ESTRACE Cream (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

A-S Medication Solutions

Λέξεις κλειδιά

50090-2321

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BOXED WARNING SECTION

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial ...

1. Description

Each gram of ESTRACE (estradiol vaginal cream, USP, 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, ...

2. Clinical Pharmacology

Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic ...

3. Indications and Usage

ESTRACE (estradiol vaginal cream, USP, 0.01%) is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

4. Contraindications

ESTRACE (estradiol vaginal cream, USP, 0.01%) should not be used in women with any of the following conditions: Undiagnosed abnormal genital bleeding. Known, suspected, or history of cancer of the breast. ...

5. Warnings

See BOXED WARNINGS. Systemic absorption may occur with the use of ESTRACE (estradiol vaginal cream, USP, 0.01%). The warnings, precautions, and adverse reactions associated with oral estrogen treatment ...

6. Precautions

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; ...

6.1. General

1. Addition of a Progestin When a Woman Has Not Had a Hysterectomy Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous ...

6.2. Information for Patients

Physicians are advised to discuss the PATIENT INFORMATION leaflet with women for whom they prescribe ESTRACE (estradiol vaginal cream, USP, 0.01%).

6.3. Laboratory Tests

Serum FSH and estradiol levels have not been shown to be useful in the management of moderate to severe symptoms of vulvar and vaginal atrophy.

6.5. Drug/Laboratory Test Interactions

Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, ...

6.6. Carcinogenesis, Mutagenesis, 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 ...

6.7. Pregnancy

ESTRACE 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 ...

6.9. Nursing Mothers

ESTRACE 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 ...

6.10. Pediatric Use

ESTRACE Vaginal Cream is not indicated in children. Clinical studies have not been conducted in the pediatric population.

6.11. Geriatric Use

There have not been sufficient numbers of geriatric patients involved in studies utilizing ESTRACE to determine whether those over 65 years of age differ from younger subjects in their response to ESTRACE. ...

7. Adverse Reactions

See BOXED WARNINGS, WARNINGS and PRECAUTIONS. Systemic absorption may occur with the use of ESTRACE. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken ...

9. 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 ...

10. Dosage and Administration

Use of ESTRACE 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 ...

11. How Supplied

Product: 50090-2321 NDC: 50090-2321-0 42.5 g in a TUBE / 1 in a CARTON Distributed by: Allergan USA, Inc., Madison, NJ 07940

13. Clinical Studies

Womens Health Initiative Studies The WHI enrolled approximately 27,000 predominantly healthy postmenopausal women in two substudies to assess the risks and benefits of daily oral CE (0.625 mg)-alone or ...

14. 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 Womens Health Initiative Randomized Trial. J Bone ...