Levonorgestrel + ethinyl estradiol

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Generic for Fayosim

ID: 00378731685

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LEVONORGESTREL ETHINYL ESTRADIOL 015 MG 20 MCG 25 MCG 30 MCG 10 MCG TABLET 0378731685

📜 Prescription Required

FORM

Tablet

STRENGTH

0.15 mg/20 mcg-25 mcg-30 mcg-10 mcg

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TL;DR — Quick Summary

Key facts from the full medication guide below

RECENT MAJOR CHANGES SECTION WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS SPL UNCLASSIFIED SECTION 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION

🩺What it's for

Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.

💊How to take it

Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack.

ℹ️Common side effects

Hyperglycemia Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in diabetic women over age 35, or females who have diabetes with hypertension, nephropathy, retinopathy, neuropathy, other vascular disease, or females with diabetes of > 20 years duration [see Contraindications (4)]. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets may decrease glucose tolerance.

⚠️Serious risks

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in women over 35 years old who smoke. (4) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.

📋Interactions & cautions

Enzyme inducers (e.g., CYP3A4): May decrease the effectiveness of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets.

📦Storage & missed dose

How Supplied Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP are available as round, unscored, biconvex tablets, packaged in an Extended-Cycle Tablet Blister Pack, each containing a 13-week supply of the tablets in the following order: 42 white to off-white tablets, each containing 0.15 mg of levonorgestrel and 0.02 mg ethinyl estradiol: debossed with 72 on one side of the tablet and plain on the other side 21 light peach tablets containing 0.15 mg of… Table 1. Instructions for Missed Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets If one white to off-white, light peach, bluish green tablet is missed Take the missed tablet as soon as possible. Take the next tablet at the regular time. Continue taking one tablet a day until the pack is finished. A back-up birth control method is not required if the patient has sex.

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Begin levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first white to off-white tablet that day. For each 91-day course, take in the following order: 1.Start the first white to off-white tablet on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Then take one white to off-whitetablet once daily for a total of 42 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms and spermicide) for the first 7 days of treatment. 2.One light peach tablet once daily for 21 consecutive days. 3.One bluish green tablet once daily for 21 days. 4.One yellow tablet once daily for 7 days. Bleeding should occur during yellowtablet use. Begin the next and all subsequent 91-day courses of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets without interruption on the same day of the week (Sunday) on which the first dose of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets was taken. Follow the same schedule as the initial 91-day course: white to off-white tablet once a day for 42 days, light peach tablet once daily for 21 days, bluish green tablet once daily for 21 days, and yellow tablet once daily for 7 days. If the next pill is not started immediately, use a non-hormonal back-up method of contraception until a white to off-white tablet has been taken once daily for 7 consecutive days. Switching to Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets from another oral hormonal contraceptive or from another contraceptive method (transdermal patch, vaginal ring, injection, intrauterine contraceptive, implant) Start on the Sunday after the patient s next period starts. Use additional non-hormonal contraceptive (such as condoms and spermicide) until the patient has taken 7 white to off-white pills (7 days). Starting Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets after Abortion or Miscarriage First-trimester Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets may be started on the Sunday after an abortion or miscarriage. The patient must use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a white to off-white tablet for 7 days. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start contraceptive therapy with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a white to off-white tablet for 7 days [see Contraindications (4) and Warnings and Precautions (5.1)]. Starting Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a white to off-white tablet for 7 days [see Contraindications (4) and Warnings and Precautions (5.1)]. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are not recommended for use in lactating women [see Use in Specific Populations ( 8.2)]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)].

