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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 anti-mineralocorticoid 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: 6/22/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Safyral Information
Safyral - User Reviews
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