Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2323
| Subject | Predicate | Object | Context |
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| dailymed-drugs:2323 | rdf:type | http://www4.wiwiss.fu-berli... | lld:dailymed |
| dailymed-drugs:2323 | rdf:type | dailymed-instance:drugs | lld:dailymed |
| dailymed-drugs:2323 | rdfs:label | Nortrel 7/7/7 (Kit) | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:dosage | To achieve maximum contraceptive effectiveness, Nortrel 7/7/7 tablets must be taken exactly as directed and at intervals not exceeding 24 hours. Nortrel 7/7/7 tablets are available in the Blister Pack Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is also available.<br/>21-Day Regimen (Sunday Start):: When taking Nortrel 7/7/7 the first tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first tablet is taken on that day. One tablet is taken daily for 21 days. For subsequent cycles, no tablets are taken for 7 days, then a tablet is taken the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration. If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (���HOW TO TAKE THE PILL���section).<br/>21-Day Regimen (Day 1 Start):: The dosage of Nortrel 7/7/7 for the initial cycle of therapy is one tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as���Day 1.���For subsequent cycles, no tablets are taken for 7 days, then a new course is started of one tablet a day for 21 days. The dosage regimen then continues with 7 days of no medication, followed by 21 days of medication, instituting a three-weeks-on, one-week-off dosage regimen. If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (���HOW TO TAKE THE PILL���section).<br/>28-Day Regimen (Sunday Start):: When taking Nortrel 7/7/7 the first tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first tablet should be taken that day. Take one active tablet daily for 21 days followed by one white placebo tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration. If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (���HOW TO TAKE THE PILL���section).<br/>28-Day Regimen (Day 1 Start):: The dosage of Nortrel 7/7/7, for the initial cycle of therapy is one active tablet administered daily from the 1st through the 21st day of the menstrual cycle, counting the first day of menstrual flow as���Day 1���followed by one white tablet daily for 7 days. Tablets are taken without interruption for 28 days. After 28 tablets have been taken, a new course is started the next day. If the patient misses one (1) active tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) active tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) active tablets in the third week or misses three (3) or more active tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling (���HOW TO TAKE THE PILL���section). The use of Nortrel 7/7/7 for contraception may be initiated 4 weeks postpartum in women who elect not to breast feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolicdisease. See also PRECAUTIONS for���Nursing mothers.���) The possibility of ovulation and conception prior to initiation of medication should be considered. (See Discussion of Dose-related risk of vascular disease from oral contraceptives.) | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:descripti... | 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg (21 Day Regimen) and (28 Day Regimen) Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. COMBINATION ORAL CONTRACEPTIVES: Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol: Nortrel���7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) (21 Day Regimen and 28 Day Regimen): Each light yellow tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol and the inactive ingredients include D&C yellow #10, lactose monohydrate, magnesium stearate and pregelatinized starch. Each blue tablet contains 0.75 mg of norethindrone and 0.035 mg of ethinyl estradiol and the inactive ingredients include FD&C blue no. 1 (aluminum lake), lactose monohydrate, magnesium stearate and pregelatinized starch. Each peach tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol and the inactive ingredients include FD&C yellow no. 6 (aluminum lake), lactose monohydrate, magnesium stearate and pregelatinized starch. Each white tablet in the (28) package contains only inert ingredients as follows: lactose monohydrate, magnesium stearate, and pregelatinized starch. The chemical name for norethindrone is 17-hydroxy-19-nor-17��-pregn-4-en-20-yn-3-one, for ethinyl estradiol is 19-nor-17��-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. The structural formulas are as follows: | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:clinicalP... | COMBINATION ORAL CONTRACEPTIVES Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:activeIng... | dailymed-ingredient:norethi... | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:contraind... | Oral contraceptives should not be used in women who currently have the following conditions: | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:supply | Nortrel���7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) (21 Day Regimen) are available in a tablet dispenser containing 21 tablets as follows; 7 light yellow tablets (0.5 mg norethindrone and 0.035 mg ethinyl estradiol), 7 blue tablets (0.75 mg norethindrone and 0.035 mg ethinyl estradiol), and 7 peach tablets (1 mg norethindrone and 0.035 mg ethinyl estradiol). The light yellow tablets are unscored and debossed with stylized b on one side and 951 on the other side; the blue tablets are unscored and debossed with stylized b on one side and 942 on the other side; and the peach tablets are unscored and debossed with stylized b on one side and 943 on the other side. (NDC 0555-9011-57). Nortrel���7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) (28 Day Regimen) are available in a tablet dispenser containing 28 tablets as follows; 7 light yellow tablets, 7 blue tablets, and 7 peach tablets as described under the 21 Day Regimen listed above, and the 7 white tablets contain inert ingredients. (NDC 0555-9012-58). | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:boxedWarn... | Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke. | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:activeMoi... | dailymed-ingredient:norethi... | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:inactiveI... | dailymed-ingredient:magnesi... | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:inactiveI... | dailymed-ingredient:lactose... | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:inactiveI... | dailymed-ingredient:pregela... | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:inactiveI... | dailymed-ingredient:D&C_yel... | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:precautio... | 1. 