Evaluate for retinal vein thrombosis immediately. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Take first active tablet without regard to meals on the first day of menses. Efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older. 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 1). Do not use Tri-Lo-Sprintec for a condition for which it was not prescribed. One of these studies reported no association between breast cancer risk and COC use. For more information, ask your healthcare provider or pharmacist. Increasing body weight by 10 kg is predicted to reduce the following parameters: NGMN Cmax by 9% and AUC0-24h by 19%, NG Cmax by 12% and AUC0-24h by 46%, EE Cmax by 13% and AUC0-24h by 12%. Generic name: norgestimate and ethinyl estradiol This survey is being conducted by the WebMD marketing sciences department. The metabolites of NGMN and EE are eliminated by renal and fecal pathways. There are two ways to start taking birth control pills, Sunday Start or Day 1 Start. Do not continue taking the pills from your previous birth control pack. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different contraceptive product. This is not a complete list of possible side effects. are breastfeeding or plan to breastfeed. It is very important to continue taking this medication exactly as prescribed by your doctor. If you have diabetes, this medication may affect your blood sugar. Many people using this medication do not have serious side effects. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Tri-Lo-Sprintec is available to women of childbearing age. If you use the Sunday Start, use non-hormonal back-up contraception such as condoms and spermicide for the first. 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. Take the two missed tablets as soon as possible and the next two active tablets the next day. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. If any information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist. Your healthcare professional will tell you which to use. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. 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]. Do not give Tri-Lo-Sprintec to other people, even if they have the same symptoms that you have. Consider the possibility of ovulation and conception prior to initiation of this product. It is important to continue taking your pills on a regular schedule to prevent a pregnancy. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. had breast cancer or any cancer that is sensitive to female hormones, are pregnant or think you may be pregnant, are depressed now or have been depressed in the past, had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy). Know the medicines you take. dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma). Your periods may be lighter and shorter than usual. Ortho Tri-Cyclen, Estarylla, Mili, Mono-Linyah, +18 more. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued. If a woman taking Tri-Lo-Sprintec develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Tri-Lo-Sprintec if indicated. ED is often a symptom of another health problem or health-related factor. Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. Adverse Reactions Leading to Study Discontinuation: In the clinical trial of norgestimate and ethinyl estradiol 4% of subjects discontinued the trial due to an adverse reaction. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Follow the sticker with the days of the week (placed above the pills). Based on data from the clinical trials, 7 to 17% of women using norgestimate and ethinyl estradiol experienced unscheduled bleeding per cycle in the first year. The pregnancy rate in women aged 18 to 35 years was approximately 2.6 pregnancies per 100 woman-years of use. A total of 3 (0.2%) women discontinued norgestimate and ethinyl estradiol, at least in part, due to bleeding or spotting. This medication may raise your blood pressure. Light blue pills: anhydrous lactose, croscarmellose sodium, FD&C blue no. Additional non-hormonal contraception (such as condoms and spermicide) should be used as backup if the patient has sex within 7 days after missing tablets. Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was pre-existent. Talk to your healthcare provider about the best birth control method for you while breastfeeding. What is the most important information I should know about Tri-Lo-Sprintec? However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. The dose of replacement thyroid hormone or cortisol therapy may need to be increased. NGMN is bound to albumin and not to SHBG, while NG is bound primarily to SHBG. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation. Discontinue Tri-Lo-Sprintec prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4)]. Do not co-administer Tri-Lo-Sprintec with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.3)]. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), ritonavir, St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine), among others. 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, Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive, Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations. Start with the gray pill on row #1 and take one pill each day, left to right, until the last white pill has been taken. However, the risk of liver cancers in COC users is less than one case per million users. Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. If you do not get your period, consult your doctor. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. On the days you take 2 pills to make up for missed pills (see, It is not uncommon to miss a period. Risk of Breast Cancer with Combined Oral Contraceptive Use. What else should I know about taking Tri-Lo-Sprintec? *Minimum order 3 cycles MORE INFO MORE INFO This trial examined healthy, nonpregnant, volunteers aged 18 to 45 (nonsmoker if 35 to 45 years of age), who were sexually active with regular coitus. 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. An estimate of the attributable risk is 3.3 cases/100,000 COC users. After a first-trimester abortion or miscarriage, Tri-Lo-Sprintec may be started immediately. Read the Instructions for Use at the end of this Patient Information. In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke, [see How Supplied/Storage and Handling (16)]. Only a small to moderate fraction (5 to 40%) of the overall variability in the pharmacokinetics of NGMN and EE following Tri-Lo-Sprintec tablets may be explained by any or all of the above demographic parameters. Safety and efficacy of Tri-Lo-Sprintec tablets have been established in women of reproductive age. Subjects were followed for up to 13 28-day cycles. If you are using a product with 28 tablets, take an inactive pill once daily for 7 days in a row after you have taken the last active pill unless otherwise directed by your doctor. Erectile dysfunction (ED) is often a symptom . What are the ingredients in Tri-Lo-Sprintec? Increasing age was associated with slight decreases (6% with increasing age by 5 years) in Cmax and AUC0-24h for NGMN and were statistically significant, but there was no significant effect for NG or EE. A small proportion of women will have adverse lipid changes while on COCs. Taking this medication after your evening meal or at bedtime may help if you have stomach upset or nausea with the medication. Start Tri-Lo-Sprintec, following the instructions in Table 1 for Day 1 or Sunday start, as desired. These are not all the possible side effects of Tri-Lo-Sprintec. Consider the possibility of ovulation and conception prior to initiation of this product. irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking Tri-Lo-Sprintec. If you often forget to take your pills as directed, contact your doctor to discuss switching to another form of birth control. All rights reserved. It may also contain 7 reminder pills with no medication. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. Irregular vaginal bleeding or spotting may happen while you are taking Tri-Lo-Sprintec, especially during the first few months of use. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Take one active pill (with hormones) once daily for 21 days in a row. Pick the Days of the Week Sticker that starts the first day of your period. Selected from data included with permission and copyrighted by First Databank, Inc. jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. These changes were statistically significant. If you are scheduled for any lab tests, tell your healthcare provider you are taking Tri-Lo-Sprintec. being able to get an erection, but not having it last long enough for sex. Certain blood tests may be affected by Tri-Lo-Sprintec. 21 days in a row to FDA at 1-800-FDA-1088 or at bedtime may if. To SHBG, while NG is bound primarily to SHBG aged 18 to 35 years approximately... 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