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PHILITH™ 28-Day (norethindrone and ethinyl estradiol tablets, USP) provide a continuous regimen for oral contraception derived from 21 tan tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are:
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The tan active tablets each contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and contain the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, iron oxide yellow, iron oxide black, lecithin (soya), lactose monohydrate, magnesium stearate and pregelatinized starch. The white tablets in the 28-Day regimen contain only inert ingredients as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.
Oral contraceptives 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 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods ofcontraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use ofmethods can result in lower failure rates.
TABLE 1: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
% of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use
| Method | Lowest Expected* | Typical** |
| (No contraception) | (85) | (85) |
| Oral contraceptives combined | 0.1 | 3*** |
| progestin only | 0.5 | 3*** |
| Diaphragm with spermicidal cream or jelly | 6 | 18 |
| Spermicides alone (foam, creams, jellies and vaginal suppositories) | 3 | 21 |
| Vaginal sponge nulliparous | 6 | 18 |
| multiparous | 9 | 28 |
| IUD | 0.8-2.0 | 3# |
| Condom without spermicides | 2 | 12 |
| Periodic abstinence (all methods) | 1-9 | 20 |
| Injectable progestogen | 0.3-0.4 | 0.3-0.4 |
| Implants 6 capsules |
0.04 | 0.04 |
| 2 rods | 0.03 | 0.03 |
| Female sterilization | 0.2 | 0.4 |
| Male sterilization | 0.1 | 0.15 |
| Reproduced with permission of the Population Council from J. Trussell, et. al: Contraceptive failure in the United States: An update. Studies in Family Planning, 21(1), January-February 1990. *The authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any reason other than pregnancy. **This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any reason other than pregnancy. ***Combined typical rate for both combined and progestin only. #Combined typical rate for both medicated and nonmedicated IUD. |
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The following is a summary of the instructions given to the patient in the "HOW TO TAKE THE PILL " section of the DETAILED PATIENT LABELING.
PHILITH™ 28-Day (norethindrone 0.4 mg and ethinyl estradiol 0.035 mg tablets, USP) are available in a compact blister card (NDC 16714-347-01). Each blister cardcontains 21 tan, biconvex round tablets debossed with "C35" on one side. Each 7 white, biconvex round tablets debossed with "P" on one side and "N" on the other side.
Carton of 1 - NDC 16714-347-02
Carton of 3 - NDC 16714-347-03
Carton of 6 - NDC 16714-347-04
Store at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].
References are available upon request.
Manufactured by: Novast Laboratories, Ltd. Nantong, China 226009. Revised: Sep 2017
To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC. Toll-Free at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):
There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:
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:
Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similarassociation, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin, and tetracyclines.
Do not co-administer PHILITH™ with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALTelevations (see WARNINGS, Risk Of Liver Enzyme Elevations With Concomitant Hepatitis C Treatment).
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 more cigarettes per day) and is quite marked in women over 35 year of age. Women who use oral contraceptives should be strongly advised not to smoke.
The use of oral contraceptives is associated with increased risk of several serious conditions including myocardial infarction, thromboembolism, stroke, hepaticneoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk ofmorbidity 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 ofestrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens andprogestogens 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 studiesprovide 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 riskdoes 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 incidenceof disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population*. Forfurther information, the reader is referred to a text on epidemiological methods.
*Adapted from Stadel BB: Oral contraceptives and cardiovascular disease. N Engl J Med , 1981; 305: 612-618, 672-677; with author's permission.
The physician should be alert to the earliest manifestations of thromboembolic thrombotic disorders as discussed below. Should any of these occur or be suspected thedrug should be discontinued immediately.
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 factorsfor coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The relative risk of heart attack for current oral contraceptiveusers 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-thirtiesor older, with smoking accounting for the majority of excess cases. Mortality rates associated with circulatory disease have been shown to increase substantially insmokers over the age of 35 and nonsmokers over the age of 40 (Figure 1) among women who use oral contraceptives.
FIGURE 1: CIRCULATORY DISEASE MORTALITY RATES PER 100,000 WOMEN-YEAR BY AGE, SMOKING STATUS AND ORAL CONTRACEPTIVE USE
 |
Layde PM, Beral V
Further analyses of mortality in oral contraceptive users: Royal College of General Practitioners' oral contraception study. (Table 5) Lancet 1981;1:541-546.
Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity. In particular, someprogestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism. Oral contraceptives havebeen shown to increase blood pressure among users (see section 9 in WARNINGS). Such increases in risk factors have been associated with an increased risk of heartdisease and the risk increases with the number of risk factors present. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found therelative risk of users compared to non-users to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and1.5 to 6 for women with predisposing conditions for venous thromboembolic disease. Cohort studies have shown the relative risk to be somewhat lower, about 3 fornew cases and about 4.5 for new cases requiring hospitalization. The risk of thromboembolic disease due to oral contraceptives is not related to length of use anddisappears after pill use is stopped.
A two- to four -fold increase in relative risk of postoperative thromboembolic complications has been reported with the use of oral contraceptives. The relative risk ofvenous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions. If feasible, oral contraceptives should bediscontinued 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 andfollowing prolonged immobilization. Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives shouldbe started no earlier than four to six weeks after delivery in women who elect not to breastfeed.
Oral contraceptives have been shown to increase both the relative and attributable risk of cerebrovascular events (thrombotic and hemorrhagic strokes); although, ingeneral, 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 non-users, forboth types of strokes, while smoking interacted to increase the risk for hemorrhagic strokes.
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 riskof hemorrhagic stroke is reported to be 1.2 for nonsmokers who used oral contraceptives, 2.6 for smokers who did not use oral contraceptives, 7.6 for smokers who usedoral contraceptives, 1.8 for normotensive users and 25.7 for users with severe hypertension. The attributable risk is also greater in older women.
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 serumhigh density lipoproteins (HDL) has been reported with many progestational agents. A decline in serum high density lipoproteins has been associated with an increasedincidence of ischemic heart disease. Because estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between dosesof estrogen and progestogen and the nature and absolute amount of progestogens used in the contraceptive. The amount of both hormones should be considered in thechoice 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 dosageregimen 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 individualpatient. New acceptors of oral contraceptive agents should be started on preparations containing 0.05 mg or less of estrogen.
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 ofdeveloping myocardial infarction after discontinuing oral contraceptives persists for at least 9 years for women 40-49 years old who had used oral contraceptives forfive 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 diseasepersisted for at least six years after discontinuation of oral contraceptives, although excess risk was very small. However, both studies were performed with oralcontraceptive formulations containing 50 micrograms or higher of estrogens.
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 2).
TABLE 2: ANNUAL NUMBER OF BIRTH - RELATED OR METHOD - RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NONSTERILE WOMEN, BY FERTILITY CONTROL METHOD AC
| AGE | |||||
| Method of control and outcome | 15 - 19 | 20 - 24 | 25 - 29 | 30 - 34 | 35 - 39 |
| No fertility control methods* | 7.0 | 7.4 | 9.1 | 14.8 | 25.7 |
| Oral contraceptives nonsmoker** | 0.3 | 0.5 | 0.9 | 1.9 | 13.8 |
| Oral contraceptives smoker** | 2.2 | 3.4 | 6.6 | 13.5 | 51.1 |
| IUD** | 0.8 | 0.8 | 1.0 | 1.0 | 1.4 |
| Condom* | 1.1 | 1.6 | 0.7 | 0.2 | 0.3 |
| Diaphragm/spermicide* | 1.9 | 1.2 | 1.2 | 1.3 | 2.2 |
| Periodic abstinence* | 2.5 | 1.6 | 1.6 | 1.7 | 2.9 |
| *Deaths are birth related. | |||||
| **Deaths are method related. | |||||
| Ory HW: Mortality associated with fertility and fertility control: 1983. Fam Plann Perspect 1983; 15:50-56. | |||||
These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Eachmethod of contraception has its specific benefits and risk. The study concluded that with the exception of oral contraceptive users 35 and older who smoke and 40 andolder 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 for oral contraceptive users is based on data gathered in the 1970's–but not reported until 1983.However, current clinical practice involves the use of lower estrogen dose formulations combined with careful restriction of oral contraceptive use to women who donot have the various risk factors listed in this labeling.
