindrone?
Do not take estradiol and norethindrone without first talking to your doctor if you
have
a circulation, bleeding, or blood-clotting disorder;
undiagnosed, abnormal vaginal bleeding;
any type of breast, uterine, or hormone-dependent cancer;
or
liver disease.
Taking estradiol and norethindrone may be dangerous in some cases if
you have any of the conditions listed above.
Before taking estradiol and norethindrone, tell your doctor if you have
high blood pressure, angina, or heart disease;
high levels of cholesterol or triglycerides in your blood;
kidney disease;
asthma;
epilepsy;
migraines;
depression;
diabetes;
gallbladder disease;
uterine fibroids; or
had a hysterectomy (uterus removed).
You may not be able to take estradiol and norethindrone, or you may
need a dosage adjustment or special monitoring during treatment if you have any of the
conditions listed above.
Estradiol and norethindrone is in the FDA pregnancy category X. This means that
estradiol and norethindrone is known to cause birth defects in an unborn baby.
Do not
take estradiol and norethindrone if you are pregnant or could become pregnant during
treatment.
Estradiol and norethindrone may decrease milk flow and have other effects on milk
composition. Do not take estradiol and norethindrone without first talking to your doctor if you
are breast-feeding a baby.
How should I take estradiol and norethindrone?
Take estradiol and norethindrone exactly as directed by your doctor. If you do not
understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a glass of water.
Try to take each dose at the same time every day.
Have yearly physical exams and examine your breasts for lumps on a monthly basis while
taking estradiol and norethindrone.
Store ethinyl estradiol and norethindrone tablets at room temperature away from
moisture, heat, and direct light.
What happens if I miss a dose of estradiol and norethindrone?
Take the missed dose as soon as you remember. However, if it is almost time for the next
dose, skip the dose you missed and take only the next regularly scheduled dose.
Do not
take a double dose of this medication.
Where can I get more information about estradiol and norethindrone?
Your pharmacist has information about estradiol and norethindrone written for health professionals that you may read.
What are the possible side effects of estradiol and norethindrone?
If you experience any of the following serious side effects, stop taking estradiol and
norethindrone and seek emergency medical attention or notify your doctor immediately:
an allergic reaction (difficulty breathing; closing of the throat;
swelling of the lips, tongue, or face; or hives);
shortness of breath or pain in the chest;
a painful, red, swollen leg;
abnormal vaginal bleeding;
pain, swelling, or tenderness in the abdomen;
severe headache or vomiting, dizziness, faintness or
changes in vision or speech;
yellowing of the skin or eyes; or
a lump in a breast.
Other, less serious side effects may be more likely to occur. Continue
to take estradiol and norethindrone and talk to your doctor if you experience
nausea and vomiting;
tenderness or enlargement of the breasts;
weakness;
swelling of the hands or feet;
spotty darkening of the skin, particularly on the face;
difficulty in wearing contact lenses;
vaginal irritation or discomfort; or
changes in menstrual cycle, painful menstruation, or
break-through bleeding.
Estradiol increases the risk of developing endometrial hyperplasia, a
condition that may lead to cancer of the lining of the uterus. Using a progestin, such as
norethindrone, with estradiol lowers the risk of developing this condition. Visit your doctor
regularly and report any unusual vaginal bleeding right away.
It is unclear to what extent estrogen and progesterone treatments may affect the risk of
breast cancer.
Side effects other than those listed here may also occur. Talk to your doctor about any
side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about estradiol and norethindrone?
Estradiol increases the risk of developing endometrial hyperplasia, a condition that may
lead to cancer of the lining of the uterus. Using a progestin, such as norethindrone, with estradiol
lowers the risk of developing this condition. Visit your doctor regularly and report any unusual
vaginal bleeding right away.
Have yearly physical exams and examine your breasts for lumps on a monthly basis while
taking estradiol and norethindrone.
What should I avoid while taking estradiol and norethindrone?
There are no restrictions on food, beverages, or activity while taking estradiol and
norethindrone unless otherwise directed by your doctor.
What other drugs will affect estradiol and norethindrone?
Before taking estradiol and norethindrone, tell your doctor if you are taking an
anticoagulant (blood thinner) such as warfarin (Coumadin). You may not be able to take estradiol
and norethindrone, or you may require a dosage adjustment or special monitoring during
treatment.
Drugs other than those listed here may also interact with estradiol and norethindrone. Talk
to your doctor and pharmacist before taking any prescription or over-the-counter medicines,
including vitamins, minerals, and herbal products.
What happens if I have an overdose of estradiol and norethindrone?
Remember, keep this and all other medicines out of the reach of children, never share
your medicines with others, and use this medication only for the indication prescribed.
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up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum
information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not
warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does
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a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or
drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any
given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information
Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug
interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse
or pharmacist.
Content provided by Multum - Last Updated 11/10/2009