ENJUVIA tablets are indicated in the:

1. Treatment of moderate to severe vasomotor symptoms associated with menopause.
2. Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. When prescribing solely for the treatment of moderate to severe vaginal dryness and pain with intercourse, topical vaginal products should be considered.

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, 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.

ENJUVIA tablets are taken orally, once daily for:

1.The treatment of moderate to severe vasomotor symptoms, associated with menopause

• ENJUVIA 0.3 mg
• ENJUVIA 0.45 mg
• ENJUVIA 0.625 mg
• ENJUVIA 0.9 mg
• ENJUVIA 1.25 mg

2.The treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. When prescribing solely for the treatment of moderate to severe vaginal dryness and pain during intercourse, topical vaginal products should be considered.

• ENJUVIA 0.3 mg

Patients should be started at the lowest approved dose of 0.3 mg ENJUVIA daily. Subsequent dosage adjustment (which will differ depending on the indication) may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.

ENJUVIA™

(synthetic conjugated estrogens, B) Tablets

0.3 mg:

The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of:

0.45 mg:

The tablets are oval, mauve, film-coated, and debossed with “E” on one side and “2” on the reverse and are available in bottles of:

0.625 mg:

The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of:

0.9 mg:

The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of:

1.25 mg:

The tablets are oval, yellow, film-coated, and debossed with “E” on one side and “4” on the reverse and are available in bottles of:

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Keep this and all drugs out of the reach of children.

Dispense in a tight container with a child-resistant closure.

Pharmacist: Include one “Patient Information” leaflet with each prescription.
DURAMED PHARMACEUTICALS, INC., Subsidiary of Barr Pharmaceuticals, Inc. Pomona, New York 10970
Revised APRIL 2007 FDA rev date: 4/23/2007

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