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TL;DR — Quick Summary
Key facts from the full medication guide below
🩺What it's for
Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel 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. (2.1) Take tablets in the order directed on the Extended-Cycle Blister Pack.
ℹ️Common side effects
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)] Vascular events [see Warnings and Precautions (5.1)] Liver disease [see Warnings and Precautions (5.2)] The most common adverse reactions ( 2%) reported during clinical trials were headache, menorrhagia, nausea, dysmenorrhea, acne, migraine, breast tenderness, weight increased, and depression.
⚠️Serious risks
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including levonorgestrel and ethinyl estradiol tablets, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1)].
📋Interactions & cautions
The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested.
📦Storage & missed dose
How Supplied Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg are available as round, biconvex, unscored tablets, packaged in carton of 3 pouches, each pouch contains Extended-Cycle Tablet Blister Pack of 91 tablets, each containing a 13-week supply of tablets: 84 white to off-white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol: debossed with 212 on the one side and plain on the other side 7 green inert tablets debossed with 279 on the one… Table 2: Instructions for Missed Levonorgestrel and Ethinyl Estradiol Tablets If one active tablet (white to off-white) is missed in Days 1 through 84 Take the tablet as soon as possible. Take the next tablet at the regular time and continue taking one tablet a day until the 91-day course is finished. If two consecutive active tablets (white to off-white) are missed in Days 1 through 84 Take 2 tablets on the day remembered and 2 tablets the next day.
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Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including levonorgestrel and ethinyl estradiol tablets, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1)]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Levonorgestrel 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. (5.1)
Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel 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. (1)
Take one tablet daily by mouth at the same time every day for 91 days. (2.1) Take tablets in the order directed on the Extended-Cycle Blister Pack. (2.2)
Levonorgestrel and ethinyl estradiol tablets are dispensed in an Extended-Cycle Blister Pack [see How Supplied/Storage and Handling (16) ]. Levonorgestrel and ethinyl estradiol tablets should be started on a Sunday (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. Table 1: Instructions for Administration of Levonorgestrel and Ethinyl Estradiol Tablets Starting levonorgestrel and ethinyl estradiol tablets in females with no current use of hormonal contraception (Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Levonorgestrel and ethinyl estradiol tablets active tablets are white to off-white (Day 1 to Day 84). Levonorgestrel and ethinyl estradiol tablets inactive tablets are green (Day 85 to Day 91). Sunday Start: For each 91-day course, take in the following order: Take the first white to off-white tablet (0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms or spermicide) for the first 7 days of treatment. Take subsequent white to off-white tablets once daily at the same time each day for a total of 84 days. Take one green tablet (inert) daily for the following 7 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 7 days that the green tablets are taken. Begin the next and all subsequent 91-day courses of levonorgestrel and ethinyl estradiol tablets without interruption on the same day of the week (Sunday) on which the patient began her first dose. Follow the same schedule as the initial 91-day course: a white to off-white tablet once a day for 84 days, and a green tablet once a day for 7 days. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a white to off-white tablet daily for 7 consecutive days. Switching from another contraceptive method to levonorgestrel and ethinyl estradiol tablets Start levonorgestrel and ethinyl estradiol tablets: Another oral contraceptive On the day when the new pack of the previous COC would have been started Transdermal patch On the day when the next application would have been scheduled. Vaginal ring On the day when the next insertion would have been scheduled. Injection On the day when the next injection would have been scheduled. Intrauterine contraceptive (IUD) On the day of removal. If the IUD is not removed on first day of the patient s menstrual cycle, additional non- hormonal contraception (such as condoms or spermicide) is needed for the first seven days of the first 91-day course. Implant On the day of removal.
About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates. The terminal elimination half-life for levonorgestrel after a single dose of levonorgestrel and ethinyl estradiol tablets was about 30 hours. EE is excreted in the urine and feces as glucuronide and sulfate conjugates, and it undergoes enterohepatic recirculation. The terminal elimination half-life of EE after a single dose of levonorgestrel and ethinyl estradiol tablets was found to be about 15 hours.
