Contraindicated with known hypersensitivity to components of drug (hydroxyprogesterone, castor oil, benzyl benzoate, benzyl alcohol); history of thrombosis or thromboembolic disorders; known or suspected breast cancer or other hormone-sensitive cancer; undiagnosed abnormal vaginal bleeding; cholestatic jaundice of pregnancy; liver tumors, active liver disease; uncontrolled hypertension.

Use cautiously with prediabetic or diabetic states, pre-eclampsia, cardiac or renal dysfunction, clinical depression, lactation, seizure disorder.