PREMARIN Vaginal Cream (conjugated estrogens) Dosage And Administration

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Dosing Considerations

The benefits and risks of HRT must always be carefully weighed, including consideration of the emergence of risks as therapy continues. Premarin® Vaginal Cream 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 clinical appropriate to determine if treatment is still necessary (see boxed 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® Vaginal Cream should be administered cyclically for short-term use only for the treatment of atrophic vaginitis, dyspareunia or kraurosis vulvae.

Premarin® Vaginal Cream should be instituted at the lowest effective dosage, and the need for continued estrogen therapy should be re-evaluated regularly.

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.

In some cases, hysterectomized women with a history of endometriosis may need a progestin, see WARNINGS AND PRECAUTIONS, Endometriosis.

Dosage Range

The lowest dose that will control symptoms should be chosen.

Low Dose

Premarin® Vaginal Cream (0.5g) is administered intravaginally or topically twice-weekly (for example, Monday and Thursday).

Maximum Recommended Dose

Premarin® Vaginal Cream is administered intravaginally or topically in a cyclic regimen (daily for 21 days and then off for 7 days). Generally, women should be started at the 0.5g daily dosage strength. Dosage adjustments (0.5 to 2 g) may be made based on individual response.

Appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.

Instructions for Use of Applicator:

  1. Remove cap.
  2. Screw nozzle end of applicator onto the tube.
  3. Gently squeeze tube to force sufficient cream into the barrel to provide the prescribed dose.
  4. Unscrew applicator from tube.
  5. Place the applicator into the vaginal opening.
  6. To release medication, press plunger downward.

To Cleanse: Pull plunger out from barrel. Wash with mild soap and warm water.
DO NOT BOIL.

Missed Dose

If a patient misses a dose, it should be taken as soon as possible. If it is close to the patient’s next scheduled dose, the missed dose should be skipped, and the patient should continue with her normal schedule. The patient should not take two doses at the same time.

Administration

Vaginal

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.