Instruct patients to take one tablet by mouth at the same time every day. The dosing of levonorgestrel and ethinyl estradiol tablets is one white to off-white pill containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one green pill (inactive pills without hormone) for 7 days. To achieve maximum contraceptive effectiveness, levonorgestrel and ethinyl estradiol tablets must be taken exactly as directed, in the order directed on the Blister Pack, and at intervals not exceeding 24 hours. Start taking the first white to off-white pill from a new Blister Pack the very next day after taking the last green inactive pill in the Blister Pack. The failure rate may increase when pills are missed or taken incorrectly.
Table 2: Instructions for Missed Levonorgestrel and Ethinyl Estradiol Tablets If one active tablet (white to off-white) is missed in Days 1 through 84 Take the tablet as soon as possible. Take the next tablet at the regular time and continue taking one tablet a day until the 91-day course is finished. If two consecutive active tablets (white to off-white) are missed in Days 1 through 84 Take 2 tablets on the day remembered and 2 tablets the next day. Then continue taking one tablet a day until the 91-day course is finished. Additional non-hormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. If three or more consecutive active tablets (white to off-white) are missed in Days 1 through 84 Do not take the missed tablets. Continue taking one tablet a day until the 91-day course is finished. Additional non-hormonal contraception (such as condoms or spermicide) must be used as back-up if the patient has sex within 7 days after missing tablets. If any of the seven green (inactive) tablets are missed Throw away the missed tablets. Continue taking the remaining tablets until the pack is finished. A backup birth control method is not needed.
In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3-4 hours after taking a white to off-white tablet, handle this as a missed tablet.
Levonorgestrel and Ethinyl Estradiol Tablets, USP are available as round, biconvex, unscored tablets, packaged in carton of 3 pouches, each pouch contains Extended-Cycle Tablet Blister Pack of 91 tablets, each containing a 13-week supply of tablets in the following order: 84 white to off-white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol; debossed with 212 on the one side and plain on the other side 7 green inert tablets debossed with 279 on the one side and plain on the other side. Levonorgestrel and ethinyl estradiol tablets, USP consist of 84 round, white to off-white tablets containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and 7 round, green inert tablets. (3)
Levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include females who are known to: oSmoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]. oHave current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions (5.1)]. oHave cerebrovascular disease [see Warnings and Precautions (5.1)]. oHave coronary artery disease [see Warnings and Precautions (5.1)]. oHave thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]. oHave inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]. oHave uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions (5.4)]. oHave diabetes mellitus and are over age of 35, diabetes mellitus hypertension or vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration [see Warnings and Precautions (5.7)]. oHave headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see Warnings and Precautions (5.8)]. Current diagnosis of, or history of breast cancer, which may be hormone sensitive [see Warnings and Precautions (5.11)]. Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)]. Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9)]. Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3)]. A high risk of arterial or venous thrombotic diseases (4) Liver tumors or liver disease, acute viral hepatitis or decompensated cirrhosis (4) Undiagnosed abnormal uterine bleeding (4) Breast cancer (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ ritonavir, with or without dasabuvir. (4)
Vascular risks: Stop if a thrombotic or thromboembolic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years. (5.1, 5.5) Liver disease: Discontinue if jaundice occurs. (5.2) Hypertension: If used in women with well-controlled hypertension, monitor blood pressure and stop if blood pressure rises significantly. (5.4) Gallbladder disease: May cause or worsen gallbladder disease. (5.5) Adverse carbohydrate and lipid effects: Monitor glucose in prediabetic and diabetic women taking levonorgestrel and ethinyl estradiol tablets. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. (5.7) Headache: Evaluate significant change in headaches and discontinue if indicated. (5.8) Uterine bleeding: May cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist. (5.9)
Stop levonorgestrel and ethinyl estradiol tablets if an arterial or venous thrombotic/thromboembolic event occurs. Stop levonorgestrel 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 during prolonged immobilization. If feasible, stop levonorgestrel 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 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 likelihood of ovulation increases after the third postpartum week. Before starting levonorgestrel 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 are contraindicated in females with a high risk of arterial or venous thrombotic/thromboembolic diseases [see Contraindications (4)].
During clinical trials with the Hepatitis C combination drug regimen that contains obmitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as levonorgestrel and ethinyl estradiol tablets. Discontinue levonorgestrel and ethinyl estradiol tablets prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4)]. Levonorgestrel and ethinyl estradiol tablets can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
Levonorgestrel and ethinyl estradiol tablets are contraindicated in females with uncontrolled hypertension or hypertension with vascular disease [see Contraindications (4)]. For all women, including those with well-controlled hypertension, monitor blood pressure at routine visits and stop levonorgestrel and ethinyl estradiol tablets if blood pressure rises significantly. An increase in blood pressure has been reported in females taking COCs, and this increase is more likely in older women and with extended duration of use. The effect of COCs on blood pressure may vary according to the progestin in the COC.
