(levonorgestrel and ethinyl estradiol tablets – triphasic regimen)
Tablets
DESCRIPTION
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
OVERDOSAGE
NONCONTRACEPTIVE HEALTH BENEFITS
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
BRIEF SUMMARY PATIENT PACKAGE INSERT
DETAILED PATIENT LABELING
IMPORTANT POINTS TO REMEMBER
Patients should be counseled that this product does not protect against HIV infection (AIDS) and
other sexually transmitted disease.
Description
Each Triphasil cycle of 21 tablets consists of three different drug phases as follows: Phase 1
comprised of 6 brown tables, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-
beta-hydroxygon 4-en-3 one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol
(19-nor-17alpha-pregna 1,3,5(10) trien-20-yne-3, 17-diol); phase 2 comprised of 5 white tablets, each
containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10
light yellow tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol. The
inactive ingredients present are cellulose, iron oxides, lactose, magnesium stearate, polacrilin
potassium, polyethylene glycol, titanium dioxide, and hydroxypropyl methylcellulose.
Combination oral contraceptives act by suppression of gonadotropins. Although the primary
mechanism of this action is inhibition of ovulation, other alterations include changes in the
cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium
(which reduce the likelihood of implantation).
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, except sterilization and the IUD, depends upon the reliability with which they are used.
Correct and consistent use of methods can result in lower failure rates.
TABLE I: 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 Typical**
Expected*
(No Contraception) (85) (85)
Oral contraceptives
combined 0.1 N/A***
progestin only 0.5 N/A***
Diaphragm with spermicidal 6 18
cream or jelly
Spermicides alone (foams 3 21
and vaginal suppositories)
Vaginal Sponge
nulliparous 6 18
multiparous 9 28
DEPO-PROVERA®(injectable progestogen) 0.3 0.3
NORPLANT SYSTEM®(implants) 0.2# 0.2#
IUD 3
progesterone 2 N/A***
copper T 380A 0.8 N/A***
Condom without spermicides 2 12
Periodic abstinence (all methods) 1-9 20
Female sterilization 0.2 0.4
Male sterilization 0.1 0.15
Adaptated from J. Trussell et al, Table 1, Studies in Family Planning, 21 (1): Jan.-Feb. 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 use for any other reason.
**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 other reason.
***N/A-Data not available.
#This data is based on Norplant System clinical trials.
Oral contraceptives should not be used in women with any of the following conditions:
Thrombophlebitis or thromboembolic disorders.
A past history of deep-vein thrombophlebitis or thromboembolic
disorders.
Cerebral-vascular or coronary-artery disease.
Known or suspected carcinoma of the breast.
Carcinoma of the endometrium or other known or suspected estrogen dependent neoplasia.
Undiagnosed abnormal genital bleeding.
Cholestatic jaundice of pregnancy or jaundice with prior pill use.
Hepatic adenomas or carcinomas.
Known or suspected pregnancy.
Cigarette smoking increases the risk of serious cardiovascular side effects from oral-
contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes
per day) and is quite marked in women over 35 years of age. Women who use oral
contraceptives should be strongly advised not to smoke.
The use of oral contraceptives associated with increased risks of several serious conditions
including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease,
and hypertension, although the risk of serious morbidity or mortality is very small in healthy
women without underlying risk factors. The risk of morbidity and mortality increases significantly
in the presence of the 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 based principally on studies carried out in
patients who used oral contraceptives with higher formulations of estrogens and progestogens
than those in common use today. The effect of long-term use of oral contraceptives with lower formulations of both estrogens and
progestogens remains to be determined.
Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or corhort studies. Case control studies provide a measure of the relative risk of disease, namely, a ratio of the incidenc
e of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual
clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral-contraceptive users and nonusers. The attributable risk does provide information about the actual o
ccurrence of a disease in the population. For further information, the reader is referred to a text on epidemiological methods.
1. THROMBOEMBOLIC DISORDERS AND OTHER VASCULAR PROBLEMS
a. Myocardial infarction
An increase risk of myocardial infarction has been attributed to oral contraceptive use. This risk
is primarily in smokers or women with other underlying risk factors for coronary-artery disease
such as hypertension, hypercholesterolemia, morbin obesity, and diabetes. The relative risk of
heart attack for current oral-contraceptive users has been estimated to be two to six. The risk is
very low under the age of 30.
