If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. A total of 3 (0.2%) women discontinued norgestimate and ethinyl estradiol, at least in part, due to bleeding or spotting. 8.4 Pediatric Use Safety and efficacy of norgestimate and ethinyl estradiol have been established in women of reproductive age. Use of COCs may worsen existing gallbladder disease. • 7 green tablets (inert).Do not prescribe norgestimate and ethinyl estradiol to women who are known to have the following conditions: • A high risk of arterial or venous thrombotic diseases. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because the serum concentration of thyroid-binding globulin increases with use of COCs. The dose of replacement thyroid hormone or cortisol therapy may need to be increased. Tri-Lo-Estarylla Oral tablet 0.18-0.215-0.25-0.025mg Drug Medication Dosage information. Some drugs or herbal products that may decrease the effectiveness of COCs include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant and products containing St. John's wort. 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. In the clinical trial of norgestimate and ethinyl estradiol, the frequency and duration of unscheduled bleeding and/or spotting was assessed in 1,673 women (11,015 evaluable cycles). Start no earlier than 4 weeks after delivery, in women who are not breastfeeding.
• The use of COCs increases the risk of VTE. ( 5.8 ) 5.1 Thromboembolic Disorders and Other Vascular Problems • Stop norgestimate and ethinyl estradiol if an arterial thrombotic event or venous thrombotic (VTE) event occurs. • Stop norgestimate and ethinyl estradiol if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. 8.6 Hepatic Impairment The pharmacokinetics of norgestimate and ethinyl estradiol has not been studied in subjects with hepatic impairment. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings. • If feasible, stop norgestimate and ethinyl estradiol at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued. doctor or pharmacist) may already be aware of this interaction and may be monitoring you for it. Consider alternative contraception for women with uncontrolled dyslipidemia. 5.5 Gallbladder Disease Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Discontinue norgestimate and ethinyl estradiol if jaundice develops.
8.7 Renal Impairment The pharmacokinetics of norgestimate and ethinyl estradiol has not been studied in women with renal impairment. Evaluate for retinal vein thrombosis immediately [see ADVERSE REACTIONS (6.2) ]. An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. Stop at least 4 weeks before and through 2 weeks after major surgery. 5.10 Depression Carefully observe women with a history of depression and discontinue norgestimate and ethinyl estradiol if depression recurs to a serious degree. The incidence of hypertension increases with increasing concentrations of progestin. 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. Page 6: Sandoz Inc: Tri-Lo-Estarylla TM.
Do not start, stop, or change the dosage of any medicine before checking with them first.Selected from data included with permission and copyrighted by First Databank, Inc. 5.7 Headache If a woman taking norgestimate and ethinyl estradiol develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue norgestimate and ethinyl estradiol if indicated.
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