The risk for cardiovascular disease and prevalence of risk factors for cardiovascular disease increase with age. Certain conditions, such as smoking and migraine headache without aura, that do not contraindicate COC use in younger females, are contraindications to use in women over 35 years of age [see Contraindications (4) and Warnings and Precautions (5.1)]. Consider the presence of underlying risk factors that may increase the risk of cardiovascular disease or VTE, particularly before initiating levonorgestrel and ethinyl estradiol tablets for women over 35 years, such as: Hypertension Diabetes Dyslipidemia Obesity
Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs, including levonorgestrel and ethinyl estradiol tablets, may worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Females with a history of pregnancy-related cholestasis may be at an increased risk for COC-related cholestasis.
Levonorgestrel and ethinyl estradiol tablets are contraindicated in females who have headaches with focal neurological symptoms or have migraine headaches with aura, and in women over age 35 years who have migraine headaches with or without aura [see Contraindications (4)]. If a female taking levonorgestrel and ethinyl estradiol tablets develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue levonorgestrel and ethinyl estradiol tablets if indicated. Consider discontinuation of levonorgestrel and ethinyl estradiol tablets if there is an increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) [see Contraindications (4)].
Bleeding and/or spotting that occurs at any time while taking the first 84 tablets of each extended-cycle regimen is considered unscheduled bleeding/spotting. Bleeding that occurs during the time a woman takes the seven green inert tablets is considered scheduled bleeding.
Carefully observe females with a history of depression and discontinue levonorgestrel and ethinyl estradiol tablets if depression recurs to a serious degree. Data on the association of COCs with onset of depression or exacerbation of existing depression are limited.
The estrogen component of levonorgestrel and ethinyl estradiol tablets may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.
In females with hereditary angioedema, exogenous estrogens, including levonorgestrel and ethinyl estradiol tablets, may induce or exacerbate symptoms of hereditary angioedema.
Chloasma may occur with levonorgestrel and ethinyl estradiol tablets use, especially in females with a history of chloasma gravidarum. Advise females with a history of chloasma to avoid exposure to the sun or ultraviolet radiation while taking levonorgestrel and ethinyl estradiol tablets.
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)] Vascular events [see Warnings and Precautions (5.1)] Liver disease [see Warnings and Precautions (5.2)] The most common adverse reactions ( 2%) reported during clinical trials were headache, menorrhagia, nausea, dysmenorrhea, acne, migraine, breast tenderness, weight increased, and depression. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 clinical practice. The clinical trial that evaluated the safety and efficacy of levonorgestrel and ethinyl estradiol tablets was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18 to 40, of whom 456 took at least one dose of levonorgestrel and ethinyl estradiol tablets (345.14 woman-years of exposure) [see Clinical Studies (14)]. Adverse Reactions Leading to Study Discontinuation: 14.9% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions ( 1% of women) leading to discontinuation in the levonorgestrel and ethinyl estradiol tablets group were menorrhagia (5.7%), mood swings (1.9%), weight/appetite increase (1.5%), and acne (1.3%). Common Adverse Reactions ( 2% of women): headache (20.6%), menorrhagia (11.6%), nausea (7.5%), dysmenorrhea (5.7%), acne (4.6%), migraine (4.4%), breast tenderness (3.5%), weight increased (3.1%), and depression (2.1%). Serious Adverse Reactions: pulmonary embolus, cholecystitis.
