This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration. What are the ingredients in Mili? any drug without checking with your doctor. Combination Pill. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. Tell all of your health care providers and lab workers that you take Mili (ethinyl estradiol and norgestimate). Mili is not to be used during pregnancy; if pregnancy occurs during use of Mili instruct the patient to stop further use, Take one tablet daily by mouth at the same time every day. If you are taking ombitasvir, paritaprevir, and. Be sure to have regular breast exams and gynecology check-ups. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. Smoking increases the risk of getting a blood clot or having a stroke while you are taking birth control pills, especially if you are more than 35 years old. Combination pills not only prevent ovulation and pregnancy, but they can also prevent acne. Carefully observe women with a history of depression and discontinue Mili if depression recurs to a serious degree. Musculoskeletal, Connective Tissue, and Bone Disorders: Muscle spasms, pain in extremity, myalgia, back pain; Metabolism In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. Sunday Start: What if I want to become pregnant? Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors (decrease [e.g., boceprevir and telaprevir]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]). Following administration of 14C-norgestimate, 47% (45 to 49%) and 37% (16 to 49%) of the administered radioactivity was eliminated in the urine and feces, respectively. Decide what time of day you want to take your pill. Start Mili, following the instructions in Table 1 for Day 1 or Sunday start, as desired. 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. If you feel sick to your stomach, do not stop taking the pill. Loading... View more photos. Important Information about taking Mili. Mili is contraindicated in women with benign and malignant liver tumors [see Contraindications (4)]. Your blister pack containing 28 individually sealed pills. Brand. Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. If a dose is missed, check the package insert or call the doctor to find out what to do. COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. It is important to take it at the same time every day and in the order as directed on your blister pack. This medicine may affect certain lab tests. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. You may report side effects to the FDA at 1-800-FDA-1088. Mili is a combination birth control pill. Throw out the rest of the pill pack and start a new pack that same day. This risk increases with age and the number of cigarettes you smoke. Take with food if it causes an, After starting Mili (ethinyl estradiol and norgestimate), you may need to use a non-hormone type of. Do not flush down a toilet or pour down a drain unless you are told to do so. For women with well-controlled hypertension, monitor blood pressure and stop Mili if blood pressure rises significantly. Keep all drugs out of the reach of children and pets. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. [See Warnings and Precautions (5.2, 5.11) and Use in Specific Populations (8.1).]. When you have picked the right sticker, throw away the others and place the sticker on the blister pack over the preprinted days of the week and make sure it lines up with the pills. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. 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. Equivalent medications For more information, ask your healthcare provider or pharmacist. Dosage Form: tablets. When you have picked the right sticker, throw away the others and place the sticker on the blister pack over the preprinted days of the week and make sure it lines up with the pills. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Know the medicines you take. Birth Control. ANALYSIS(65862-776), MANUFACTURE(65862-776). Overdosage may cause withdrawal bleeding in females and nausea. However, pregnancy increases the risk of VTE as much or more than the use of COCs. Some products are also used to treat acne. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. However, many people have no side effects or only have minor side effects. Tell all of your health care providers that you take Mili (ethinyl estradiol and norgestimate). Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. NGM’s primary active metabolite is NGMN. swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). (This is the day you begin bleeding or spotting, even if it is midnight when bleeding begins.) Signs of high blood pressure like very bad headache or. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. No specific pharmacodynamic studies were conducted with Mili. They are used to prevent ovulation and pregnancy. Liver Tumors However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant. ● On the day when next application would have been scheduled, ● On the day when next insertion would have been scheduled, ● On the day when next injection would have been scheduled. What should I do if I miss any Mili pills? Do not share your drugs with others and do not take anyone else's drugs. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill. Mili® (norgestimate and ethinyl estradiol tablets USP) 0.250 mg/0.035 mg Each dark blue coated tablet contains norgestimate Mili is a combination pill containing the hormones progestin and estrogen. If you miss 2 periods in a row, take a pregnancy test before starting a new cycle. Cysts and Polyps): Breast cancer, benign breast neoplasm, hepatic adenoma, focal nodular hyperplasia, breast cyst; This medicine may raise blood sugar. At this time Nurx only offers Mili for pickup at your local pharmacy, but we carry similar birth control options available for delivery. 2. 1. You do not need back-up contraception if your IUD or IUS is removed on the first day (Day 1) of your period. Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Tell your doctor about the allergy and Consider discontinuation of Mili in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event). Active ingredients: Each dark blue pill contains norgestimate and ethinyl estradiol. Discontinue Mili use if pregnancy is confirmed. Mili has not been studied in postmenopausal women and are not indicated in this population. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. There may be drug take-back programs in your area. Do not skip doses, even if you do not have sex very often. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. What else should I know about taking Mili? Take first active tablet without regard to meals on the first Sunday after the onset of menses. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Additional Information Birth control type. Price. Administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy [see Use in Specific Populations (8.1)]. If you are allergic to Mili (ethinyl estradiol and norgestimate); any part of Mili (ethinyl estradiol and norgestimate); or any other drugs, foods, or substances. Have blood work checked as you have been told by the doctor. These include spotting or bleeding between cycles. Each box on the chart contains a list of birth control methods that are similar in effectiveness. This risk increases with age, particularly in women over 35 years of age who smoke. Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or Rx only One Blister Card of 28 tablets each Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Mili has green inactive tablets (Day 22 to Day 28). Mili can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen. If this is the first time you are taking birth control pills, read, “When should I start taking Mili?” above. If you have had any of these health problems: If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use. Mili is not recommended for use in lactating women. Unchanged NGM was not detected in the urine. 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. Immune System Disorders: Hypersensitivity; Use non-hormonal contraception when you stop taking. Serious Adverse Reactions: breast cancer (1 subject), mood disorders including depression, irritability, and mood swings (1 subject), myocardial infarction (1 subject), and venous thromboembolic events including pulmonary embolism (1 subject) and deep vein thrombosis (DVT) (1 subject). There are 2 ways to start taking your birth control pills. I’ve now been prescribed Mili which I believe has a higher dose. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. How does Mili work for contraception? Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Mili Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)]. 2. Nervous System Disorders: Syncope, convulsion, paresthesia, dizziness; Amenorrhea and Oligomenorrhea age (mainly in women older than 35 years of age). By Karen Springen. Food Effect Anytime you start the pills later than directed, protect yourself by using another method of birth control until you have taken a pill a day for seven consecutive days. The safety of Mili was evaluated in 1,647 healthy women of child-bearing potential who participated in 3 clinical trials and received at least 1 dose of Mili for contraception. Each blister pack (28 tablets) contains in the following order: The blister packs are available in the following packages: Carton of 1 Blister Pack NDC 65862-776-28 If you have any questions about Mili (ethinyl estradiol and norgestimate), please talk Manufactured by: Counsel patients about the following information: Mili (Norgestimate and Ethinyl Estradiol Tablets USP 0.250 mg/0.035 mg) This medicine does not stop the spread of diseases like. with your doctor, nurse, pharmacist, or other health care provider. eyes; fever with chills; Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet). Combination Pill. Mili do not protect against HIV infection (AIDS) and other sexually transmitted infections. taken, how much, and when it happened. You can ask your pharmacist or healthcare provider for information about Mili that is written for health professionals. 4. Based on the results of clinical studies, about 1 out of 100 women may get pregnant during the first year they use Mili. Have your blood pressure checked as you have been told by your doctor. A lump in the breast, breast pain or soreness, or nipple discharge. If you have questions about side effects, call your doctor. Start your new Mili pack on the same day that you would start the next pack of your previous birth control method. Mili may affect the way other medicines work, and other medicines may affect how well Mili works. This chance is raised with At this time Nurx only offers Mili for pickup at your local pharmacy, but we carry similar birth control options available for delivery. Adverse Reactions Leading to Study Discontinuation: Over the three trials, between 11 to 21% of subjects discontinued the trial due to an adverse reaction. If a woman taking Mili develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Mili if indicated. How should I take Mili? Call your doctor or get medical 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. Talk with the doctor. Do not use Mili for a condition for which it was not prescribed. Common Adverse Reactions (≥ 2% of subjects): The most common adverse reactions reported by at least 2% of the 1,647 women were the following in order of decreasing incidence: headache/migraine (32.9%), abdominal/gastrointestinal pain (7.8%), vaginal infection (8.4%), genital discharge (6.8%), breast issues (including breast pain, discharge, and enlargement) (6.3%), mood disorders (including depression and mood altered) (5.0%), flatulence (3.2%), nervousness (2.9%), and rash (2.6%). See FDA-approved patient labeling (Patient Information and Instructions for Use). Mili may decrease the amount of breast milk you make. The pharmacokinetics of Mili has not been studied in women with renal impairment. This risk increases with age and the number of cigarettes you smoke. Carefully monitor prediabetic and diabetic women who take Mili. Be ready to tell or show what was Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. 3. The problem will usually go away. The pharmacokinetics of NGMN is dose-proportional following NGM doses of 180 mcg to 250 mcg. Start Mili no earlier than 4 weeks after delivery, in women who are not breastfeeding. Do not give Mili to other people, even if they have the same symptoms that you have. This Patient Information summarizes the most important information about Mili. Mili if you smoke cigarettes and are over 35 years old. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. may need to be stopped before certain types of surgery as your doctor has told you. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. 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. In addition to 17-deacetyl norgestimate, a number of metabolites of NGM have been identified in human urine following administration of radiolabeled NGM. No drug-drug interaction studies were conducted with Mili. Each green tablet contains inert ingredients. It works mainly by preventing the release of … Although NGMN and its metabolites inhibit a variety of P450 enzymes in human liver microsomes, under the recommended dosing regimen, the in vivo concentrations of NGMN and its metabolites, even at the peak serum levels, are relatively low compared to the inhibitory constant (Ki). This medicine The conducted epidemiological studies did not show an increase in the birth defects’ risk in future children whose mothers applied oral birth control before pregnancy. If Mili (ethinyl estradiol and norgestimate) is stopped, your doctor will tell you when to What should I know about my period when taking Mili? Substances decreasing the plasma concentrations of COCs: The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. Some products are also used to treat acne. Refer to the sample of the blister pack below: Do not take Mili if you: If any of these conditions happen while you are taking Mili, stop taking Mili right away and talk to your healthcare provider. If using Mili (ethinyl estradiol and norgestimate) to prevent pregnancy, another Norgestimate (NGM) and EE are rapidly absorbed following oral administration. Start taking Mili on the day of removal of your implant or on the day when you would have had your next injection. Safety and efficacy of Mili Tablets have been established in women of reproductive age. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. $20/month or free with most insurance. 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. The most effective methods are at the top of the chart. 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