Lo Loestrin Fe
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) provides an oral contraceptive regimen consisting of 24 blue active tablets and 2 white active tablets that contain the active ingredients specified for each tablet below, followed by 2 non-hormonal placebo tablets:
- 24 blue, round tablets each containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol
- 2 white, hexagonal tablets each containing 10 mcg ethinyl estradiol
- 2 brown, round tablets each containing 75 mg ferrous fumarate
Each blue tablet also contains the inactive ingredients mannitol, microcrystalline cellulose, FD&C Blue No. 1 Aluminum Lake, sodium starch glycolate, magnesium stearate, povidone, vitamin E and lactose monohydrate.
Each white tablet also contains the inactive ingredients mannitol, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, povidone, vitamin E and lactose monohydrate.
Each brown tablet contains ferrous fumarate, mannitol, povidone, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, sucralose and spearmint flavor. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay.
The empirical formula of ethinyl estradiol is C20H24O2 and the structural formula is:
The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-].
The empirical formula of norethindrone acetate is C22H28O3 and the structural formula is:
The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-].
Sources
Lo Loestrin Fe Manufacturers
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Warner Chilcott (Us), Llc
![Lo Loestrin Fe (Norethindrone Acetate And Ethinyl Estradiol, Ethinyl Estradiol And Ferrous Fumarate) Kit [Warner Chilcott (Us), Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lo Loestrin Fe | Warner Chilcott (us), Llc
2.1 How to Take Lo Loestrin FeTo achieve maximum contraceptive effectiveness, Lo Loestrin Fe must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed pills, see FDA-Approved Patient Labeling. Lo Loestrin Fe tablets may be administered without regard to meals [see Clinical Pharmacology (12.3)].
2.2 How to Start Lo Loestrin FeInstruct the patient to begin taking Lo Loestrin Fe on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding) [see FDA-Approved Patient Labeling]. One blue tablet should be taken daily for 24 consecutive days, followed by one white tablet daily for 2 consecutive days, followed by one brown tablet daily for 2 consecutive days. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Lo Loestrin Fe other than on the first day of her menstrual cycle.
For postpartum women who do not breastfeed or after a second trimester abortion, Lo Loestrin Fe may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When COCs are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered [see Warnings and Precautions (5.1)]. The possibility of ovulation and conception before starting COCs should also be considered.
Lo Loestrin Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Lo Loestrin Fe immediately, additional contraceptive measures are not needed.
2.3 Switching from another Hormonal Method of ContraceptionIf the patient is switching from a combination hormonal method such as:
○ Another pill
○ Vaginal ring
○ Patch
Instruct her to take the first blue tablet on the day she would have taken her next COC pill. She should not continue taking the tablets from her previous birth control pack, and should not skip any days between packs. If she does not have a withdrawal bleed, rule out pregnancy before starting Lo Loestrin Fe. If she previously used a vaginal ring or transdermal patch, she should start using Lo Loestrin Fe on the day she would have resumed the previous product.If the patient is switching from a progestin-only method such as a:
○ Progestin-only pill
○ Implant
○ Intrauterine system
○ Injection
Instruct her to take the first blue tablet on the day she would have taken her next progestin-only pill, or had her next injection or on the day of removal of her implant. If switching from an IUD, depending on the timing of removal, back-up contraception may be needed. 2.4 Advice in Case of Gastrointestinal DisturbancesIf the patient vomits or has diarrhea (within 3 to 4 hours after she takes a blue or white pill), she should follow the instructions in the “What to Do if You Miss Pills” section [see FDA-Approved Patient Labeling].
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