Seasonique (Levonorgestrel, Ethinyl Estradiol)
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Seasonique (Levonorgestrel, Ethinyl Estradiol)

Seasonique
(levonorgestrel/ethinyl estradioland ethinyl estradiol)  Tablets for Oral Use

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. [See CONTRAINDICATIONS.]

DRUG DESCRIPTION

Seasonique (levonorgestrel, ethinyl estradiol) (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol.

The structural formulas for the active components are:

Levonorgestrel structural illustration

Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17a)-, (-)-.

Ethinyl Estradiol structural illustration

Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17a)-.

Each light blue-green tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.

Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.

What are the possible side effects of ethinyl estradiol and levonorgestrel extended-cycle (Jolessa, LoSeasonique, Quasense, Seasonale, Seasonique)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea,...

Read All Potential Side Effects and See Pictures of Seasonique »

What are the precautions when taking levonorgestrel, ethinyl estradiol (Seasonique)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or levonorgestrel; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), severe high blood pressure, abnormal breast exam, cancer (especially endometrial and breast cancer), diabetes that has caused...

Read All Potential Precautions of Seasonique »

Last reviewed on RxList: 8/30/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Seasonique (levonorgestrel, ethinyl estradiol) ® (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy.

DOSAGE AND ADMINISTRATION

Take one tablet by mouth at the same time every day. The dosage of Seasonique (levonorgestrel, ethinyl estradiol) is one light blue-green tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one yellow ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, Seasonique (levonorgestrel, ethinyl estradiol) must be taken exactly as directed and at intervals not exceeding 24 hours.

Instruct the patient to begin taking Seasonique (levonorgestrel, ethinyl estradiol) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first light blue-green tablet is taken that day. One light blue-green tablet should be taken daily for 84 consecutive days, followed by one yellow tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until a light blue-green tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the yellow tablets are taken.

Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of Seasonique (levonorgestrel, ethinyl estradiol) , following the same schedule: 84 days taking a light blue-green tablet followed by 7 days taking a yellow tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a light blue-green tablet daily for 7 consecutive days. If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.

For patient instructions regarding missed pills, see FDA-Approved Patient Labeling.

For postpartum women who are not breastfeeding, start Seasonique (levonorgestrel, ethinyl estradiol) no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on Seasonique (levonorgestrel, ethinyl estradiol) postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken a light blue-green tablet for 7 consecutive days.

HOW SUPPLIED

Dosage Forms And Strengths

Seasonique (levonorgestrel, ethinyl estradiol) tablets (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) are available in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets: 84 light blue-green tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets each containing 0.01 mg of ethinyl estradiol. The light blue-green tablets are round, film-coated, biconvex, unscored tablets debossed with stylized b on one side and 555 on the other side. The yellow tablets are round, biconvex, film-coated, unscored tablets debossed with stylized b on one side and 556 on the other side.

Storage And Handling

How Supplied

Seasonique (levonorgestrel, ethinyl estradiol) tablets (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) are available in Extended-Cycle Tablet Dispensers (NDC 51285-087-87), each containing a 13-week supply of tablets: 84 light blue-green tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets each containing 0.01 mg of ethinyl estradiol. The light blue-green tablets are round, film-coated, biconvex, unscored tablets debossed with stylized b on one side and 555 on the other side. The yellow tablets are round, biconvex, film-coated, unscored tablets debossed with stylized b on one side and 556 on the other side.

Box of 2 Extended-Cycle Tablet Dispensers NDC 51285-087-87

Storage Conditions

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

DURAMED PHARMACEUTICALS, INC., Subsidiary of Barr Pharmaceuticals, Inc. Pomona, New York 10970. Revised July 2010

Last reviewed on RxList: 8/30/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Adverse reactions commonly reported by COC users are:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The clinical trial that evaluated the safety and efficacy of Seasonique (levonorgestrel, ethinyl estradiol) was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18-40, of whom 1,006 took at least one dose of Seasonique (levonorgestrel, ethinyl estradiol) .

