Ortho Tri Cyclen Lo Information
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol)
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Description
ORTHO TRI-CYCLEN Lo Tablets is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.
Each white tablet contains 0.180 mg of the progestational compound, norgestimate (+)-13-Ethyl-17-hydroxy-18, 19-dinor-17α-pregn-4-en-20-yn-3-one oxime acetate (ester) and 0.025 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include lactose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, and purified water.
Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (+)-13-Ethyl-17-hydroxy-18, 19-dinor-17α-pregn-4-en-20-yn-3-one oxime acetate (ester) and 0.025 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, and purified water.
Each dark blue tablet contains 0.250 mg of the progestational compound norgestimate (+)-13-Ethyl-17-hydroxy-18, 19-dinor-17α-pregn-4-en-20-yn-3-one oxime acetate (ester) and 0.025 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, polysorbate 80, carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, and purified water.
Each dark green tablet contains only inert ingredients, as follows: FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, pregelatinized starch, ferric oxide, hypromellose, polyethylene glycol, titanium dioxide, talc and purified water.
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Clinical Pharmacology
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).
Receptor binding studies, as well as studies in animals and humans, have shown that norgestimate and 17-deacetyl norgestimate, the major serum metabolite, combine high progestational activity with minimal intrinsic androgenicity. Norgestimate, in combination with ethinyl estradiol, does not counteract the estrogen-induced increases in sex hormone binding globulin (SHBG), resulting in lower serum testosterone.
Although norelgestromin and its metabolites inhibit a variety of P450 enzymes in human liver microsomes, under the recommended dosing regimen, the in vivo concentrations of norelgestromin and its metabolites, even at the peak serum levels, are relatively low compared to the inhibitory constant (K).
Interactions between oral contraceptives and other drugs have been reported in the literature. No formal drug-drug interaction studies were conducted with ORTHO TRI-CYCLEN Lo (see ).
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Indications And Usage
ORTHO TRI-CYCLEN Lo Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
In an active controlled clinical trial 1,673 subjects completed 11,003 cycles of ORTHO TRI-CYCLEN Lo use and a total of 20 pregnancies were reported in ORTHO TRI-CYCLEN Lo users. This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 2.36 per 100 women-years of use.
Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant system, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Contraindications
Oral contraceptives should not be used in women who have any of the following conditions:
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Warnings
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.
The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.
Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (adapted from refs. 2 and 3 with the author's permission). For further information, the reader is referred to a text on epidemiological methods.
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 3). These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Each method of contraception has its specific benefits and risks. The study concluded that with the exception of oral contraceptive users 35 and older who smoke, and 40 and older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth. The observation of an increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970's. Current clinical recommendation involves the use of lower estrogen dose formulations and a careful consideration of risk factors. In 1989, the Fertility and Maternal Health Drugs Advisory Committee was asked to review the use of oral contraceptives in women 40 years of age and over.
The Committee concluded that although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception. The Committee recommended that the benefits of low-dose oral contraceptive use by healthy non-smoking women over 40 may outweigh the possible risks.
Of course, older women, as all women, who take oral contraceptives, should take an oral contraceptive which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and individual patient needs.
Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using oral contraceptives.
The risk of having breast cancer diagnosed may be slightly increased among current and recent users of combination oral contraceptives. However, this excess risk appears to decrease over time after discontinuation of combination oral contraceptives and by 10 years after cessation the increased risk disappears. Some studies report an increased risk with duration of use while other studies do not and no consistent relationships have been found with dose or type of steroid. Some studies have found a small increase in risk for women who first use combination oral contraceptives before age 20. Most studies show a similar pattern of risk with combination oral contraceptive use regardless of a woman's reproductive history or her family breast cancer history.
Breast cancers diagnosed in current or previous oral contraceptive users tend to be less clinically advanced than in nonusers.
Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is usually a hormonally-sensitive tumor.
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.
Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use especially with oral contraceptives of higher dose. Rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) 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.
Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. The majority of recent studies also do not indicate a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy.
The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral contraceptive use should be discontinued if pregnancy is confirmed.
Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users. This effect has been shown to be directly related to estrogen dose. Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents. However, in the non-diabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. Because of these demonstrated effects, prediabetic and diabetic women in particular should be carefully monitored while taking oral contraceptives.
A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see and ), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.
Women with significant hypertension should not be started on hormonal contraception. 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 extended duration of use. Data from the Royal College of General Practitioners and subsequent randomized trials have shown that the incidence of hypertension increases with increasing progestational activity and 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 elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued. For most women, elevated blood pressure will return to normal after stopping oral contraceptives, and there is no difference in the occurrence of hypertension between former and never users.
Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Non-hormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out.
Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was preexistent.
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Precautions
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Information For The Patient
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Adverse Reactions
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see ).
There is evidence of an association between the following conditions and the use of oral contraceptives:
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:
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Overdosage
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.
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Non-contraceptive Health Benefits
The following non-contraceptive health benefits related to the use of combination oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg mestranol.
Effects on menses:
Effects related to inhibition of ovulation:
Other effects:
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Dosage And Administration
When taking ORTHO TRI-CYCLEN Lo the first white "active" tablet should be taken on the first Sunday after menstruation begins. If the menstrual period begins on Sunday, the first white "active" tablet should be taken that day. Take one white, light blue or dark blue "active" tablet daily for 21 days followed by one dark green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.
If the patient misses one (1) white, light blue, or dark blue "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) white or light blue "active" tablets in Week 1 or Week 2, the patient should take two (2) "active" tablets the day she remembers and two (2) "active" tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) dark blue "active" tablets in the third week or misses three (3) or more "active" tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.
Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("" section).
The dosage of ORTHO TRI-CYCLEN Lo for the initial cycle of therapy is one white, light blue or dark blue "active" tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1" followed by one dark green "reminder" tablet daily for 7 days. Tablets are taken without interruption for 28 days. After 28 tablets have been taken, a new course is started the next day.
If the patient misses one (1) white, light blue, or dark blue "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) white or light blue "active" tablets in Week 1 or Week 2, the patient should take two (2) "active" tablets the day she remembers and two (2) "active" tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) dark blue "active" tablets in the third week or misses three (3) or more "active" tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.
Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).
When switching from another oral contraceptive, ORTHO TRI-CYCLEN Lo should be started on the same day that a new pack of the previous oral contraceptive would have been started.
The use of ORTHO TRI-CYCLEN Lo for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See and concerning thromboembolic disease. See also .) The possibility of ovulation and conception prior to initiation of medication should be considered.
(See Discussion of .)
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Additional Instructions For All Dosing Regimens
Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.
Use of oral contraceptives in the event of a missed menstrual period:
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) How Supplied
ORTHO TRI-CYCLEN Lo Tablets are available in a blister card (NDC 50458-251-00 or NDC 0062-1251-00) with a DIALPAK Tablet Dispenser (unfilled). The blister card contains 28 tablets. Each of the 7 white, round, convex, coated tablets imprinted "O-M" on one side and "180" on the other side contains 0.180 mg of the progestational compound, norgestimate, together with 0.025 mg of the estrogenic compound, ethinyl estradiol. Each of the 7 light blue, round, convex, coated tablets imprinted "O-M" on one side and "215" on the other side contains 0.215 mg of the progestational compound, norgestimate, together with 0.025 mg of the estrogenic compound, ethinyl estradiol. Each of the 7 dark blue, round, convex, coated tablets imprinted "O-M" on one side and "250" on the other side contains 0.250 mg of the progestational compound, norgestimate, together with 0.025 mg of the estrogenic compound, ethinyl estradiol. Each of the 7 dark green, round, convex, coated tablets imprinted "O-M" on one side and "P" on the other side contains inert ingredients. ORTHO TRI-CYCLEN Lo Tablets are packaged in a carton (NDC 50458-251-15 or NDC 0062-1251-15) containing 6 blister cards and 6 unfilled DIALPAK Tablet Dispensers.
