Jane S. Ricciuti, RPh, MS

Disclosures

April 22, 2003

In This Article

Estrogens

Femring
(estradiol acetate vaginal ring)

Manufacturer: Galen Limited

Drug Approval Classification: Original New Drug Application (Approval Date: 03/20/03)

Indication: Femring therapy is indicated in the:

Treatment of moderate to severe vasomotor symptoms associated with the menopause.

  • Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, other vaginal products should be considered.

  • Dosing: Femring is an off-white, soft, flexible ring with a central core containing estradiol acetate. Femring is available in two strengths:

    Femring 0.05 mg/day has a central core that contains 12.4 mg of estradiol acetate, which releases at a rate equivalent to 0.05 mg of estradiol per day for 3 months.

  • Femring 0.10 mg/day has a central core that contains 24.8 mg of estradiol acetate, which releases at a rate equivalent to 0.10 mg of estradiol per day for 3 months.

  • Clinical Summary: The efficacy of Femring for the treatment of moderate to severe vasomotor symptoms was assessed in a 13-week, double-blind, placebo-controlled clinical trial in 333 postmenopausal women. Femring was superior to placebo at 4 and 12 weeks for relief of frequency and severity of moderate to severe vasomotor symptoms. Also observed was an increase of 16% to 18.9% of vaginal superficial cells, and a corresponding reduction in parabasal cells was observed at week 13.

    Adverse Effects: The labeling for Femring contains a boxed warning and a description of adverse events similar to those noted for other estrogen products. The boxed warning highlights the increased risk of endometrial cancer and cardiovascular risks associated with estrogen use.

    Femring (estradiol acetate vaginal ring) Labeling

    Prempro
    and Premphase
    (conjugated estrogens / medroxyprogesterone
    acetate) Tablets

    Manufacturer: Wyeth Pharmaceuticals

    Drug Approval Classification: Supplemental New Drug Application (Approval Date: 03/12/03)

    Indication: This supplemental application provides for the approval of a lower dose of Prempro and Premphase (0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate) for:

    Treatment of moderate to severe vasomotor symptoms associated with the menopause.

  • Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause.

  • Dosing:

    For treatment of moderate to severe vasomotor symptoms, and/or moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. -- Patients should be started at Prempro 0.45/1.5 daily. In patients where bleeding or spotting remains a problem, after appropriate evaluation, consideration should be given to increasing the dose level. This dose should be periodically reassessed by the healthcare provider.

  • For prevention of postmenopausal osteoporosis.

    -- Patients should be started at Prempro 0.625/2.5 daily. In patients where bleeding or spotting remains a problem, after appropriate evaluation, consideration should be given to increasing the MPA dose to Prempro 0.625/5 daily. This dose should be periodically reassessed by the healthcare provider.

  • Prempro and Premphase (conjugated estrogens /medroxyprogesterone acetate) Tablets Labeling

    Prempro and Premphase (conjugated estrogens /medroxyprogesterone acetate) Tablets

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