Because of these changes in practice and, also, because of some limited new data which suggest that the risk of cardiovascular disease with the use of oralcontraceptives may now be less than previously observed (Porter JB, Hunter J, Jick H, et al. Oral contraceptives and nonfatal vascular disease. Obstet Gynecol 1985;66:1-4 and Porter JB, Jick H, Walker AM. Mortality among oral contraceptive users. Obstet Gynecol 1987; 70:29-32), the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. The Committee concluded that although cardiovascular disease risk may be increased with oral contraceptive useafter age 40 in healthy nonsmoking women (even with the newer low-dose formulations), there are greater potential health risks associated with pregnancy in olderwomen and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means ofcontraception.
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.
Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian and cervical cancer in women using oral contraceptives. Theoverwhelming evidence in the literature suggests that use of oral contraceptives is not associated with an increase in the risk of developing breast cancer, regardless ofthe age and parity of first use or with most of the marketed brands and doses. The Cancer and Steroid Hormone (CASH) study also showed no latent effect on the riskof breast cancer for at least a decade following long-term use. A few studies have shown a slightly increased relative risk of developing breast cancer, although themethodology of these studies, which included differences in examination of users and nonusers and differences in age at start of use, has been questioned.
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.
In spite of many studies of the relationship between oral contraceptive use and breast cancer and cervical cancers, a cause-and-effect relationship has not beenestablished.
Benign hepatic adenomas are associated with oral contraceptive use, although their occurrence is rare in the United States. Indirect calculations have estimated theattributable 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. Rupture of hepatic adenomas may cause deaththrough intra-abdominal hemorrhage.
Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral contraceptive users. However, these cancers areextremely rare in the U.S. and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users.
During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greaterthan 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs. Discontinue PHILITH™ prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with orwithout dasabuvir [see CONTRAINDICATIONS] . PHILITH™ can be restarted approximately 2 weeks following completion of treatment with the combination drugregimen.
There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives. Oral contraceptives should be discontinued if there isunexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Appropriate diagnostic and therapeutic measuresshould be undertaken immediately.
Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do notsuggest 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 duringpregnancy 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 patienthas 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 bediscontinued if pregnancy is confirmed.
Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. More recent studies, however, haveshown 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.
Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users. Oral contraceptives containing greater than 75 micrograms ofestrogens cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance. Progestogens increase insulin secretion and create insulin resistance, thiseffect varying with different progestational agents.
However, in the nondiabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. Because of these demonstrated effects, prediabetic anddiabetic women should be carefully observed while taking oral contraceptives.
A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see WARNINGS), changes in serumtriglycerides and lipoprotein levels have been reported in oral contraceptive users.
An increase in blood pressure has been reported in women taking oral contraceptives and this increase is more likely in older oral contraceptive users and withcontinued use. Data from the Royal College of General Practitioners and subsequent randomized trials have shown that the incidence of hypertension increases withincreasing concentrations of progestogens.
Women with a history of hypertension or hypertension-related diseases, or renal disease should be encouraged to use another method of contraception. If women electto use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued. For mostwomen, elevated blood pressure will return to normal after stopping oral contraceptives, and there is no difference in the occurrence of hypertension among ever- andnever-users.
The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent or severe requires discontinuation of oralcontraceptives and evaluation of the cause.
Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Nonhormonal causesshould 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 abnormalvaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should beruled out.
Women with a history of oligomenorrhea or secondary amenorrhea or young women without regular cycles prior to taking oral contraceptives may again have irregularbleeding or amenorrhea after discontinuation of oral contraceptives.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
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 examinationshould include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case ofundiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family historyof breast cancer or who have breast nodules should be monitored with particular care.
Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels andmay 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 impairedliver function.
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditionswhich might be aggravated by fluid retention.
Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt todetermine whether the symptom is drug related.
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
See WARNINGS section.
See CONTRAINDICATIONS and WARNINGS sections.
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, includingjaundice and breast enlargement. In addition, 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 oral contraceptives but to use other forms of contraception until she has completely weaned herchild.
Although a cause-and-effect relationship has not been clearly established, several cases of oral contraceptive failure have been reported in association with vomitingand/or diarrhea. If significant gastrointestinal disturbance occurs in any woman receiving contraceptive steroids, the use of a back-up method of contraception for theremainder of that cycle is recommended.