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. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.<br/>2. Lipid disorders: Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.<br/>3. Liver function: If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.<br/>4. Fluid retention: Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.<br/>5. Emotional disorders: Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.<br/>6. Contact lenses: Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.<br/>7. Drug interactions: Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, carbamazepine, and possibly with griseofulvin, ampicillin and tetracyclines.<br/>8. Interactions with laboratory tests: Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:<br/>9. Carcinogenesis: See WARNINGS section.<br/>10. Pregnancy: Pregnancy Category X. See CONTRAINDICATIONS and WARNINGS sections.<br/>11. 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. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use combination oral contraceptives but to use other forms of contraception until she has completely weaned her child.<br/>12. Pediatric Use: Safety and efficacy of norethindrone and ethinyl estradiol tablets has been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 years and for users 16 years and older. Use of this product before menarche is not indicated.<br/>13. Sexually transmitted diseases: Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:overdosag... | Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females. | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:genericMe... | norethindrone and ethinyl estradiol | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:fullName | Nortrel 7/7/7 (Kit) | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:adverseRe... | An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section). The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:warning | Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke. The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (adapted from refs. 2 and 3 with the author's permission). For further information, the reader is referred to a text on epidemiological methods.<br/>1. Thromboembolic disorders and other vascular problems:<br/>a. Myocardial Infarction: An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six.The risk is very low under the age of 30. Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older with smoking accounting for the majority of excess cases.Mortality rates associated with circulatory disease have been shown to increase substantially in smokers, especially in those 35 years of age and older among women who use oral contraceptives. Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity.In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism.Oral contraceptives have been shown to increase blood pressure among users (see section 9 in WARNINGS). Similar effects on risk factors have been associated with an increased risk of heart disease. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.<br/>b. Thromboembolism: An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to nonusers to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease.Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization.The risk of thromboembolic disease associated with oral contraceptives is not related to length of use and disappears after pill use is stopped. A two- to four-fold increase in relative risk of post-operative thromboembolic complications has been reported with the use of oral contraceptives.The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions.If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization. Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four weeks after delivery in women who elect not to breast feed or fourweeks after a second trimester abortion.<br/>c. Cerebrovascular diseases: 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 (>35 years), hypertensive women who also smoke. Hypertension was found to be a risk factor for both users and nonusers, for both types of strokes, and smoking interacted to increase the risk of stroke. In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normotensive users to 14 for users with severe hypertension.The relative risk of hemorrhagic stroke is reported to be 1.2 for non-smokers who used oral contraceptives, 2.6 for smokers who did not use oral contraceptives, 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users and 25.7 for users with severe hypertension.The attributable risk is also greater in older women.<br/>d. 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.A decline in serum high density lipoproteins (HDL) has been reported with many progestational agents.A decline in serum high density lipoproteins has been associated with an increased incidence of ischemic heart disease. Because estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between doses of estrogen and progestogen and the activity of the progestogen used in the contraceptive. The activity and amount of both hormones should be considered in the choice of an oral contraceptive. Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. For any particular estrogen/progestogen combination, the dosage regimen prescribed should be one which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and the needs of the individual patient. New acceptors of oral contraceptive agents should be started on preparations containing 0.035 mg or less of estrogen.<br/>e. 