This drug has been prescribed specifically for you; do not give it to others who may want birth control pills. In addition to preventing pregnancy, use of oral contraceptives may provide certain benefits.
They are:. If you want more information about birth control pills, ask your doctor or pharmacist. Remembering to take tablets according to schedule is stressed because of its importance in providing you the greatest degree of protection.
At times there may be no menstrual period after a cycle of pills. Therefore, if you miss one menstrual period but have taken the pills exactly as you were supposed to , continue as usual into the next cycle. If you have not taken the pills correctly and miss a menstrual period, you may be pregnant and should stop taking oral contraceptives until your doctor or healthcare provider determines whether or not you are pregnant.
Until you can get to your doctor or healthcare provider, use another form of contraception. If two consecutive menstrual periods are missed, you should stop taking pills until it is determined whether or not you are pregnant.
Although there does not appear to be any increase in birth defects in newborn babies if you become pregnant while using oral contraceptives, you should discuss the situation with your doctor or healthcare provider. Your doctor or healthcare provider will take a complete medical and family history before prescribing oral contraceptives. At that time and about once a year thereafter, he or she will generally examine your blood pressure, breasts, abdomen, and pelvic organs including a Papanicolaou smear, i.
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Norethindrone Acetate, USP. Pharmacokinetics The pharmacokinetics of Junel have not been characterized; however, the following pharmacokinetic information regarding norethindrone acetate and ethinyl estradiol is taken from the literature. Absorption Norethindrone acetate appears to be completely and rapidly deacetylated to norethindrone after oral administration, since the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone 1.
Metabolism Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. Excretion Norethindrone and ethinyl estradiol are excreted in both urine and feces, primarily as metabolites 5,6. Special Population Race: The effect of race on the disposition of Junel has not been evaluated. Renal Insufficiency The effect of renal disease on the disposition of Junel has not been evaluated.
Hepatic Insufficiency The effect of hepatic disease on the disposition of Junel has not been evaluated. Drug-Drug Interactions Numerous drug-drug interactions have been reported for oral contraceptives. Thromboembolic Disorders and Other Vascular Problems a. Myocardial infarction An increased risk of myocardial infarction has been attributed to oral contraceptive use.
Adapted from P. Layde and V. Beral, Reference Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Cerebrovascular disease Oral contraceptives have been shown to increase both the relative and attributable risks of cerebrovascular events thrombotic and hemorrhagic strokes , although, in general, the risk is greatest among older greater than 35 years , hypertensive women who also smoke. Dose-related risk of vascular disease from oral contraceptives A positive association has been observed between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease Persistence of risk of vascular disease There are two studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives.
Estimates of Mortality from Contraceptive Use One study gathered data from a variety of sources which have estimated the mortality rate associated with different methods of contraception at different ages Table III. Ory, Reference Carcinoma of the Reproductive Organs Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using oral contraceptives.
Hepatic Neoplasia Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign tumors is rare in the United States. Ocular Lesions There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives. Oral Contraceptive Use Before and During Early Pregnancy Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy Gallbladder Disease Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens 66, Carbohydrate And Lipid Metabolic Effects Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users Elevated Blood Pressure An increase in blood pressure has been reported in women taking oral contraceptives 74 and this increase is more likely in older oral contraceptive users 75 and with continued use Headache The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause.
Bleeding Irregularities Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Physical Examination and Follow-Up It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. Lipid Disorders Women who are being treated for hyperlipidemia should be followed closely if they elect to use oral contraceptives.
Liver Function If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Fluid Retention Oral contraceptives may cause some degree of fluid retention. Emotional Disorders Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree. Contact Lenses Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
Drug Interactions Effects of Other Drugs on Oral Contraceptives 78 Rifampin: Metabolism of both norethindrone and ethinyl estradiol is increased by rifampin.
Effects of Oral Contraceptives on Other Drugs Oral contraceptive combinations containing ethinyl estradiol may inhibit the metabolism of other compounds. Interactions With Laboratory Tests Certain endocrine and liver function tests and blood components may be affected by oral contraceptives: Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
Increased thyroid binding globulin TBG leading to increased circulating total thyroid hormone, as measured by protein-bound iodine PBI , T 4 by column or by radioimmunoassay. Free T 3 resin uptake is decreased, reflecting the elevated TBG; free T 4 concentration is unaltered. Other binding proteins may be elevated in serum. Sex-binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged.
