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12621-2
Necon 1/35-21
Necon 1/35-28
(norethindrone and ethinyl estradiol tablets, USP)
Necon 10/11-21
Necon 10/11-28
(norethindrone and ethinyl estradiol tablets, USP)
Necon 0.5/35-21
Necon 0.5/35-28
(norethindrone and ethinyl estradiol tablets, USP)
Necon 1/50-21
Necon 1/50-28
(norethindrone and mestranol tablets, USP)
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Necon 1/35-21 and Necon 1/35-28 (Norethindrone and Ethinyl Estradiol Tablets, USP). Each dark yellow tablet contains 1 mg of norethindrone and 35 mcg of ethinyl estradiol, and the inactive ingredients include microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium and povidone. In addition, the coloring agent is D&C Yellow No. 10. Each white tablet in the Necon 1/35-28 package is a placebo containing no active ingredients and the inactive ingredients include microcrystalline cellulose, lactose (anhydrous), and magnesium stearate.
Necon 0.5/35-21 and Necon 0.5/35-28 (Norethindrone and Ethinyl Estradiol Tablets, USP) . Each light yellow tablet contains 0.5 mg of norethindrone and 35 mcg of ethinyl estradiol, and the inactive ingredients include microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium and povidone. In addition, the coloring agent is D&C Yellow No. 10. Each white tablet in the Necon 0.5/35-28 package is a placebo containing no active ingredients and the inactive ingredients include microcrystalline cellulose, lactose (anhydrous), and magnesium stearate.
Necon 10/11-21 and Necon 10/11-28 (Norethindrone and Ethinyl Estradiol Tablets, USP) . Each light yellow tablet (10) contains 0.5 mg of norethindrone and 35 mcg of ethinyl estradiol. Each dark yellow tablet (11) contains 1 mg of norethindrone and 35 mcg of ethinyl estradiol. The inactive ingredients include microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium and povidone. In addition, the coloring agent is D&C Yellow No. 10. Each white tablet in the Necon 10/11-28 package is a placebo containing no active ingredients and the inactive ingredients include microcrystalline cellulose, lactose (anhydrous), and magnesium stearate.
Necon 1/50-21 and Necon 1/50-28 (Norethindrone and Mestranol Tablets, USP). Each light blue tablet contains 1 mg of norethindrone and 50 mcg of mestranol, and the inactive ingredients include microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium and povidone. In addition, the coloring agent is FD&C Blue No. 1 Aluminum Lake. Each white tablet in the Necon 1/50-28 package is a placebo containing no active ingredients and the inactive ingredients include microcrystalline cellulose, lactose (anhydrous), and magnesium stearate.
The chemical name for norethindrone is 17-hydroxy-19- nor -17(alpha)-pregn-4-en-20-yn-3-one. The chemical name of ethinyl estradiol is 19-nor-17(alpha)-pregna-1, 3, 5(10)-trien-20-yne-3, 17-diol. The chemical name for mestranol is 3-methoxy-19-nor-17(alpha)-pregna-1, 3, 5(10)-trien-20-yn-17-ol. The structural formulas are as follows:
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Combination oral contraceptives act primarily by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations in the genital tract, including changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which may reduce the likelihood of implantation).
Necon 1/35, Necon 0.5/35, Necon 10/11 and Necon 1/50 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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.
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Oral contraceptives should not be used in women who have the following conditions:
| Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels 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 are strongly advised not to smoke. |
The use of oral contraceptives is associated with increased risk of several serious conditions including venous and arterial thromboembolism, thrombotic and hemorrhagic stroke, myocardial infarction, liver tumors or other liver lesions, and gallbladder disease. The risk of morbidity and mortality increases significantly in the presence of other risk factors such as hypertension, hyperlipidemia, obesity, and diabetes mellitus.
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these and other risks. The information contained herein is principally based on studies carried out in patients who use oral contraceptives with formulations containing higher amounts of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lesser amounts of both estrogens and progestogens remains to be determined.