Safety and efficacy of norethindrone and ethinyl estradiol tablets have been established in women of reproductive age. Safety and efficacy are expected to be the samein postpubertal adolescents under the age of 16 years and in users ages 16 years and older. Use of this product before menarche is not indicated.
See PATIENT INFORMATION printed below.
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, andwithdrawal bleeding may occur in females.
The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oralcontraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.
Oral contraceptives should not be used in women who currently have the following conditions:
Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations includechanges in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitteddiseases.
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 about 1% per yearwhen 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.
Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated withtaking oral contraceptives increase significantly if you:
You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.
Do not take if you take any Hepatitis C drug combination containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liverenzyme "alanine aminotransferase" (ALT) in the blood.
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 more cigarettes per day) and is quite marked in women over 35 year of age. Women who use oral contraceptives should be strongly advised not to smoke.
Most side effects of the pill are not serious. The most common side 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 medicalconditions 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 careprovider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibioticsmay decrease oral contraceptive effectiveness.
Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to ruleout the possibility that the pill may cause such cancers.
Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvicinfections, 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 beforeprescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health care provider believesthat it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives youfurther information which you should read and discuss with your health care professional.
DOSAGE AND ADMINISTRATION
HOW TO TAKE THE PILL
The instructions given in the COMBINATION DETAILED PATIENT LABELING AND BRIEF SUMMARY insert are included inside each compact dispenser.The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient isadvised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is alsoinstructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use aback-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.
Instructions on how to use the blister card for the (28 Tablets) are included in the DETAILED PATIENT LABELING.
DETAILED PATIENT LABELING
This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitteddiseases.
INTRODUCTION:
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.
Although the oral contraceptives have important advantages over other methods of contraception, they have certain risks that no other method has and some of theserisks may continue after you have stopped using the oral contraceptive. This brochure will give you much of the information you will need to make this decision andwill 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 aseffective as possible. However, this brochure is not a replacement for a careful discussion between you and your health care professional.
You should discuss the information provided in this brochure with him or her, both when you first start taking the pill and during your revisits. You should also followyour health care professional's advice with regard to regular check-ups while you are on the pill.
EFFECTIVENESS OF ORAL CONTRACEPTIVES:
Oral contraceptives or "birth control pills" or "the pill" are used to prevent pregnancy and are more effective than other nonsurgical methods of birth control. The chanceof becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use) when the pills are used correctly and no pills are missed. Typical failure rates areactually 3% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.
In comparison, typical accidental pregnancy rates for other nonsurgical methods of birth control during the first year of use are as follows:
WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES:
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 more cigarettes per day) and is quite marked in women over 35 year of age. Women who use oral contraceptives should not 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 youhave or have ever had any of the following conditions:
Tell your health care professional if you have ever had any of these conditions. Your health care professional can recommend a safer method of birth control.
OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES:
Tell your health care professional if you have:
Women with any of these conditions should be checked often by their health care professional if they choose to use oral contraceptives.
Also, be sure to inform your doctor or health care professional if you smoke or are on any medications.
RISKS OF TAKING ORAL CONTRACEPTIVES
Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives. In particular, a clot in the legs can cause thrombophlebitis and aclot that travels to the lungs can cause a sudden blocking of the vessel carrying blood to the lungs. Either of these can cause death or disability. Rarely, clots occur in theblood vessels of the eye and may cause blindness, double vision, or impaired vision.
If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness, or have recently delivered a baby, you may be at risk of developingblood clots. You should consult your doctor about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks aftersurgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby. It is advisable to wait for at least four weeks after delivery if youare not breastfeeding. If you are breastfeeding, see the section on Breastfeeding in GENERAL PRECAUTIONS.
Oral contraceptives may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage ofblood vessels in the heart). Any of these conditions can cause death or disability.
Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increase the chances ofdeveloping and dying of heart disease.
Oral contraceptive users probably have a greater risk than nonusers of having gallbladder disease, although this risk may be related to pills containing high doses ofestrogens.
In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, apossible, but not definite, association has been found with the pill and liver cancers in two studies, in which a few women who developed these very rare cancers werefound to have used oral contraceptives for long periods. However, liver cancers in general are extremely rare and the chance of developing liver cancer from using thepill is thus even rarer.
