Elestrin

Elestrin Manufacturers

• Meda Pharmaceuticals
  

  ×

  Elestrin | Meda Pharmaceuticals

  

  ---

  Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer.
  A woman without a uterus does not need progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2), (5.14)].
  Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
  The gel is applied onto the skin in a thin layer. The recommended area of application is the upper arm to shoulder (approximately 320 cm2).

  2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

  ELESTRIN is applied once daily to the upper arm for the treatment of moderate to severe vasomotor symptoms due to menopause using a metered-dose pump which delivers 0.87 gram of estradiol gel (0.52 mg estradiol) per actuation (1 pump).
  Patients should be started with the lowest effective dose of ELESTRIN, which is one pump per day (0.87 g per day, which contains 0.52 mg of estradiol). Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.

  Close
  No Recall

  More Info
• Jazz Pharmaceuticals Commercial Corp.
  

  ×

  Elestrin | Jazz Pharmaceuticals Commercial Corp.

  

  ---

  When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

  Elestrin® is applied once daily to the upper arm for the treatment of moderate to severe vasomotor symptoms associated with menopause using a metered-dose pump which delivers 0.87 gram of estradiol gel per actuation.

  Patients should be started with the lowest effective dose of Elestrin®, which is one pump actuation per day (0.87 g/day, which contains 0.52 mg of estradiol).

  Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.

  Close
  No Recall

  More Info
• Jazz Pharmaceuticals Commercial Corp.
  

  ×

  Elestrin | Jazz Pharmaceuticals Commercial Corp.

  

  ---

  Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer.

  A woman without a uterus does not need progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2), (5.14)]. 

  Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

  2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

  ELESTRIN is applied once daily to the upper arm for the treatment of moderate to severe vasomotor symptoms due to menopause using a metered-dose pump which delivers 0.87 gram of estradiol gel per actuation.

  Patients should be started with the lowest effective dose of ELESTRIN, which is one pump per day (0.87 g per day, which contains 0.52 mg of estradiol).

  Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.

  Close
  No Recall

  More Info