ESTRADIOL 1MG 100 TAB
ESTRADIOL 1MG 100 TAB
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Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Iclevia TM (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Iclevia is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 Wallet. (2.2) 2.1 How to Start and Take Iclevia Iclevia is dispensed in an Extended-Cycle Wallet [see How Supplied/Storage and Handling (16) ]. Iclevia 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 Iclevia Starting Iclevia 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: Iclevia active tablets are white (Day 1 to Day 84). Iclevia 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 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 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 Iclevia 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 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 tablet daily for 7 consecutive days. Switching from another contraceptive method to Iclevia Start Iclevia: 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. Starting Iclevia after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Iclevia may be started immediately. An additional method of contraception is not needed if Iclevia is started immediately. If Iclevia is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first 91-day course of Iclevia. Second-trimester Do not start Iclevia until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Iclevia following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first 91-day course of Iclevia [see Contraindications (4) , Warnings and Precautions (5.1) ]. Starting Iclevia after Childbirth Do not start Iclevia until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Iclevia following the instructions in Table 1 for women not currently using hormonal contraception. Iclevia is 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 Iclevia [see Contraindications (4) , Warnings and Precautions (5.1) , Use in Specific Populations (8.1 and 8.2) ]. 2.2 Dosing Iclevia Instruct patients to take one tablet by mouth at the same time every day. The dosing of Iclevia is one 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, Iclevia must be taken exactly as directed, in the order directed on the Wallet, and at intervals not exceeding 24 hours. Start taking the first white pill from a new Wallet the very next day after taking the last green inactive pill in the Wallet. The failure rate may increase when pills are missed or taken incorrectly. 2.3 Missed Doses Table 2: Instructions for Missed Iclevia Tablets If one active tablet (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) 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) 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. 2.4 Advice in Case of Gastrointestinal Disturbances 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 to 4 hours after taking a white tablet, handle this as a missed tablet.
Adverse Reactions
6 ADVERSE REACTIONS 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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience 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. 6.2 Postmarketing Experience 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 to 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 to 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 to 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 Figure 2
Information for Patients
17 PATIENT COUNSELING INFORMATION 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 Iclevia [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 Iclevia if pregnancy is confirmed during treatment. Sexually Transmitted Infections Iclevia does 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 Iclevia pills” section in FDA-approved Instructions for Use [see Dosage and Administration (2.3) ]. Need for Additional Contraception Postpartum females who start Iclevia who have not yet had a period when they start Iclevia need to use an additional method of contraception until they have taken a 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 Iclevia [see Drug Interactions (7.1) ] . Lactation Iclevia 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 Iclevia 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) ] . Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 07/2024
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.