"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Overdosage may cause nausea, and withdrawal bleeding may occur in females. Serious ill effects have not been reported following acute ingestion of large doses of estrogen/progestin-containing oral contraceptives by young children. In the event of a possible overdosage, the system should be removed immediately and medical attention sought.
CombiPatch (estradiol, norethindrone acetate transdermal system) should not be used in women under any of the following conditions:
3. Known or suspected estrogen-dependent neoplasia
7. CombiPatch (estradiol, norethindrone acetate transdermal system) should not be used in patients with known hypersensitivity to its ingredients.
8. Known or suspected pregnancy. There is no indication for CombiPatch (estradiol, norethindrone acetate transdermal system) in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy (see PRECAUTIONS.)
Last reviewed on RxList: 10/5/2006
This monograph has been modified to include the generic and brand name in many instances.
Additional CombiPatch Information
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