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 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). 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 2: 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 levonorgestrel and ethinyl estradiol tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not 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 disorder: hypersensitivity reactions, including itching, rash, and angioedema 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 Skin and subcutaneous tissue disorders: alopecia Vascular disorders: thrombosis, pulmonary embolism, pulmonary thrombosis
The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested. Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations. No drug-drug interaction studies were conducted with levonorgestrel and ethinyl estradiol tablets. Enzyme inducers (e.g., CYP3A4): May decrease the effectiveness of levonorgestrel 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. (7.1)
Table 6 provides significant drug interaction information for drugs co-administered with levonorgestrel and ethinyl estradiol tablets. Table 6: Significant Drug Interaction Information for Drugs Co-Administered With COCs Lamotrigine Clinical effect Concomitant use of COCs with lamotrigine may significantly decrease systemic exposure of lamotrigine due to induction of lamotrigine glucuronidation [See Clinical Pharmacology (12.3)]. Decreased systemic exposure of lamotrigine may reduce seizure control. Prevention or management Dose adjustment may be necessary. Consult the approved product labeling for lamotrigine. Thyroid Hormone Replacement Therapy or Corticosteroid Replacement Therapy Clinical effect Concomitant use of COCs with thyroid hormone replacement therapy or corticosteroid replacement therapy may increase systemic exposure of thyroid-binding and cortisol-binding globulin [see Warnings and Precautions (5.12)]. Prevention or management The dose of replacement thyroid hormone or cortisol therapy may need to be increased. Consult the approved product labeling for the therapy in use [see Warnings and Precautions (5.12)]. Other Drugs Clinical effect Concomitant use of COCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam. Concomitant use with ethinyl estradiol-containing COCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole). Prevention or management The dosage of drugs that can be affected by this interaction may need to be increased. Consult the approved product labeling for the concomitantly used drug.
Co-administration of levonorgestrel and ethinyl estradiol tablets with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir is contraindicated due to potential for ALT elevations [see Warning and Precautions (5.3)]. Co-administration of levonorgestrel and ethinyl estradiol tablets and glecaprevir/pibrentasvir is not recommended due to potential for ALT elevations.
The use of COCs may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
Pregnancy: Discontinue if pregnancy occurs. (8.1) Lactation: Advise use of another contraceptive method; levonorgestrel and ethinyl estradiol tablets; may decrease milk production. (8.2)
Contraceptive hormones and/or metabolites are present in human milk. COCs 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 [see Dosage and Administration (2.1)]. The developmental and health benefits of breastfeeding should be considered along with the mother s clinical need for levonorgestrel and ethinyl estradiol tablets and any potential adverse effects on the breastfed child from levonorgestrel and ethinyl estradiol tablets or the underlying maternal condition.
Safety and efficacy of levonorgestrel and ethinyl estradiol tablets have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of levonorgestrel and ethinyl estradiol tablets before menarche is not indicated.
Levonorgestrel and ethinyl estradiol tablets have not been studied in postmenopausal women and is not indicated in this population.
The pharmacokinetics of levonorgestrel and ethinyl estradiol tablets have not been studied in subjects with hepatic impairment. However, COCs may be poorly metabolized in patients with hepatic impairment. Levonorgestrel and ethinyl estradiol tablets are contraindicated in females with acute hepatitis or severe decompensated cirrhosis [see Contraindications (4) and Warnings and Precautions (5.2)].
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.
Levonorgestrel and ethinyl estradiol tablets, USP are an extended-cycle combination oral contraceptive consisting of 84 white to off-white active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 green inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17 )-, (-)-. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17 )-. Each white to off-white active tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate and polacrilin potassium. Each green inert tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, lactose monohydrate, magnesium stearate, polacrilin potassium and yellow oxide of iron.
COCs prevent pregnancy primarily by suppressing ovulation.
No specific pharmacodynamic studies were conducted with levonorgestrel and ethinyl estradiol tablets.
The effect of food on the rate and the extent of levonorgestrel and EE absorption following oral administration of levonorgestrel and ethinyl estradiol tablets has not been evaluated.
See Warnings and Precautions (5.2, 5.11).
In a 12-month, multicenter, randomized, open-label clinical trial, 456 women aged 18-40 were studied to assess the safety and efficacy of levonorgestrel and ethinyl estradiol tablets, completing 809 91-day cycles of exposure. The racial demographic of those enrolled was: Caucasian (77%), African-American (11%), Hispanic (7%), Asian (2%), and Other (3%). There were no exclusions for body mass index (BMI) or weight. The weight range of those women treated was 84 to 304 pounds, with a mean weight of 157 pounds and a median weight of 147 pounds. Among the women in the trial, 63% were current or recent hormonal contraceptive users, 29% were prior users (who had used hormonal contraceptives in the past but not in the 6 months prior to enrollment), and 8% were new starts. The pregnancy rate (Pearl Index [PI]) in the 397 women aged 18-35 years was 1.98 pregnancies per 100 women-years of use (95% CI: 0.54 to 5.03), based on 4 pregnancies that occurred after the onset of treatment and within 14 days after the last combination pill. Cycles in which conception did not occur, but which included the use of back-up contraception, were not included in the calculation of the PI.
