MICROGESTIN 1.5/30- norethindrone acetate/ethinyl estradiol kit

United States - English - NLM (National Library of Medicine)

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Active ingredient:
NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Available from:
Mayne Pharma Inc.
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Microgestin 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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. 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 ● Cerebral vascular or coronary artery disease ● Known or suspected carcinoma of the breast ● Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia ● Undiagnosed abnormal genital bleeding ● Cholestatic jaundice of pregnancy or jaundice with prior pill use ● Hepatic
Product summary:
Microgestin 1.5/30 is available in dispensers (NDC 51862-872-01) each containing 21 yellow tablets. Each yellow, biconvex, round tablet debossed with "L3" on one side contains 1.5mg of norethindrone acetate and 30 mcg of ethinyl estradiol. Microgestin 1.5/30 Tablets are available in the following configurations: Carton of 1 NDC 51862-872-02 Carton of 3 NDC 51862-872-03 Carton of 6 NDC 51862-872-06 Store at 20 ˚C ~ 25 ˚C (68 ˚F~77 ˚F) [See USP Controlled Room Temperature].
Authorization status:
Abbreviated New Drug Application
Authorization number:
51862-872-01, 51862-872-02, 51862-872-03, 51862-872-06

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MICROGESTIN 1.5/30 - norethindrone acetate/ethinyl estradiol

Mayne Pharma Inc.

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Microgestin® 1.5/30

(Norethindrone Acetate and Ethinyl Estradiol Tablets, USP)

Rx only

Patients should be counseled that this product does not protect against HIV infection (AIDS) and

other sexually transmitted diseases.

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.

DESCRIPTION

Microgestin 1.5/30 is a progestogen-estrogen combination.

Microgestin 1.5/30 provides a continuous dosage regimen consisting of 21 yellow oral contraceptive

tablets.

Each yellow tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg;

ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30mcg. Also contains polyvinyl

alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350 NF, lecithin (soya), iron oxide yellow,

FD&C Blue No.2 Aluminum Lake, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No.6

Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch.

The structural formulas are as follows:

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).

Pharmacokinetics

The pharmacokinetics of Microgestin 1.5/30 has not been characterized; however, the following

pharmacokinetic information regarding norethindrone acetate and ethinyl estradiol is taken from the

literature.

Abs orption

Norethindrone acetate appears to be completely and rapidly deacetylated to norethindrone after oral

administration, since the disposition of norethindrone acetate is indistinguishable from that of orally

administered norethindrone (1). Norethindrone acetate and ethinyl estradiol are subject to first-pass

metabolism after oral dosing, resulting in an absolute bioavailability of approximately 64% for

norethindrone and 43% for ethinyl estradiol (1 to 3).

Dis tribution

Volume of distribution of norethindrone and ethinyl estradiol ranges from 2 to 4 L/kg (1 to 3). Plasma

protein binding of both steroids is extensive (greater than 95%); norethindrone binds to both albumin and

sex hormone binding globulin, whereas ethinyl estradiol binds only to albumin (4).

Metabolis m

Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and

glucuronide conjugation. The majority of metabolites in the circulation are sulfates, with glucuronides

accounting for most of the urinary metabolites (5). A small amount of norethindrone acetate is

metabolically converted to ethinyl estradiol. Ethinyl estradiol is also extensively metabolized, both by

oxidation and by conjugation with sulfate and glucuronide. Sulfates are the major circulating conjugates

of ethinyl estradiol and glucuronides predominate in urine. The primary oxidative metabolite is 2-

hydroxy ethinyl estradiol, formed by the CYP3A4 isoform of cytochrome P450. Part of the first-pass

metabolism of ethinyl estradiol is believed to occur in gastrointestinal mucosa. Ethinyl estradiol may

undergo enterohepatic circulation (6).

Excretion

Norethindrone and ethinyl estradiol are excreted in both urine and feces, primarily as metabolites (5,6).

Plasma clearance values for norethindrone and ethinyl estradiol are similar (approximately 0.4 L/hr/kg)

(1 to 3).

Special Population

Race:

The effect of race on the disposition of Microgestin 1.5/30 has not been evaluated.

Renal Insufficiency

The effect of renal disease on the disposition of Microgestin 1.5/30 has not been evaluated. In

premenopausal women with chronic renal failure undergoing peritoneal dialysis who received multiple

doses of an oral contraceptive containing ethinyl estradiol and norethindrone, plasma ethinyl estradiol

concentrations were higher and norethindrone concentrations were unchanged compared to

concentrations in premenopausal women with normal renal function.

Hepatic Insufficiency

The effect of hepatic disease on the disposition of Microgestin 1.5/30 has not been evaluated.

However, ethinyl estradiol and norethindrone may be poorly metabolized in patients with impaired liver

function.