Smoking in combination with oral-contraceptive use has been shown to contribute substantially
to the incidence of myocardial infarction in women in their mid-thirties or older with smoking
accounting for the majority of excess cases. Mortality rates associated with circulatory disease
have been shown to increase substantially in smokers over the age of 35 and nonsmokers over
the age of 40 (table II) among women who use oral contraceptives.
TABLE II. (Adapted from P.M. Layde and V.Beral, Lancet, 1:541-546, 1981.)
Oral contraceptives may compound the effects of well-known risk factors, such as hypertension,
diabetes, hyperlipemias, age, and obesity. In particular, some progestogens are known to decrease
HDL Cholesterol and cause glucose intolerance, while estrogens may create a state of
hyperinsulinism. Oral contraceptives have been shown to increase blood pressure among users
(see section 9 in “Warnings”). Similar effects on risk factors have been associated with an
increased risk of heart disease. Oral contraceptives must be used with caution in women with
cardiovascular disease risk factors.
b. Thromboembolism
An increased risk of thromboembolic and thrombotic disease associated with the use of
contraceptives is well established. Case control studies have found the relative risk of users
compared to nonusers to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for
deep-vein thrombosis or pulmonary embolism, and 1.5 to 6 women with predisposing conditions
for venous thromboembolic disease. Cohort studies have shown the relative risk to be
somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization.
The risk of thromboembolic disease due to oral contraceptives is not related to length of use and
disappears after pill use is stopped.
A two-to-four fold increase in relative risk of postoperative thromboembolic complications has
been reported with the use of oral contraceptives. The relative risk of venous thrombosis in
women who have predisposing conditions is twice that of women without such medical
conditions. If feasible, oral contraceptives should be discontinued at least four weeks prior to
and for two weeks after elective surgery of a type associated with an increase in risk of
thromboembolism and during and following prolonged immobilization. Since the immediate
postpartum period is also associated with an increased risk of thromboembolism, oral
contraceptives should be started no earlier than four to six weeks after delivery in women who
elect not to breast-feed, or a midtrimester pregnancy termination.
c. Cerebrovascular diseases
Oral contraceptives have been shown to increase both the relative and attributable risks of
cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is
greatest among older (>35 years), hypertensive women who also smoke. Hypertension was
found to be a risk factor for both users and nonusers, both 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 risk of 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 used oral contraceptives, 1.8 for normotensive users, and
25.7 for users with severe hypertension. The attributable risk is also greater in older women.
d. Dose-related risk of vascular disease from oral contraceptives
A positive association has been observed between the amount of estrogen and progestogen in
oral contraceptives and the risk of vascular disease. A decline in serum high-density
lipoproteins (HDL) has been reported with many progestational agents. A decline in serum high
density lipoproteins has been associated with an increased incidence of ischemic heart disease.
Because estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between doses of estrogen and progestogen and
the nature and absolute amount of progestogen used in the contraceptive. The amount of both
hormones should be considered in the choice of an oral contraceptive.
Minimizing exposure to
estrogen and progestogen is in keeping with good principles of therapeutics. For any particular
estrogen/progestogen combination, the dosage regimen prescribed should be one which contains
the least amount of estrogen and progestogen that is compatiable with a low failure rate and the
needs of the individual patient. New acceptors of oral-contraceptive agents should be started on
preparations containing less than 50 mcg of estrogen.
e. Persistence of risk of vascular disease
There are two studies which have shown persistence of risk of vascular disease for ever-users of
oral contraceptives. In a study in the United States, the risk of developing myocardial infarction
after discontinuing oral contraceptives persists for at least 9 years for women 40 to 49 years who
had used oral contraceptives for five or more years, but this increased risk was not demonstrated
in other age groups. In another study in Great Britain, the risk of developing cerebrovascular
disease persisted for at least 6 years after discontinuation of oral contraceptives, although
excess risk was very small. However, both studies were performed with oral-contraceptive
formulations containing 50 micrograms or higher of estrogens.
2. ESTIMATES OF MORTALITY FROM CONTRACEPTIVE USE
One study gathered data from a variety of sources which have estimated the mortality rate
associated with different methods of contraception at different ages (Table III). These estimates
include the combined risk of death associated with contraceptive methods plus the risk
attributable to pregnancy in the event of method failure. Each method of 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 less than 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 do not 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 oral contraceptives may now be
less than previously observed, 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 which 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.
