Norethindrone concentrations more than double by Day 24 due to both accumulation and increased SHBG concentration. Steady state with respect to ethinyl estradiol and norethindrone is reached by Day 5 and Day 13, respectively.
Figure 1. Figure 2. Food Effect : Lo Loestrin Fe tablets may be administered without regard to meals. Administration of food with a single-dose of a Lo Loestrin Fe combination tablet did not affect the maximum concentration of norethindrone and increased the extent of absorption by 24 percent; it decreased the maximum concentration of ethinyl estradiol by 23 percent and did not affect the extent of absorption.
Administration of food with a single-dose of a Lo Loestrin Fe ethinyl estradiol alone tablet decreased the maximum concentration of ethinyl estradiol by 31 percent and did not affect the extent of absorption. Metabolism Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites.
A small amount of norethindrone acetate is metabolically converted to ethinyl estradiol. Ethinyl estradiol is also extensively metabolized, both by oxidation and by conjugation with sulfate and glucuronide. Sulfates are the major circulating conjugates of ethinyl estradiol and glucuronides predominate in urine.
The primary oxidative metabolite is 2-hydroxy ethinyl estradiol, formed by the CYP3A4 isoform of cytochrome P Part of the first-pass metabolism of ethinyl estradiol is believed to occur in gastrointestinal mucosa. Ethinyl estradiol may undergo enterohepatic circulation. Excretion Norethindrone and ethinyl estradiol are excreted in both urine and feces, primarily as metabolites. Plasma clearance values for norethindrone and ethinyl estradiol are similar approximately 0.
Specific populations The pharmacokinetics of Lo Loestrin Fe in presence of renal or hepatic impairment has not been evaluated [see Use in Specific Populations 8. In a one year thirteen day cycles multicenter open-label clinical trial, 1, women 18 to 35 years of age, were studied to assess the efficacy of Lo Loestrin Fe, completing the equivalent of 12, day evaluable cycles of exposure. The racial demographic of all enrolled women was: Caucasian The weight range for those women treated was 89 to lbs.
Among the women in the trial, 51 percent had not used hormonal contraception immediately prior to enrolling in this study. Of treated women, The pregnancy rate Pearl Index [PI] in women 18 to 35 years of age was 2. Cycles in which conception did not occur, but which included the use of backup contraception, were not included in the calculation of the PI.
The PI includes women who did not take the drug correctly. See www. All rights reserved. Guide for Using Lo Loestrin Fe.
Birth control pills help to lower the chances of becoming pregnant when taken as directed. Lo Loestrin Fe is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called norethindrone acetate. How well does Lo Loestrin Fe work? Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant. Based on the results of one clinical study, about 2 to 4 out of women may get pregnant during the first year they use Lo Loestrin Fe.
If you are overweight, discuss with your healthcare provider whether Lo Loestrin Fe is the best choice for you. The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
Decide what time of day you want to take your pill. It is important to take it at the same time every day. The pill pack also has 2 "reminder" brown pills without hormones for the last part of Week 4.
Birth control pills may not be as effective if you miss any blue or white pills, especially if you miss the first few or the last few blue pills in a pack. If you miss ONE blue pill , follow these steps :. If you miss TWO pills blue or white in a row in W eek 3 or Week 4 of your pack , follow these steps :. If you forget either of the 2 brown "reminder" pills in Week 4 , follow these steps :. I f you are still not sure what to do about the pills you have missed:.
Birth control pills may not be a good choice for you if you have ever had jaundice yellowing of the skin or eyes caused by pregnancy, also called cholestasis of pregnancy. Tell your healthcare provider if you have ever had any of the above conditions your healthcare provider may recommend another method of birth control. What else should I know about taking Lo Loestrin Fe?
If you miss a period, you could be pregnant. However, some women miss periods or have light periods on birth control pills, even when they are not pregnant. Contact your healthcare provider for advice if you:. Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects. You should stop Lo Loestrin Fe at least four weeks before you have surgery and not restart it until at least two weeks after the surgery, due to an increased risk of blood clots.
If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Lo Loestrin Fe, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk. Tell your healthcare provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including:. Consider using another birth control method when you take medicines that may make birth control pills less effective.
Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine. If you have vomiting or diarrhea, your birth control pills may not work as well.
Use another birth control method, like a condom and spermicide, until you check with your healthcare provider. If you are scheduled for any laboratory tests, tell your healthcare provider that you are taking birth control pills. Certain blood tests may be affected by birth control pills. What are the most serious risks of taking Lo Loestrin Fe?
Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke.
This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.
Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones. Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners. What should I know about my period when taking Lo Loestrin Fe? When you take Lo Loestrin Fe you may have bleeding and spotting between periods, called unscheduled bleeding.
Approximately half of the women who use Lo Loestrin Fe have unscheduled bleeding or spotting in the first months of use, and about one-third of users continue to have unscheduled bleeding or spotting after one year of use.
If the unscheduled bleeding or spotting is heavy or lasts for more than a few days, you should discuss this with your healthcare provider. What if I miss my scheduled period when taking Lo Loestrin Fe? It is not uncommon to miss your period. However, if you go two or more months in a row without a period, or you miss your period after a month where you did not take all your pills correctly, call your healthcare provider because you may be pregnant.
Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking Lo Loestrin Fe if you are pregnant. You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill. Your healthcare provider prescribed Lo Loestrin Fe for you. Please do not share Lo Loestrin Fe with anyone else.
Keep Lo Loestrin Fe out of the reach of children. If you have concerns or questions, ask your healthcare provider. You may also ask your pharmacist for a more detailed label written for healthcare professionals. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.
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We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. View Package Photos. Drug Label Info. Check with your pharmacist for your copay discount. Maximum savings limits apply; patient out-of-pocket expense will vary.
This offer is not valid for use by patients enrolled in Medicare, Medicaid, or other federal or state programs including any state pharmaceutical assistance programs , or private indemnity or HMO insurance plans that reimburse you for the entire cost of your prescription drugs. Patients may not use this offer if they are Medicare-eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees.
This offer is not valid for cash-paying patients. Each card is valid for up to thirteen 13 prescription fills of a day supply each OR up to four 4 prescription fills of an day supply each.
This card is not transferable. The selling, purchasing, trading, or counterfeiting of this card is prohibited by law. This card has no cash value and may not be used in combination with any other discount, coupon, rebate, free trial, or similar offer for the specified prescription.
By redeeming this card, you acknowledge that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer. For questions about the program, including savings on mail order prescriptions, please call 1. When you redeem this card, you certify that you have not submitted and will not submit a claim for reimbursement under any federal, state, or other government programs for this prescription.
Reimbursement will be received from Change Healthcare. Lo Loestrin Fe norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets is a prescription birth control pill used for the prevention of pregnancy.
Register online. Gallbladder disease. Pregnancy-related cholestasis. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Do regular complete physical exams. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use see full labeling. Pregnancy: do not use. Postmenopausal women, nursing mothers: not recommended. See Contraindications.
May be antagonized by CYP3A4 or other enzyme inducers eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St.
May be potentiated by atorvastatin, acetaminophen, ascorbic acid, or CYP3A4 inhibitors eg, itraconazole, ketoconazole.
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