How Supplied Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg are available as round, biconvex, unscored tablets, packaged in carton of 3 pouches, each pouch contains Extended-Cycle Tablet Blister Pack of 91 tablets, each containing a 13-week supply of tablets: 84 white to off-white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol: debossed with 212 on the one side and plain on the other side 7 green inert tablets debossed with 279 on the one side and plain on the other side Carton of 3 pouches NDC 0378-7281-53 Storage and Handling Store at 20 to 25 C (68 to 77 F). [See USP Controlled Room Temperature.] Protect from light.
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). 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 [see Boxed Warning and Warnings and Precautions (5.1)]. Venous Thromboembolism The 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 further intake of levonorgestrel and ethinyl estradiol tablets if pregnancy is confirmed during treatment. Sexually Transmitted Infections Levonorgestrel and ethinyl estradiol tablets do not protect against HIV-infection (AIDS) and other sexually transmitted infections. Dosing and Missed Pill Instructions Patients should take one tablet daily by mouth at the same time every day [see Dosage and Administration (2.1)]. Instruct patients what to do in the event tablets are missed. See What should I do if I miss any levonorgestrel and ethinyl estradiol tablets pills section of FDA-Approved Instructions for Use [see Dosage and Administration (2.3)]. Need for Additional Contraception Postpartum females who start levonorgestrel and ethinyl estradiol tablets who have not yet had a period when they start levonorgestrel 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 (2.1)]. There is a need for a back-up or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets [see Drug Interactions (7.1)]. Lactation Levonorgestrel 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. Because women using levonorgestrel and ethinyl estradiol tablets will likely have scheduled bleeding only 4 times per year, advise women to contact their health care provider in the event of amenorrhea with symptoms of pregnancy such as morning sickness or unusual breast tenderness [see Warnings and Precautions (5.9)]. 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)].
Patient Information Levonorgestrel and Ethinyl Estradiol Tablets, USP WARNING TO WOMEN WHO SMOKE Do not use levonorgestrel and ethinyl estradiol tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. What is the most important information I should know about levonorgestrel and ethinyl estradiol tablets? Do not use levonorgestrel and ethinyl estradiol tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. What are levonorgestrel and ethinyl estradiol tablets? Levonorgestrel and ethinyl estradiol tablets are birth control pills (oral contraceptive) used by women to prevent pregnancy. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel. Levonorgestrel and ethinyl estradiol tablets do not protect against HIV infections (AIDS) and other sexually transmitted infections. How do levonorgestrel and ethinyl estradiol tablets work for contraception? 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 clinical studies, about 1 to 5 out of 100 women may get pregnant during the first year they use levonorgestrel and ethinyl estradiol tablets. 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. Who should not take levonorgestrel and ethinyl estradiol tablets? Do not take levonorgestrel and ethinyl estradiol tablets if you: smoke and are over 35 years of age have or had blood clots in your arms, legs, lungs, or eyes had a stroke had a heart attack have certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart have or had a problem with your blood that makes it clot more than normal have high blood pressure that cannot be controlled by medicine or have high blood pressure with blood vessels problems have diabetes oand are over the age of 35 owith high blood pressure owith kidney, eye, nerve, or blood vessel damage ofor more than 20 years have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age have or had breast cancer have liver problems, including liver tumors have any unexplained vaginal bleeding take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme alanine aminotransferase (ALT) in the blood. If any of these conditions happen to you while you are taking levonorgestrel and ethinyl estradiol tablets, stop taking levonorgestrel and ethinyl estradiol tablets right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking levonorgestrel and ethinyl estradiol tablets. What should I tell my healthcare provider before taking levonorgestrel and ethinyl estradiol tablets? Tell your healthcare provider if you: are pregnant or think you may be pregnant are scheduled for surgery. Levonorgestrel and ethinyl estradiol tablets may increase your risk of blood clots after surgery. You should stop taking levonorgestrel and ethinyl estradiol tablets at least 4 weeks before you have surgery and not restart levonorgestrel and ethinyl estradiol tablets until at least 2 weeks after your surgery. are depressed now or have been depressed in the past had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy) are breastfeeding or plan to breastfeed. Levonorgestrel and ethinyl estradiol tablets may decrease the amount of breast milk you make. A small amount of the hormones in levonorgestrel and ethinyl estradiol tablets may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding. Tell your healthcare provider if you have ever had any of the conditions listed in, Who should not take levonorgestrel and ethinyl estradiol tablets above. Your healthcare provider may recommend another method of birth control. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Levonorgestrel and ethinyl estradiol tablets may affect the way other medicines work, and other medicines may affect how well levonorgestrel and ethinyl estradiol tablets work. Some medicines and herbal products may make birth control pills less effective, including: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John s wort topiramate Use a back-up or alternative 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 physician may need to adjust the dose of lamotrigine. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take levonorgestrel and ethinyl estradiol tablets? Read the Instructions for Use at the end of this Patient Information. What are the most serious risks of taking levonorgestrel and ethinyl estradiol tablets? Like pregnancy, levonorgestrel and ethinyl estradiol tablets may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you: ofirst start taking birth control pills orestart the same or different birth control pills after not using them for a month or more Call your healthcare provider or go to a hospital emergency room right away if you have: oleg pain that will not go away osudden severe shortness of breath osudden change in vision or blindness ochest pain oa sudden, severe headache unlike your usual headaches oweakness or numbness in your arm or leg otrouble speaking oyellowing of your skin or eyes Other serious side effects include: liver problems, including: orare liver tumors ojaundice (cholestasis), especially if you previously had cholestasis of pregnancy. high blood pressure. You should see your healthcare provider to check your blood pressure regularly. gallbladder problems changes in the sugar and fat (cholesterol and triglycerides) levels in your blood new or worsening headaches including migraine headaches irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking levonorgestrel and ethinyl estradiol tablets. depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself. possible cancer in your breast and cervix swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher is you have a history of angioedema. dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma). Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking levonorgestrel and ethinyl estradiol tablets. Use sunscreen if you have to be in the sunlight. What are the most common side effects of levonorgestrel and ethinyl estradiol tablets? headache (migraine) heavier or longer periods, pain with periods nausea acne breast tenderness increase in weight These are not all the possible side effects of levonorgestrel and ethinyl estradiol tablets. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-1088. What else should I know about taking levonorgestrel and ethinyl estradiol tablets? If you are scheduled for any lab tests, tell your healthcare provider you are taking levonorgestrel and ethinyl estradiol tablets. Certain blood tests may be affected by levonorgestrel and ethinyl estradiol tablets. Do not skip any pills, even if you do not have sex often. 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 levonorgestrel and ethinyl estradiol tablets at least four weeks before you have major surgery and not restart it for 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 levonorgestrel and ethinyl estradiol tablets, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk, but this has not caused harmful effects in breastfeeding infants. If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms or a spermicide, until you check with your healthcare provider. How should I store levonorgestrel and ethinyl estradiol tablets? Store levonorgestrel and ethinyl estradiol tablets at room temperature between 20 C to 25 C (68 F to 77 F). Protect from light. Keep levonorgestrel and ethinyl estradiol tablets and all medicines out of the reach of children. General information about the safe and effective use of levonorgestrel and ethinyl estradiol tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use levonorgestrel and ethinyl estradiol tablets for a condition for which it was not prescribed. Do not give levonorgestrel and ethinyl estradiol tablets to other people, even if they have the same symptoms that you have. This Patient Information summarizes the most important information about levonorgestrel and ethinyl estradiol tablets. You can ask your pharmacist or healthcare provider for information about levonorgestrel and ethinyl estradiol tablets that is written for health professionals. For more information, call 1-877-446-3679 (1-877-4-INFO-RX). Do birth control pills cause cancer? It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use. If you have breast cancer now, or have had it in the past, do not use hormonal birth control 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 if I want to become 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. What should I know about my period when taking levonorgestrel and ethinyl estradiol tablets? When you take levonorgestrel and ethinyl estradiol tablets, which has a 91-day extended dosing cycle, you should have 4 scheduled periods a year (bleeding when you are taking the 7 green pills). However, you will probably have more bleeding or spotting between your scheduled periods than if you were using a birth control pill with a 28-day dosing cycle. During the first levonorgestrel and ethinyl estradiol tablets 91-day treatment cycle, about 1 in 3 women may have 20 or more days of unplanned bleeding or spotting. This bleeding or spotting tends to decrease with time. Do not stop taking levonorgestrel and ethinyl estradiol tablets because of this bleeding or spotting. If the spotting continues for more than 7 days in a row or if the bleeding is heavy, call your healthcare provider. What if I miss my scheduled period when taking levonorgestrel and ethinyl estradiol tablets? You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking green pills). Since scheduled periods are less frequent when you are taking levonorgestrel and ethinyl estradiol tablets, notify your healthcare provider that you have missed your period and that you are taking levonorgestrel and ethinyl estradiol tablets. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant. Stop taking levonorgestrel and ethinyl estradiol tablets if it is determined that you are pregnant. What are the ingredients in levonorgestrel and ethinyl estradiol tablets? Active ingredients: Each white to off-white pill contains levonorgestrel and ethinyl estradiol. Inactive ingredients: White to off-white pills: Lactose monohydrate, magnesium stearate and polacrilin potassium. Green pills: FD&C Blue No. 1 Aluminum Lake, lactose monohydrate, magnesium stearate, polacrilin potassium and yellow oxide of iron.
