Vagifem (Estradiol Vaginal) - Indications and Dosage

Indications and Usage

VAGIFEM^® is indicated for the treatment of atrophic vaginitis.

Dosage and Administration

VAGIFEM is gently inserted into the vagina as far as it can comfortably go without force, using the supplied applicator.

•Initial dose: One (1) VAGIFEM tablet, inserted vaginally, once daily for two (2) weeks. It is advisable to have the patient administer treatment at the same time each day.

•Maintenance dose: One (1) VAGIFEM tablet, inserted vaginally, twice weekly.

The need to continue therapy should be assessed by the physician with the patient. Attempts to discontinue or taper medication should be made at three to six month intervals.

How Supplied

Each VAGIFEM^® (estradiol vaginal tablets), 25µg is contained in a disposable, single-use applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset tablets.

8 applicators: NDC 0169-5173-03

18 applicators: NDC 0169-5173-04

Storage: Store at 25ºC (77ºF);

excursions permitted to 15ºC-30ºC (59ºF-86ºF). [See USP Controlled Room Temperature.]

Vagifem^® is a trademark owned by Novo Nordisk A/S

Revised July 2003

Novo Nordisk Pharmaceuticals, Inc.

Princeton, NJ 08540

1-888-824-4336

www.novonordisk-us.com

Manufactured by

Novo Nordisk A/S

2880 Bagsvaerd, Denmark