TABLE III-ANNUAL NUMBER OF BIRTH-RELATED OR METHOD RELATED DEATHS
ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NONSTERILE WOMEN, BY
FERTILITY-CONTROL METHOD ACCORDING TO AGE
Method of control 15-29 20-24 25-29 30-34 35-39 40-44 and outcome
No fertility- 7.0 7.4 9.1 14.8 25.7 28.2 control methods* Oral contraceptives 0.3 0.5 0.9 1.9 13.8 31.6 non-smoker** Oral contraceptives 2.2 3.4 6.6 13.5 51.1 117.2 smoker** IUD** 0.8 0.8 1.0 1.0 1.4 1.4 Condom* 1.1 1.6 0.7 0.2 0.3 0.4 Diaphragm/ 1.9 1.2 1.2 1.3 2.2 2.8 spermicide* Periodic abstinence* 2.5 1.6 1.6 1.7 2.9 3.6 *Deaths are birth related **Deaths are method related
Adapted from H.W. Ory, Family Planning Perspectives, 15:57-63, 1983.
3. CARCINOMA OF THE REPRODUCTIVE ORGANS
Numerous epidemiological studies have been performed on the incidence of breast, endometrial,
ovarian, and cervical cancer in women using oral contraceptives. The overwhelming evidence in
the literature suggests that use of oral contraceptives is not associated with an increase in the
risk of developing breast cancer, regardless of the 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 risk of 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 the methodology 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 and
cervical cancers, a cause-and-effect relationship has not been established.
4. HEPATIC NEOPLASIA
Benign hepatic adenomas are associated with oral-contraceptive use, although the incidence of
benign tumors is rare in the United States. Indirect calculations have estimated the attributable
risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more
years of use. Rupture of rare, benign, hepatic adenomas may cause death through intra-
abdominal hemorrhage.
Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in
long-term (>8years) oral-contraceptive users. However, these cancers are extremely 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.
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. Studies also do not suggest a teratogenic
effect, particularly insofar as cardiac anomalies and limb-reduction defects are concerned, when
taken inadvertently during early pregnancy.
The administration of oral contraceptives to induce withdrawal bleeding should not be used as a
test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened
or habitual abortion.
It is recommended that for any patient who has missed two consecutive periods, pregnancy
should be ruled out before continuing oral-contraceptive use. If the patient has not adhered to the
prescribe 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 confirmed.
7. GALLBLADDER DISEASE
Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of
oral contraceptives and estrogens. More recent studies, however, have shown that the relative
risk of developing gallbladder disease among oral-contraceptive users may be minimal. The
recent findings of minimal risk may be related to the use of oral-contraceptive formulations
containing lower hormonal doses of estrogens and progestogens.
8. CARBOHYDRATE AND LIPID METABOLIC EFFECTS
Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of
users. Oral contraceptives containing greater than 75 micrograms of estrogens cause
hyperinsulinism, while lower doses of estrogen cause less glucose intolerance. Progestogens
increase insulin secretion and create insulin resistance, this effect varying with different
progestational agents. However, in the nondiabetic women, oral contraceptives appear to have
no effect on fasting blood glucose. Because of these demonstrated effects, prediabetic and
diabetic women should be carefully observed while taking oral contraceptives.
A small proportion of women will have persistent hypertriglyceridemia while one the pill. As
discussed earlier (see “Warnings,” 1a. and 1d.), changes in serum triglycerides and lipoprotein
levels have been reported in oral-contraceptive users.
9. ELEVATED BLOOD PRESSURE
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 with continued use. Data from the
Royal College of General Practitioners and subsequent randomized trials have shown that the
incidence of hypertension increases with increasing quantities 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 with hypertension 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 among ever- and never-users.
10. HEADACHE
The onset or exacerbation of migraine or development of headache with an new pattern that 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. The type and dose of
progestogen may be important. Nonhormonal causes should be considered and adequate
diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough
bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time
or a change to another formulation may solve the problem. In the event of amenorrhea,
pregnancy should be ruled out.
Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a
condition was preexistent.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and
other sexually transmitted diseases.
1. PHYSICAL EXAMINATION AND FOLLOW-UP
A periodic history and physical examination is appropriate for all women, 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. (See “Warnings,” 1d.)
3. LIVER FUNCTION
If jaundice develops in any woman receiving such drugs, the medication should be discontinued.
Steroid hormones may be poorly metabolized in patients with impaired liver function.
4. FLUID RETENTION
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in
patients with conditions which might be aggravated by fluid retention.
5. EMOTIONAL DISORDERS
Patients becoming significantly depressed while taking oral contraceptives should stop the
medication and use an alternate method of contraception in an attempt to determine whether the
symptom is drug related.