Throughout this labeling, epidemiological studies reported are of two types: retrospective case-control studies and prospective cohort studies. Case-control studies provide an estimate of the relative risk of a disease, which is defined as the ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk (or odds ratio) does not provide information about the actual clinical occurrence of a disease. Cohort studies provide a measure of both the relative risk and the attributable risk. The latter is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence or incidence of a disease in the subject population. For further information, the reader is referred to a text on epidemiological methods.
An increased risk of myocardial infarction has been associated with oral contraceptive use. 2-21 This increased risk is primarily in smokers or in women with other underlying risk factors for coronary artery disease such as hypertension, obesity, diabetes, and hypercholesterolemia. The relative risk for myocardial infarction in current oral contraceptive users has been estimated to be 2 to 6. The risk is very low under the age of 30. However, there is the possibility of a risk of cardiovascular disease even in very young women who take oral contraceptives.
Smoking in combination with oral contraceptive use has been reported to contribute substantially to the risk of myocardial infarction in women in the mid-thirties or older, with smoking accounting for the majority of excess cases. 22 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.(Table II.)
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Oral contraceptives may compound the effects of well-known cardiovascular risk factors such as hypertension, diabetes, hyperlipidemias, hypercholesterolemia, age, cigarette smoking, and obesity. In particular, some progestogens decrease HDL cholesterol 23-31 and cause glucose intolerance, while estrogens may create a state of hyperinsulinism. 32 Oral contraceptives have been shown to increase blood pressure among some users (see WARNING No. 9 ). Similar effects on risk factors have been associated with an increased risk of heart disease.
An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. 17, 33-51 Case-control studies have estimated the relative risk 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. 34-37, 45, 46 Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases (subjects with no past history of venous thrombosis or varicose veins) and about 4.5 for new cases requiring hospitalization. 42, 47, 48 The risk of venous thromboembolic disease associated with oral contraceptives is not related to duration of use.
A two- to seven-fold increase in relative risk of postoperative thromboembolic complications has been reported with the use of oral contraceptives. 38, 39 The relative risk of venous thrombosis in women who have predisposing conditions is about twice that of women without such medical conditions. 43 If feasible, oral contraceptives should be discontinued at least 4 weeks prior to and for 2 weeks after elective surgery of a type associated with an increased risk of thromboembolism, and also 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 4 to 6 weeks after delivery in women who elect not to breast feed.
Both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes) have been reported to be increased with oral contraceptive use, 14, 17, 18, 34, 42, 46, 52-59 although, in general, the risk was greatest among older (over 35 years) hypertensive women who also smoked. Hypertension was reported to be a risk factor for both users and nonusers for both types of strokes, while smoking increased the risk factor for both users and nonusers for both types of strokes, while smoking increased the risk for hemorrhagic strokes.
In one large study, 52 the relative risk for thrombotic stroke was reported as 9.5 times greater in users than in nonusers. It ranged from 3 for normotensive users to 14 for users with severe hypertension. 54 The relative risk for hemorrhagic stroke was reported to be 1.2 for nonsmokers who used oral contraceptives, 1.9 to 2.6 for smokers who did not use oral contraceptives, 6.1 to 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users, and 25.7 for users with severe hypertension. The risk is also greater in older women and among smokers.
A positive association has been reported between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease. 41, 43, 53, 59-64 A decline in serum high density lipoproteins (HDL) has been reported with many progestogens. 23-31 A decline in serum high density lipoproteins has been associated with an increased incidence of ischemic heart disease. 65 Because estrogens increase HDL-cholesterol, the net effect of an oral contraceptive depends on the balance achieved between doses of estrogen and progestogen and the nature and absolute amount of progestogens used in the contraceptives. The amount of both steroids 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 that 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 contraceptives should be started on preparations containing the lowest estrogen content that produces satisfactory results in the individual.
