"Today, the U.S. Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013 order of the Uni"...
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.
Additional Safyral Information
Safyral - User Reviews
Safyral User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.