Triglycerides may be increased. Glucose tolerance may be decreased. Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives. Pregnancy Pregnancy Category X. Nursing Mothers Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers, and a few adverse effects on the child have been reported, including jaundice and breast enlargement.
Pediatric Use Safety and efficacy of Junel have been established in women of reproductive age. See patient labeling printed below. Effects on menses: Increased menstrual cycle regularity Decreased blood loss and decreased incidence of iron deficiency anemia Decreased incidence of dysmenorrhea Effects related to inhibition of ovulation: Decreased incidence of functional ovarian cysts Decreased incidence of ectopic pregnancies Effects from long-term use: Decreased incidence of fibroadenomas and fibrocystic disease of the breast Decreased incidence of acute pelvic inflammatory disease Decreased incidence of endometrial cancer Decreased incidence of ovarian cancer.
The possibility of ovulation and conception prior to initiation of use should be considered. Dosage and Administration for Day Dosage Regimen To achieve maximum contraceptive effectiveness, Junel 21 must be taken exactly as directed and at intervals not exceeding 24 hours. Sunday-Start Regimen: The patient begins taking tablets from the top row on the first Sunday after menstrual flow begins.
When menstrual flow begins on Sunday, the first tablet is taken on the same day. The last tablet in the dispenser will then be taken on a Saturday, followed by no tablets for a week 7 days. For all subsequent cycles, the patient then begins a new tablet regimen on the eighth day, Sunday, after taking her last tablet. Following this regimen, of 21 days on days off, the patient will start all subsequent cycles on a Sunday.
Day-1 Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive days of the week sticker that corresponds to her starting day over the preprinted days on the blister card. She starts taking one tablet daily, beginning with the first tablet in the top row. The patient completes her tablet regimen when she has taken the last tablet in the tablet dispenser. She will then take no tablets for a week 7 days. For all subsequent cycles, the patient begins a new tablet regimen on the eighth day after taking her last tablet, again starting with the first tablet in the top row after placing the appropriate days of the week sticker over the preprinted days on the blister card.
Following this regimen of 21 days on days off, the patient will start all subsequent cycles on the same day of the week as the first course. Likewise, the interval of no tablets will always start on the same day of the week. Special Notes on Administration Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after discontinuing medication. Dosage and Administration for Day Dosage Regimen To achieve maximum contraceptive effectiveness, Junel Fe should be taken exactly as directed and at intervals not exceeding 24 hours.
When the menstrual flow begins on Sunday, the first light yellow or pink tablet is taken on the same day. The patient takes one light yellow or pink tablet daily for 21 days. The last light yellow or pink tablet in the dispenser will be taken on a Saturday. Upon completion of all 21 light yellow or pink tablets, and without interruption, the patient takes one brown tablet daily for 7 days.
Upon completion of this first course of tablets, the patient begins a second course of day tablets, without interruption, the next day Sunday , starting with the Sunday light yellow or pink tablet in the top row. Adhering to this regimen of one light yellow or pink tablet daily for 21 days, followed without interruption by one brown tablet daily for seven days, the patient will start all subsequent cycles on a Sunday. She starts taking one light yellow or pink tablet daily, beginning with the first light yellow or pink tablet in the top row.
After the last light yellow or pink tablet at the end of the third row has been taken, the patient will then take the brown tablets for a week 7 days. For all subsequent cycles, the patient begins a new 28 tablet regimen on the eighth day after taking her last light yellow or pink tablet, again starting with the first tablet in the top row after placing the appropriate days of the week sticker over the preprinted days on the blister card.
Following this regimen of 21 light yellow or pink tablets and 7 brown tablets, the patient will start all subsequent cycles on the same day of the week as the first course. Special Notes on Administration Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after the brown tablets have been started.
Use of Oral Contraceptives in the Event of a Missed Menstrual Period If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period and oral contraceptives should be withheld until pregnancy has been ruled out. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.
Single-dose kinetics. Clin Pharmacol Ther ; Humpel M, Nieuwober B, Wendt H and Speck U: Investigations of pharmacokinetics of ethinyl estradiol to specific consideration of a possible first-pass effect in women. Contraception ; An investigation of the pharmacokinetics of ethinyl estradiol in women using radioimmunoassay. Distribution and percentages of non-protein bound contraceptive steroids in human serum.
J Steriod Biochem ; Fotherby K. Goldzieher JW. Hatcher RA, et al. Contraceptive Technology, Sixteenth Edition. New York: Irvington Publishers. Stadel, B. New England Journal of Medicine , , Adam, S. Thorogood: Oral contraception and myocardial infarction revisited: The effects of new preparations and prescribing patterns.
