Minastrin 24 Fe
"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Minastrin 24 Fe
There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
Do not prescribe Minastrin 24 Fe to women who are known to have the following conditions:
- A high risk of arterial or venous thrombotic diseases.
Examples include women who are known to:
- Smoke, if over age 35 [see
- Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS]
- BOXED WARNING and 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 aura
- All women over age 35 with migraine headaches [see WARNINGS AND PRECAUTIONS]
- Liver tumors, benign or malignant, or liver disease [see WARNINGS AND PRECAUTIONS]
- Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS]
- Pregnancy, because there is no reason to use COCs during pregnancy [see WARNINGS AND PRECAUTIONS and Use in Specific Populations]
- Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see WARNINGS AND PRECAUTIONS]
Last reviewed on RxList: 5/6/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Minastrin 24 Fe Information
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.
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