July 26, 2016
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How Supplied


Indications And Clinical Use

Estragyn Vaginal Cream is prescribed in the treatment of menopausal and post menopausal symptoms.

Estragyn Vaginal Cream should be prescribed with an appropriate dosage of a progestin for women with intact uteri to prevent endometrial hyperplasia/carcinoma.

Estragyn Vaginal Cream is intended for short term use.

Geriatrics ( > 65 years of age): See above INDICATIONS

Pediatrics ( < 16 years of age): Estragyn Vaginal Cream is not indicated for use in children.


Dosing Considerations

Estrogens are usually prescribed in a cyclical regimen of 25 days on drug followed by 5 days off or in a continuous uninterrupted therapy.

The treatment is initiated by the patient at a time of day convenient to the patient. Repeat dosages should coincide with this chosen schedule.

Recommended Dose and Dosage Adjustment

The recommended dose is 2.0 to 4.0 g intravaginally per day, adjusted to the lowest amount that controls symptoms. Estragyn Vaginal Cream is intended for short-term use.

Missed Dose

If a dose has been clearly missed it is safer to restart at the time of the next dose. Do not double dose.


Estragyn Vaginal Cream is administered with the use of the supplied vaginal applicator, which consists of a calibrated plunger and a barrel. The applicator is calibrated in half gram increments to measure and deliver 0.5 to 4.0 grams of cream.

Vaginal applicator - Illustration

Instructions for the proper use of the supplied vaginal applicator: Before piercing the tube, screw the applicator barrel to the tube. Repeat this at least twice to ensure that the applicator screws on with ease.

Fill the applicator by proceeding as follows: use the inversed cap to pierce the tube seal. Screw the applicator barrel firmly to the tube with the plunger fully in. Squeeze the tube to fill cream into the barrel. Measure the required amount of cream by aligning the line calibrator on the plunger to the barrel end.

Use the inversed cap to pierce the tube seal - Illustration

Inserting the vaginal applicator with cream: patients should be lying on their back. Using either hand, grasp the barrel of the applicator firmly with thumb and middle finger. Do not push the plunger with the index finger until after the applicator is in the proper position in the vagina. Pointing the applicator slightly downward, insert it deeply into the vagina as far as it will comfortably go without using force. Now, push the plunger all the way down to deposit the cream in the vagina. Withdraw the applicator from the vagina when the cream has been deposited

Insert it deeply into the vagina - Illustration

Care of the applicator: Separate the plunger from the barrel by pulling it all the way out. Wash both sections of the applicator thoroughly with mild detergent and warm water, allowing the water to flow through the barrel to rinse well. Sterilisation of the applicator is not necessary and extremely hot water should not be used because it may soften the plastic applicator. Dry the applicator and store it in a clean place.

Caution: the applicator should be used only on the advice of a physician.

Estragyn Vaginal Cream 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.


Storage And Stability

Store at room temperature between 15°C and 30°C. Avoid freezing as it may cause the cream to separate destroying its properties.

Dosage Forms, Composition And Packaging

Estragyn Vaginal Cream is a vaginal cream containing 0.1% estrone. If used continuously then lower the dosage to the lowest amount that controls the symptoms. Estragyn Vaginal Cream comes only in 0.1% w/w concentration of estrone.

Non medicinal ingredients are as follows: arlacel 165, isopropyl myristate, methyl paraben, mineral oil, Peg 40 stearate, propyl paraben, sorbitan monostearate, stearic acid, water.

Estragyn Vaginal Cream is available as a 45g size tube and comes complete with 0 to 4 gram applicator calibrated in 0.5g increments. Included in the boxed package are the detailed applicator instructions on its use and its hygienic maintenance.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/31/2014

How Supplied

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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