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Duavee

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Duavee

INDICATIONS

DUAVEE is indicated in women with a uterus for:

Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause

Prevention of Postmenopausal Osteoporosis

Important Limitations of Use

  • Use DUAVEE for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
  • When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.

DOSAGE AND ADMINISTRATION

Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause

The recommended dosage is one DUAVEE tablet daily.

Prevention of Postmenopausal Osteoporosis

The recommended dosage is one DUAVEE tablet daily.

General Dosing Information

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

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.

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.

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 and CLINICAL PHARMACOLOGY].

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.

HOW SUPPLIED

Dosage Forms And Strengths

DUAVEE (conjugated estrogens/bazedoxifene) tablets, 0.45 mg/20 mg are oval, biconvex, pink tablets, branded with “0.45/20” in black ink on one side.

Storage And Handling

DUAVEE tablets contain 0.45 mg conjugated estrogens and 20 mg bazedoxifene. The tablets are oval, biconvex, and pink, branded with “0.45/20” in black ink on one side.

DUAVEE® tablets are supplied as follows:

  Package NDC number
Conjugated estrogens 0.45 mg/bazedoxifene 20 mg 2 blisters of 15 tablets each NDC 0008-1123-12

Storage

Blisters

DUAVEE tablets should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Dispense product in the original package. Tablets should not be removed from blisters until immediately before use. Protect from moisture. After opening foil pouch, product must be used within 60 days.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Distributed by: Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., A subsidiary of Pfizer Inc Philadelphia, PA 19101. Revised October 2013

Last reviewed on RxList: 11/7/2013
This monograph has been modified to include the generic and brand name in many instances.

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