There are three studies that have shown persistence of risk of vascular disease for users of oral contraceptives. In a study in the United States, the risk of developing myocardial infarction after discontinuing oral contraceptives persisted for at least 9 years for women 40-49 years old who had used oral contraceptives for 5 or more years, but this increased risk was not demonstrated in other age groups. 16 Another American study reported former use of oral contraceptives was significantly associated with increased risk of subarachnoid hemorrhage. 57 In another study, in Great Britain, the risk of developing non-rheumatic heart disease plus hypertension, subanoid hemorrhage, cerebral thrombosis, and transient ischemic attacks persisted for at least 6 years after discontinuation of oral contraceptives, although the excess risk was small. 14, 18, 66 It should be noted that these studies were performed with oral contraceptive formulations containing 50 mcg or more of estrogens.
One study 67 gathered data from a variety of sources that have estimated the mortality rates associated with different methods of contraception at different ages. (Table 2). 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 contraception has 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 a possible increase in risk of mortality with age of oral contraceptive users is based on data gathered in the 1970's, but not reported until 1983. 67 However, current clinical practice involves the use of lower estrogen dose formulations combined with careful restriction of oral contraceptive use to women who do not have various risk factors listed in this labeling.
Because of these changes in practice and, also, because of some limited new data that suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed, 48, 152 the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. The Committee concluded that, although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, nonsmoking women (even with the newer low-dose formulations), there are greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures that may be necessary if such women do not have access to effective and acceptable means of contraception.
Therefore, the Committee recommended that the benefits of oral contraceptive use by healthy nonsmoking women over 40 may outweigh the possible risks. Of course, older women, as all women who take oral contraceptives, should take the lowest possible dose formulation that is effective.
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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 the use of oral contraceptives is not associated with an overall increase in the risk of developing breast cancer. 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 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 suggested that oral contraceptive use was associated with an increase in the risk of cervical intraepithelial neoplasia, dysplasia, erosion, carcinoma, or microglandular dysplasia in some populations of women. 17, 50, 103-115 However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
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 per 100,000 for users, a risk that increases after four or more years of use, especially with oral contraceptives of higher dose (49). Rupture of benign, hepatic adenomas may cause death through intraabdominal hemorrhage (50, 51).
Studies have shown an increased risk of developing hepatocellular carcinoma in oral contraceptive users. However, these cancers are rare in the United States, and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users.
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.
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 (56,57). 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, (55, 56, 58, 59), 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 if pregnancy is ruled out.
Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens (60,61). More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal (62-64). The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens.
8. CARBOHYDRATE AND LIPID METABOLIC EFFECTS
Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users (17). This effect has been shown to be directly related to estrogen dose (65). Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents (17,66). However, in the non-diabetic woman, oral contraceptives appear to have no effect on fasting blood glucose (67). 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 1a and 1d ), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.
An increase in blood pressure has been reported in women taking oral contraceptives (68) and this increase is more likely in older oral contraceptive users (69) and with extended duration of use (61). Data from the Royal College of General Practitioners (12) and 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 disease (70) should 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 (68-71).
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.
11. BLEEDING IRREGULARITIES
Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Non-hormonal 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.
Ectopic as well as intrauterine pregnancy may occur in contraceptive failures. However, in progestogen-only oral contraceptive failures, the ratio of ectopic to intrauterine pregnancies is higher than in women who are not receiving oral contraceptives, since the drugs are more effective in preventing intrauterine than ectopic pregnancies.
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.
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.
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.
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.
5. EMOTIONAL DISORDERS
Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
6. CONTACT LENSES
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
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 (72).
8. INTERACTIONS WITH LABORATORY TESTS
Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
See section.
10. PREGNANCY
Pregnancy Category X. See CONTRAINDICATIONS and sections.
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.
12. SEXUALLY TRANSMITTED DISEASES
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
13. PEDIATRIC USE
Safety and efficacy of NECON 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 and for users 16 years and older. Use of this product before menarche is not indicated.
See Patient Labeling Printed Below.
ADVERSE REACTIONS
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see 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:
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.
The following non-contraceptive health benefits related to the use of combination oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol (73-78).
Effects on menses:
Effects related to inhibition of ovulation:
Other effects:
To achieve maximum contraceptive effectiveness, Necon®™ Tablets must be taken exactly as directed and at intervals not exceeding 24 hours.
