Lo Minastrin Fe
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Questions & Answers
Side Effects & Adverse Reactions
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Lo Minastrin Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)].
The efficacy of Lo Minastrin Fe in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
History
There is currently no drug history available for this drug.
Other Information
Lo Minastrin Fe (norethindrone acetate and ethinyl estradiol chewable tablets, ethinyl estradiol tablets and ferrous fumarate tablets) provides an oral contraceptive regimen consisting of 24 blue, mint-flavored active chewable tablets and 2 white active tablets that contain the active ingredients, followed by 2 brown non-hormonal placebo tablets as specified below:
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- 24 blue, round chewable tablets (active) imprinted with “WC” on one side and “537” on the other and each containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol
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- 2 white, hexagonal tablets (active) imprinted with “WC” on one side and “422” on the other and each containing 10 mcg ethinyl estradiol
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- 2 brown, round tablets (non-hormonal placebo) imprinted with “WC” on one side and “624” on the other and each containing 75 mg ferrous fumarate
Each blue, active chewable tablet also contains the inactive ingredients mannitol, microcrystalline cellulose, FD&C Blue No. 1 Aluminum Lake, sodium starch glycolate, magnesium stearate, povidone, vitamin E, lactose monohydrate, spearmint flavor and sucralose.
Each white active tablet also contains the inactive ingredients mannitol, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, povidone, vitamin E and lactose monohydrate.
Each brown placebo 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 do not meet USP criteria for dissolution and assay.
The chemical name of ethinyl estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol, (17α). The empirical formula of ethinyl estradiol is C20H24O2 and the structural formula is:
The chemical name of norethindrone acetate is 19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α). The empirical formula of norethindrone acetate is C22H28O3 and the structural formula is:
Sources
Lo Minastrin Fe Manufacturers
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Warner Chilcott (Us), Llc
![Lo Minastrin 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 Minastrin Fe | Warner Chilcott (us), Llc
2.1 How to Take Lo Minastrin FeTo achieve maximum contraceptive effectiveness, Lo Minastrin Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The blue tablet should be chewed and swallowed. The patient should drink a full glass (8 ounces) of water immediately after chewing and swallowing the blue tablet. The white tablet and the brown tablet are swallowed. 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 tablets [see FDA-approved patient labeling]. Lo Minastrin Fe may be administered without regard to meals [see Clinical Pharmacology (12.3)].
2.2 How to Start Lo Minastrin FeInstruct the patient to begin taking Lo Minastrin 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 Minastrin 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 Minastrin 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 Minastrin Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Lo Minastrin 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:
o Another pill o Vaginal ring o 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 Minastrin Fe.
• If she previously used a vaginal ring or transdermal patch, she should start using Lo Minastrin Fe on the day she would have resumed the previous product.
o Progestin-only pill o Implant o Intrauterine system o Injection
If the patient is switching from a progestin-only method such as a:• She may switch any day from a progestin-only pill; instruct her to take the first blue tablet on the day she would have taken her next progestin-only pill.
• If switching from an implant or injection, start the first blue tablet on the day her next injection would have been due 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 tablet), she should follow the instructions in the “What to Do if You Miss Tablets” section [see FDA-approved patient labeling].
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