Drug-Drug Interactions

Numerous drug-drug interactions have been reported for oral contraceptives. A summary of these is

found under PRECAUTIONS, Drug Interactions.

INDICATIONS AND USAGE

Microgestin 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral

contraceptives 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.

CONTRAINDICATIONS

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

Cerebral vascular or coronary artery disease

Known or suspected carcinoma of the breast

Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia

Undiagnosed abnormal genital bleeding

Cholestatic jaundice of pregnancy or jaundice with prior pill use

Hepatic adenomas or carcinomas

Known or suspected pregnancy

Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or

without dasabuvir, due to the potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME

ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).

WARNINGS

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 References 8 and 9 with the

author's permission). For further information, the reader is referred to a text on epidemiological

methods.

1. Thromboembolic Disorders and Other Vascular Problems

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 (10 to 16). 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 (17). Mortality rates associated with circulatory disease have been shown

to increase substantially in smokers over the age of 35 and non-smokers over the age of 40 (Table II)

among women who use oral contraceptives.

Oral contraceptives may compound the effects of well-known risk factors, such as hypertension,

diabetes, hyperlipidemias, age and obesity (19). In particular, some progestogens are known to decrease

HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism

(20 to 24). Oral contraceptives have been shown to increase blood pressure among users (see section

10 in WARNINGS). Similar effects on risk factors have been associated with an increased risk of heart

disease. Oral contraceptives must be used with caution in women with cardiovascular disease risk

factors.

b. Thromboembolism

An increased risk of thromboembolic and thrombotic disease associated with the use of 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 (9,10,25 to 30). 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 (31). The risk of

thromboembolic disease due to oral contraceptives is not related to length of use and disappears after

pill use is stopped (8).

A two- to four-fold increase in relative risk of postoperative thromboembolic complications has been

reported with the use of oral contraceptives (15,32). The relative risk of venous thrombosis in women

reported with the use of oral contraceptives (15,32). The relative risk of venous thrombosis in women

who have predisposing conditions is twice that of women without such medical conditions (15,32). 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.

c. Cerebrovascular Diseases

Oral contraceptives have been shown to increase both the relative and attributable risks of

cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest

among older (> 35 years), hypertensive women who also smoke. Hypertension was found to be a risk

factor for both users and nonusers, for both types of strokes, while smoking interacted to increase the

risk for hemorrhagic strokes (33 to 35).

In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for

normotensive users to 14 for users with severe hypertension (36). The relative risk of hemorrhagic

stroke is reported to be 1.2 for non-smokers who used oral contraceptives, 2.6 for smokers who did not

use oral contraceptives, 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users, and

25.7 for users with severe hypertension (36). The attributable risk is also greater in older women (9).

d. Dose-Related Risk of Vascular Disease from Oral Contraceptives

A positive association has been observed between the amount of estrogen and progestogen in oral

contraceptives and the risk of vascular disease (37 to 39). A decline in serum high-density lipoproteins

(HDL) has been reported with many progestational agents (20 to 22). A decline in serum high-density

lipoproteins has been associated with an increased incidence of ischemic heart disease. Because

estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance

achieved between doses of estrogen and progestin and the nature of the progestin used in the

contraceptives. The amount and activity of both hormones should be considered in the choice of an oral

contraceptive.

Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics.

For any particular oral contraceptive, the dosage regimen prescribed should be one which contains the

least amount of estrogen and progestogen that is compatible with the needs of the individual patient.

New acceptors of oral contraceptive agents should be started on preparations containing the lowest

dose of estrogen which produces satisfactory results for the patient.

e. Persistence of Risk of Vascular Disease

There are two studies which have shown persistence of risk of vascular disease for ever-users of oral

contraceptives. In a study in the United States, the risk of developing myocardial infarction after

discontinuing oral contraceptives persists for at least 9 years for women 40 to 49 years who had used

oral contraceptives for 5 or more years, but this increased risk was not demonstrated in other age

groups (14). In another study in Great Britain, the risk of developing cerebrovascular disease persisted

for at least 6 years after discontinuation of oral contraceptives, although excess risk was very small

(40). However, both studies were performed with oral contraceptive formulations containing 50 mcg or

higher of estrogens.

2. Estimates of Mortality from Contraceptive Use

One study gathered data from a variety of sources which have estimated the mortality rate associated

with different methods of contraception at different ages (Table III). These estimates include the

combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in

the event of method failure. Each method of contraception has its specific benefits and risks. The study

concluded that with the exception of oral contraceptive users 35 and older who smoke and 40 and older

who do not smoke, mortality associated with all methods of birth control is 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 (41). 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. Obstet

Gynecol 1985;66:1–4; and Porter JB, Hershel J, Walker AM. Mortality among oral contraceptive users.