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, and possibly
with griseofulvin, ampicillin, and tetracyclines.
8. INTERACTIONS WITH LABORATORY TESTS
Certain endocrine- and liver-function tests and blood components may be affected by oral
contraceptives:
a. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased
norepinephrine-induced platelet aggregability.
b. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid
hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay.
Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is
unaltered.
c. Other binding proteins may be elevated in serum.
d. Sex-binding globulins are increased and result in elevated levels of total circulating sex
steroids and corticoids; however, free or biologically active levels remain unchanged.
e. Triglycerides may be increased.
f. Glucose tolerance may be decreased.
g. Serum folate levels may be depressed by oral-contraceptive therapy.
This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral
contraceptives.
9. CARCINOGENESIS
See “Warnings” section.
10. PREGNANCY
Pregnancy Category X. See “Contraindications” and “Warnings” 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, 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 her child.
An increased risk of the following serious adverse reactions has been associated with the use of
oral contraceptives (see “Warnings” section):
Thrombophlebitis.
Arterial thromboembolism.
Pulmonary embolism.
Myocardial infarction.
Cerebral hemorrhage.
Cerebral thrombosis.
Hypertension.
Gallbladder disease.
Hepatic adenomas or benign liver tumors.
There is evidence of an association between the following conditions and the use of oral
contraceptives, although additional confirmatory studies are needed:
Mesenteric thrombosis.
Retinal thrombosis.
The following adverse reactions have been reported in patients receiving oral contraceptives
and are believed to be drug related:
Nausea.
Vomiting.
Gastrointestinal symptoms (such as abdominal cramps and bloating).
Breakthrough bleeding.
Spotting.
Change in menstrual flow.
Amenorrhea.
Temporary infertility after discontinuation of treatment.
Edema.
Melasma which may persist.
Breast changes; tenderness, enlargement, secretion.
Change in weight (increase or decrease).
Change in cervical erosion and secretion.
Diminution in lactation when given immediately postpartum.
Cholestatic jaundice.
Migraine.
Rash (allergic).
Mental depression.
Reduced tolerance to carbohydrates.
Vaginal candidiasis.
Change in corneal curvature (steepening).
Intolerance to contact lenses.
The following adverse reactions have been reported in users of oral contraceptives, and the
association has been neither confirmed nor refuted:
Congenital anomalies.
Premenstrual syndrome.
Cataracts.
Optic neuritis.
Changes in appetite.
Cystitis-like syndrome.
Headache.
Nervousness.
Dizziness.
Hirsutism.
Loss of scalp hair.
Erythema multiforme.
Erythema nodosum.
Hemorrhagic eruption.
Vaginitis.
Porphyria.
Impaired renal function.
Hemolytic uremic syndrome.
Budd-Chiari syndrome.
Acne.
Changes in libido.
Colitis.
Sickle-cell disease.
Cerebral-vascular disease with mitral valve prolapse.
Lupus-like syndromes.
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 noncontraceptive health benefits related to the use of oral contraceptives are
supported by epidemiological studies which largely utilized oral-contraceptive formulation
containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.
Effects on menses:
Increased menstrual cycle regularity.
Decreased blood loss and decreased incidence of iron-deficiency anemia.
Decreased incidence of dysmenorrhea.
Effects related to inhibition of ovulation.
Decreased incidence of ectopic pregnancies.
Effects from long-term use:
Decreased incidence of fibroadenomas and fibrocystic disease of the breast.
Decreased incidence of acute pelvic inflammatory disease.
Decreased incidence of endometrial cancer.
Decreased incidence of ovarian cancer.
To achieve maximum contraceptive effectiveness, Triphasil-21 Tablets (levonorgestrel and
ethinyl estradiol tablets-triphasic regimen) must be taken exactly as directed and at intervals not
exceeding 24 hours.
Triphasil-21 tablets are a three-phase preparation. The dosage of Triphasil-21 Tablets is one
tablet daily for 21 consecutive days per menstrual cycle in the following order: 6 brown tablets
(phase 1), followed by five white tablets (phase 2), and them followed by the last 10 light-yellow
tablets (phase 3), according to the prescribed schedule. Tablets are then discontinued for 7
days (three weeks on, one week off). It is recommended that Triphasil-21 Tablets be taken at
the same time each day, preferably after the evening meal or at bedtime. During the first cycle
of medication, the patient should be instructed to take one Triphasis-21 Tablet daily in the order
of 6 brown, 5 white and, finally 10 light-yellow tablets for twenty-one (21) consecutive days,
beginning on day one (1) of her menstrual cycle. (The first day of menstruation is day one.) The
tablets are then discontinued for one week (7 days). Withdrawal bleeding usually occurs within 3
days following discontinuation of Triphasil-21 Tablets. (If Triphasil-21 Tablets are first taken
later than the first day of the first menstrual cycle of medication or postpartum, contraceptive
reliance should not be placed on Triphasil-21 Tablets until after the first 7 consecutive days of
administration. The possibility of ovulation and conception prior to initiation of medication should
be considered.)
