Start contraceptive therapy with Mili following the instructions in Table 1 for women not currently using hormonal contraception. The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Food Effect Follow the sticker with the days of the week (placed above the pills). Keep all drugs out of the reach of children and pets. The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. Cysts and Polyps): Breast cancer, benign breast neoplasm, hepatic adenoma, focal nodular hyperplasia, breast cyst; Tri-Lo-Mili and pregnancy Tri-Lo-Mili has defined as X FDA category. The dose of replacement thyroid hormone or cortisol therapy may need to be increased. Start with the dark blue pill on row #1 and take one pill each day, left to right, until the last green pill has been taken. If this is the first time you are taking birth control pills, read, “When should I start taking Mili?” above. Use COCs with caution in women with cardiovascular disease risk factors. If you have high blood sugar (diabetes), talk with your doctor. You may report side effects to the FDA at 1-800-FDA-1088. If you are scheduled for any lab tests, tell your healthcare provider you are taking Mili. Use non-hormonal contraception when you stop taking Mili. Not moving Examples include women who are known to: Have deep vein thrombosis or pulmonary embolism, now or in the past, Have inherited or acquired hypercoagulopathies, Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation), Have diabetes mellitus with vascular disease, Have headaches with focal neurological symptoms or migraine headaches with aura, Women over age 35 with any migraine headaches, Liver tumors, benign or malignant, or liver disease, Pregnancy, because there is no reason to use COCs during pregnancy, Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past, Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with. Start taking Mili on the day of removal of your implant or on the day when you would have had your next injection. Mili can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of Mili. Use Mili (ethinyl estradiol and norgestimate) as ordered by your doctor. help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. Do not use in children who have not had their first menstrual period. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. Mili is a combination birth control pill. Ethinyl estradiol and norgestimate is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary). Some studies suggest that COC use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued. Rx only One Blister Card of 28 tablets each What is Mili? Eyesight changes or loss, bulging eyes, or change in how contact lenses feel. Two trials were randomized active-controlled trials and 1 was an uncontrolled open-label trial. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. What is the most important information I should know about Mili? Some drugs may have another patient information leaflet. This risk increases with age, particularly in women over 35 years of age who smoke. These include 18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-hydroxy-13-ethyl,(17α)-(-);18,19-Dinor-5β-17-pregnan-20-yn,3α,17β-dihydroxy-13-ethyl,(17α), various hydroxylated metabolites and conjugates of these metabolites. Available for Android and iOS devices. Reproductive System and Breast Disorders: Ovarian cyst, suppressed lactation, vulvovaginal dryness; Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. The better you follow the directions, the less chance you have of getting pregnant. Talk to your healthcare provider about the best birth control method for you while breastfeeding. Signs of an allergic reaction, like rash; Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or Generic Name: Ethinyl Estradiol and Norgestimate (ETH in il es tra DYE ole & nor JES ti mate)Brand Name: Estarylla, Femynor, Mili, Mono-Linyah, MonoNessa, ...show all 25 brand names.Ortho Tri-Cyclen (28), Ortho Tri-Cyclen Lo, Ortho-Cyclen (28), Previfem, Sprintec 28, Tri Femynor, Tri-Estarylla, Tri-Linyah, Tri-Lo-Estarylla, Tri-Lo-Marzia, Tri-Lo-Mili, Tri-Lo-Sprintec, Tri-Mili, Tri-Previfem, Tri-Sprintec, Tri-VyLibra, Tri-VyLibra Lo, TriNessa (28), TriNessa Lo, VyLibra. Additional Information Birth control type. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Tell all of your health care providers that you take Mili (ethinyl estradiol and norgestimate). But for others, the traditional Pill is not an option. 1. Metabolism Carton of 6 Pouches NDC 65862-776-92. Mili (norgestimate and ethinyl estradiol tablets USP 0.250 mg/0.035 mg) are available in a blister pack. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Human immunodeficiency virus (HIV)/Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors: NGM’s primary active metabolite is NGMN. With typical usage, it is about 91 percent effective at preventing pregnancy. Call your doctor or get medical The incidence of hypertension increases with increasing concentrations of progestin. Tri-Mili™ is an estrogen/progestin COC, indicated for use by women to prevent pregnancy and is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. What is Mili? Respiratory, Thoracic and Mediastinal Disorders: Dyspnea; Skin and Subcutaneous Tissue Disorders: Angioedema, erythema nodosum, hirsutism, night sweats, hyperhidrosis, photosensitivity reaction, urticaria, pruritus, acne; Use of this product before menarche is not indicated. Take the two missed tablets as soon as possible and the next two active tablets the next day. Administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy [see Use in Specific Populations (8.1)]. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation. A lump in the breast, breast pain or soreness, or nipple discharge. The best birth control pills for women with acne typically contain at least 35 mcg (.035 mg) of Ethinyl Estradiol and progestin with a low androgenic effect. Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Discontinue Mili use if pregnancy is confirmed. You can either start on a Sunday (Sunday Start) or on the first day (Day 1) of your natural menstrual period (Day 1 Start). A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Carefully observe women with a history of depression and discontinue Mili if depression recurs to a serious degree. Non-hormonal methods of contraception are compatible with breastfeeding though no method is 100% effective against pregnancy regardless of whether you are breastfeeding or not. Do not smoke or use tobacco. Examples include: Barrier methods (condom, diaphragm, cervical cap, sponge ) Distribution Take with food if it causes an upset stomach. You will use a Day 1 Start if your doctor told you to take your first pill (Day 1) on the first day of your period. If you are breast-feeding or plan to breast-feed. If using Mili (ethinyl estradiol and norgestimate) to prevent pregnancy, another prevent pregnancy. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The most effective methods are at the top of the chart. jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Quantity. Mili and you have not used a hormonal birth control method before: Mili and you are switching from another birth control pill: Mili and previously used a vaginal ring or transdermal patch: Mili and you are switching from a progestin-only method such as an implant or injection: Mili and you are switching from an intrauterine device or system (IUD or IUS): If you have any questions or are unsure about the information in this leaflet, call your healthcare provider. Eye Disorders: Visual impairment, dry eye, contact lens intolerance; Women with a history of pregnancy-related cholestasis may be at an increased risk for COC related cholestasis. If you have trouble remembering to take Mili, talk to your healthcare provider. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Check with your Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles, had blood clots in your arms, legs, lungs, or eyes, had a problem with your blood that makes it clot more than normal, have certain heart valve problems or irregular heart beat that increases your risk of having blood clots, have high blood pressure that cannot be controlled by medicine, have diabetes with kidney, eye, nerve, or blood vessel damage, 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 liver problems, including liver tumors. COCs can reduce milk production in breastfeeding mothers. Medically reviewed by Drugs.com. Consider alternative contraception for women with uncontrolled dyslipidemia. These effects usually resolve within 2–3 months, but they can persist.. If you have had any of these health problems: If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. Avoid sun, sunlamps, and tanning beds. Some other examples of serious blood clots include blood clots in the legs or eyes. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. Who should not take Mili? Check your blood sugar as you have been told by your doctor. Check with your pharmacist. Excretion If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling]. The pharmacokinetics of Mili has not been studied in women with renal impairment. Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. Your healthcare provider should tell you when to start taking your birth control pill. However, the risk of liver cancers in COC users is less than one case per million users. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. If you miss pills (including starting the pack late). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus. Mili Tablets are available in blister packs. Counsel patients about the following information: Mili (Norgestimate and Ethinyl Estradiol Tablets USP 0.250 mg/0.035 mg) Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. 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