Adverse Reactions Leading to Study Discontinuation: 16.3% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥ 1% of women) leading to discontinuation were irregular and/or heavy uterine bleeding (5.9%), weight gain (2.4%), mood changes (1.5%), and acne (1.0%).

Common Treatment-Emergent Adverse Reactions (≥ 5% of women):

irregular and/or heavy uterine bleeding (17%), weight gain (5%), acne (5%).

Serious Adverse Reactions: migraine, cholecystitis, cholelithiasis, pancreatitis, abdominal pain, and major depressive disorder.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Seasonique (levonorgestrel, ethinyl estradiol) . Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency of establish a causal relationship to drug exposure.

Gastrointestinal disorders: abdominal distension, vomiting

General disorders and administration site conditions: chest pain, fatigue, malaise, edema peripheral, pain

Immune system disorders: hypersensitivity reaction

Investigations: blood pressure increased

Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity

Nervous system disorders: dizziness, loss of consciousness

Psychiatric disorders: insomnia

Reproductive and breast disorders: dysmenorrhea

Respiratory, thoracic and mediastinal disorders: pulmonary embolism, pulmonary thrombosis

Skin and subcutaneous tissue disorders: alopecia

Vascular disorders: thrombosis

Read the Seasonique (levonorgestrel, ethinyl estradiol) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No drug-drug interaction studies were conducted with Seasonique (levonorgestrel, ethinyl estradiol) .

Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products

If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include:

  • barbiturates
  • bosentan
  • carbamazepine
  • felbamate
  • griseofulvin
  • oxcarbazepine
  • phenytoin
  • rifampin
  • St. John's wort
  • topiramate

HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of the estrogen and progestin have been noted in some cases of co-administration of HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.

Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Increase in Plasma Levels of Estradiol Associated with Co-Administered Drugs

Co-administration of atorvastatin and certain COCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.

Changes in Plasma Levels of Co-Administered Drugs

COCs containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations.

Last reviewed on RxList: 8/30/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Thrombotic and Other Vascular Events

Stop Seasonique (levonorgestrel, ethinyl estradiol) if an arterial or deep venous thrombotic event occurs. Although the use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. The excess risk is highest during the first year of use of a COC. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.

Use of Seasonique (levonorgestrel, ethinyl estradiol) provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing the same strength synthetic estrogens and progestins (an additional 9 and 13 weeks of exposure to progestin and estrogen, respectively, per year).

If feasible, stop Seasonique (levonorgestrel, ethinyl estradiol) at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start Seasonique (levonorgestrel, ethinyl estradiol) no earlier than 4-6 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

COCs 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 of age), and hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.

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

Stop Seasonique (levonorgestrel, ethinyl estradiol) if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

Carcinoma of the Breast and Cervix

Women who currently have or have had breast cancer should not use Seasonique (levonorgestrel, ethinyl estradiol) because breast cancer may be hormonally sensitive.

There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.

Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings are due to differences in sexual behavior and other factors.

Liver Disease

Discontinue Seasonique (levonorgestrel, ethinyl estradiol) ifjaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded.

Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users.

Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COC-related cholestasis may have the condition recur with subsequent COC use.

High Blood Pressure

For women with well-controlled hypertension, monitor blood pressure and stop Seasonique (levonorgestrel, ethinyl estradiol) if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.

An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin.

Gallbladder Disease

Studies suggest a small increased relative risk of developing gallbladder disease among COC users.

Carbohydrate and Lipid Metabolic Effects

Carefully monitor prediabetic and diabetic women who are taking Seasonique (levonorgestrel, ethinyl estradiol) . COCs may decrease glucose tolerance in a dose-related fashion.