Levonorgestrel and Ethinyl Estradiol Tablets, USP Important information about taking levonorgestrel and ethinyl estradiol tablets Take 1 pill every day at the same time. Take the pills in the order directed on your pill dispenser. Do not skip your pills, even if you do not have sex often. If you miss pills (including starting the pack late) you could get pregnant. The more pills you miss, the more likely you are to get pregnant. If you have trouble remembering to take levonorgestrel and ethinyl estradiol tablets, talk to your healthcare provider. When you first start taking levonorgestrel and ethinyl estradiol tablets, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months. You may feel sick to your stomach (nauseous), especially during the first few months of taking levonorgestrel and ethinyl estradiol tablets. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider. Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills (see, What should I do if I miss any levonorgestrel and ethinyl estradiol pills? below), you could also feel a little sick to your stomach. It is not uncommon to miss a period. However, if you miss a period and have not taken levonorgestrel and ethinyl estradiol tablets according to directions, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking levonorgestrel and ethinyl estradiol tablets. If you have vomiting or diarrhea within 3-4 hours of taking a white to off-white pill, take another white to off-white pill as soon as possible. Continue taking one pill a day until the 91-day course is finished. If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. Use an additional birth control method, like condoms or spermicide, until you check with your healthcare provider. Stop taking levonorgestrel and ethinyl estradiol tablets at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of contraception (like condoms or spermicide) during this time period. Before you start taking levonorgestrel and ethinyl estradiol tablets: Decide what time of day you want to take your pill. It is important to take it at about the same time every day. Look at your Extended-Cycle Tablet Blister Pack. Your Blister Pack consists of 3 trays with cards that hold 91 individually sealed pills (a 13- week or 91-day cycle). The 91 pills consist of 84 white to off-white and 7 green pills. The cards in trays 1 and 2 each contain 28 white to off-white pills (4 rows of 7 pills). See Figure A. The card in tray 3 contains 35 pills consisting of 28 white to off-white pills (4 rows of 7 pills) and 7 green pills (1 row of 7 pills). See Figure B. Figure A Figure B Also find: oWhere on the first tray in the pack to start taking pills (upper left corner) and oIn what order to take the pills (follow the weeks) Be sure you have ready at all times another kind of birth control (such as condoms or spermicide), to use as a back-up in case you miss pills. When should I start taking levonorgestrel and ethinyl estradiol tablets? If you start taking levonorgestrel and ethinyl estradiol tablets and you have not used a hormonal birth control method before: Take the first white to off-white pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first white to off-white pill that same day. Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first white to off-white pill until the next Sunday (first 7 days). If you have recently given birth and have not yet had a period, use another method of birth control if you have sex (such as condoms and spermicides) as a back-up method until you have taken levonorgestrel and ethinyl estradiol tablets for 7 days. If you start taking levonorgestrel and ethinyl estradiol tablets and you are switching from another birth control pill: Start your new levonorgestrel and ethinyl estradiol tablets pack on the same day that you would start the next pack of your previous birth control method. Do not continue taking the pills from your previous birth control pack. If you start taking levonorgestrel and ethinyl estradiol tablets and previously used a vaginal ring: Start using levonorgestrel and ethinyl estradiol tablets on the day you would have reapplied the next ring. If you start taking levonorgestrel and ethinyl estradiol tablets and previously used a transdermal patch: Start using levonorgestrel and ethinyl estradiol tablets on the day you would have started a new cycle (first patch application). If you start taking levonorgestrel and ethinyl estradiol tablets and you are switching from a progestin-only method such as an implant or injection: Start taking levonorgestrel and ethinyl estradiol tablets on the day of removal of your implant, or on the day when you would have had your next injection. If you start taking levonorgestrel and