From the Guidelines
Vagifem (estradiol vaginal tablet) should be prescribed at a dose of 10 mcg inserted vaginally once daily for the first two weeks of treatment, followed by a maintenance dose of 10 mcg inserted twice weekly. This dosing regimen is based on the standard treatment guidelines for vaginal atrophy and is supported by studies on the effectiveness of vaginal estrogens in relieving symptomatic atrophic vaginitis 1. The key benefits of using Vagifem include its localized delivery system, which minimizes systemic absorption and reduces the risk of side effects associated with oral estrogen therapy. Some important considerations when prescribing Vagifem include:
- The availability of a lower strength 4 mcg tablet, which follows the same dosing schedule
- The importance of using Vagifem regularly as prescribed to maintain its effectiveness
- The need for patients to discuss with their healthcare provider how long treatment should continue based on their individual needs and risk factors, particularly in cases where the patient has a history of breast cancer or is using aromatase inhibitors (AI) 1. It is also worth noting that vaginal preparations containing estriol may be preferable to those containing estradiol in certain cases, such as in AI users, due to the potential for estradiol to reverse the efficacy of AI in suppressing estrogens 1.
From the FDA Drug Label
DOSAGE AND ADMINISTRATION ... For treatment of moderate to severe vasomotor symptoms, 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.
The question asks about Vagifem (estradiol) but the provided label is for Estradiol valerate injection, USP. However, based on the information about estradiol,
The usual dosage is 10 to 20 mg Estradiol valerate injection, USP every four weeks
The dose of estradiol is 10 to 20 mg every four weeks for treatment of moderate to severe vasomotor symptoms, vulvar and vaginal atrophy associated with the menopause. However, Vagifem (estradiol) dose is not directly mentioned in the provided label, it is mentioned that patients should be started at the lowest dose for the indication. 2
From the Research
Dose of Vagifem (Estradiol)
- The dose of Vagifem (estradiol) is 10 mcg, as indicated in the study published in 2011 3.
- This ultra-low-dose vaginal estrogen tablet is the lowest approved dose available, with an annual estradiol exposure of only 1.14 mg 4.
- The 10 mcg dose is used to treat postmenopausal vaginal atrophy, and has been shown to be safe and effective in relieving symptoms such as vaginal dryness and irritation 4, 5.
- Compared to other treatments, such as vaginal estrogen cream, Vagifem has been found to be equally effective in treating atrophic vaginitis, but with fewer hygienic problems and greater ease of use 5.
- The efficacy and safety of Vagifem have been demonstrated in several studies, including a 12-month prospective, randomized study that compared Vagifem to a low-dose estradiol-releasing vaginal ring 6.