Consider alternative contraception for women with uncontrolled dyslipidemias. A small proportion of women will have adverse lipid changes while on COCs.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

Headache

If a woman taking Seasonique (levonorgestrel, ethinyl estradiol) develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Seasonique (levonorgestrel, ethinyl estradiol) if indicated.

An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC.

Bleeding Irregularities

Unscheduled (breakthrough) bleeding and spotting sometimes occur in patients on COCs, especially during the first 3 months of use. If bleeding persists, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC.

When prescribing Seasonique (levonorgestrel, ethinyl estradiol) , the convenience of fewer planned menses (4 per year instead of 13 per year) should be weighed against the inconvenience of increased unscheduled bleeding and/or spotting. The primary clinical trial (PSE-301) that evaluated the efficacy of Seasonique (levonorgestrel, ethinyl estradiol) also assessed unscheduled bleeding. The participants in the 12-month clinical trial (N=1,006) completed the equivalent of 8,681 28-day cycles of exposure and were composed primarily of women who had used oral contraceptives previously (89%) as opposed to new users (11%). A total of 82 (8.2%) of the women discontinued Seasonique (levonorgestrel, ethinyl estradiol) , at least in part, due to bleeding or spotting.

Scheduled (withdrawal) bleeding and/or spotting remained fairly constant over time, with an average of 3 days of bleeding and/or spotting per each 91-day cycle. Unscheduled bleeding and unscheduled spotting decreased over successive 91-day cycles. Table 1 below presents the number of days with unscheduled bleeding in treatment cycles 1 and 4. Table 2 presents the number of days with unscheduled spotting in treatment cycles 1 and 4.

Table 1: Total Number of Days with Unscheduled Bleeding

91-Day Treatment Cycle Days per 84-Day Interval Days per 28-Day Interval
Q1 Median Q3 Mean Mean
1st 1 4 10 6.9 1.7
4th 0 1 4 3.2 0.8
Q1=Quartile 1: 25% of women had this number of days of unscheduled bleeding
Median: 50% of women had ≤ this number of days of unscheduled bleeding
Q3=Quartile 3: 75% of women had ≤ this number of days of unscheduled bleeding

Table 2: Total Number of Days with Unscheduled Spotting

91-Day Treatment Cycle Days per 84-Day Interval Days per 28-Day Interval
Q1 Median Q3 Mean Mean
1st 1 4 11 7.4 1.9
4th 0 2 7 4.4 1.1
Q1=Quartile 1: 25% of women had ≤ this number of days of unscheduled spotting
Median: 50% of women had ≤ this number of days of unscheduled spotting
Q3=Quartile 3: 75% of women had ≤ this number of days of unscheduled spotting

Figure 1 shows the percentage of Seasonique (levonorgestrel, ethinyl estradiol) subjects participating in trial PSE-301 with ≥ 7 days or ≥ 20 days of unscheduled bleeding and/or spotting, or only unscheduled bleeding, during each 91-day treatment cycle.

Figure 1. Percent of Women Taking Seasonique (levonorgestrel, ethinyl estradiol) who Reported Unscheduled Bleeding and/or Spotting or only Unscheduled Bleeding

Percent of Women Taking Seasonique who Reported Unscheduled Bleeding - illustration

Amenorrhea sometimes occurs in women who are using COCs. Pregnancy should be ruled out in the event of amenorrhea. Some women may encounter amenorrhea or oligomenorrhea after stopping COCs, especially when such a condition was pre-existent.

COC 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. Oral contraceptive use should be discontinued if pregnancy is confirmed.

The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy [see Use in Specific Populations].

Emotional Disorders

Women with a history of depression should be carefully observed and Seasonique (levonorgestrel, ethinyl estradiol) discontinued if depression recurs to a serious degree.

Interference with Laboratory Tests

The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid binding globulin increase with use of COCs.

Monitoring

A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated health care.

Other Conditions

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking COCs.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

[See WARNINGS AND PRECAUTIONS].

Use In Specific Populations

Pregnancy

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.

