Estradiol (Page 6 of 7)

HOW SUPPLIED

Estradiol V agi n al C re a m U S P 0.0 1% .

N DC 0093-3541-43: Tube containing 1 ½ oz (42.5 g) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 g. Smooth semi solid cream. White or off-white.

S t o r e at r o o m t e m p er a t u r e 20° t o 25°C ( 59° t o 77° F ) . P r o t ec t f r o m t e m p er a t u re s in e x c e ss of 40°C ( 104° F ) .

Keep Estradiol Vaginal Cream USP 0.01% out of the reach of children.

REFERENCES

  1. Jackson RD, et al. Effects of Conjugated Equine Estrogen on Risk of Fractures and BMD in Postmenopausal Women With Hysterectomy: Results From the Women’s Health Initiative Randomized Trial. J Bone M in e r R e s. 2006;21:817-828.
  2. Hendrix SL, et al. Effects of Conjugated Equine Estrogen on Stroke in the Women’s Health Initiative. Circulation. 2006;113:2425-2434.
  3. Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. J A M A. 2007;297:1465-1477.
  4. Hsia J, et al. Conjugated Equine Estrogens and Coronary Heart Disease. Arch Int Med. 2006;166:357-365.
  5. Curb JD, et al. Venous Thrombosis and Conjugated Equine Estrogen in Women Without a Uterus. Ar c h I nt M e d. 2006;166:772-780.
  6. Cushman M, et al. Estrogen Plus Progestin and Risk of Venous Thrombosis. J A M A. 2004;292:1573-1580.
  7. Stefanick ML, et al. Effects of Conjugated Equine Estrogens on Breast Cancer and Mammography Screening in Postmenopausal Women With Hysterectomy. J A M A. 2006;295:1647-1657.
  8. Chlebowski RT, et al. Influence of Estrogen Plus Progestin on Breast Cancer and Mammography in Healthy Postmenopausal Women. J A M A. 2003;289:3234-3253.
  9. Anderson GL, et al. Effects of Estrogen Plus Progestin on Gynecologic Cancers and Associated Diagnostic Procedures. J A M A. 2003;290:1739-1748.
  10. Shumaker SA, et al. Conjugated Equine Estrogens and Incidence of Probable Dementia and Mild Cognitive Impairment in Postmenopausal Women. J A M A. 2004;291:29472958.

Manufactured In Canada by:
Contract Pharmaceuticals Limited
Mississauga, Ontario, Canada L5N 6L6

Distributed by:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
1-888-838-2872
© 2024 Teva Pharmaceuticals USA Inc. All rights reserved. Rev. D 2/2024

PATIENT INFORMATION EST RA DIOL- ESTRADIOL CREAM ( E stradiol V aginal C ream USP 0.01%)
Read this Patient Information before you start using estradiol vaginal cream USP 0.01% and each time you refill. There may be new information. This information does not take the place of talking with your healthcare provider about your menopausal symptoms or your treatment.
W h at is t h e m ost i m p o r t a n t i n f o r m a t ion I s h o u ld kn o w a b o u t Estradiol Vagi n al Cream USP 0.01% ( an e s tr o g e n h o r m o ne ) ?
  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using estradiol vaginal cream USP 0.01%. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Have your healthcare provider check any unusual vaginal bleeding to find out the cause.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline in brain function).
  • Using estrogen-alone may increase your chances of getting strokes or blood clots.
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women — 65 years of age or older.
  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia.
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
  • Talk regularly with your healthcare provider about whether you still need treatment with estradiol vaginal cream USP 0.01%.
W h at is Estradiol Vaginal Cream USP 0.01 % ? Estradiol vaginal cream USP 0.01% is a prescription medicine that contains estradiol (an estrogen hormone).
W h at is Estradiol Vaginal Cream USP 0.01% u s e d f o r? Estradiol Vaginal Cream USP 0.01% is u s e d a f te r me n o p a u se t o:
  • T re at m o d e r a t e t o s e v e r e m e n o p a u sal c h a n g e s in a n d a r o u n d t h e vagi n a. Talk regularly with your healthcare provider about whether you still need treatment with estradiol vaginal cream USP 0.01%.
W h o s h o u l d n ot u se Estradiol Vaginal Cream USP 0.01 % ? Do not start using Estradiol Vaginal Cream USP 0.01% if you:
  • have unu s u a l vagi n al b l ee d i ng. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Have your healthcare provider check any unusual bleeding to find out the cause.
  • c u rre n t ly h ave or h ave h ad cert ain c a n cers.Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus.If you have or have had cancer, talk with your healthcare provider about whether you should use estradiol vaginal cream USP 0.01%.
  • c u rre n t ly h ave or h ave h ad b lo o d c lo t s.
  • had a stroke or heart attack.
  • a r e all er g i c t o estradiol vaginal cream USP 0.01% or a n y of i t s i n g re d i e n t s. See the list of ingredients in estradiol vaginal cream USP 0.01% at the end of this leaflet.
  • c u rre n t ly h ave or h ave h ad liv e r p r o b l e m s.
  • have b ee n d iag n os e d wi t h a b l ee d i n g d iso r d e r.
  • th i n k you m ay b e p re g n a n t.
Before you use Estradiol Vaginal Cream USP 0.01 %, tell your healthcare provider about all of your medical conditions, including if you:
  • h ave unu s u al va g i n al b l ee d i ng. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • have any other medical conditions. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), diabetes, epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
  • a r e goi n g t o h ave s u r g er y or w ill b e on be d re s t . Your healthcare provider will let you know if you need to stop using estradiol vaginal cream USP 0.01%.
  • are breastfeeding. The hormone in estradiol vaginal cream USP 0.01% can pass into your breast milk.
Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how estradiol vaginal cream USP 0.01% works. Estradiol vaginal cream USP 0.01% may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How s h o u ld I u se Estradiol Vaginal Cream USP 0.01 % ? Estradiol vaginal cream USP 0.01% is a cream that you place in your vagina with the applicator provided with the cream.
  • Take the dose recommended by your healthcare provider and talk to them about how well that dose is working for you.
  • Use estrogens at the lowest dose possible for your treatment only as long as needed. Talk regularly (for example, every 3 to 6 months) with your healthcare provider about the dose you are using and whether you still need treatment with estradiol vaginal cream USP 0.01%.
Tube, Nozzle, Cap
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Plunger
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Do not attach the plunger end of the applicator onto the open estradiol vaginal cream USP 0.01% tube (see F igure C ).
Threaded End
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2G
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A picture containing linedrawing