Obstet Gynecol 1987;70:29–32), the Fertility and Maternal Health Drugs Advisory Committee was

asked to review the topic in 1989. The Committee concluded that although cardiovascular disease 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 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 non-

smoking women over age 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.

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. Most of the studies on breast cancer

and oral contraceptive use report that the use of oral contraceptives is not associated with an increase in

the risk of developing breast cancer (42,44,89). Some studies have reported an increased risk of

developing breast cancer in certain subgroups of oral contraceptive users, but the findings reported in

these studies are not consistent (43,45 to 49,85 to 88).

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 (51 to 54). However, there continues to

be controversy about the extent to which such findings may be due to differences in sexual behavior and

other factors.

In spite of many studies of the relationship between oral contraceptive use and breast and cervical

cancers, a cause and effect relationship has not been established.

4. Hepatic Neoplasia

Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign

tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the

range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use (55). Rupture

of rare, benign, hepatic adenomas may cause death through intra-abdominal hemorrhage (56 to 57).

Studies from Britain have shown an increased risk of developing hepatocellular carcinoma (58 to 60) in

long-term (greater than 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.

5. Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment

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

Microgestin 1.5/30 prior to starting therapy with the combination drug regimen

ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4)]. Microgestin

1.5/30 can be restarted approximately 2 weeks following completion of treatment with the combination

drug regimen.

6. 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.

7. Oral Contraceptive Use Before and During Early Pregnancy

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have

used oral contraceptives prior to pregnancy (61 to 63). Studies also do not suggest a teratogenic effect,

particularly insofar as cardiac anomalies and limb reduction defects are concerned (61,62,64,65) 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.

8. Gallbladder Disease

Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral

contraceptives and estrogens (66,67). More recent studies, however, have shown that the relative risk

of developing gallbladder disease among oral contraceptive users may be minimal (68 to 70). The

recent findings of minimal risk may be related to the use of oral contraceptive formulations containing

lower hormonal doses of estrogens and progestogens.

9. Carbohydrate and Lipid Metabolic Effects

Oral contraceptives have shown to cause glucose intolerance in a significant percentage of users (23).

Oral contraceptives containing greater than 75 mcg of estrogens cause hyperinsulinism, while lower

doses of estrogen cause less glucose intolerance (71). Progestogens increase insulin secretion and

create insulin resistance, this effect varying with different progestational agents (23,72). However, in

the non-diabetic woman, oral contraceptives appear to have no effect on fasting blood glucose (73).

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 WARNINGS1a. and 1d.), changes in serum triglycerides and lipoprotein levels have been

reported in oral contraceptive users.

10. Elevated Blood Pressure

An increase in blood pressure has been reported in women taking oral contraceptives (74) and this

increase is more likely in older oral contraceptive users (75) and with continued use (74). Data from the

Royal College of General Practitioners (18) 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 (76) 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 (75), and there is no difference in the occurrence of hypertension among ever and

never users (74,76,77).

11. 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.

12. Bleeding Irregularities

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.

PRECAUTIONS

1. 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 hyperlipidemia 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.

7. Contact Lenses

Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by

an ophthalmologist.

8. Drug Interactions

Effects of Other Drugs on Oral Contraceptives (78)

Rifampin: Metabolism of both norethindrone and ethinyl estradiol is increased by rifampin. A reduction

in contraceptive effectiveness and increased incidence of breakthrough bleeding and menstrual

irregularities have been associated with concomitant use of rifampin.

Anticonvulsants: Anticonvulsants such as phenobarbital, phenytoin, and carbamazepine, have been

shown to increase the metabolism of ethinyl estradiol and/or norethindrone, which could result in a

reduction in contraceptive effectiveness.

Troglitazone: Administration of troglitazone with an oral contraceptive containing ethinyl estradiol and

norethindrone reduced the plasma concentrations of both by approximately 30%, which could result in a

reduction of contraceptive effectiveness.

Antibiotics: Pregnancy while taking oral contraceptives has been reported when the oral contraceptives

were administered with antimicrobials such as ampicillin, tetracycline, and griseofulvin. However,

clinical pharmacokinetic studies have not demonstrated any consistent effect of antibiotics (other than

rifampin) on plasma concentrations of synthetic steroids.

Atorvastatin: Coadministration of atorvastatin and an oral contraceptive increased AUC values for

norethindrone and ethinyl estradiol by approximately 30% and 20%, respectively.

Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer

[DRUG] with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without

dasabuvir, due to potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME

ELEVATIONS WITHCONCOMITANT HEPATITIS C TREATMENT)

Others: Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations,

possibly by inhibition of conjugation. A reduction in contraceptive effectiveness and increased

incidence of breakthrough bleeding has been suggested with phenylbutazone.

Effects of Oral Contraceptives on Other Drugs

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