The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion.

Women who do not breastfeed may start COCs no earlier than four to six weeks postpartum.

Nursing Mothers

When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. Estrogen-containing COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

Pediatric Use

Safety and efficacy of Seasonique (levonorgestrel, ethinyl estradiol) have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of Seasonique (levonorgestrel, ethinyl estradiol) before menarche is not indicated.

Geriatric Use

Seasonique (levonorgestrel, ethinyl estradiol) has not been studied in women who have reached menopause and is not indicated in this population.

Hepatic Impairment

No studies have been conducted to evaluate the effect of hepatic disease on the disposition of Seasonique (levonorgestrel, ethinyl estradiol) . However, steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal. [See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Renal Impairment

No studies have been conducted to evaluate the effect of renal disease on the disposition of Seasonique (levonorgestrel, ethinyl estradiol) .

Last reviewed on RxList: 8/30/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

CONTRAINDICATIONS

Do not prescribe Seasonique (levonorgestrel, ethinyl estradiol) to women who are known to have the following:

Last reviewed on RxList: 8/30/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of action

COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Pharmacokinetics

Absorption

Ethinyl estradiol and levonorgestrel are absorbed with maximum plasma concentrations occurring within 2 hours after Seasonique (levonorgestrel, ethinyl estradiol) administration. Levonorgestrel is completely absorbed after oral administration (bioavailability nearly 100%) and is not subject to first-pass metabolism. Ethinyl estradiol is absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of ethinyl estradiol is approximately 43%.

The daily exposure to levonorgestrel and ethinyl estradiol on Day 21, corresponding to the end of a typical 3-week contraceptive regimen, and on Day 84, at the end of an extended cycle regimen, were similar. There was no additional accumulation of ethinyl estradiol after dosing a 0.03 mg ethinyl estradiol tablet during Days 84-91. The mean plasma pharmacokinetic parameters of Seasonique (levonorgestrel, ethinyl estradiol) following a single dose of one levonorgestrel/ethinyl estradiol combination tablet, for 84 days, in normal healthy women are reported in Table 3.

Table 3: Mean Pharmacokinetic Parameters for Seasonique (levonorgestrel, ethinyl estradiol) during Daily One Tablet Dosing for 84 Days

  AUC0-24 hr
(mean ± SD)
Cmax
(mean ± SD)
Tmax
(mean ± SD)
Levonorgestrel
Day 1 18.2 ± 6.1 ng•hr/mL 3.0 ± 1.0 ng/mL 1.3 ± 0.4 hours
Day 21 64.4 ± 25.1 ng•hr/mL 6.2 ± 1.6 ng/mL 1.3 ± 0.4 hours
Day 84 60.2 ± 24.6 ng•hr/mL 5.5 ± 1.6 ng/mL 1.3 ± 0.3 hours
Ethinyl Estradiol
Day 1 509.3 ± 172.0 pg•hr/mL 69.8 ± 26 pg/mL 1.5 ± 0.3 hours
Day 21 837.1 ± 271.2 pg•hr/mL 99.6 ± 31 pg/mL 1.5 ± 0.3 hours
Day 84 791.5 ± 215.0 pg•hr/mL 91.3 ± 32 pg/mL 1.6 ± 0.3 hours

The effect of food on the rate and the extent of levonorgestrel and ethinyl estradiol absorption following oral administration of Seasonique (levonorgestrel, ethinyl estradiol) has not been evaluated.

Distribution

The apparent volume of distribution of levonorgestrel and ethinyl estradiol are reported to be approximately 1.8 L/kg and 4.3 L/kg, respectively. Levonorgestrel is about 97.5 - 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin. Ethinyl estradiol is about 95 - 97% bound to serum albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis, which leads to decreased levonorgestrel clearance. Following repeated daily dosing of levonorgestrel/ethinyl estradiol oral contraceptives, levonorgestrel plasma concentrations accumulate more than predicted based on single-dose pharmacokinetics, due in part, to increased SHBG levels that are induced by ethinyl estradiol, and a possible reduction in hepatic metabolic capacity.

