PREMPRO or PREMPHASE therapy is indicated in women who have a uterus for the:

1. Treatment of moderate to severe vasomotor symptoms due to menopause.
2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
3. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See Clinical Studies)

The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and Vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.

Use of estrogens, 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 reevaluated periodically as clinically appropriate (for example at 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.

PREMPRO therapy consists of a single tablet to be taken once daily.

1. For treatment of moderate to severe vasomotor symptoms and/or moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of moderate to severe vulvar and vaginal atrophy, topical vaginal products should be considered.

• PREMPRO 0.3 mg/1.5 mg
• PREMPRO 0.45 mg/1.5 mg
• PREMPRO 0.625 mg/2.5 mg
• PREMPRO 0.625 mg/5 mg
• PREMPHASE

Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg/1.5 mg PREMPRO daily. Subsequent dosage adjustment may be made based upon the individual patient response. In patients where bleeding or spotting remains a problem, after appropriate evaluation, consideration should be given to changing the dose level. This dose should be periodically reassessed by the healthcare provider.

2. For prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should be considered only for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate.

• PREMPRO 0.3 mg/1.5 mg
• PREMPRO 0.45 mg/1.5 mg
• PREMPRO 0.625 mg/2.5 mg
• PREMPRO 0.625 mg/5 mg
• PREMPHASE

Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg/1.5 mg PREMPRO daily. Dosage may be adjusted depending on individual clinical and bone mineral density responses. This dose should be periodically reassessed by the healthcare provider.

In patients where bleeding or spotting remains a problem, after appropriate evaluation, consideration should be given to changing the dose level. This dose should be periodically reassessed by the healthcare provider.

PREMPHASE therapy consists of two separate tablets; one maroon 0.625 mg Premarin tablet taken daily on days 1 through 14 and one light-blue tablet, containing 0.625 mg conjugated estrogens and 5 mg of medroxyprogesterone acetate, taken on days 15 through 28.

PREMPRO therapy consists of a single tablet to be taken once daily.

PREMPRO 0.3 mg/1.5 mg

Each carton contains 3 EZ DIAL® dispensers containing 28 tablets. One EZ DIAL dispenser contains 28 oval, cream tablets containing 0.3 mg of the conjugated estrogens found in Premarin tablets and 1.5 mg medroxyprogesterone acetate for oral administration (NDC 0046-0938-09).

PREMPRO 0.45 mg/1.5 mg

Each carton includes 3 EZ DIAL dispensers containing 28 tablets. One EZ DIAL dispenser contains 28 oval, gold tablets containing 0.45 mg of the conjugated estrogens found in Premarin tablets and 1.5 mg medroxyprogesterone acetate for oral administration (NDC 0046-0937-09).

PREMPRO 0.625 mg/2.5 mg

Each carton includes 3 EZ DIAL dispensers containing 28 tablets. One EZ DIAL dispenser contains 28 oval, peach tablets containing 0.625 mg of the conjugated estrogens found in Premarin tablets and 2.5 mg of medroxyprogesterone acetate for oral administration (NDC 0046- 0875-06).

PREMPRO 0.625 mg/5 mg

Each carton includes 3 EZ DIAL dispensers containing 28 tablets. One EZ DIAL dispenser contains 28 oval, light-blue tablets containing 0.625 mg of the conjugated estrogens found in Premarin tablets and 5 mg of medroxyprogesterone acetate for oral administration (NDC 0046- 0975-06).

PREMPHASE therapy consists of two separate tablets; one maroon Premarin tablet taken daily on days 1 through 14 and one light-blue tablet taken on days 15 through 28.

Each carton includes 1 blister pack containing 28 tablets. One blister pack contains 14 oval, maroon Premarin tablets containing 0.625 mg of conjugated estrogens and 14 oval, light-blue tablets that contain 0.625 mg of the conjugated estrogens found in Premarin tablets and 5 mg of medroxyprogesterone acetate for oral administration (NDC 0046-2579-11).

The appearance of PREMPRO tablets is a trademark of Wyeth Pharmaceuticals.

The appearance of PREMARIN tablets is a trademark of Wyeth Pharmaceuticals. The appearance of the conjugated estrogens/medroxyprogesterone acetate combination tablets is a registered trademark.

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101. Rev March 2008. FDA rev date: 3/3/2008

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