ethinyl estradiol tablets and you are switching from an intrauterine device or system (IUD or IUS): Start taking levonorgestrel and ethinyl estradiol tablets on the day of removal of your IUD or IUS. You do not need back-up contraception if your IUD or IUS is removed on the first day (Day 1) of your period. If your IUD or IUS is removed on any other day, use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days that you take levonorgestrel and ethinyl estradiol tablets. Keep a calendar to track your period: If this is the first time you are taking birth control pills, read, When should I start taking levonorgestrel and ethinyl estradiol tablets? above. Follow these instructions for a Sunday Start. Instructions for using your levonorgestrel and ethinyl estradiol tablets extended-cycle blister pack: Sunday Start: Take pill 1 on the Sunday after your period starts. To remove your pill from the dispenser, press the pill through the hole in the bottom of the dispenser. See Figure C. Figure C If your period starts on a Sunday, take pill 1 that same day. Take 1 pill at about the same time every day until you have taken the last pill in the blister pack. After taking the last green pill on Day 91 from the pill dispenser, start taking the first white to off-white pill from a new Extended-Cycle Blister Pack on the very next day (this should be a Sunday). Take the first pill in the new pack whether or not you are having your period. Use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days of the first cycle that you take levonorgestrel and ethinyl estradiol tablets. What should I do if I miss any levonorgestrel and ethinyl estradiol pills? If you miss 1 white to off-white pill, follow these steps: Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day. Then continue taking 1 pill every day until you finish the pack. You do not need to use a back-up birth control method if you have sex. If you miss 2 white to off-white pills in a row, follow these steps: Take 2 pills on the day you remember and 2 pills the next day. Then continue to take 1 pill every day until you finish the pack. You could become pregnant if you have sex in the 7 days after you miss two pills. You must use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. If you miss 3 or more white to off-white pills in a row, follow these steps: Do not take the missed pills. Keep taking 1 pill every day until you have completed all of the remaining pills in the pack. For example, if you start taking the pill on Thursday, take the pill under Thursday and do not take the missed pills. You may have bleeding during the week following the missed pills. You could become pregnant if you have sex during the days of 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 or spermicide) as a back-up when you miss pills and for the first 7 days after you restart your pills. If you do not have your period when you are taking the green pills, call your healthcare provider because you may be pregnant. If you miss any of the 7 green pills: Throw away the missed pills. Keep taking the scheduled pills until the pack is finished. You do not need a back-up method of birth control. Finally, if you are still not sure what to do about the pills you have missed Use a back-up method anytime you have sex. Keep taking one pill each day until you contact your healthcare provider. If you have any questions or are unsure about the information in this leaflet, call your healthcare provider. This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Ahmedabad - 382 213, India Code No.: GUJ-DRUGS/G/28/1297 75099045 Revised: 9/2023 FC:OT:7281:R12
NDC 0378-7281-53 Rx only Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg /0.03 mg Each extended-cycle tablet blister pack each containing 91 tablets: 84 white to off-white tablets,each containing 0.15 mg levonorgestrel with 0.03 mg ethinyl estradiol, and7 green inert tablets. 3 extended-cycle blister packs containing 91 tablets each This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIVinfection (AIDS) and other sexually transmitted diseases. USUAL DOSAGE: One tablet daily for 91 consecutive days in the following order: 84 white to off-white tablets followed by 7 greentablets as prescribed. Please see enclosed full prescribing information. IMPORTANT: The Patient Instructions leaflet which is packaged inside each pouch provides important instructionsto the patient. Please supply these instructions to the patient when dispensing. Store at 20 to 25 C (68 to 77 F). [See USP Controlled Room Temperature.] Keep this and all medications out of the reach of children. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Code No.: GUJ-DRUGS/G/28/1297 Mylan.com FC:7281:3C:R7