When switching from another oral contraceptive, Triphasil-21 Tablets should be started on the
first day of bleeding following the last active tablet taken of the previous oral contraceptive.
The patient begins her next and all subsequent 21-day courses of Triphasil-21 Tablets on the
same day of the week that she began her first course, following the same schedule; 21 days on 7
days off. She begins taking her brown tablets on the 8th day after discontinuance, regardless of
whether or not a menstrual period has occurred or is still in progress. Any time the next cycle of
Triphasil-21 Tablets is started later than the 8th day, the patient should be protected by another
means of contraception until she has taken a tablet daily for seven consecutive days.
If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same
regimen. This type of bleeding is usually transient and without significance; however, if the
bleeding is persistent or prolonged, the patient is advised to consult her physician. Although the
occurrence of pregnancy is highly unlikely if Triphasil-21 Tablets are taken according to
directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be
considered. If the patient has not adhered to the prescribed schedule (missed one or more
tablets or started taking them on a day later than she should have), the probability of pregnancy
should be considered at the time of the first missed period and appropriate diagnostic measures
taken before the medication is resumed. If the patients has adhered to the prescribed regimen
and misses two consecutive periods, pregnancy should be ruled out before continuing the
contraceptive regimen.
The risk of pregnancy increases with each tablet missed. For additional patient instructions
regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED
PATIENT LABELING below. If breakthrough bleeding occurs following missed tablets, it will
usually be transient and of no consequence.
In the nonlactating mother, Triphasil-21 may be initiated postpartum, for contraception. When
the tablets are administered in the postpartum period, the increased risk of thromboembolic
disease associated with the postpartum period must be considered (see “Contraindications,”
“Warnings,” and “Precautions” concerning thromboembolic disease). It is to be noted that early
resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the
prevention of lactation.
Triphasil-21 Tablets (levonorgestrel and ethinyl estradiol tablets-triphasic regimen). NDC 0008-
2535, are available in packages of 3 dial dispensers. Each cycle contains 21 round, coated
tablets as follows:
NDC 0008-0641, six brown tablets marked “W” and “641”, each containing 0.050 mg
levonorgestrel and 0.030 mg ethinyl estradiol;
NDC 0008-0642, five white to off-white tablets marked “W” and “642”, each containing 0.075 mg levonorgestrel and 0.040 mg ehinyl estradiol; and
NDC 0008-0643, ten light-yellow tablets marked “W” and “643”, each containing 0.125 mg
levonorgestrel and 0.030 mg ethinlyl estradiol.
References available upon request.
This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect
against HIV infection (AIDS) and other sexually transmitted diseases.
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 1.0% per year when used
without missing any pills. The typical failure rate of large numbers of pill users is less than 3.0%
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 life-threatening or may
cause temporary or permanent disability or death. The risks associated with taking oral
contraceptives increase significantly if you:
* smoke.
* have high blood pressure, diabetes, high cholesterol.
* have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or
sex organs, jaundice, or malignant or benign liver tumors.
You should not take the pill if you suspect you are or have unexplained vaginal bleeding.
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS ADVERSE EFFECTS ON THE
HEART AND BLOOD VESSELS FROM ORAL-CONTRACEPTIVE USE. THE RISK
INCREASES WITH AGE AND WITH HEAVY SMOKING (15 OR MORE CIGARETTES PER
DAY) AND IS QUITE MARKED IN WOMEN OVER 35 YEARS OF AGE. WOMEN WHO USE
ORAL CONTRACEPTIVES SHOULD NOT SMOKE.
Most side effects of the pill are not serious. The most common such effects are nausea,
vomiting, bleeding between menstral periods, weight gain, breast tenderness, and difficulty
wearing contact lenses. The 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 do not smoke. However, you should know that the following medical conditions have been
associated with or made worse by the the pill:
1. Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stopping or rupture of
a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack and
angina pectoris) or other organs of the body. As mentioned above, smoking increases the risk of
heart attacks and strokes and subsequent serious medical consequences.