There is, at present, no confirmed evidence that oral contraceptives increase the risk of cancer of the reproductive organs and breasts in human studies. Several studieshave found no overall increase in the risk of developing breast cancer. However, women who use oral contraceptives and have a strong family history of breast cancer,or who have breast nodules or abnormal mammograms, should be closely followed by their doctors.
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 factorsother than the use of oral contraceptives.
ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY
All methods of birth control and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. An estimate of the number ofdeaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table.
ANNUAL NUMBER OF BIRTH - RELATED OR METHOD - RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NONSTERILE WOMEN, BY FERTILITY CONTROL METHOD AC
| AGE | |||||
| Method of control and outcome | 15 - 19 | 20 - 24 | 25 - 29 | 30 - 34 | 35 - 39 |
| No fertility control methods* | 7.0 | 7.4 | 9.1 | 14.8 | 25.7 |
| Oral contraceptives nonsmoker** | 0.3 | 0.5 | 0.9 | 1.9 | 13.8 |
| Oral contraceptives smoker** | 2.2 | 3.4 | 6.6 | 13.5 | 51.1 |
| IUD** | 0.8 | 0.8 | 1.0 | 1.0 | 1.4 |
| Condom* | 1.1 | 1.6 | 0.7 | 0.2 | 0.3 |
| Diaphragm/spermicide* | 1.9 | 1.2 | 1.2 | 1.3 | 2.2 |
| Periodic abstinence* | 2.5 | 1.6 | 1.6 | 1.7 | 2.9 |
| *Deaths are birth related. **Deaths are method related. |
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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 pillusers 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 32deaths 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 numberof 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 (117/100,000women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group.
The suggestion that women over 40 who don't smoke should not take oral contraceptives is based on information from older high-dose pills and on less selective use ofpills than is practiced today.
An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral contraceptive use by healthy, nonsmoking women over 40years of age may outweigh the possible risks. However, all women, especially older women, are cautioned to use the lowest dose pill that is effective.
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 smokeand pill users over the age of 40 even if they do not smoke.
You should discuss this information with your health care professional.
WARNING SIGNALS
If any of these adverse conditions occur while you are taking oral contraceptives, call your doctor immediately:
SIDE EFFECTS OF ORAL CONTRACEPTIVES
In addition to the risks and more serious side effects discussed above (see RISKS OF TAKING ORAL CONTRACEPTIVES, ESTIMATED RISK OF DEATH FROMA BIRTH CONTROL METHOD OR PREGNANCY and WARNING SIGNALS sections above), the following may also occur:
Irregular vaginal bleeding or spotting may occur while you are taking the pills. Irregular bleeding may vary from slight staining between menstrual periods tobreakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use, but mayalso occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important tocontinue taking your pills on schedule. If the bleeding occurs in more than one cycle or lasts for more than a few days, talk to your doctor or health care provider.
The most frequent, unpleasant side effects are nausea and vomiting, stomach cramps, bloating, and a change in appetite.
If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or health care provider.
Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention,contact your doctor or health care professional.
A spotty darkening of the skin is possible, particularly of the face.
Other side effects may include change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections.
If any of these side effects bother you, call your doctor or health care professional.
GENERAL PRECAUTIONS
There may be times when you may not menstruate regularly after you have completed taking a cycle of pills. If you have taken your pills regularly and miss onemenstrual period, continue taking your pills for the next cycle but be sure to inform your health care professional before doing so. If you have not taken the pills daily asinstructed and missed a menstrual period, or if you missed two consecutive menstrual periods, you may be pregnant. Check with your health care professionalimmediately to determine whether you are pregnant. Do not continue to take oral contraceptives until you are sure you are not pregnant, but continue to use anothermethod of contraception.
There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects, when taken inadvertently during early pregnancy. Previously,a few studies had reported that oral contraceptives might be associated with birth defects, but these studies have not been confirmed. Nevertheless, oral contraceptivesor any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor. You should check with your doctor about risks to yourunborn child of any medication taken during pregnancy.
If you are breastfeeding, consult your doctor before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on thechild have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, oral contraceptives may decrease the amount and quality ofyour milk. If possible, do not use oral contraceptives while breast feeding. You should use another method of contraception since breastfeeding provides only partialprotection from becoming pregnant and this partial protection decreases significantly as you breastfeed for longer periods of time. You should consider starting oralcontraceptives only after you have weaned your child completely.
