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norethindrone and ethinyl estradiol
Overview
What is Vyfemla?
Vyfemla™ (norethindrone and ethinyl estradiol tablets USP) provides a continuous regimen for oral contraception derived from 21 light peach tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are:
The light peach active Vyfemla (norethindrone and ethinyl estradiol tablets USP) contains 0.4 mg norethindrone and 0.035 mg ethinyl estradiol and contain the following inactive ingredients: FD&C yellow No. 6 (aluminum lake), lactose anhydrous, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate. The white tablets in the 28 Day regimen contains only inert ingredients as follows croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
What does Vyfemla look like?
What are the available doses of Vyfemla?
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What should I talk to my health care provider before I take Vyfemla?
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How should I use Vyfemla?
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:
What interacts with Vyfemla?
- Oral contraceptives should not be used in women who currently have the following conditions:
- Thrombophlebitis or thromboembolic disorders
- A past history of deep vein thrombophlebitis or thromboembolic disorders
- Cerebrovascular 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
- Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see ).
What are the warnings of Vyfemla?
ID17
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.
N Engl J Med
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
An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid 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 infarctions 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 (Figure 1) among women who use oral contraceptives.
Layde PM, Beral V: Further analyses of mortality in oral contraceptive users: Royal College of General Practitioners' oral contraception study. (Table 5) 1981; 1:541-546.
Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity. In particular, 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 in]. Such increases in risk factors have been associated with an increased risk of heart disease and the risk increases with the number of risk factors present. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
b. Thromboembolism
An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to non-users to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease. Cohort studies have shown the relative risk to be somewhat lower, about 3 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 breastfeed.
| Ory HW: Mortality associated with fertility and fertility control: 1983. 1983; 15:50-56. | ||||||
| No fertility control methods | 7.0 | 7.4 | 9.1 | 14.8 | 25.7 | 28.2 |
| Oral contraceptives nonsmoker | 0.3 | 0.5 | 0.9 | 1.9 | 13.8 | 31.6 |
| Oral contraceptives smoker | 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/spermicide | 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 |
What are the precautions of Vyfemla?
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 levonorgestrel and ethinyl estradiol tablets with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see , ).
9. Interactions with Laboratory Tests
Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
10. Carcinogenesis
See section.
11. Pregnancy
Pregnancy Category X
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 Vyfemla (norethindrone and ethinyl estradiol tablets USP) have been established in women of reproductive age. Safety and efficacy are expected to be the same in postpubertal adolescents under the age of 16 years and in users ages 16 years and older. Use of this product before menarche is not indicated.
- Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
- 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.
- Other binding proteins may be elevated in serum.
- 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.
- Triglycerides may be increased.
- Glucose tolerance may be decreased.
- 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.
What are the side effects of Vyfemla?
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 Vyfemla?
Oral contraceptives should not be used in women who currently have the following conditions:
Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see ).
What might happen if I take too much Vyfemla?
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.
NONCONTRACEPTIVE HEALTH BENEFITS
The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.
Effects on menses:
Effects related to inhibition of ovulation:
Effects from long-term use:
How should I store and handle Vyfemla?
Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].References are available upon request.Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAMay 26, 2017 ID#252106Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].References are available upon request.Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAMay 26, 2017 ID#252106Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].References are available upon request.Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAMay 26, 2017 ID#252106Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].References are available upon request.Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAMay 26, 2017 ID#252106Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].References are available upon request.Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAMay 26, 2017 ID#252106Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].References are available upon request.Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAMay 26, 2017 ID#252106Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].References are available upon request.Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAMay 26, 2017 ID#252106Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].References are available upon request.Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAMay 26, 2017 ID#252106Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].References are available upon request.Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAMay 26, 2017 ID#252106Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].References are available upon request.Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAMay 26, 2017 ID#252106Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].References are available upon request.Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAMay 26, 2017 ID#252106Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].References are available upon request.Distributed by:Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United StatesManufactured by: Lupin LimitedPithampur (M.P.) - 454 775INDIAMay 26, 2017 ID#252106
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:Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see ).
In patients receiving mercaptopurine or azathioprine, the concomitant administration of 300-600 mg of allopurinol per day will require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine. Subsequent adjustment of doses of mercaptopurine or azathioprine should be made on the basis of therapeutic response and the appearance of toxic effects (see ).
It has been reported that allopurinol prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when allopurinol is given to patients already on dicumarol therapy.
Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and allopurinol has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with allopurinol alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on allopurinol alone or in combination with uricosuric agents, the possibility should be kept in mind.
The reports that the concomitant use of allopurinol and thiazide diuretics may contribute to the enhancement of allopurinol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of allopurinol was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thiazide diuretics and allopurinol even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected.
An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both drugs. The cause of the reported association has not been established.
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol. However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine and/or mechlorethamine.
Tolbutamide’s conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of this observation is unknown.
Chlorpropamide’s plasma half-life may be prolonged by allopurinol, since allopurinol and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if allopurinol and chlorpropamide are given concomitantly in the presence of renal insufficiency.
Rare reports indicate that cyclosporine levels may be increased during concomitant treatment with allopurinol. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.
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 levonorgestrel and ethinyl estradiol tablets with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see , ).
9. Interactions with Laboratory Tests
Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
10. Carcinogenesis
See section.
11. Pregnancy
Pregnancy Category X
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 Vyfemla (norethindrone and ethinyl estradiol tablets USP) have been established in women of reproductive age. Safety and efficacy are expected to be the same in postpubertal adolescents under the age of 16 years and in users ages 16 years and older. Use of this product before menarche is not indicated.
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/"
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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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