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Use of Premarin Vaginal Cream, 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. Post-menopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
When estrogen is prescribed for a post-menopausal 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 a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin.
Treatment of Atrophic Vaginitis and Kraurosis Vulvae: Premarin Vaginal Cream is administered intravaginally in a cyclic regimen (daily for 21 days and then off for 7 days). Generally, women should be started at the 0.5 g dosage strength. Dosage adjustments (0.5 to 2 g) may be made based on individual response.
Treatment of Dyspareunia: Premarin Vaginal Cream (0.5 g) is administered intravaginally in a twice-weekly (for example, Monday and Thursday) continuous regimen or in a cyclic regimen of 21 days of therapy followed by 7 days off of therapy.
Use in children: CE vaginal cream is not indicated in children.
Use in elderly patients: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing estrogens to determine whether those over 65 years of age differ from younger subjects in their response to estrogens.
The Women's Health Initiative Study (WHI): In the WHI estrogen-alone substudy (daily CE [0.625 mg] versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age (see Pharmacology: Pharmacodynamics: WHI Studies under Actions).
The Women's Health Initiative Memory Study (WHIMS): In the WHIMS of post-menopausal women 65 to 79 years of age, there was increased risk of developing probable dementia in women receiving estrogen alone when compared with placebo. It is unknown whether this finding applies to younger postmenopausal women (see Pharmacology: Pharmacodynamics: WHIM Study under Actions and Dementia under Precautions).
Instructions for Use of Gentle Measure Applicator: Remove cap from tube.
Screw nozzle end of applicator onto tube.
Gently squeeze tube from the bottom to force sufficient cream into the barrel to provide the prescribed dose. Use the marked stopping points on the applicator as a guideline to measure the correct dose.
Unscrew applicator from tube.
Lie on back with knees drawn up. To deliver medication, gently insert applicator deeply into vagina and press plunger downward to its original position.
To Cleanse: Pull plunger to remove it from barrel. Wash with mild soap and warm water.
DO NOT BOIL OR USE HOT WATER.
