If you are:
FDB Only When Necessary: NOT INDICATED DURING PREGNANCY; NO KNOWN DEV TOX WITH EXPOSURE DURING PREGNANCY
No Known Risk: HUMAN DATA INDICATE NO KNOWN ADVERSE EFFECT ON NURSING INFANT
Precaution: MAY DECREASE QUANTITY AND QUALITY OF BREASTMILK.
An adult over 60:
management or monitoring precaution: Neuro/Psych-The Women's Health Initiative Memory Study demonstrated an increased relative risk (2.05, 95% CI) of probable dementia in the elderly when used in combination with estrogens.
management or monitoring precaution: General-Use lowest possible dose for shortest duration and in combination with a progestin as indicated to reduce the risk of endometrial hyperplasia and breast cancer. Cardiovascular-May increase risk for thromboembolic events. Avoid use in patients with known, suspected, or history of arterial or venous thromboembolic disease. Neuro/Psych-May increase the risk for dementia.
Giving Premphase to a child under 12:
management or monitoring precaution: May cause premature epiphyseal closure. Limited information for inducing puberty. Monitor growth in patient with bone immaturity.
management or monitoring precaution: Safety and efficacy not established.