Limited information in patients w/ severe & clinically unstable concomitant disease (eg, liver, CV or lung disease, neurological or psychiatric disorders, cancer or AIDS & other endocrine disorders). Efficacy of OCs may be reduced in case of severe diarrhea & use of additional contraception is recommended. Monitor all patients for persistent worsening of depression or emergence of suicidal thoughts & behavior. Patients w/ renal impairment. Women of childbearing potential should use effective contraception during treatment. Not recommended during pregnancy & breast-feeding. Not recommended in childn & adolescents <18 yr.