When taking NECON® 1/35-21, Necon® 0.5/35-21, Necon® 10/11-21 and Necon® 1/50-21, 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 dispenser. The patient should be instruted 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 missess 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 dispenser and start a new dispenser 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 a patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).
The dosage of Nacon® 1/35-21, Necon® 0.5/35-21, Necon® 10/11-21 and Necon® 1/50-21, for the initial cycle of therapy is one tablet adminstered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow "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 dispenser. 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 3rd week or misses three (3) or more active tablets in a row, the patient should throw out the rest of the dispenser and start a new dispenser 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).
When taking Necon® 1/35-28, Necon® 0.5/35-28, Necon® 10/11-28 and Necon® 1/50-28, 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 dispenser. 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 dispenser and start a new dispenser 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 dosage of Necon® 1/35 -28, Necon® 0.5/35-28, Necon® 10/11-28 and Necon® 1/50-28, 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 dispenser. 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 dispenser and start a new dispenser 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 Necon® 1/35, Necon® 0.5/35, Necon® 10/11 and Necon® 1/50 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 concerning thromboembolic disease. 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.)
Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.
Use of oral contraceptives in the event of a missed menstrual period:
Necon® 1/35: (Norethindrone and Ethinyl Estradiol Tablets, USP)
Each dark yellow Necon® 1/35 tablets is round in shape, unscored, with a debossed WATSON on one side and 508 on the other side, and contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol.
Necon® 1/35-21 (NDC 52544-508-21) is packaged in cartons of six tablet dispensers of 21 tablets each.
Necon® 1/35-28 (NDC 52544-552-28) is packaged in cartons of six tablet dispensers. Each dispenser contains 21 dark yellow tablets and 7 white placebo tablets. (Placebo tablets have a debossed WATSON on one side and P on the other side.)
Necon® 0.5/35: (Norethindrone and Ethinyl Estradiol Tablets, USP)
Each light yellow Necon® 0.5/35 tablet is round in shape, unscored, with a debossed WATSON on one side and 507 on the other side, and contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol.
Necon® 0.5/35-21 (NDC 52554-507-21) is packaged in cartons of six tablet dispensers of 21 tablets each.
Necon® 0.5/35-28 (NDC 52544-550-28) is packaged in cartons of six tablet dispensers. Each dispenser contains 21 light yellow tablets and 7 white placebo tablets (Placebo tablets have a debossed WATSON on one side and P on the other side.)
Necon® 10/11: (Norethindrone and Ethinyl Estradiol Tablets, USP)
Each light yellow Necon® 10/11 tablet is round in shape, with a debossed WATSON on one side and 507 on the other side, and contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. Each dark yellow Necon® 10/11 tablet is round in shape, with a debossed WATSON on one side and 508 on the other side, and contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol.
Necon® 10/11-21 (NDC 5244-553-21) is packaged in cartons of six tablet dispensers. Each dispenser contains 10 light yellow tablets and 11 dark yellow tablets.
Necon® 10/11-28 (NDC 52544-554-28) is packaged in cartons of six tablet dispensers. Each dispenser contains 10 light yellow tablets and 11 dark yellow tablets, and 7 white placebo tablets. (Placebo tablets have a debossed WATSON on one side and P on the other side.)
Necon® 1/50: (Norethindrone and Mestranol Tablets, USP)
Each light blue Necon® 1/50 tablet is round in shape, unscored, with a debossed WATSON on one side and 510 on the other side, and contains 1 mg of norethindrone and 0.050 mg of mestranol. Necon® 1/50-21 (NDC 52544-510-21) is packaged in cartons of six tablet dispensers of 21 tablets each.
Necon® 1/50-28 (NDC 52544-56-28) is packaged in cartons of six tablet dispensers. Each dispenser contains 21 light blue tablets and 7 white placebo tablets. (Placebo tablets have a debossed WATSON on one side and P on the other side.)
Store at controlled room temperature 15°C to 30°C (59°F to 86°F).