Metabolism

Following absorption, levonorgestrel is conjugated at the 17p-OH position to form sulfate and to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3a,5p-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3a,5a-tetrahydrolevonorgestrel and 16p-hydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.

First-pass metabolism of ethinyl estradiol involves formation of ethinyl estradiol-3-sulfate in the gut wall, followed by 2-hydroxylation of a portion of the remaining untransformed ethinyl estradiol by hepatic cytochrome P-450 3A4 (CYP3A4). Levels of CYP3A4 vary widely among individuals and can explain the variation in rates of ethinyl estradiol hydroxylation. Hydroxylation at the 4-, 6-, and 16- positions may also occur, although to a much lesser extent than 2-hydroxylation. The various hydroxylated metabolites are subject to further methylation and/or conjugation.

Excretion

About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates. The terminal elimination half-life for levonorgestrel after a single dose of Seasonique (levonorgestrel, ethinyl estradiol) was about 34 hours.

Ethinyl estradiol is excreted in the urine and feces as glucuronide and sulfate conjugates, and it undergoes enterohepatic recirculation. The terminal elimination half-life of ethinyl estradiol after a single dose of Seasonique (levonorgestrel, ethinyl estradiol) was found to be about 18 hours.

Race

The effect of race on the pharmacokinetics of Seasonique (levonorgestrel, ethinyl estradiol) has not been evaluated.

Clinical Studies

In a 12-month, multicenter, randomized, open-label clinical trial, 1,006 women aged 18-40 were studied to assess the safety and efficacy of Seasonique (levonorgestrel, ethinyl estradiol) , completing the equivalent of 8,681 28-day cycles of exposure. The racial demographic of those enrolled was: Caucasian (80%), African-American (11%), Hispanic (5%), Asian (2%), and Other (2%). There were no exclusions for body mass index (BMI) or weight. The weight range of those women treated was 91 to 360 lbs., with a mean weight of 156 lbs. Among the women in the trial, 63% were current or recent hormonal contraceptive users, 26% were prior users (who had used hormonal contraceptives in the past but not in the 6 months prior to enrollment), and 11% were new starts. Of treated women, 14.8% were lost to follow-up, 16.3% discontinued due to an adverse event, and 12.9% discontinued by withdrawing their consent.

The pregnancy rate (Pearl Index [PI]) in women aged 18-35 years was 1.34 pregnancies per 100 women-years of use (95% confidence interval 0.54-2.75), based on 7 pregnancies that occurred after the onset of treatment and within 14 days after the last combination pill. Cycles in which conception did not occur, but which included the use of backup contraception, were not included in the calculation of the PI. The PI includes patients who did not take the drug correctly.

Patient Counseling Information

See FDA- Approved Patient Labeling

  • Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs.
  • Counsel patients that this product does not protect against HIV-infection (AIDS) and other sexually transmitted diseases.
  • Counsel patients on WARNINGS AND PRECAUTIONS associated with COCs.
  • Counsel patients to take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed. See WHAT TO DO IF YOU MISS PILLS section of FDA-Approved Patient Labeling.
  • Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.
  • Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established.
  • Counsel any patient who starts COCs postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken a light blue-green tablet for 7 consecutive days.
  • Counsel patients that amenorrhea may occur. Pregnancy should be considered in the event of amenorrhea, and should be ruled out if amenorrhea is associated with symptoms of pregnancy, such as morning sickness or unusual breast tenderness.

Last reviewed on RxList: 8/30/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Guide for Using Seasonique (levonorgestrel, ethinyl estradiol)

WARNING TO WOMEN WHO SMOKE

Do not use Seasonique (levonorgestrel, ethinyl estradiol) if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Birth control pills help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

What Is Seasonique (levonorgestrel, ethinyl estradiol) ?

