Discontinue if thrombotic event, unexplained visual changes, jaundice, migraine or other severe headaches occur, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Uncontrolled hypertension. Gallbladder disease.
Uncontrolled dyslipidemias. Pregnancy-related cholestasis. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor blood pressure. Do regular complete physical exams. Nursing mothers: not recommended. May be antagonized by CYP3A4 or other enzyme inducers eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. Discontinue use of ethinyl norethindrone; ethinyl estradiol; ferrous fumarate if jaundice develops during COC use.
Steroid hormones may be poorly metabolized in patients with liver impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COCs until markers of liver function return to normal and COC causation has been excluded.
Patients with hepatitis C who are being treated with ombitasvir; paritaprevir; ritonavir, with or without dasabuvir are contraindicated to receive COCs. During clinical trials with the hepatitis C combination drug regimen that contains ombitasvir; paritaprevir; ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal ULN , including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications.
Discontinue COCs before starting hepatitis C therapy with ombitasvir; paritaprevir; ritonavir, with or without dasabuvir; COCs can be restarted approximately 2 weeks after completing treatment with the hepatitis C combination drug regimen.
Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long term more than 8 years COC users. However, the attributable risk of liver cancers in COC users is less than 1 case per million users.
In general, COCs should be used cautiously in patients with pre-existing gallbladder disease and acute or intermittent porphyria. Both progestins and estrogens appear to be excreted into breast milk. Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few reports of effects on the infant exist, including jaundice and breast enlargement. Experts often recommend avoidance of estrogen-containing hormonal contraceptives, in the first 21 days postpartum or longer, if other risks for thromboembolism exist due to maternal post-partum clot risks following obstetric delivery , and the potential for OCs to interfere with the establishment of lactation.
It is generally accepted that estrogen-containing combined contraceptives may be used after this period in healthy women without other risk factors; general monitoring of the infant for effects such as appetite changes, breast changes, and proper weight gain and growth should occur. Manufacturers, however, recommend avoidance of combined hormonal oral contraceptives OCs if possible until a mother has completely weaned her child.
One study found that lower dose oral combined contraceptives e. However, a systematic review concluded that the available evidence, even from randomized controlled trials, is limited and of poor quality; the authors concluded that properly designed and conducted trials are needed to make determinations on the appropriateness of hormonal contraception during lactation and the effects on the health and growth of the infant.
However, in general, deleterious effects have not been noted in most infants. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.
If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA. Alternate contraceptive agents for consideration include non-hormonal contraceptive methods and also progestin-only contraceptives, such as medroxyprogesterone injection e.
Preliminary studies have suggested that obesity may be a risk factor for norethindrone; ethinyl estradiol; ferrous fumarate failure, particularly with the predominantly lower-dose i. Also, pre-existing morbid obesity can be one factor that may increase cardiovascular or thromboembolic risks associated with combination hormonal contraceptive use in selected individuals. Altered glucose tolerance secondary to decreased insulin sensitivity has been reported with hormone therapy, though the effects appear to be minimal in most non-diabetic patients receiving norethindrone; ethinyl estradiol; ferrous fumarate.
Patients with hyperglycemia or diabetes mellitus should be observed for changes in glucose tolerance when initiating or discontinuing norethindrone; ethinyl estradiol; ferrous fumarate therapy.
Because of the increased potential for embolic risk, norethindrone; ethinyl estradiol; ferrous fumarate is contraindicated in patients with diabetes with vascular involvement. Estrogens generally have a favorable effect on blood lipids, and reduce LDL and increase HDL cholesterol concentrations.
Progestins, however, may attenuate some of these effects by raising LDL and may make control of pre-existing hyperlipidemia more difficult. Serum triglycerides may increase with estrogen administration. A small proportion of women may have persistent hypertriglyceridemia while using norethindrone; ethinyl estradiol; ferrous fumarate. Accordingly, oral contraceptive OC use has been reported to induce, unmask, and exacerbate lupus; case reports and other anecdotal data indicate that a temporal relationship between OC use and lupus flares exist.
However, several retrospective studies dispute a relationship between OCs causing or exacerbating lupus, and a large prospective, randomized clinical trial SELENA evaluating the safety of estrogen therapy both as OCs and hormone replacement therapy in postmenopausal women has been completed and is being analyzed. Determining the risk of OC use in SLE patients is important as women with lupus benefit from OCs; not only do they offer reliable birth control, but they also possibly protect patients requiring chronic corticosteroid therapy from bone fractures and osteoporosis.