ORTHO TRI-CYCLEN Lo Tablets are available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE refills (NDC 50458-251-20 or NDC 0062-1251-20).
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Brief Summary Patient Package Insert
Oral contraceptives, also known as "birth control pills" or "the pill," are taken to prevent pregnancy. When taken correctly without missing any pills, oral contraceptives are highly effective; however the typical failure rate of large numbers of pill users is 5% per year when women who miss pills are included. Forgetting to take pills considerably increases the chances of pregnancy. For most women oral contraceptives are also free of serious or unpleasant side effects.
For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be fatal or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:
Although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women.
You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Detailed Patient Labeling
ORTHO TRI-CYCLEN Lo Tablets
Each white tablet contains 0.180 mg norgestimate and 0.025 mg ethinyl estradiol.
Each light blue tablet contains 0.215 mg norgestimate and 0.025 mg ethinyl estradiol.
Each dark blue tablet contains 0.250 mg norgestimate and 0.025 mg ethinyl estradiol.
Each dark green tablet contains inert ingredients.
Any woman who considers using oral contraceptives (the birth control pill or the pill) should understand the benefits and risks of using this form of birth control. This patient labeling will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this labeling is not a replacement for a careful discussion between you and your healthcare professional. You should discuss the information provided in this labeling with him or her, both when you first start taking the pill and during your revisits. You should also follow your healthcare professional's advice with regard to regular check-ups while you are on the pill.
Oral contraceptives or "birth control pills" or "the pill" are used to prevent pregnancy and are more effective than most other non-surgical methods of birth control. When taken correctly without missing any pills, oral contraceptives are highly effective; however, typical failure rates are 5% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.
In comparison, typical failure rates for other non-surgical methods of birth control during the first year of use are as follows:
Implant:
Injection:
IUD: 1 to 2%
Diaphragm with spermicides: 20%
Spermicides alone: 26%
Vaginal sponge: 20 to 40%
Female sterilization:
Male sterilization:
Cervical Cap with spermicide: 20 to 40%
Condom alone (male): 14%
Condom alone (female): 21%
Periodic abstinence: 25%
No methods: 85%
Withdrawal: 19%
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Principal Display Panel - Dialpak And Refills Carton
NDC 0062-1251-15
Each white tablet contains 0.180 mg norgestimate and 0.025 mg ethinyl estradiol. Each light blue tablet contains 0.215 mg norgestimate and 0.025 mg ethinyl estradiol. Each dark blue tablet contains 0.250 mg norgestimate and 0.025 mg ethinyl estradiol. Each green tablet contains inert ingredients.
Store at 25°C (77°F); excursions permitted to 15° - 30°C(59° - 86°F). Protect from light.
www.ortho-tricyclenlo.com
Mfd. for:ORTHO-McNEILPHARMACEUTICAL, INC.Raritan, New Jersey 08869
Mfd. by:Janssen Ortho, LLCManati, Puerto Rico00674
Ortho tri cyclen lo (Norgestimate/ethinyl estradiol) Principal Display Panel - Dialpak And Refills Carton
NDC 0062-1251-29
Each white tablet contains 0.180 mg norgestimate and0.025 mg ethinyl estradiol. Each light blue tablet contains0.215 mg norgestimate and 0.025 mg ethinyl estradiol.Each dark blue tablet contains 0.250 mg norgestimateand 0.025 mg ethinyl estradiol. Each green tabletcontains inert ingredients.
Mfd. for:ORTHO-McNEIL PHARMACEUTICAL, INC.RARITAN, NEW JERSEY 08869 www.ortho-tricyclenlo.com
Mfd. by:Janssen Ortho, LLCManati, Puerto Rico 00674
