Dosing Considerations
The benefits and risks of HRT must always be carefully weighed, including consideration of the emergence of risks as therapy continues. Use of estrogens alone or in combination with progestins therapy should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re- evaluated periodically as clinically appropriate to determine if treatment is still necessary (see boxed Serious Warnings and Precautions). For women who have intact uteri, 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. In the absence of comparable data, the risks of HRT should be assumed to be similar for all estrogens and estrogen/progestin combinations.
Hormone replacement therapy (HRT) involving either estrogen alone or estrogen plus progestin combined therapy should only be continued as the benefits outweigh the risks for the individual.
Recommended Dose and Dosage Adjustment
PREMARIN therapy may be given continuously with no interruption in therapy, or in cyclical regimens (regimens such as 25 days on drug followed by five days off drug) as is medically appropriate on an individualized basis.
Continuous, non-cyclic therapy may be indicated in hysterectomized women or in cases where the signs and symptoms of estrogen deficiency become problematic during the treatment-free interval. In women with an intact uterus, a progestin should be coadministered for a minimum of 10, but preferably at least 12 to 14 days per cycle to avoid overstimulation of the endometrium. In addition, progestin should be administered to minimize the occurrence of endometrial hyperplasia. Unexpected or abnormal vaginal bleeding in such patients requires institution of prompt diagnostic measures, such as endometrial biopsy or curettage to rule out the possibility of uterine malignancy. Since progestins are administered to reduce the risk of hyperplastic changes of the endometrium, patients without a uterus do not require a progestin for this purpose.
In some cases, hysterectomized women with a history of endometriosis may need a progestin, see WARNINGS AND PRECAUTIONS, Endometriosis.
For maintenance therapy one should always use the lowest dose that still proves effective. The requirement for hormone replacement therapy for menopausal symptoms should be reassessed periodically.
PREMARIN may be taken without regard to meals. Tablets should be taken whole; do not divide, crush, chew, or dissolve tablets in mouth.
Usual Dosage Range
Menopausal symptoms
Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg PREMARIN daily, cyclically or continuously as is medically required. Adjust dosage according to severity of symptoms and response of the patient. For maintenance, adjust dosage to lowest level providing effective control.
Osteoporosis (loss of bone mass)
Patients should be treated with the lowest effective dose. Generally, women should be started at 1.3 mg PREMARIN daily. Subsequent dosage adjustments may be made based upon the individual clinical and bone mineral density responses. This dose should be periodically reassessed by the healthcare provider.
Hypoestrogenism due to
- Female hypogonadism: 0.3 mg to 0.625 mg daily, administered cyclically (e.g., 3 weeks on and 1 week off) or continuously as required. Doses are adjusted depending on the severity of symptoms and responsiveness of the endometrium.
- Female castration or primary ovarian failure: 1.25 mg daily, cyclically or continuously as required. Adjust dosage according to severity of symptoms and response of the patient. For maintenance, adjust dosage to lowest level that will provide effective control.
Atrophic Vaginitis
Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg PREMARIN daily depending upon the tissue response of the individual patient. Administer cyclically or continuously as required.
Vulvar Atrophy
Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg PREMARIN daily depending upon the tissue response of the individual patient. Administer cyclically or continuously as required.
Administration
Oral
PREMARIN should be prescribed with an appropriate dosage of a progestin for women with intact uteri in order to prevent endometrial hyperplasia/carcinoma. Progestin therapy is not required as part of hormone replacement therapy in women who have had a previous hysterectomy.
Missed Dose
If a patient misses a dose, advise them to take the dose as soon as possible. If it is almost time for the patient’s next dose, advise the patient to skip the missed dose and go back to their normal schedule. Patients should not take 2 doses at the same time.