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Norethindrone and Ethinyl Estradiol
Overview
What is BRIELLYN?
BRIELLYN 28-Day (norethindrone and ethinyl estradiol tablets USP) provide a continuous regimen for oral contraception derived from 21 light peach tablets composed of norethindrone USP and ethinyl estradiol USP to be followed by 7 white to off-white tablets of inert ingredients. The structural formulas are:
The light peach active tablets each contain 0.4 mg norethindrone USP and 0.035 mg ethinyl estradiol USP, and contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, povidone, sodium starch glycolate and talc. The white to off-white tablets in the 28-Day regimen contain only inert ingredients as follows: lactose monohydrate, magnesium stearate, pregelatinized starch and talc.
What does BRIELLYN look like?
What are the available doses of BRIELLYN?
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What should I talk to my health care provider before I take BRIELLYN?
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How should I use BRIELLYN?
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 of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
The following is a summary of the instructions given to the patient in the “ section of the
The patient is given instructions in five (5) categories:
1. IMPORTANT POINTS TO REMEMBER: The patient is told (a) that she should take one pill every day at the same time, (b) many women have spotting or light bleeding or gastric distress during the first one to three cycles, (c) missing pills can also cause spotting or light bleeding, (d) she should use a back-up method for contraception if she has vomiting or diarrhea or takes some concomitant medications, and/or if she has trouble remembering the pill, (e) if she has any other questions, she should consult her physician.
2. BEFORE SHE STARTS TAKING HER PILLS: She should decide what time of day she wishes to take the pill, check whether her pill pack has 28 pills, and note the order in which she should take the pills (diagrammatic drawings of the pill pack are included in the patient insert).
3. WHEN SHE SHOULD START THE FIRST PACK: The Day-One start is listed as the first choice and the Sunday start (the Sunday after her period starts) is given as the second choice. If she uses the Sunday start she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills.
4. WHAT TO DO DURING THE CYCLE: The patient is advised to take one pill at the same time every day until the pack is empty. If she is on the 28 day regimen, she should start the next pack the day after the last inactive tablet and not wait any days between packs.
5. WHAT TO DO IF SHE MISSES A PILL OR PILLS: The patient is given instructions about what she should do if she misses one, two or more than two pills at varying times in her cycle for both the Day-One and the Sunday start. The patient is warned that she may become pregnant if she has unprotected intercourse in the seven days after missing pills. To avoid this, she must use another birth control method such as condom, foam, or sponge in these seven days.
What interacts with BRIELLYN?
- Oral contraceptives should not be used in women who currently have the following conditions:
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- RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT
What are the warnings of BRIELLYN?
Because buspirone hydrochloride tablets have no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic 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 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 risk 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 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 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*. For further information, the reader is referred to a text on epidemiological methods.
*Adapted from Stadel BB: Oral contraceptives and cardiovascular disease. 1981; 305: 612-618, 672-677; with author’s permission.
1. Thromboembolic Disorders and Other Vascular Problems:
The physician should be alert to the earliest manifestations of thromboembolic thrombotic disorders as discussed below. Should any of these occur or be suspected the drug should be discontinued immediately.
a. Myocardial Infarction:
The physician should be alert to the earliest manifestations of thromboembolic thrombotic disorders as discussed below. Should any of these occur or be suspected the drug should be discontinued immediately.
b. Thromboembolism:
The physician should be alert to the earliest manifestations of thromboembolic thrombotic disorders as discussed below. Should any of these occur or be suspected the drug should be discontinued immediately.
c. Cerebrovascular Diseases:
The physician should be alert to the earliest manifestations of thromboembolic thrombotic disorders as discussed below. Should any of these occur or be suspected the drug should be discontinued immediately.
d. Dose-Related Risk of Vascular Disease from Oral Contraceptives:
The physician should be alert to the earliest manifestations of thromboembolic thrombotic disorders as discussed below. Should any of these occur or be suspected the drug should be discontinued immediately.
e. Persistence of Risk:
There are two studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives. In a study in the United States, the risk of developing myocardial infarction after discontinuing oral contraceptives persists for at least 9 years for women 40-49 years old 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 six 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 ().
*Deaths are birth related.
**Deaths are method related.
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 risk. The study concluded that with the exception of oral contraceptive users 35 and older who smoke and 40 and older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth.