Women with hypercoagulable states are at increased risk of venous thromboembolism when taking OCs; given the increased prevalence of hypercoagulable states in patients with SLE in particular antiphospholipid antibodies and lupus anticoagulant , presence of a hypercoagulable state should be determined prior to initiation of norethindrone; ethinyl estradiol; ferrous fumarate in this population.
OCs should be avoided in SLE patients with a history of venous or arterial thrombosis or the presence of a hypercoagulable state.
If OCs are initiated in SLE patients without hypercoagulable states, low-dose estrogen contraceptives i. In addition, it may be prudent to avoid OC therapy in patients with unstable or severe SLE or a history of SLE exacerbation with estrogen therapy until more data regarding the use of OCs in this population are available.
Patients undergoing elective surgery of a type associated with an increased risk of thromboembolism should usually stop norethindrone; ethinyl estradiol; ferrous fumarate at least 4 weeks before and 2 weeks after surgery, dependent upon the continued potential for thromboembolic risk. Combination hormonal contraceptives should also be stopped during and after any prolonged immobilization.
Norethindrone; ethinyl estradiol; ferrous fumarate is contraindicated in patients with uncontrolled hypertension. Use cautiously in patients with controlled hypertension or kidney disease. Blood pressure should be monitored closely in these individuals. Any significant increase in blood pressure while on hormonal contraceptives may require discontinuation of the medication. Hormonal contraceptives may also cause fluid retention, and patients predisposed to complications from edema should be closely monitored.
Norethindrone; ethinyl estradiol; ferrous fumarate is contraindicated in patient with headache, such as migraine, which is accompanied by focal neurological symptoms, such as aura. The onset or exacerbation of migraine or the development of headache with a new pattern which is recurrent, persistent or severe requires evaluation of the cause.
Mood disorders, like depression, may be aggravated in women taking norethindrone; ethinyl estradiol; ferrous fumarate. Women with a history of depression may need special monitoring.
Low-dose oral contraceptive products may have minimal effect on depressive symptoms. If significant depression occurs, the oral contraceptive should be discontinued. Estrogens can increase the curvature of the cornea and may lead to intolerance of contact lenses. Consistent with potential thrombotic effects of oral contraceptives, there have been clinical case reports of retinal thrombosis or retinal vascular occlusion. Any change in vision or visual acuity should be examined by an ophthalmologist, and periodic eye examination is recommended in most patients during oral contraceptive use.
Patients developing any unexplained visual disturbance require evaluation; if retinal vascular occlusion occurs, hormonal oral contraception should be discontinued. Long-term oral contraceptive use may play a potential role in the development of glaucoma. According to research presented at a meeting of the American Acadamy of Opthomology, the use of oral contraceptives for more than 3 years, irrespective of formulation, was associated with a reported doubling of the incidence of glaucoma.
Survey respondents women, 40 years of age and older reported on oral contraceptive use between and ; participants completed the survey's vision and reproductive health questionnaire and underwent eye exams. Women reporting oral contraceptive use for more than 3 years were 2. Although causality was not determined, experts caution patients and providers to be aware of this association and recommend glaucoma screening for patients with additional risk factors.
Black patients, patients with a family history of glaucoma, and patients with a history of ocular hypertension or existing visual field defects represent groups with additional risk factors.
Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss 2 menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You may need to use back-up birth control, such as condoms with spermicide, when you first start using this medication.
Follow your doctor's instructions. Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day.
You may get pregnant if you do not take one pill daily. Some birth control packs contain "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills. You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy. If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time.
Any doctor or surgeon who treats you should know that you are using ethinyl estradiol and norethindrone. Follow the patient instructions provided with your medicine. Missing a pill increases your risk of becoming pregnant. If you miss 1 active pill, take 2 pills on the day you remember. Then take 1 pill per day for the rest of the pack.
If you miss 2 active pills in a row in Week 1 or 2, take 2 pills per day for 2 days in a row. Use back-up birth control for at least 7 days following the missed pills. If you miss 2 active pills in a row in Week 3, throw out the rest of the pack and start a new pack the same day if you are a Day 1 starter.
If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day. If you miss 3 active pills in a row in Week 1, 2, or 3 , throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter.
If you miss 2 or more active pills, you may not have a period during the month. If you miss a period for 2 months in a row, call your doctor because you might be pregnant. If you miss a reminder pill, throw it away and keep taking 1 reminder pill per day until the pack is empty. Seek emergency medical attention or call the Poison Help line at Overdose may cause nausea or vaginal bleeding.
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