ESTRAGYN Vaginal cream Ref.[10724] Active ingredients: Estrone

Source: Health Products and Food Branch (CA)  Revision Year: 2016 

Indications and clinical use

Estragyn Vaginal Cream is indicated for the treatment of the symptoms of vulvovaginal atrophy due to estrogen deficiency.

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.

Dosage and administration

Dosing Considerations

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

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

Recommended Dose and Dosage Adjustment

Patients should be started at the lowest dose.

The recommended dose is 0.5 to 4 grams per day taken intravaginally, adjusted to the lowest amount that controls symptoms. Estragyn Vaginal Cream is intended for short term use. Administration should be cyclic (e.g., three weeks on one week off).

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.

Administration

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 grams of cream.

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.
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.

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.

Overdosage

Symptoms of overdose

Numerous reports of ingestion of large doses of estrogen products and estrogencontaining oral contraceptives by young children have not revealed acute serious ill effects. Over dosage with estrogen may cause nausea, breast discomfort, fluid retention, bloating or vaginal bleeding in women.

Treatment of overdose

Symptomatic treatment should be given.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

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.

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