Seasonique (levonorgestrel, ethinyl estradiol) is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel.

How Well Does Seasonique (levonorgestrel, ethinyl estradiol) Work?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The more carefully you follow the directions, the less chance you have of getting pregnant.

Based on the results of a single clinical study lasting 12 months, 1 to 3 women, out of 100 women, may get pregnant during the first year they use Seasonique (levonorgestrel, ethinyl estradiol) .

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

Chance of getting pregnant for women who use different methods of birth control - illustration

How Do I Take Seasonique (levonorgestrel, ethinyl estradiol) ?

  1. Take one pill every day at the same time. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
  2. Many women have spotting or light bleeding, or may feel sick to their stomach during the first few months of taking Seasonique (levonorgestrel, ethinyl estradiol) . If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare provider.
  3. Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
  4. If you have trouble remembering to take Seasonique (levonorgestrel, ethinyl estradiol) , talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.

Before you start taking Seasonique (levonorgestrel, ethinyl estradiol)

  1. Decide what time of day you want to take your pill. It is important to take it at about the same time every day.
  2. Look at your Extended-Cycle Tablet Dispenser. Your Tablet Dispenser consists of 3 trays with cards that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consist of 84 light blue-green and 7 yellow pills. Trays 1 and 2 each contain 28 light blue-green pills (4 rows of 7 pills). Tray 3 contains 35 pills consisting of 28 light blue-green pills (4 rows of 7 pills) and 7 yellow pills (1 row of 7 pills).
  3. Extended-Cycle Tablet Dispenser - illustration

    Extended-Cycle Tablet Dispenser - illustration

    Extended-Cycle Tablet Dispenser - illustration

  4. Also find:
    • Where on the first tray in the pack to start taking pills (upper left corner at the start arrow) and
    • In what order to take the pills (follow the weeks and arrow).
  5. Be sure you have ready at all times another kind of birth control (such as condoms or spermicides), to use as a backup in case you miss pills.

When to Start Seasonique (levonorgestrel, ethinyl estradiol)

  1.  Take the first light blue-green pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first light blue-green pill that same day.
  2.  Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first light blue-green pill until the next Sunday (first 7 days). If you have been using a different hormonal method of birth control (such as a different pill, the "patch," or the "vaginal ring"), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken Seasonique (levonorgestrel, ethinyl estradiol) for 7 days.

How to Take Seasonique (levonorgestrel, ethinyl estradiol)

  1. Take one pill at the same time every day until you have taken the last pill in the tablet dispenser.
    •  Do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea).
    •  Do not skip pills even if you do not have sex very often.
  2. When you finish a tablet dispenser
    • After taking the last yellow pill, start taking the first light blue-green pill from a new Extended-Cycle Tablet Dispenser the very next day (this should be on a Sunday) regardless of when your period started.
  3. If you miss your scheduled period when you are taking the yellow pills, contact your healthcare provider because you may be pregnant. If you are pregnant, you should stop taking Seasonique (levonorgestrel, ethinyl estradiol) .

What To Do If You Miss Pills

If you MISS 1 light blue-green pill:

  1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.
  2. You do not need to use a back-up birth control method if you have sex.

If you MISS 2 light blue-green pills in a row:

  1. Take 2 pills on the day you remember, and 2 pills the next day.
  2. Then take 1 pill a day until you finish the pack.
  3. You could become pregnant if you have sex in the 7 days after you miss two pills. You MUST use another birth control method (such as condoms or spermicide) as a back up for the 7 days after you restart your pills.

If you MISS 3 OR MORE light blue-green pills in a row:

  1. Do not take the missed pills. Keep taking 1 pill every day as indicated on the pack until you have completed all of the remaining pills in the pack. For example: If you resume taking the pill on Thursday, take the pill under "Thursday" and do not take the missed pills. You may experience bleeding during the week following the missed pills.
  2. You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills.
  3. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up when you miss pills and for the first 7 days after you restart your pills. If you do not have your period when you are taking the yellow pills, call your healthcare provider because you may be pregnant.

