Estradiol Vaginal (Page 5 of 5)
E. Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term continuous administration of estrogen, with and without progestin, in women with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer. (See BOXED WARNINGS, WARNINGS and PRECAUTIONS.)
Long term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.
F. Pregnancy
Estradiol Vaginal Cream, 0.01% should not be used during pregnancy [see CONTRAINDICATIONS ].
There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy.
G. Nursing Mothers
Estradiol Vaginal Cream, 0.01% should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens have been identified in the milk of women receiving estrogen therapy. Caution should be exercised when Estradiol Vaginal Cream, 0.01% is administered to a nursing woman.
H. Pediatric Use
Estradiol Vaginal Cream, 0.01% work out is not indicated in children. Clinical studies have not been conducted in the pediatric population.
I. Geriatric Use
There have not been sufficient numbers of geriatric patients involved in studies utilizing Estradiol Vaginal Cream, 0.01% to determine whether those over 65 years of age differ from younger subjects in their response to Estradiol Vaginal Cream, 0.01%.
The Women’s Health Initiative Study
In the WHI estrogen-alone substudy (daily CE [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see CLINICAL STUDIES and WARNINGS ].
In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see CLINICAL STUDIES and WARNINGS ].
The Women’s Health Initiative Memory Study
In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see CLINICAL STUDIES and WARNINGS ].
Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women10 [see CLINICAL STUDIES and WARNINGS ].
ADVERSE REACTIONS
See BOXED WARNINGS, WARNINGS and PRECAUTIONS.
Systemic absorption may occur with the use of Estradiol Vaginal Cream, 0.01%. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.
The following adverse reactions have been reported with estrogen and/or progestin therapy.
1. Genitourinary System
Abnormal uterine bleeding or spotting; dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in cervical secretion; cystitis-like syndrome; application site reactions of vulvovaginal discomfort including burning and irritation; genital pruritus; ovarian cancer; endometrial hyperplasia; endometrial cancer.
2. Breasts
Tenderness, enlargement, pain, nipple discharge, fibrocystic breast changes; breast cancer.
3. Cardiovascular
Deep and superficial venous thrombosis; pulmonary embolism; myocardial infarction; stroke; increase in blood pressure.
4. Gastrointestinal
Nausea, vomiting; abdominal cramps, bloating; increased incidence of gallbladder disease.
5. Skin
Chloasma that may persist when drug is discontinued; loss of scalp hair; hirsutism; rash.
6. Eyes
Retinal vascular thrombosis, intolerance to contact lenses.
7. Central Nervous System
Headache; migraine; dizziness; mental depression; nervousness; mood disturbances; irritability; dementia.
8. Miscellaneous
Increase or decrease in weight; glucose intolerance; edema; arthralgias; leg cramps; changes in libido; urticaria; exacerbation of asthma; increased triglycerides; hypersensitivity (including erythema multiforme).
To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
OVERDOSAGE
Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of Estradiol Vaginal Cream, 0.01% therapy together with institution of appropriate symptomatic care.
DOSAGE AND ADMINISTRATION
Use of Estradiol Vaginal Cream, 0.01% alone or in combination with a progestin, should be limited to the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should reevaluate periodically as clinically appropriate to determine if treatment is still necessary. For treatment of vulvar and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. For women who have a uterus, adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal genital bleeding.
Usual Dosage: The usual dosage range is 2 to 4 g (marked on the applicator) daily for one or two weeks, then gradually reduced to one half initial dosage for a similar period. A maintenance dosage of 1 g, one to three times a week, may be used after restoration of the vaginal mucosa has been achieved.
NOTE: The number of doses per tube will vary with dosage requirements and patient handling.
HOW SUPPLIED
Estradiol Vaginal Cream USP, 0.01%
NDC 63629-8654-1: Tube containing 1½ oz (42.5 g) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 g.
Store at room temperature 20° to 25°C (68° to 77°F). Protect from temperatures in excess of 40°C (104°F).
Keep Estradiol Vaginal Cream, 0.01% out of the reach of children.
INFORMATION FOR THE PATIENT
Read this PATIENT INFORMATION before you start using Estradiol Vaginal Cream, 0.01% and read what you get each time you refill your Estradiol Vaginal Cream, 0.01% prescription. 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.
| What is the most important information I should know about Estradiol Vaginal Cream, 0.01% (an estrogen hormone)? |
|
What is Estradiol Vaginal Cream, 0.01%?
Estradiol Vaginal Cream, 0.01% is a medicine that contains an estrogen hormone.
What is Estradiol Vaginal Cream, 0.01% used for? Estradiol Vaginal Cream, 0.01% is used after menopause to:
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- Treat moderate to severe menopausal changes in and around the vagina
You and your healthcare provider should talk regularly about whether you still need treatment with Estradiol Vaginal Cream, 0.01% to control these problems.
Who should not use Estradiol Vaginal Cream, 0.01%?
Do not start using Estradiol Vaginal Cream, 0.01% if you:
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- Have unusual vaginal bleeding
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- Currently have or have had certain cancers
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, 0.01%.
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- Had a stroke or heart attack
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- Currently have or have had blood clots
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- Currently have or have had liver problems
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- Have been diagnosed with a bleeding disorder
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- Are allergic to Estradiol Vaginal Cream, 0.01% or any of its ingredients
See the list of ingredients in Estradiol Vaginal Cream, 0.01% at the end of this leaflet.
