17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information).
17.1 Instructions for Patients
- Keep DUAVEE in the original container to protect from moisture. Do not place DUAVEE in pill boxes or pill organizers.
- If more than one blister package is dispensed to the patient, instruct them to open one foil pouch at a time.
- Instruct patient to record the date the blister package is opened in the space provided on the blister package label. Do not use if the blister package has been open more than 60 days.
- Instruct patient to remove only one tablet from the blister package at the time of use.
17.2 Venous Thromboembolic Events
Advise patients to immediately report to their physician any signs or symptoms related to venous thrombosis and thromboembolic events [see Warnings and Precautions (5.2)].
17.3 Abnormal Vaginal Bleeding
Inform postmenopausal women of the importance of reporting abnormal vaginal bleeding to their healthcare provider as soon as possible [see Warnings and Precautions (5.3)].
17.4 Possible Serious Adverse Reactions with Estrogen Therapy
Inform postmenopausal women of possible serious adverse reactions of estrogen therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [see Warnings and Precautions (5.2, 5.3, 5.4)].