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
- 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.
- Hendrix SL, et al. Effects of Conjugated Equine Estrogen on Stroke in the Women’s Health Initiative. Circulation. 2006;113:2425-2434.
- 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.
- Hsia J, et al. Conjugated Equine Estrogens and Coronary Heart Disease. Arch Int Med. 2006;166:357-365.
- 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.
- Cushman M, et al. Estrogen Plus Progestin and Risk of Venous Thrombosis. J A M A. 2004;292:1573-1580.
- 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.
- 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.
- Anderson GL, et al. Effects of Estrogen Plus Progestin on Gynecologic Cancers and Associated Diagnostic Procedures. J A M A. 2003;290:1739-1748.
- 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 ) ?
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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:
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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:
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Before you use Estradiol Vaginal Cream USP 0.01 %, tell your healthcare provider about all of your medical conditions, including if you:
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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.
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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:
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How should I store Estradiol vaginal cream USP 0.01 %?
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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% ?
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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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