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- Think you may be pregnant
Tell your healthcare provider:
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- If you have unusual vaginal bleeding
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.
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- About all of your medical problems
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
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- About all the medicines you take
This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Estradiol Vaginal Cream, 0.01% works.
Estradiol Vaginal Cream, 0.01% may also affect how your other medicines work.
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- If you are going to have surgery or will be on bed rest.
You may need to stop using Estradiol Vaginal Cream, 0.01%.
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- If you are breastfeeding
The estrogen hormone in Estradiol Vaginal Cream, 0.01% can pass into your breast milk.
How should I use Estradiol Vaginal Cream, 0.01%?
Estradiol Vaginal Cream, 0.01% is a cream that you place in your vagina with the applicator provided with the cream.
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- Take the dose recommended by your healthcare provider and talk to him or her about how well that dose is working for you
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- Estrogens should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are using and whether you still need treatment with Estradiol Vaginal Cream, 0.01%
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- Step 1. Remove the cap from the tube. (There is no seal on tube)
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- Step 2. Do not separate plunger from applicator.
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- Step 3. Screw threaded end of applicator onto the open tube until secure.
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- Step 4. Position upright in order to view the calibrated gram amounts.
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- Step 5. Gently squeeze tube from the bottom to expel the prescribed amount of
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- Estradiol Vaginal Cream, 0.01% into the applicator. As cream is squeezed out, plunger will rise to indicate amount of grams.
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- Step 6. Unscrew applicator from tube.
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- Step 7. Replace cap on tube.
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- Step 8. Lie on back with knees drawn up. To deliver medication, gently insert applicator deeply into vagina and press plunger downward to its original position.
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- Step 9. To cleanse applicator: Pull plunger to remove it from barrel. Wash with mild soap and warm water (DO NOT BOIL OR USE HOT WATER)
What are the possible side effects of Estradiol Vaginal Cream, 0.01%?
Although Estradiol Vaginal Cream, 0.01% is only used in and around the vagina, the risks associated with oral estrogens should be taken into account.
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious, but less common side effects include:
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- Heart attack
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- Stroke
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- Blood clots
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- Dementia
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- Breast cancer
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- Cancer of the lining of the uterus (womb)
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- Cancer of the ovary
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- High blood pressure
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- High blood sugar
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- Gallbladder disease
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- Liver problems
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- Enlargement of benign tumors of the uterus (“fibroids”)
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- Severe allergic reaction
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
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- New breast lumps
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- Unusual vaginal bleeding
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- Changes in vision or speech
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- Sudden new severe headaches
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- Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
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- Swollen lips, tongue or face
Less serious, but common side effects include:
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- Headache
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- Breast pain
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- Irregular vaginal bleeding or spotting
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- Stomach or abdominal cramps, bloating
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- Nausea and vomiting
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- Hair loss
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- Fluid retention
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- Vaginal yeast infection
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- Reactions from inserting Estradiol Vaginal Cream, 0.01%, such as vaginal burning,
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- irritation, and itching
These are not all the possible side effects of Estradiol Vaginal Cream, 0.01%. For more information, ask your healthcare provider or pharmacist for advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
What can I do to lower my chances of a serious side effect with Estradiol Vaginal Cream, 0.01%?
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- Talk with your healthcare provider regularly about whether you should continue using Estradiol Vaginal Cream, 0.01%.
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- If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus.
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- See your healthcare provider right away if you get vaginal bleeding while using Estradiol Vaginal Cream, 0.01%.
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- 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.
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- 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.
General information about safe and effective use of Estradiol Vaginal Cream, 0.01%
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Estradiol Vaginal Cream, 0.01% for conditions for which it was not prescribed. Do not give Estradiol Vaginal Cream, 0.01% to other people, even if they have the same symptoms you have. It may harm them.
Keep Estradiol Vaginal Cream, 0.01% out of the reach of children.
This leaflet provides a summary of the most important information about Estradiol Vaginal Cream, 0.01%. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Estradiol Vaginal Cream, 0.01% that is written for health professionals. You can get more information by calling the toll free number 1-866-634-9120.
What are the ingredients in Estradiol Vaginal Cream, 0.01%?
Each gram of Estradiol Vaginal Cream, 0.01% contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono-and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium, tertiary -butylhydroquinone and polysorbate 80.
HOW SUPPLIED
Estradiol Vaginal Cream USP, 0.01%
NDC 45802-097-35: Tube containing 1½ oz (42.5 g) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 g.
Store at room temperature 20° to 25°C (68° to 77°F). Protect from temperatures in excess of 40°C (104°F).
For more information, you may also contact Padagis at 1-866-634-9120.
Distributed By Padagis
Allegan, MI 49010
www.padagis.com
Made in Israel
Manufactured By Padagis
Yeruham, Israel
Rev 09-21
4H700 RC J3
Estradiol 0.01% Cream, #42.5
| ESTRADIOL VAGINAL estradiol cream | ||||||||||||||||||||||||||
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| Labeler — Bryant Ranch Prepack (171714327) |
| Registrant — Bryant Ranch Prepack (171714327) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bryant Ranch Prepack | 171714327 | REPACK (63629-8654), RELABEL (63629-8654) | |
Revised: 04/2022 Bryant Ranch Prepack
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