Loestrin fe how does it work
Uncontrolled dyslipidemias. 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. Create a personalised content profile. Measure ad performance. Select basic ads.
Create a personalised ads profile. Select personalised ads. Apply market research to generate audience insights. Measure content performance. Develop and improve products. List of Partners vendors. Lo Loestrin Fe is a combination birth control pill that contains a low dose of ethinyl estradiol , a synthetic form of the hormone estrogen, and norethindrone acetate, a synthetic form of progesterone, also known as progestin.
Lo Loestrin Fe provides effective contraception with the lowest dose of estrogen possible, which may reduce side effects, especially in perimenopausal women. Lo Loestrin Fe is used to prevent pregnancy. When you choose to use Lo Loestrin Fe for contraception, you may experience some benefits beyond preventing pregnancy, including:. Discuss your birth control options with your healthcare provider if weight is an issue for you. Women over 35 who smoke cigarettes should not use Lo Loestrin Fe due to the increased risk for heart attack, blood clots, and stroke.
Your risk increases due to age as well as the number of cigarettes you smoke each day. People with liver disease, breast cancer, and another estrogen- or progesterone-sensitive cancers should not use Lo Loestrin Fe. How do I take Lo Loestrin Fe? When can I start taking Lo Loestrin Fe? If you are starting a hormonal birth control pill for the first time: Take the first blue pill of the first pack during the first 24 hours of your period.
You will not need to use a backup method of birth control because you are starting the pill at the beginning of your period. However, if you start on a day other than the first day of your period, or if you start after having a baby and you have not yet had a period, use a backup method of birth control, such as a condom and spermicide, until you have taken a blue pill for 7 days in a row. After taking the last brown pill Day 28 of the blister pack, start taking the blue pill from a new blister pack the very next day whether or not you have your period.
You should not skip any days between packs. Learn more about starting or switching to Lo Loestrin Fe. What if I want to become pregnant? What are the most serious risks of taking Lo Loestrin Fe? What are the most common side effects of Lo Loestrin Fe? Does Lo Loestrin Fe affect weight or cause anxiety or depression? What should I know about my period when taking Lo Loestrin Fe? What if I miss my scheduled period when taking Lo Loestrin Fe?
What should I do if I miss any pills? Take the next pill at your regular time. This means you may take 2 pills in 1 day You do not need to use a backup birth control method if you have sex If you MISS 2 blue pills in a row in WEEK 1 or WEEK 2 of your pack: Take 2 pills on the day you remember and 2 pills the next day Then take 1 pill a day until you finish the pack You could become pregnant if you have sex during the 7 days after you restart your pills.
You MUST use a non-hormonal birth control method, such as a condom and spermicide, as a backup for those 7 days after you restart your pills If you MISS 2 blue or white pills in a row in WEEK 3 or WEEK 4 of your pack: Throw out the rest of the pill pack and start a new pack that same day You may not have your period this month but this is normal.
If you miss your period 2 months in a row, call your healthcare provider because you might be pregnant You could become pregnant if you have sex during the 7 days after you restart your pills. You MUST use a non-hormonal birth control method, such as a condom and spermicide, as a backup for those 7 days after you restart your pills If you MISS 3 or MORE blue or white pills in a row at any time: Throw out the rest of the pill pack and start a new pack that same day You may not have your period this month but this is normal.
If you miss your period 2 months in a row, call your healthcare provider because you might be pregnant You could become pregnant if you have sex on the days when you missed pills or during the first 7 days after restarting your pills. You MUST use a non-hormonal birth control method, such as a condom and spermicide, as a backup method the next time you have sex and for the first 7 days after you restart your pills If you are not sure of what to do about the pills you have missed, you should call your healthcare provider.
What else should I know about taking Lo Loestrin Fe? What are the possible side effects of Lo Loestrin Fe?
Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Carefully monitor prediabetic and diabetic women who are taking Lo Loestrin Fe.
COCs may decrease glucose tolerance in a dose-related fashion. Consider alternative contraception for women with uncontrolled dyslipidemias. A small proportion of women will have adverse lipid changes while on COCs. Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs. If a woman taking Lo Loestrin Fe develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Lo Loestrin Fe if indicated.
An increase in frequency or severity of migraine during COC use which may be prodromal of a cerebrovascular event may be a reason for immediate discontinuation of the COC. Unscheduled breakthrough or intracyclic bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use.
If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC. A total of 1, women In the clinical trial with Lo Loestrin Fe, the incidence of amenorrhea increased from 32 percent in Cycle 1 to 49 percent by Cycle If scheduled withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule missed one or more active tablets or started taking them on a day later than she should have , consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures.
If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Some women may experience amenorrhea or oligomenorrhea after stopping COCs, especially when such a condition was preexistent. Extensive epidemiologic studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy.
Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy.
Lo Loestrin Fe use should be discontinued if pregnancy is confirmed. Administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy [see Use in Specific Populations 8. Women with a history of depression should be carefully observed and Lo Loestrin Fe discontinued if depression recurs to a serious degree.
The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid binding globulin increase with use of COCs. A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking COCs. The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. A multicenter phase 3 clinical trial evaluated the safety and efficacy of Lo Loestrin Fe for pregnancy prevention.
The study was a one year, open-label, single-arm, uncontrolled study. A total of 1, women aged 18 to 45 were enrolled and took at least one dose of Lo Loestrin Fe [ s ee Clinical Studies 14 ]. Adverse Reactions Leading to Study Discontinuation : Serious Adverse Reactions : deep vein thrombosis, ovarian vein thrombosis, cholecystitis.
If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives or increase breakthrough bleeding.
Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include:. HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors : Significant changes increase or decrease in the plasma levels of the estrogen and progestin have been noted in some cases of co-administration of HIV protease inhibitors or of non-nucleoside reverse transcriptase inhibitors.
Antibiotics : There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.
Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Co-administration of atorvastatin and certain COCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20 percent. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.
COCs containing some synthetic estrogens for example, ethinyl estradiol may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations. There is no use for contraception in pregnancy; therefore, Lo Loestrin Fe should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects including cardiac anomalies and limb reduction defects following exposure to combined hormonal contraceptives CHCs before conception or during early pregnancy.
In the U. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects including cardiac anomalies and limb-reduction defects following exposure to CHCs before conception or during early pregnancy.
CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding. Safety and efficacy of Lo Loestrin Fe have been established in women of reproductive age.
Safety and efficacy are expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated. Lo Loestrin Fe has not been studied in postmenopausal women and is not indicated in this population. The pharmacokinetics of Lo Loestrin Fe has not been studied in subjects with renal impairment. No studies have been conducted to evaluate the effect of hepatic impairment on the disposition of Lo Loestrin Fe.
However, steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded [ s ee Contraindications 4 and Warnings and Precautions 5. 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. 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:.
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 C 20 H 24 O 2 and the structural formula is:. The empirical formula of norethindrone acetate is C 22 H 28 O 3 and the structural formula is:.
Norethindrone acetate is deacetylated to norethindrone after oral administration, and the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone. Norethindrone acetate and ethinyl estradiol are absorbed from Lo Loestrin Fe, with maximum plasma concentrations of norethindrone and ethinyl estradiol generally occurring 1 to 2 hours postdose. Both are subject to first-pass metabolism after oral dosing, resulting in an absolute bioavailability of approximately 64 percent for norethindrone and 55 percent for ethinyl estradiol.
Ethinyl estradiol bioavailability from Lo Loestrin Fe tablets containing 10 mcg ethinyl estradiol alone is equivalent to that from an ethinyl estradiol solution.
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