2. Liver tumors, which may rupture and cause severe bleeding. on seeded rye with mustard. A possible but not definite
association has been found with the pill and liver cancer. However, liver cancers are extremely
rare. The chance of developing liver cancer from using the pill is thus even rarer.
3. High blood pressure, although blood pressure usually returns to normal when the pill is
stopped.
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 anticonvulsants and some antibiotics, may 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 rule out the possibility that pills
may cause such cancers.
Taking the pill provides some important noncontraceptive 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 appropriate to postpone it. You should be
reexamined at least once a year while taking oral contraceptives. The detailed patient
information leaflet 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 HIV infection (AIDS) and other sexually transmitted diseases.
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. This leaflet 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 leaflet is not a
replacement for a careful discussion between you and your health-care provider. you should
discuss the information provided in this leaflet 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.
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. When they are taken correctly,
the chance of becoming pregnant is less than 1.0 when used perfectly, without missing any
pills. Typical failure rates are less than 3.0% per year. The chance of becoming pregnant
increases with each missed pill during the menstrual cycle.
In comparison, typical failure rates for other nonsurgical methods of birth control during the first
year of use are as follows:
IUD:3%.
DEPO-PROVERA® (injectable progestogen): 0.3%.
NORPLANT® SYSTEM (implants): 0.2%.
Diaphragm with spermicides: 18%.
Spermicides alone: 21%.
Vaginal sponge: 18 to 28%.
Condom alone: 12%.
Periodic abstinence: 20%.
No methods: 85%.
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 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 you have had any of
the following conditions:
* Heart attack or stroke.
* Blood clots in the legs(thrombophlebitis), lungs (pulmonary embolism), or eyes.
* Blood clots in the veins of your legs.
* Known or suspected breast cancer or canc„8Tf the lining of the uterus, cervix or vagina.
* Liver tumor (benign or cancerous).
Or, if you have any of the following:
* Chest pain (angina pectoris).
* Unexplained vaginal bleeding (until a diagnosis is reached by your doctor).
* Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during pervious
use of the pill.
* Known or suspected pregnancy.
Tell your health-care provider if you have ever had any of these conditions. Your health-care
provider can recommend another method of birth control.
OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES
Tell your health-care provider if you or any family member has ever had:
* Breast nodules, fibrocystic disease of the breast, an abnormal breast X-ray or mammogram.
* Diabetes.
* Elevated cholesterol or triglycerides.
* High blood pressure.
* Migraine or other headaches or epilepsy.
* Mental depression.
* Gallbladder, heart or kidney disease.
* History of scanty or irregular menstrual periods.
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.
RISKS OF TAKING ORAL CONTRACEPTIVES
1. Risk of developing blood clots
Blood clots and blockage of blood vessels are the most serious side effects of taking oral
contraceptives and can be fatal. In particular, a clot in the legs can cause thrombophlebitis and
clot that travels to the lungs can cause a sudden blocking of the 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 developing blood clots. You
should consult your doctor about stopping oral contraceptives three to four weeks before surgery
and not taking oral contraceptives for two weeks after surgery or during bed rest. You should
consult your doctor about stopping oral contraceptives three to four weeks before surgery and
not taking oral contraceptives for two weeks after surgery or during bed rest. You should not
take oral contraceptives soon after delivery of a baby or a midtrimester pregnancy termination.
It is advisable to wait for at least four weeks after delivery if you are not breast-feeding. If you
are breast-feeding, you should wait until you have weaned your child before using the pill. (See
also the section on breast-feeding in “General Precautions.”)
2. Heart attacks and strokes
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 of blood vessels in the
heart.) Any of these conditions can cause death or serious disability.
Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore,
smoking and the use of oral contraceptives greatly increase the chances of developing and dying
of heart disease.
3. Gallbladder 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 of estrogens.
4. Liver tumors
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, a possible 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 were found to have used oral contraceptives for long
periods. However, liver cancers are extremely rare. The chance of developing liver cancer from
using the pill is thus even rarer.
5. Cancer of the reproductive organs
There is, at present, no confirmed evidence that oral contraceptives increase the risk of cancer
of the reproductive organs in human studies. Several studies have 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 factors other 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 of deaths 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 ACCORDING TO AGE.