Stop levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if an arterial or deep venous thrombotic event occurs. Stop levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. Discontinue levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets during prolonged immobilization. If feasible, stop levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets no earlier than 4 weeks after delivery, in females who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. Before starting levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females with a high risk of arterial or venous/thromboembolic diseases [see Contraindications (4)]. Arterial Events COCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and females with hypertension, dyslipidemia, diabetes, or obesity. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in women over 35 years of age who smoke [see Contraindications ( 4)]. Cigarette smoking increases the risk of serious cardiovascular events from COC use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Venous Events Use of COCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs [see Contraindications ( 4)]. While the increased risk of VTE associated with use of COCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1). The rate of VTE in females using COCs has been estimated to be 3 to 9 cases per 10,000 woman years. The risk of VTE is highest during the first year of use of a COC and when restarting hormonal contraception after a break of four weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued. Figure 1 shows the risk of developing a VTE for females who are not pregnant and do not use oral contraceptives, for females who use oral contraceptives, and for females in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 females who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these females will develop a VTE. Use of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing the same strength synthetic estrogens and progestins (an additional 9 and 13 weeks of exposure to progestin and estrogen, respectively, per year). In the clinical trial, three cases of deep vein thrombosis were reported.

Bleeding and/or spotting that occurs at any time while taking the first 84 tablets (white to off-white, light peach and bluish green) of each extended-cycle regimen is considered unscheduled bleeding/spotting. Bleeding that occurs during the time a woman takes the seven tablets (yellow) containing 0.01 mg of ethinyl estradiol is considered scheduled bleeding. Unscheduled and Scheduled Bleeding and Spotting Females using levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets may experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first 3 months of use. Bleeding irregularities may resolve over time or by changing to a different contraceptive product. If unscheduled bleeding persists or occurs after previously regular cycles on levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, evaluate for causes such as pregnancy or malignancy. When prescribing levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, consider the occurrence of fewer scheduled menses (4 per year instead of 13 per year) against the occurrence of increased unscheduled bleeding and/or spotting. A 12-month open-label study of the efficacy of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets in preventing pregnancy assessed scheduled and unscheduled bleeding [see Clinical Studies (14)] in 3,597 women who completed 34,087 28-day cycles of exposure. A total of 178 (4.9%) of the women discontinued levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, at least in part, due to bleeding and/or spotting. Scheduled (withdrawal) bleeding and/or spotting remained fairly stable over time, with an average of 3 to 4 days of bleeding and/or spotting per each 91-day cycle. Unscheduled bleeding and unscheduled spotting decreased over successive 91-day cycles. Table 2 below presents the number of days with unscheduled bleeding, spotting, and unscheduled bleeding and/or spotting in Treatment Cycles 1 to 4. Table 2. Number of Unscheduled Bleeding, Spotting and Bleeding and/or Spotting Days per 91-day Cycle Q1=Quartile 1: 25% of women had this number of days of unscheduled bleeding/spotting Median: 50% of women had this number of days of unscheduled bleeding/spotting Q3=Quartile 3: 75% of women had this number of days of unscheduled bleeding/spotting Cycle (N) Days of Unscheduled Bleeding per 84-Day Interval Median Days Per Subject-Month Mean Q1 Median Q3 1 (3330) 7.2 0 4 10 1.0 2 (2820) 3.3 0 0 4 0.0 3 (2433) 2.5 0 0 3 0.0 4 (2213) 2.2 0 0 2 0.0 Cycle (N) Days of Unscheduled Spotting per 84-Day Interval Median Days Per Subject-Month Mean Q1 Median Q3 1 (3330) 10.7 2 7 15 1.8 2 (2820) 6.7 0 3 9 0.8 3 (2433) 5.2 0 2 6 0.5 4 (2213) 4.4 0 1 5 0.3 Cycle (N) Days of Unscheduled Bleeding and/or Spotting per 84-Day Interval Median Days Per Subject-Month Mean Q1 Median Q3 1 (3330) 17.9 5 14 27 3.5 2 (2820) 10.0 1 5 14 1.3 3 (2433) 7.7 0 3 10 0.8 4 (2213) 6.6 0 3 8 0.8 Figure 2 shows the percent of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets subjects in the primary clinical trial with greater than or equal to 7 days or 20 days of unscheduled bleeding and/or spotting, or just unscheduled bleeding, during each 91-day treatment cycle. Figure 2: Percent of Women Taking Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets Who Reported Unscheduled Bleeding and/or Spotting If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider. Amenorrhea and Oligomenorrhea Females who use levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets may experience absence of scheduled (withdrawal) bleeding, even if they are not pregnant. Based on data from the clinical trial, amenorrhea occurred in approximately 1.9% of women during Cycle 1, 7.7% during Cycle 2, 10.7% during Cycle 3, and 10.1% during Cycle 4 using levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. Rule out pregnancy in the event of amenorrhea. Some women may experience amenorrhea or oligomenorrhea after stopping levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, especially if these conditions were pre-existent.

Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 3). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 3). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. Figure 3: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives RR = relative risk; OR = odds ratio; HR = hazard ratio. ever COC are females with current or past COC use; never COC use are females that never used COCs. The following adverse reactions have been identified during post-approval use of extended-cycle COCs containing levonorgestrel and ethinyl estradiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disorders: abdominal distension, vomiting General disorders and administration site conditions: chest pain, fatigue, malaise, edema peripheral, pain Immune system disorders: hypersensitivity reaction Investigations: blood pressure increased Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity Nervous system disorders: dizziness, loss of consciousness Psychiatric disorders: insomnia Reproductive and breast disorders: dysmenorrhea Respiratory, thoracic and mediastinal disorders: pulmonary embolism, pulmonary thrombosis Skin and subcutaneous tissue disorders: alopecia Vascular disorders: thrombosis

Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs: Table 3 includes substances that demonstrated an important drug interaction with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. Table 3: Significant Drug Interactions Involving Substances That Affect COCs Metabolic Enzyme Inducers Clinical effect Concomitant use of COCs with metabolic enzyme inducers may decrease the plasma concentrations of the estrogen and/or progestin component of COCs. Decreased exposure of the estrogen and/or progestin component of COCs may potentially diminish the effectiveness of COCs and may lead to contraceptive failure or an increase in breakthrough bleeding. Prevention or management Counsel females to use an alternative method of contraception or a backup method when enzyme inducers are used with COCs. Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John s worta, and certain protease inhibitors (see separate section on protease inhibitors below). Colesevelam Clinical effect Concomitant use of COCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol. Decreased exposure of the estrogen component of COCs may potentially reduce contraceptive efficacy or result in an increase in breakthrough bleeding, depending on the strength of ethinyl estradiol in the COC. Prevention or management Administer 4 or more hours apart to attenuate this drug interaction. a Induction potency of St. John s wort may vary widely based on preparation. Substances increasing the systemic exposure of COCs: Co-administration of atorvastatin or rosuvastatin and COCs containing ethinyl estradiol increase systemic exposure of ethinyl estradiol by approximately 20 to 25 percent. Ascorbic acid and acetaminophen may increase systemic exposure of ethinyl estradiol, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of COCs. Human immunodeficiency virus (HIV)/hepatitis C virus (HCV) protease inhibitors and nonnucleoside reverse transcriptase inhibitors: Significant decreases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g., boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine). In contrast, significant increases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine).