The observation of a possible increase in risk of mortality with age 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 (Porter JB, Hunter J, Jick H, et al. Oral contraceptives and nonfatal vascular disease. 1985; 66:1-4 and Porter JB, Jick H, Walker AM. Mortality among oral contraceptive users. 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 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.
| No fertility control methods* | 7.0 | 7.4 | 9.1 | 14.8 | 25.7 | 28.2 |
| Oral contraceptives nonsmokers** | 0.3 | 0.5 | 0.9 | 1.9 | 13.8 | 31.6 |
| Oral contraceptives smokers** | 2.2 | 3.4 | 6.6 | 13.5 | 51.1 | 117.2 |
| 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/spermicides* | 1.9 | 1.2 | 1.2 | 1.3 | 2.2 | 2.8 |
| Periodic abstinence* | 2.5 | 1.6 | 1.6 | 1.7 | 2.9 | 3.6 | Ory HW: Mortality associated with fertility and fertility control: 1983. 1983; 15:50-56 |
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 cancer 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 their occurrence 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 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.
During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 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 BRIELLYN prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see CONTRAINDICATIONS ()].BRIELLYN can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.
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 in so far as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy.
The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral contraceptive use should be discontinued 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 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 woman, 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 on the pill. As discussed earlier (see , and ), 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 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 among ever- and never-users.
10. Headache:
The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent or severe requires discontinuation of oral contraceptives and evaluation of the cause.
11. Bleeding Irregularities:
Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. 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.
Women with a history of oligomenorrhea or secondary amenorrhea or young women without regular cycles prior to taking oral contraceptives may again have irregular bleeding or amenorrhea after discontinuation of oral contraceptives.
What are the precautions of BRIELLYN?
1. Sexually -Transmitted Diseases:
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
2. Physical Examination and Follow-Up:
It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
3. 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.
4. 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.
5. 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.
6. Emotional Disorders:
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 to determine whether the symptom is drug related.
7. Contact Lenses:
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
8. 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.
Concomitant Use with HCV Combination Therapy - Liver Enzyme Elevation
Do not co-administer BRIELLYN with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see WARNINGS, ).
9. 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), T by column or by radioimmunoassay. Free Tresin uptake is decreased, reflecting the elevated TBG; free T 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.
10. Carcinogenesis:
See section.
11. Pregnancy:
See and sections.
12. 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.
13. Vomiting and/or Diarrhea:
Although a cause-and-effect relationship has not been clearly established, several cases of oral contraceptive failure have been reported in association with vomiting and/or diarrhea. If significant gastrointestinal disturbance occurs in any woman receiving contraceptive steroids, the use of a back-up method of contraception for the remainder of that cycle is recommended.
14. Pediatric Use:
Safety and efficacy of BRIELLYN (norethindrone and ethinyl estradiol tablets, USP) have been established in women of reproductive age. Safety and efficacy are expected to be the same in post-pubertal adolescents under the age of 16 years and in users ages 16 years and older. Use of this product before menarche is not indicated
Information for Patients
See patient labeling printed below.
What are the side effects of BRIELLYN?
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see 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:
What should I look out for while using BRIELLYN?
Oral contraceptives should not be used in women who currently have the following conditions:
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 risk 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 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 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*. For further information, the reader is referred to a text on epidemiological methods.
*Adapted from Stadel BB: Oral contraceptives and cardiovascular disease. 1981; 305: 612-618, 672-677; with author’s permission.
What might happen if I take too much BRIELLYN?
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.
How should I store and handle BRIELLYN?
Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017BRIELLYN 28-Day (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg) are available in cartons of 3 blister cards each containing 28 tablets.Each blister card contains:21 active tablets: Light peach, round, flat faced, beveled-edged, uncoated tablets with debossed on one side and on the other side.7 Inert tablets: White to off-white, capsule-shaped, biconvex, uncoated tablet with debossed on one side and ‘’ on the other side. (NDC 68462-316-29) Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature.] References are available upon request.Manufactured by:Glenmark Pharmaceuticals Ltd.Manufactured for:Glenmark Pharmaceuticals Inc., USAQuestions? 1 (888)721-7115www.glenmarkpharma.com/usaMay 2017
Clinical Information
Chemical Structure
No Image foundClinical 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).
Non-Clinical Toxicology
Oral contraceptives should not be used in women who currently have the following conditions: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 risk 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 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 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*. For further information, the reader is referred to a text on epidemiological methods.
*Adapted from Stadel BB: Oral contraceptives and cardiovascular disease. 1981; 305: 612-618, 672-677; with author’s permission.
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.
Concomitant Use with HCV Combination Therapy - Liver Enzyme Elevation
Do not co-administer BRIELLYN with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see WARNINGS, ).
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see 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:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).