If you MISS ANY of the 7 yellow pills:

  1. Throw away the missed pills.
  2. Keep taking the scheduled pills until the pack is finished.
  3. You do not need a back-up method of birth control.

Finally, if you are still not sure what to do about the pills you have missed

  1. Use a back-up method anytime you have sex.
  2. Keep taking one pill each day until you contact your healthcare provider.

Who Should Not Take Seasonique (levonorgestrel, ethinyl estradiol) ?

Your healthcare provider will not give you Seasonique (levonorgestrel, ethinyl estradiol) if you have:

  • Ever had breast cancer or any cancer that is sensitive to female hormones
  • Liver disease, including liver tumors
  • Ever had blood clots in your arms, legs, or lungs
  • Ever had a stroke
  • Ever had a heart attack
  • Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
  • An inherited problem with your blood that makes it clot more than normal
  • High blood pressure that medicine can't control
  • Diabetes with kidney, eye, or blood vessel damage
  • Certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision

Also, do not take birth control pills if you:

  • Smoke and are over 35 years old
  • Are pregnant

Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy.

What Else Should I Know About Taking Seasonique (levonorgestrel, ethinyl estradiol) ?

Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.

Do not skip any pills, even if you do not have sex often.

Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.

If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Seasonique (levonorgestrel, ethinyl estradiol) , may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk.

Tell your healthcare provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including:

  • barbiturates
  • bosentan
  • carbamazepine
  • felbamate
  • griseofulvin
  • oxcarbazepine
  • phenytoin
  • rifampin
  • St. John's wort
  • topiramate

Consider using another birth control method when you take medicines that may make birth control pills less effective.

Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your physician may need to adjust the dose of lamotrigine.

If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms or a spermicide, until you check with your healthcare provider.

What Are The Most Serious Risks Of Taking Birth Control Pills?

Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age > 35. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

Women who take birth control pills may get:

  • High blood pressure
  • Gallbladder problems
  • Rare cancerous or noncancerous liver tumors All of these events are uncommon in healthy women.

Call your healthcare provider right away if you have:

  • Persistent leg pain
  • Sudden shortness of breath
  • Sudden blindness, partial or complete
  • Severe pain in your chest
  • Sudden, severe headache unlike your usual headaches
  • Weakness or numbness in an arm or leg, or trouble speaking
  • Yellowing of the skin or eyeballs

What Are Common Side Effects Of Birth Control Pills?

The most common side effects of birth control pills are:

  • Spotting or bleeding between menstrual periods
  • Nausea
  • Breast tenderness
  • Headache

These side effects are usually mild and usually disappear with time.

Less common side effects are:

  • Acne
  • Less sexual desire
  • Bloating or fluid retention
  • Blotchy darkening of the skin, especially on the face
  • High blood sugar, especially in women who already have diabetes
  • High fat levels in the blood
  • Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.
  • Problems tolerating contact lenses
  • Weight changes

This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.

No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.

Do Birth Control Pills Cause Cancer?

Birth control pills do not appear to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What Should I Know About My Period When Taking Seasonique (levonorgestrel, ethinyl estradiol) ?

When you take Seasonique (levonorgestrel, ethinyl estradiol) , which has a 91-day extended dosing cycle, you should expect to have 4 scheduled periods per year (bleeding when you are taking the 7 yellow pills). Each period is likely to last about 3 days. However, you will probably have more bleeding or spotting between your scheduled periods than if you were using a birth control pill with a 28-day dosing cycle. During the first Seasonique (levonorgestrel, ethinyl estradiol) 91-day treatment cycle, about 3 in 10 women may have 20 or more days of unplanned bleeding or spotting. This bleeding or spotting tends to decrease with time. Do not stop taking Seasonique (levonorgestrel, ethinyl estradiol) because of this bleeding or spotting. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, call your healthcare provider.

