There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

DRSP is a spironolactone analogue which has antimineralocorticoid properties. Serum concentration of potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose.

Levomefolate calcium doses of 17 mg/day (37-fold higher than the levomefolate calcium dose of Safyral) were well tolerated after long-term treatment up to 12 weeks.

Do not prescribe Safyral to women who are known to have the following:

• Renal impairment
• Adrenal insufficiency
• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
  • Smoke, if over age 35 [see BOXED WARNING and WARNINGS AND PRECAUTIONS ]
  • Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS]
  • Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS]
  • Have coronary artery disease [see WARNINGS AND PRECAUTIONS]
  • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS]
  • Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS]
  • Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS]
  • Have diabetes mellitus with vascular disease [see WARNINGS AND PRECAUTIONS]
  • Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see WARNINGS AND PRECAUTIONS]
• Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS]
• Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see WARNINGS AND PRECAUTIONS]
• Liver tumor (benign or malignant) or liver disease [see WARNINGS AND PRECAUTIONS and Use In Specific Populations]
• Pregnancy, because there is no reason to use COCs during pregnancy [see WARNINGS AND PRECAUTIONS and Use in Specific Populations]

Last reviewed on RxList: 4/20/2012
This monograph has been modified to include the generic and brand name in many instances.