Ferrous Fumarate (8 brand names, 1 dosage form, 2 routes)
Available dosage forms: TABLET.
Routes of administration: ORAL-28, ORAL.
Brand Names
- FERROUS FUMARATE
- LO-BLISOVI FE
- LO/OVRAL FE
- NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; FERROUS FUMARATE
- NORLESTRIN FE 1/50
- NORLESTRIN FE 2.5/50
- NORMINEST FE
- NORQUEST FE
Boxed Warning
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC ) use. This risk increases with age , particularly in women over 35 years of age , and with the number of cigarettes smoked . For this reason, COCs should not be used by w omen who are over 35 years of age and smoke [ see Contraindications (4) ] .
Indications and Usage
Lo Loestrin® Fe is indicated for use by women to prevent pregnancy [ see Clinical Studies (14) ]. The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.
Contraindications
Lo Loestrin Fe is contraindicated in females who are known to have or develop 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 Boxed Warning and Warnings and Precautions (5.1) ] • Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ] • Have cerebrovascular disease [see Warnings and Precautions (5.1) ] • Have coronary artery disease [see Warnings and Precautions (5.1) ] • 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 (5.1) ] • Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] • Have uncontrolled hypertension [see Warnings and Precautions (5.5) ] • Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.7) ] • Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.8) ] Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.2) ] Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.3) ] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9) ] Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.4) ].
Adverse Reactions
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and smoking [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.3) ] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache
Drug Interactions
No drug-drug interaction studies were conducted with Lo Loestrin Fe.
Mechanism of Action
CHCs prevent pregnancy primarily by suppressing ovulation.
Overdosage
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.