Method of control 15-19 20-24 25-29 30-34 35-39 40-44 and outcome
No fertility- 7.0 7.4 9.1 14.8 25.7 28.2 control methods* Oral contraceptives 0.3 0.5 0.9 1.9 13.8 31.6 non-smoker** Oral contraceptives 2.2 3.4 6.6 13.5 51.1 117.2 smoker IUD* 0.8 0.8 1.0 1.0 1.4 1.4 Condom* 1.1 1.6 0.7 0.2 0.3 0.4 Diaphragm/ 1.9 1.2 1.2 1.3 2.2 2.8 Spermicide* Periodic abstinence* 2.5 1.6 1.6 1.7 2.9 3.6 *Deaths are birth related **Deaths are method related
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 to 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, except for those women over the age of 40,
when 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 women) in that age
group.
a:
WARNING SIGNALS
If any of these adverse effects occur while you are taking oral contraceptives, call your doctor
immediately:
* Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in
the lung).
* Pain in the calf (indicating a possible clot in the leg).
* Crushing chest pain or heaviness in the chest (indicating a possible heart attack.)
* Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech,
weakness, or numbness in an arm or leg (indicating a possible stroke).
* Sudden partial or complete loss of vision (indicating a possible clot in the eye).
* Breast lumps(indicating possible breast cancer or fibrocystic disease of the breast; ask your
doctor or health-care provider to show you how to examine your breasts).
* Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor).
* Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating
severe depression).
* Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of
appetite, dark-colored urine, or light-colored bowel movements (indicating possible liver
problems).
SIDE EFFECTS OF ORAL CONTRACEPTIVES
1. Vaginal bleeding
Irregular vaginal bleeding or spotting may occur while you are taking the pills. Irregular bleeding
may vary from slight staining between menstrual periods to breakthrough 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 may also 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 to continue 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.
2. Contact lenses
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.
3. Fluid retention
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 provider.
4. Melasma
A spotty darkening of the skin is possible, particularly of the face.
5. Other side effects
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 provider.
GENERAL PRECAUTIONS
1. Missed periods and use of oral contraceptives before or during early pregnancy
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 one menstrual period, continue
taking your pills for the next cycle but be sure to inform your health-care provider before doing
so. If you have not taken the pills daily as instructed and missed a menstrual period, or if you
missed two consecutive menstrual periods, you may be pregnant. Check with your health-care
provider immediately 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 another method 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 contraceptives or 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 your unborn child of any medication taken during pregnancy.
2. While breast-feeding
If you are breast-feeding, 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 the child have been
reported, including yellowing of the skin(jaundice) and breast enlargement. In addition, oral
contraceptives may decrease the amount and quality of your milk. If possible, do not use oral
contraceptives while breast-feeding. You should use another method of contraception since
breast-feeding provides only partial protection from becoming pregnant, and this partial
protection decreases significantly as you breast-feed for longer periods of time. You should
consider starting oral contraceptive only after you have weaned your child completely.
3. Laboratory tests
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.
4. Drug interactions
Certain drugs may interact with birth-control pills to make them less effective in preventing
pregnancy or cause an increase in breakthrough bleeding. Such drugs include 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 certain antibiotics.
You may need to use an additional method of contraception during any cycle in which you take
drugs that can make oral contraceptives less effective.
HOW TO TAKE THE PILL
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.
BEFORE YOU START TAKING YOUR PILLS:
1. BE SURE TO READ THESE DIRECTIONS:
Before you start taking your pills.
Anytime you are not sure what to do.
2. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME
TIME.
If you miss pills you could get pregnant. This includes starting the pack late. The more pills you
miss, the more, the more likely you are to get pregnant.
3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR
STOMACH DURING THE FIRST 1-3 PACKS OF PILLS.
If you 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.
4. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING,
even when you make up these missed pills.
On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your
stomach.
5. IF YOU HAVE VOMITING OR DIARRHEA, for any reason, or IF YOU TAKE SOME
MEDICINES, including some antibiotics, you pill may not work as well.
Use a back-up method (such as condoms, foam, or sponge) until you check with your doctor or
clinic.
6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or clinic
about how to make pill-taking easier or about using another method of birth control.
7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS
LEAFLET, call your doctor or clinic.
BEFORE YOU START TAKING YOUR PILLS
1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILLS.
it is important to take it at about the same time every day..
2. LOOK AT YOUR PILL PACK TO SEE IF IT HAS 21 OR 28 PILLS:
The 21-pill pack has 21 active brown, white or light-yellow pills(with hormones) to take for 3
weeks, followed by 1 week without pills.
