DUAVEE® Dosage and Administration

(conjugated estrogens/bazedoxifene)

2 DOSAGE AND ADMINISTRATION

2.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause

The recommended dosage is one DUAVEE tablet daily.

2.2 Prevention of Postmenopausal Osteoporosis

The recommended dosage is one DUAVEE tablet daily.

2.3 General Dosing Information

Take DUAVEE once daily, without regard to meals. Tablets should be swallowed whole.

2.4 Recommendations for Calcium and Vitamin D Supplementation

Women taking DUAVEE for prevention of postmenopausal osteoporosis should add supplemental calcium and/or vitamin D to their diet if daily intake is inadequate.

2.5 Administration Instructions for Missed Doses

If a dose of DUAVEE is missed, instruct patients to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time.

2.6 Use in Patients with Renal Impairment

The pharmacokinetics of DUAVEE have not been evaluated in patients with renal impairment. Use in patients with renal impairment is not recommended [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

2.7 Use in the Elderly

DUAVEE has not been studied in women over 75 years of age. Use in women over 75 years of age is not recommended.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause

The recommended dosage is one DUAVEE tablet daily.

2.2 Prevention of Postmenopausal Osteoporosis

The recommended dosage is one DUAVEE tablet daily.

2.3 General Dosing Information

Take DUAVEE once daily, without regard to meals. Tablets should be swallowed whole.

2.4 Recommendations for Calcium and Vitamin D Supplementation

Women taking DUAVEE for prevention of postmenopausal osteoporosis should add supplemental calcium and/or vitamin D to their diet if daily intake is inadequate.

2.5 Administration Instructions for Missed Doses

If a dose of DUAVEE is missed, instruct patients to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time.

2.6 Use in Patients with Renal Impairment

The pharmacokinetics of DUAVEE have not been evaluated in patients with renal impairment. Use in patients with renal impairment is not recommended [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

2.7 Use in the Elderly

DUAVEE has not been studied in women over 75 years of age. Use in women over 75 years of age is not recommended.

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