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. In a study in the United States, the risk of developing myocardial infarction after discontinuing oral contraceptives persists for at least 9 years for women 40-49 years who had used oral contraceptives for five or more years, but this increased risk was not demonstrated in other age groups.In another study in Great Britain, the risk of developing cerebrovascular disease persisted for at least 6 years after discontinuation of oral contraceptives, although excess risk was very small.However, both studies were performed with oral contraceptive formulations containing 50 micrograms or higher of estrogens.<br/>2. 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). These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Each method of contraceptionhas its specific benefits and risks. The study concluded that with the exception of oral contraceptive users 35 and older who smoke, and 40 and older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth. The observation of an increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970's.Current clinical recommendation involves the use of lower estrogen dose formulations and a careful consideration of risk factors. In 1989, the Fertility and Maternal Health Drugs Advisory Committee was asked to review the use of oral contraceptives in women 40 years of age and over. The Committee concluded that although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception. The Committee recommended that the benefits of low-dose oral contraceptive use by healthy non-smoking women over 40 may outweigh the possible risks. Of course, older women, as all women who take oral contraceptives, should take an oral contraceptive which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and individual patient needs.<br/>3. Carcinoma of the reproductive organs and breasts: Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian and cervical cancer in women using oral contraceptives. While there are conflicting reports, most studies suggest that use of oral contraceptives is not associated with an overall increase in the risk of developing breast cancer. Some studies have reported an increased relative risk of developing breast cancer particularly at a younger age. This increased relative risk has been reported to be related to duration of use. A meta-analysis of 54 studies reports that women who are currently using combined oral contraceptives or have used them in the past 10 years are at a slightly increased risk of having breast cancer diagnosed although the additional cancers tend to be localized to the breast. There is no evidence of an increased risk of having breast cancer diagnosed 10 or more years after cessation of use. Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women.However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.<br/>4. Hepatic neoplasia: Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use especially with oral contraceptives of higher dose.Rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinomain oral contraceptive users. However, these cancers are rare in the U.S.<br/>5. Ocular lesions: There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be undertaken immediately.<br/>6. Oral contraceptive use before or during early pregnancy: Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy.The majority of recent studies also do not indicate a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned,when taken inadvertently during early pregnancy. The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion. It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral contraceptive use should be discontinued until pregnancy is ruled out.<br/>7. Gallbladder disease: Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens.More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal.The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens.<br/>8. Carbohydrate and lipid metabolic effects: Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users.This effect has been shown to be directly related to estrogen dose.Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents.However, in the non-diabetic woman, oral contraceptives appear to have no effect on fasting blood glucose.Because of these demonstrated effects, prediabetic and diabetic women in particular should be carefully monitored while taking oral contraceptives. A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see WARNINGS 1a and 1d), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.<br/>9. Elevated blood pressure: An increase in blood pressure has been reported in women taking oral contraceptivesand this increase is more likely in older oral contraceptive usersand with extended duration of use.Data from the Royal College of General Practitionersand subsequent randomized trials have shown that the incidence of hypertension increases with increasing progestational activity. Women with a history of hypertension or hypertension-related diseases, or renal diseaseshould be encouraged to use another method of contraception. If women elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued. For most women, elevated blood pressure will return to normal after stopping oral contraceptives, and there is no difference in the occurrence of hypertension between former and never users.<br/>10. 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.<br/>11. Bleeding irregularities: Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Nonhormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was preexistent.<br/>12. Ectopic pregnancy: Ectopic as well as intrauterine pregnancy may occur in contraceptive failures. | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:indicatio... | Nortrel���7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) (21 Day Regimen and 28 Day Regimen) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:represent... | http://www4.wiwiss.fu-berli... | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:routeOfAd... | http://www4.wiwiss.fu-berli... | lld:dailymed |
| dailymed-drugs:2323 | dailymed-instance:name | Nortrel 7/7/7 | lld:dailymed |
| http://www4.wiwiss.fu-berli... | dailymed-instance:producesD... | dailymed-drugs:2323 | lld:dailymed |