The 28-pill pack has 21 active brown, white or light-yellow pills(with hormones)to take for 3
weeks, followed by 1 week of reminder light-green pills (without hormones)
3. ALSO FIND
1) where on the pack to start taking pills, and
2) in what order to take the pills(follow arrow).
4. BE SURE YOU HAVE READY AT ALL TIMES:
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. Decide with your doctor or
clinic which is the best day for you. Pick a time of day which will be easy to remember.
DAY 1 START:
1. take the first “active” brown pill of the first pack during the first 24 hours of your period.
2. 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.
SUNDAY START:
1. Take the first “active” brown pill of the first pack on the Sunday after your period starts, even
if you are still bleeding. If your period begins on Sunday, start the pack that same day.
2. Use another method of birth control as a back-up method if you have sex anytime from the
Sunday you start your first pack until the next Sunday (7 days). Condoms, foam, or the sponge
are good back-up methods of birth control.
WHAT TO DO DURING THE MONTH:
1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.
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.
2. WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS:
21 pills: Wait 7 days to start the next pack. You will probably have your period during that week.
Be sure that no more than 7 days pass between 21-day packs.
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 brown, white, or light-yellow “active” pill:
1. Take it as soon as you remember. Take the next pill at your regular time. This means you
take 2 pills in 1 day.
2. You do not need to use a back-up-birth-control method if you have sex.
If you Miss 2 brown, white or light-yellow “active” pills in a row in WEEK 1 OR WEEK 2 of your
pack.
1. Take 2 pills on the day you remember and 2 pills the next day.
2 Then take one pill a day until you finish the pack.
3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You
MUST use another birth-control method (such as condoms, foam, or sponge) as a back-up for
those 7 days.
If you MISS 2 brown, , white or light-yellow active pills in a row in THE 3rd WEEK:
1. If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start an 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 pill that same day.
2. You may not have your period this month but this is expected. However, if you miss your
period 2 months in a row, call your doctor or clinic because you might be pregnant.
3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You
MUST use another birth-control method (such as condoms, foam, or sponge) as a back-up for
those 7 days.
If you MISS 3 OR MORE brown, white or light-yellow “active” pills in a row (during the first 3 weeks):
1. If you are a Day 1 Starter:
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.
2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.
3. You MAY BECOEM PREGNANT if you have sex in the 7 days after you miss pills. You MUST ue another birth-control method (such as condoms, foam, or sponge) as back-up for those 7 days.
A REMINDER FOR THOSE ON 28-DAY PACKS
If you forget any of the 7 light-green “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 if you start your next pack on time.
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 PILL EACH DAY until you can reach your doctor or clinic.
Pregnancy due to pill failure
The incidence of pill failure resulting in pregnancy is approximately less than 1.0% if taken every
day as directed, but more typical failure rates are less than 3.0%. If failure doses occur, the risk
to the fetus is minimal.
RISK TO THE FETUS
If you do become pregnant while using oral contraceptives, the risk to the fetus is small, on the
order of no more than one per thousand. You should, however, discuss the risks to the developing
child with your doctor.
Pregnancy after stopping the pill
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 newbord babies when pregnancy
occurs soon after stopping the pill.
Overdosage
Serious ill effects have not been reported following ingestion of large doses of oral
contraceptives by young children. Overdose may cause nausea and withdrawal bleeding in
females. In case overdosage, contact your health-care provider or pharmacist.
Other information
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 if and the health-care provider believes that it is appropriate to postpone it. You
should be reexamined at lest 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 the 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
HEALTH BENEFITS FROM ORAL CONTRACEPTIVES
In addition to preventing pregnancy, use of oral contraceptives may provide certain benefits.
They are:
* Menstrual cycles may become more regular.
* Blood flow during menstruation may be lighter, and less iron may be lost. Therefore, anemia
due to iron deficiency is less likely to occur.
* Pain or other symptoms during menstruation may be encountered less frequently.
* Ovarian cysts may occur less frequently.
* Ectopic (tubal) pregnancy may occur less frequently.
* Noncancerous cysts or lumps in the breast may occur less frequently.
* Acute pelvic inflammatory disease may occur less frequently.
* Oral-contraceptive use may provide some protection against developing two forms of cancer:
cancer of the ovaries and cancer of the lining of the uterus.
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.
WYETH LABORATORIES INC.
A Wyeth-Ayerst Company
Philadelphia, PA 19101
CI 4242-2 Revised June 24, 1994
Printed in USA