Rx only
Oral contraceptives, also known as "birth control pills" or "the pill," are taken to prevent pregnancy and when taken correctly, have a failure rate of less than 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included. For most women oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy.
For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be fatal or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:
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.
You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.
| 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 are strongly advised not to smoke. |
Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.
The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:
The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or health care provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anti-convulsants and some antibiotics may decrease oral contraceptive effectiveness. There is conflict among studies regarding breast cancer and oral contraceptive use. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use. The majority of studies have found no overall increase in the risk of developing breast cancer. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives. There is insufficient evidence to rule out the possibility pills may cause such cancers.
Taking the combination pill provides some important non-contraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.
Be sure to discuss any medical condition you may have with your health care provider. Your health care provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. Your pharmacist should have given you the detailed patient information labeling which gives you further information which you should read and discuss with your health care provider.
This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
PLEASE NOTE: This labeling is revised from time to time as important new medical information becomes available. Therefore, please review this labeling carefully.
The following oral contraceptive products contain a combination of estrogen and progestogen, the two kinds of female hormones.
Necon® 1/35-21 and Necon® 1/35-28
Each dark yellow tablet contains 1 mg norethindrone and 0.035 mg ethinyl estraidol. Each white tablet in Necon® 1/35-28 contains inert ingredients.
Necon® 0.5/35-21 and Necon® 0.5/35-28
Each light yellow tablet contains 0.5 mg norethindrone and 0.035 mg ethinyl estradiol. Each white tablet in Necon® 0.5/35-28 contains inert ingredients.
Necon® 10/11-21 and Necon® 10/11-28
Each light yellow tablet contains 0.5 mg norethindrone and 0.035 mg ethinyl estradiol. Each dark yellow tablet contains 1 mg norethindrone and 0.035 mg ethinyl estradiol. Each white tablet in Necon® 10/11-28 contains inert ingredients.
Necon® 1/50-21 and Necon® 1/50-28
Each light blue tablet contains 1 mg norethindrone and 0.05 mg mestranol. Each white tablet in Necon® 1/50-28 contains inert ingredients.
Any woman who considers using oral contraceptives (the birth control pill or the pill) should understand the benefits and risks of using this form of birth control. This patient labeling will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this labeling is not a replacement for a careful discussion between you and your health care provider. You should discuss the information provided in this labeling with him or her, both when you first start taking the pill and during your revisits. You should also follow your health care provider's advice with regard to regular check-ups while you are on the pill.
Oral contraceptives or "birth control pills" or "the pill" are used to prevent pregnancy and are more effective than other non-surgical methods of birth control. When they are taken correctly, the chance of becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use) when used perfectly, without missing any pills. Typical failure rates are actually 3% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.
In comparison, typical failure rates for other non-surgical methods of birth control during the first year of use are as follows:
Implant: < 1%
Injection: <1%
IUD: 1 to 2%
Diaphragm with spermicides: 18%
Spermicides alone: 21%
Cervical Cap: 18 to 36%
Condom alone (male): 12%
Condom alone (female): 21%
Periodic abstinence: 20%
No methods: 85%
| 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 are strongly advised not to smoke. |
Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You should also not use the pill if you have any of the following conditions
Tell your health care provider if you have ever had any of these conditions. Your health care provider can recommend a safet method of birth control.
Tell your health care provider if you have or have had:
Women with any of these conditions should be checked often by their health care provider if they choose to use oral contraceptives.
Also be sure to inform your doctor or health care provider if you smoke or are on any medications.
Use a BACK-UP METHOD anytime you have sex. KEEP TAKING ONE "ACTIVE" PILL EACH DAY until you can reach your doctor or clinic.
The incidence of pill failure resulting in pregnancy is approximately one percent (i.e., one pregnancy per 100 women per year) if taken every day as directed, but more typical failure rates are about 3%. If failure does occur, the risk to the fetus is minimal.
There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy.
There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill.
Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your health care provider or pharmacist.