If you are scheduled for any laboratory tests, tell your doctor you are taking birth control pills. Certain blood tests may be affected by birth control pills.
Certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Such drugsinclude rifampin, drugs used for epilepsy such as barbiturates (for example, phenobarbital) and phenytoin (Dilantin is one brand of this drug), phenylbutazone(Butazolidin is one brand) and possibly ampicillin and tetracyclines (several brand names). You may need to use an additional method of contraception when you takedrugs which can make oral contraceptives less effective.
HOW TO TAKE THE PILL
IMPORTANT POINTS TO REMEMBER
SEXUALLY TRANSMITTED DISEASES
This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexuallytransmitted diseases such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
BEFORE YOU START TAKING YOUR PILLS:
Before you start taking your pills.
Anytime you are not sure what to do.
If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
If you do feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your doctor or clinic.
On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
Use a back-up method (such as condoms, foam or sponge) until you check with your doctor or clinic.
BEFORE YOU START TAKING YOUR PILLS
It is important to take it at about the same time every day.
The 28 pill pack has 21 "active" tan pills (with hormones) to take for 3 weeks, followed by 1 week of reminder white pills (without hormones).
Refer to the sample of the blister card below.
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ANOTHER KIND OF BIRTH CONTROL (such as condoms, foam or sponge) to use as a back-up in case you miss pills.
An EXTRA, FULL PILL PACK.
WHEN TO START THE FIRST PACK OF PILLS
You have a choice of which day to start taking your first pack of pills. PHILITH™ (norethindrone and ethinyl estradiol tablets, USP): is available in a compact blistercard which is designed for a Sunday Start. Day 1 Start is also provided. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will beeasy to remember. Pick the Days of the Week Sticker that starts with the first day of your period. When you have picked the right sticker, throw away the others andplace the sticker on the compact over the pre-printed days of the week and make sure it lines up with the pills. If your Physician has instructed you to use a "SundayStart" method, then use the blister card which is set up for a Sunday start.
DAY-1 START:
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SUNDAY START:
WHAT TO DO DURING THE MONTH
Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).
Do not skip pills even if you do not have sex very often.
28 pills: Start the next pack on the day after your last "reminder" pill. Do not wait any days between packs.
WHAT TO DO IF YOU MISS PILLS
If you MISS 1 tan "active" pill:
If you MISS 2 tan "active" pills in a row in WEEK 1 OR WEEK 2 of your pack:
If you MISS 2 tan "active" pills in a row in THE 3rd WEEK:
THROW OUT the rest of the pill pack and start a new pack that same day.
If you are a Sunday Starter:
Keep taking 1 pill every day until Sunday.
On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.
If you MISS 3 OR MORE tan "active" pills in a row (during the first 3 weeks):
THROW OUT the rest of the pill pack and start a new pack that same day.
If you are a Sunday Starter:
Keep taking 1 pill every day until Sunday.
On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.
A REMINDER FOR THOSE ON 28-DAY PACKS:
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 pack is empty. You do not need a back-up method.
FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED:
Use a BACK-UP METHOD anytime you have sex.
KEEP TAKING ONE "ACTIVE" PILL EACH DAY until you can reach your doctor or clinic.
GENERAL:
The incidence of pill failure resulting in pregnancy is approximately 1% (i.e., one pregnancy per 100 women per year) if taken every day as directed, but more typicalfailure 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 oralcontraceptives. 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 withdrawalbleeding in females. In case of overdosage, contact your poison control center, health care professional, or nearest emergency room. KEEP THIS DRUG AND ALLDRUGS OUT OF THE REACH OF CHILDREN.
Your health care professional will take a medical and family history before prescribing oral contraceptives and examine you. The physical examination may be delayedto 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 per year.Be sure to inform your health care professional if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments withyour health care professional, 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 whomay want birth control pills.
NONCONTRACEPTIVE EFFECTS OF ORAL CONTRACEPTIVES:
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. They have a more technical leaflet called the Professional Labeling, which youmay wish to read.
To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC. Toll-Free at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
