Estradiol

Estring

0.0075MG/24HR insert, extended releaseVereinigte StaatenIm HandelZugelassen am 26. Apr. 1996

Inhalt auf Englisch

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Anwendungsgebiete

ESTRING is indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

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ESTRING is contraindicated in women with any of the following conditions: 1. Abnormal genital bleeding with unknown etiology. 2. Known or suspected estrogen-dependent neoplasia. 3. Active DVT, PE, or a history of these conditions. 4. Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. 5. Known anaphylactic reaction or angioedema or hypersensitivity to ESTRING. 6. Known liver impairment or disease. 7.

Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

Warnhinweise und Vorsichtsmaßnahmen

1. Endometrial Cancer with Unopposed Estrogen in Women with a Uterus In ESTRING-treated menopausal women with a uterus with persistent or recurring abnormal genital bleeding of unknown etiology, perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to assess for endometrial cancer. There is an increased risk of endometrial cancer with the use of systemic estrogens alone in women with a uterus.

The reported endometrial cancer risk among unopposed systemic estrogen users is about 2 to 12 times greater than in non-users and appears dependent on duration of treatment and on estrogen dose. Most studies show no significant increased risk associated with the use of systemically administered estrogens for less than one year. The greatest risk appears to be associated with prolonged use, with increased risks of 15- to 24-fold for 5 to 10 years or more.

This risk has been shown to persist for at least 8 to 15 years after systemic estrogen therapy is discontinued. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose. Adding a progestogen to estrogen-alone therapy has been shown to reduce the risk of endometrial hyperplasia (possible precursor to endometrial cancer).

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Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

Warnhinweise und Vorsichtsmaßnahmen

Nebenwirkungen

See WARNINGS and PRECAUTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the two ESTRING controlled studies, discontinuation of treatment due to an adverse event was required by 5.4 percent of patients receiving ESTRING and 3.9 percent of patients receiving conjugated estrogens vaginal cream.

The most common reasons for withdrawal from ESTRING treatment due to an adverse event were vaginal discomfort and gastrointestinal symptoms. The adverse events reported with a frequency of 3 percent or greater in the two pivotal controlled studies by patients receiving ESTRING or conjugated estrogens vaginal cream are listed in Table 3. TABLE 3: Adverse Events Reported by 3 Percent or More of Patients Receiving Either ESTRING or Conjugated Estrogens Vaginal Cream in Two Pivotal Controlled Studies ADVERSE EVENT ESTRING (n = 257) % Conjugated Estrogens Vaginal Cream (n = 129) % Musculoskeletal Back Pain 6 8 Arthritis 4 2 Arthralgia 3 5 Skeletal Pain 2 4 CNS/Peripheral Nervous System Headache 13 16 Psychiatric Insomnia 4 0 Gastrointestinal Abdominal Pain 4 2 Nausea 3 2 Respiratory Upper Respiratory Tract Infection 5 6 Sinusitis 4 3 Pharyngitis 1 3 Urinary Urinary Tract Infection 2 7 Female Reproductive Leukorrhea 7 3 Vaginitis 5 2 Vaginal Discomfort/Pain 5 5 Vaginal Hemorrhage 4 5 Asymptomatic Genital Bacterial Growth 4 6 Breast Pain 1 7 Resistance Mechanisms Genital Moniliasis 6 7 Body as a Whole Flu-Like Symptoms 3 2 Hot Flushes 2 3 Allergy 1 4 Miscellaneous Family Stress 2 3 Postmarketing Experience Cases of toxic shock syndrome (TSS) have been reported in women using vaginal rings.

TSS is a rare, but serious disease that may cause death. Warning signs of TSS include fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness, or a sunburn-rash on face and body. Vaginal erosion, vaginal ulceration, adherence of the vaginal ring to the vaginal wall:

Cases of ring adherence to the vaginal wall, making ring removal difficult, have occurred. Some cases have required surgical removal of vaginal rings.
Cases of vaginal erosion and vaginal ulceration that may manifest as vaginal irritation, erythema. abrasion or spotting have occurred. Vaginal wall ulceration or erosion should be carefully evaluated. If an ulceration or erosion has occurred, consideration should be given to leaving the ring out and not replacing it until healing is complete in order to prevent the ring from adhering to the healing tissue. Cases of bowel obstruction and vaginal ring use have been reported. Persistent abdominal complaints consistent with obstruction should be carefully evaluated. Cases of hypersensitivity have been reported. The following additional adverse events were reported at least once by patients receiving ESTRING in the worldwide clinical program, which includes controlled and uncontrolled studies. A causal relationship with ESTRING has not been established. Body as a Whole : allergic reaction CNS/Peripheral Nervous System : dizziness Gastrointestinal : enlarged abdomen, vomiting Metabolic/Nutritional Disorders : weight decrease or increase Musculoskeletal : arthropathy (including arthrosis) Psychiatric : depression, decreased libido, nervousness Reproductive : breast engorgement, breast enlargement, intermenstrual bleeding, genital edema, vulval disorder Skin/Appendages : pruritus, pruritus ani Urinary : micturition frequency, urethral disorder Vascular : thrombophlebitis Vision : abnormal vision

Estring

Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

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Estring

Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

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