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)?

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, 0.01%. 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.
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 age 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 age 65 years of age or older
You and your healthcare provider should talk regularly about whether you still need treatment with Estradiol Vaginal Cream, 0.01%

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:

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:

Have unusual vaginal bleeding
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%.

Had a stroke or heart attack
Currently have or have had blood clots
Currently have or have had liver problems
Have been diagnosed with a bleeding disorder
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.

Think you may be pregnant

Tell your healthcare provider:

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.

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.

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.

If you are going to have surgery or will be on bed rest.

You may need to stop using Estradiol Vaginal Cream, 0.01%.

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.

Take the dose recommended by your healthcare provider and talk to him or her about how well that dose is working for you
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%
Step 1. Remove the cap from the tube. (There is no seal on tube)
Step 2. Do not separate plunger from applicator.
Step 3. Screw threaded end of applicator onto the open tube until secure.
Step 4. Position upright in order to view the calibrated gram amounts.
Step 5. Gently squeeze tube from the bottom to expel the prescribed amount of
Estradiol Vaginal Cream, 0.01% into the applicator. As cream is squeezed out, plunger will rise to indicate amount of grams.
Step 6. Unscrew applicator from tube.
Step 7. Replace cap on tube.
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.
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:

Heart attack
Stroke
Blood clots
Dementia
Breast cancer
Cancer of the lining of the uterus (womb)
Cancer of the ovary
High blood pressure
High blood sugar
Gallbladder disease
Liver problems
Enlargement of benign tumors of the uterus (“fibroids”)
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:

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

Less serious, but common side effects include:

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, 0.01%, such as vaginal burning,
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%?

Talk with your healthcare provider regularly about whether you should continue using Estradiol Vaginal Cream, 0.01%.
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.
See your healthcare provider right away if you get vaginal bleeding while using Estradiol Vaginal Cream, 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.

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

Label
(click image for full-size original)
ESTRADIOL VAGINAL
estradiol cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-8654(NDC:45802-097)
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
STEARYL ALCOHOL
CERESIN
HYPROMELLOSE 2208 (4000 MPA.S)
SODIUM LAURYL SULFATE
METHYLPARABEN
EDETATE DISODIUM
TERT-BUTYLHYDROQUINONE
POLYSORBATE 80
GLYCERYL MONOSTEARATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-8654-1 1 TUBE in 1 CARTON contains a TUBE
1 42.5 g in 1 TUBE This package is contained within the CARTON (63629-8654-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210194 01/06/2021
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

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.