Your health care provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year. Be sure to inform your health care provider if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your health care provider, because this is a time to determine if there are early signs of side effects of oral contraceptive use.
Do not use the drug for any condition other than the one for which it was prescribed. 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 combination oral contraceptives may provide certain benefits. They are:
If you want more information about birth control pills, ask your doctor or pharmacist. They have a more technical leaflet called the Professional Labeling, which you may wish to read. The Professional Labeling is also published in a book entitled Physicians' Desk Reference, available in many book stores and public libraries.
Manufactured by
Watson Laboratories, Inc.
a subsidiary of Watson Pharmaceuticals, Inc.
Corona, CA 92880
Revised: September 30, 1999
Necon® 1/35-21
Necon® 1/35-28
Necon® 0.5/35-21
Necon® 0.5/35-28
Necon® 10/11-21
Necon® 10/11-28
(norethindrone and ethinyl estradiol tablets USP)
Necon® 1/50-21
Necon® 1/50-28
(norethindrone and mestranol tablets USP)
12621-2
IMPORTANT POINTS TO REMEMBER
BEFORE YOU START TAKING THE PILLS:
BEFORE YOU START TAKING YOUR PILLS
WHEN TO START THE FIRST DISPENSER OF PILLS:
You have a choice of which day to start taking your first dispenser of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember.
SUNDAY START:
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Necon® 10/11:
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Necon® 1/35:
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Necon® 0.5/35:
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Necon® 1/50:
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Use another method of birth control as back-up method if you have sex anytime from the Sunday you start your first dispenser until the next Sunday (7 days). Condoms, foam, or the sponge are good back-up methods of birth control.
DAY 1 START:
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Necon® 10/11:
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Necon® 1/35:
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Necon® 0.5/35:
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Necon® 1/50:
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You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period.
WHAT TO DO DURING THE MONTH:
WHAT TO DO IF YOU MISS PILLS:
Necon® 10/11:
If you MISS 1 light yellow or dark yellow "active" pill:
If you MISS 2 light yellow or dark yellow "active" pills in a row in WEEK 1 or WEEK 2 of your dispenser:
If you MISS 2 dark yellow "active" pills in a row in THE 3RD WEEK:
If you MISS 3 OR MORE light yellow or dark yellow "active" pills in a row (during the first 3 weeks):
If you MISS 1 dark yellow "active" pill:
If you MISS 2 dark yellow "active" pills in a row in WEEK 1 or WEEK 2 of your dispenser:
If you MISS 2 dark yellow "active" pills in a row in THE 3RD WEEK:
If you MISS 3 OR MORE dark yellow "active" pills in a row (during the first 3 weeks):
If you MISS 1 light yellow "active" pill:
If you MISS light yellow "active" pills in a row in WEEK 1 or WEEK 2 of your dispenser:
If you MISS 2 light yellow "active" pills in a row in THE 3RD WEEK:
If you MISS 3 OR MORE light yellow "active" pills in a row (during the first 3 weeks):
If you MISS 1 light blue "active" pill:
If you MISS 2 light blue "active" pills in a row in WEEK 1 or WEEK 2 of your dispenser:
If you MISS 2 light blue "active" pills in a row in THE 3RD WEEK:
If you MISS 3 OR MORE light blue "active" pills in a row (during the first 3 weeks):
If you forget any of the 7 white "reminder" pills in Week 4:
THROW AWAY the pills you missed.
Keep taking 1 pill each day until the dispenser is empty.
You do not need a back-up method.
All methods of birth control and pregnancy are associated with a risk of developing certain diseases that may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table:
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In the above table, the risk of death from any birth control method is less than the risk of childbirth, except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy (7-26 deaths per 100,000 women, depending on age). Among pill users who do not smoke, the risk of death was always lower than that associated with pregnancy for any age group, although over the age of 40, the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35, the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is four times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000) in that age group.
The suggestion that women over 40 who do not smoke should not take oral contraceptives is based on information from older, higher dose pills. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of low-dose oral contraceptive use by healthy, non-smoking women over 40 years of age may outweight the possible risks.
If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately:
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