Absorption Ethinyl estradiol and levonorgestrel are absorbed with maximum plasma concentrations occurring within 2 hours after levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets administration. Levonorgestrel is completely absorbed after oral administration (bioavailability nearly 100%) and is not subject to first-pass metabolism. Ethinyl estradiol is absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of ethinyl estradiol is approximately 40%. The effect of food on the rate and the extent of levonorgestrel and ethinyl estradiol absorption following oral administration of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets has not been evaluated. The mean plasma pharmacokinetic parameters of levonorgestrel following administration of another levonorgestrel/ethinyl estradiol combination tablet with an equal dose of levonorgestrel for 84 days, in healthy women are reported in Table 5. Table 5: Mean Pharmacokinetic Parameters for 0.15 mg Levonorgestrel Following Administration of a Levonorgestrel/Ethinyl Estradiol Combination Tablet Once Daily for 84 Days AUC0-24 hr (mean SD) Cmax (mean SD) Tmax (mean SD) Day 1 18.2 6.1 ng hr/mL 3.0 1.0 ng/mL 1.3 0.4 hours Day 21 64.4 25.1 ng hr/mL 6.2 1.6 ng/mL 1.3 0.4 hours Day 84 60.2 24.6 ng hr/mL 5.5 1.6 ng/mL 1.3 0.3 hours Following repeated daily dosing of levonorgestrel/ethinyl estradiol oral contraceptives, levonorgestrel plasma concentrations accumulate more than predicted based on single-dose pharmacokinetics, due in part, to increased SHBG levels that are induced by ethinyl estradiol, and a possible reduction in hepatic metabolic capacity. Systemic exposure to ethinyl estradiol following administration of a levonorgestrel/ethinyl estradiol combination tablet increases linearly in an approximate dose-proportional manner over the range of doses of 0.02 mg to 0.03 mg within this product. Systemic exposure to ethinyl estradiol (as assessed by AUC) at steady state following administration of levonorgestrel/ethinyl estradiol oral contraceptives is approximately 20% higher than expected based on single-dose data for the dose range of 0.02 mg - 0.03 mg. Distribution The apparent volume of distribution of levonorgestrel is reported to be approximately 1.8 L/kg. Levonorgestrel is about 97.5 - 99% protein-bound, principally to SHBG and, to a lesser extent, serum albumin. The apparent volume of distribution of ethinyl estradiol is reported to be approximately 4.3 L/kg. Ethinyl estradiol is about 95-97% bound to serum albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis, which leads to decreased levonorgestrel clearance. Metabolism Following absorption, levonorgestrel is conjugated at the 17 -OH position to form sulfate and to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3 , 5 -tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3 ,5 -tetrahydrolevonorgestrel and 16 -hydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users. First-pass metabolism of ethinyl estradiol involves formation of ethinyl estradiol-3-sulfate in the gut wall, followed by 2-hydroxylation of a portion of the remaining untransformed ethinyl estradiol by hepatic cytochrome P-450 3A4 (CYP3A4). Levels of CYP3A4 vary widely among individuals and can explain the variation in rates of ethinyl estradiol hydroxylation. Hydroxylation at the 4-, 6-, and 16- positions may also occur, although to a much lesser extent than 2-hydroxylation. The various hydroxylated metabolites are subject to further methylation and/or conjugation. Excretion About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates. The mean terminal elimination half-life for levonorgestrel after a single dose of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets ranged from 36-41 hours. Ethinyl estradiol is excreted in the urine and feces as glucuronide and sulfate conjugates, and it undergoes enterohepatic recirculation. The terminal elimination half-life of ethinyl estradiol following single doses of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is approximately 16.5 hours.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Counsel patients about the following information: Cigarette Smoking Cigarette smoking increases the risk of serious cardiovascular events from COC use. Women who are over 35 years old and smoke should not use levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets [see Boxed Warning and Warnings and Precautions (5.1)]. Venous Thromboembolism Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions (5.1)]. Use during Pregnancy Instruct females to stop levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if pregnancy is confirmed during treatment. Sexually Transmitted Infections Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets do not protect against HIV infection and other sexually transmitted infections. Dosing and Missed Pill Instructions Patients should take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed. See [see Dosage and Administration ( 2.3)]. Instruct patients to see, What to do if you miss pills section of the FDA-Approved Instructions for Use. Need for Additional Contraception Postpartum females who have not yet had a period when they start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets need to use an additional method of contraception until they have taken a white to off-white tablet for 7 consecutive days [see Dosage and Administration (2.2)]. There is a need for a back-up or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets [see Drug Interactions ( 7.1)]. Lactation Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets may reduce breast milk production. This is less likely to occur if breastfeeding is well established. When possible, nursing women should use other methods of contraception until they have discontinued breastfeeding [see Use in Specific Populations ( 8.2)]. Amenorrhea and Possible Symptoms of Pregnancy Amenorrhea may occur [see Warnings and Precautions (5.9)]. Advise the patient to contact a healthcare provider in the event of amenorrhea with symptoms of pregnancy, such as morning sickness or unusual breast tenderness [see Use in Specific Populations ( 8.1]. Depression Depressed mood and depression may occur. Women should contact their healthcare provider if mood changes and depressive symptoms occur, including shortly after initiating the treatment [see Warnings and Precautions (5.10)].