Mann, J. Inman: Oral contraceptives and death from myocardial infarction. Vessey, M. Thorogood, and R. Doll: Myocardial infarction in young women with special reference to oral contraceptive practice. Lancet , , Slone, D. Shapiro, D. Kaufman, L. Rosenberg, O. Miettinen, and P. Stolley: Risk of myocardial infarction in relation to current and discontinued use of oral contraceptives. Russell-Briefel, R. Ezzati, R. Fulwood, J. Perlman, and R. Murphy: Cardiovascular risk status and oral contraceptive use, United States, Preventive Medicine , , Goldbaum, G.
Kendrick, G. Hogelin, and E. Gentry: The relative impact of smoking and oral contraceptive use on women in the United States.
Layde, P. Table 5 Lancet , , Knopp, R. Krauss, R. Roy, D. Mishell, J. Casagrande, and M. Pike: Effects of two low-dose oral contraceptives on serum lipids and lipoproteins: Differential changes in high-density lipoproteins subclasses. Wahl, P. Walden, R. Knopp, J. Hoover, R. Wallace, G. Heiss, and B. Wynn, V. Niththyananthan: The effect of progestin in combined oral contraceptives on serum lipids with special reference to high-density lipoproteins.
Godsland: Effects of oral contraceptives on carbohydrate metabolism. Medicine , 31 9 Supplement : , LaRosa, J. Inman, W. Vessey: Investigations of death from pulmonary, coronary, and cerebral thrombosis and embolism in women of child-bearing age. Maguire, M. Tonascia, P. Sartwell, P. Stolley, and M. Tockman: Increased risk of thrombosis due to oral contraceptives: A further report. Epidemiology , 2 : , Pettiti, D. Wingerd, F. Pellegrin, and S.
Ramacharan: Risk of vascular disease in women: Smoking, oral contraceptives, noncontraceptive estrogens, and other factors. Doll: Investigation of relation between use of oral contraceptives and thromboembolic disease.
Doll: Investigation of relation between use of oral contraceptives and thromboembolic disease: A further report. Porter, J. Hunter, D. Danielson, H. Jick, and A. Stergachis: Oral contraceptives and non-fatal vascular disease: Recent experience. Doll, R. Peto, B. Johnson, and P. Wiggins: A long-term follow-up study of women using different methods of contraception: An interim report. Royal College of General Practitioners: Oral contraceptives, venous thrombosis, and varicose veins.
Collaborative Group for the study of stroke in young women: Oral contraception and increased risk of cerebral ischemia or thrombosis. Petitti, D. Wingerd: Use of oral contraceptives, cigarette smoking, and risk of subarachnoid hemorrhage.
Collaborative Group for the study of stroke in young women: Oral contraceptives and stroke in young women: Associated risk factors. Vessey, B. Westerholm, and A. Engelund: Thromboembolic disease and the steroidal content of oral contraceptives. A report to the Committee on Safety of Drugs.
Meade, T. Greenberg, and S. Thompson: Progestogens and cardiovascular reactions associated with oral contraceptives and a comparison of the safety of and mcg estrogen preparations. Kay, C. Royal College of General Practitioners: Incidence of arterial disease among oral contraceptive users. Ory, H. Family Planning Perspectives , , Pike, M. Henderson, M. Krailo, A. Duke, and S.
Roy: Breast cancer in young women and use of oral contraceptives: Possible modifying effect of formulation and age at use. Paul, C. Skegg, G. Spears, and J. Kaldor: Oral contraceptives and breast cancer: A national study.
Miller, D. Rosenberg, D. Kaufman, D. Schottenfeld, P. Stolley, and S. Shapiro: Breast cancer risk in relation to early oral contraceptive use. Olson, H. Olson, T. Moller, J. Ranstam, P. Holm: Oral contraceptive use and breast cancer in young women in Sweden letter.
McPherson, K. Vessey, A. Neil, R. Doll, L. Jones, and M. Roberts: Early contraceptive use and breast cancer: Results of another case-control study.
Cancer , , Huggins, G. Zucker: Oral contraceptives and neoplasia: update. Drife: The pill and breast cancer: Why the uncertainty? Shapiro, S. Naib, S. Conger, R. Hatcher, and C. Birth control has long been prescribed as treatment for acne. If acne is a concern for you, let us know in the consultation and our doctors will help you find the right brand for you. During these 7 days, you should use backup contraception like condoms during vaginal sex, since there is still a possibility you could get pregnant.
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