1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Limitation of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.
Cenestin (synthetic conjugated estrogens, A) tablets contain a blend of nine (9) synthetic estrogenic substances. The estrogenic substances are sodium estrone sulfate, sodium equilin sulfate, sodium 17α-dihydroequilin sulfate, sodium 17α-estradiol sulfate, sodium 17β-dihydroequilin sulfate, sodium 17α-dihydroequilenin sulfate, sodium 17β-dihydroequilenin sulfate, sodium equilenin sulfate and sodium 17β-estradiol sulfate.
The structural formulae for these estrogens are:
Sodium Estrone Sulfate
Sodium Equilin Sulfate
Sodium 17α-Dihydroequilin Sulfate
Sodium 17α-Estradiol Sulfate
Sodium 17β-Dihydroequilin Sulfate
Sodium 17α-Dihydroequilenin Sulfate
Sodium 17β-Dihydroequilenin Sulfate
Sodium Equilenin Sulfate
Sodium 17β-Estradiol Sulfate
Tablets for oral administration, are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg strengths of synthetic conjugated estrogens, A. Tablets also contain the following inactive ingredients: ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80 (except 0.45 mg tablets ), pregelatinized starch, titanium dioxide, and triethyl citrate.
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0.3 mg tablets also contain FD&C Blue No. 2 aluminum lake and D&C Yellow No. 10 aluminum lake.
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 reevaluated periodically as clinically appropriate to determine if treatment is still necessary.
2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Cenestin therapy consists of a single tablet taken orally once daily.
Patients should be started at Cenestin 0.45 mg daily. Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider. The lowest effective dose of Cenestin for the treatment of moderate to severe vasomotor symptoms has not been determined.
2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Cenestin therapy consists of a single tablet taken orally once daily.
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Cenestin 0.3 mg
When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.