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Do not boil or use hot water) (see Figure F).
A picture containing linedrawing

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W h at a r e t h e p ossi b le si d e e ff ect s of Estradiol Vaginal Cream USP 0.01% ? S i d e ef f ect s a r e g r o up e d b y h o w s er io u s t h e y a r e a n d h ow o f te n t h e y h a pp e n w h e n you a r e tre a t e d . S er io u s, bu t l e ss c o m m o n si d e ef f ect s i n c l ud e:
  • stroke
  • blood clots
  • breast cancer
  • dementia
  • high blood calcium (hypercalcemia)
  • severe allergic reaction
  • high blood pressure
  • liver problems
  • fluid retention
  • worsening of endometriosis
  • changes in certain laboratory test results
  • heart disease
  • cancer of the lining of the uterus (womb)
  • cancer of the ovary
  • gallbladder disease
  • changes in vision
  • worsening of angioedema (swelling of face and tongue)
  • high triglyceride (fat) levels in your blood
  • low thyroid levels in your blood
  • low blood calcium (hypocalcemia)
  • worsening of other medical conditions
Call yo u r h e al t h c a r e pr ovi d e r r ig h t a w ay if y o u g e t a n y of t h e f oll o w i n g w a r n i n g s ig n s or a n y o t h e r unu s u al sy m p t o m s t h at c o n c e r n yo u:
  • new breast lumps
  • unusual vaginal bleeding
  • changes in vision or speech
  • sudden new severe headaches
  • severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
  • swollen lips, tongue or face
L e ss s er io u s, bu t c o m m on si d e ef f ect s i n c l ud e:
  • headache
  • breast pain
  • irregular vaginal bleeding or spotting
  • stomach or abdominal cramps, bloating
  • nausea and vomiting
  • hair loss
  • fluid retention
  • vaginal yeast infection
  • reactions from inserting estradiol vaginal cream USP 0.01%, such as vaginal burning, irritation, and itching
These are not all the possible side effects of estradiol vaginal cream USP 0.01%. For more information, ask your healthcare provider or pharmacist for advice about side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Estradiol vaginal cream USP 0.01 %?
  • Store Estradiol Vaginal Cream USP 0.01% at room temperature between 59°F to 77°F (20°C to 25°C)
  • Protect from temperatures above 104°F (40°C)
  • Keep Estradiol Vaginal Cream USP 0.01% and all medicines out of the reach of children
W h at c an I d o t o lo w e r m y c h a n ce s of a s er io u s si d e e ff ec t w i t h Estradiol Vagi n al Cream USP 0.01% ?
  • Talk with your healthcare provider regularly about whether you should continue using estradiol vaginal cream USP 0.01%.
  • If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you. In general, the addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus.
    • See your healthcare provider right away if you get vaginal bleeding while using estradiol vaginal cream USP 0.01%.
  • Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
  • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.
G e ne r al i n f o r m a t ion a b o u t sa f e a n d e ff ect ive u se of Estradiol Vagi n al Cream USP 0.01% Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use estradiol vaginal cream USP 0.01% for conditions for which it was not prescribed. Do not give estradiol vaginal cream USP 0.01% to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about estradiol vaginal cream USP 0.01% that is written for health professionals.
W h at a r e t h e i n g re d i e n t s in Estradiol Vagi n al Cream USP 0.01% ? Active ingredient: estradiolInactive Ingredients: purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di- glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di- sodium and t e rtiar y -butylhydroquinone.
Manufactured In Canada by:Contract Pharmaceuticals LimitedMississauga, Ontario, Canada L5N 6L6Distributed by:Teva Pharmaceuticals USA, Inc.North Wales, PA 194541-888-838-2872© 2024 Teva Pharmaceuticals USA Inc. All rights reserved. Rev. D 2/2024

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