What If I Miss My Scheduled Period When Taking Seasonique (levonorgestrel, ethinyl estradiol) ?

You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking yellow tablets). Since scheduled periods are less frequent when you are taking Seasonique (levonorgestrel, ethinyl estradiol) , notify your healthcare provider that you have missed your period and that you are taking Seasonique (levonorgestrel, ethinyl estradiol) . Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant. Stop taking Seasonique (levonorgestrel, ethinyl estradiol) if it is determined that you are pregnant.

What If I Want To Become Pregnant?

You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.

General Advice About Seasonique (levonorgestrel, ethinyl estradiol)

Your healthcare provider prescribed Seasonique (levonorgestrel, ethinyl estradiol) for you. Do not share Seasonique (levonorgestrel, ethinyl estradiol) with anyone else. Keep Seasonique (levonorgestrel, ethinyl estradiol) out of the reach of children.

If you have concerns or questions, ask your healthcare provider. You may also ask your healthcare providers for a more detailed label written for medical professionals.

Last reviewed on RxList: 8/30/2010
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Guide for Using Seasonique (levonorgestrel, ethinyl estradiol)

WARNING TO WOMEN WHO SMOKE

Do not use Seasonique (levonorgestrel, ethinyl estradiol) if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Birth control pills help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

What Is Seasonique (levonorgestrel, ethinyl estradiol) ?

Seasonique (levonorgestrel, ethinyl estradiol) is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel.

How Well Does Seasonique (levonorgestrel, ethinyl estradiol) Work?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The more carefully you follow the directions, the less chance you have of getting pregnant.

Based on the results of a single clinical study lasting 12 months, 1 to 3 women, out of 100 women, may get pregnant during the first year they use Seasonique (levonorgestrel, ethinyl estradiol) .

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

Chance of getting pregnant for women who use different methods of birth control - illustration

How Do I Take Seasonique (levonorgestrel, ethinyl estradiol) ?

  1. Take one pill every day at the same time. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
  2. Many women have spotting or light bleeding, or may feel sick to their stomach during the first few months of taking Seasonique (levonorgestrel, ethinyl estradiol) . If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare provider.
  3. Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
  4. If you have trouble remembering to take Seasonique (levonorgestrel, ethinyl estradiol) , talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.

Before you start taking Seasonique (levonorgestrel, ethinyl estradiol)

  1. Decide what time of day you want to take your pill. It is important to take it at about the same time every day.
  2. Look at your Extended-Cycle Tablet Dispenser. Your Tablet Dispenser consists of 3 trays with cards that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consist of 84 light blue-green and 7 yellow pills. Trays 1 and 2 each contain 28 light blue-green pills (4 rows of 7 pills). Tray 3 contains 35 pills consisting of 28 light blue-green pills (4 rows of 7 pills) and 7 yellow pills (1 row of 7 pills).
  3. Extended-Cycle Tablet Dispenser - illustration

    Extended-Cycle Tablet Dispenser - illustration

    Extended-Cycle Tablet Dispenser - illustration

  4. Also find:
    • Where on the first tray in the pack to start taking pills (upper left corner at the start arrow) and
    • In what order to take the pills (follow the weeks and arrow).
  5. Be sure you have ready at all times another kind of birth control (such as condoms or spermicides), to use as a backup in case you miss pills.

When to Start Seasonique (levonorgestrel, ethinyl estradiol)

  1.  Take the first light blue-green pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first light blue-green pill that same day.
  2.  Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first light blue-green pill until the next Sunday (first 7 days). If you have been using a different hormonal method of birth control (such as a different pill, the "patch," or the "vaginal ring"), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken Seasonique (levonorgestrel, ethinyl estradiol) for 7 days.

How to Take Seasonique (levonorgestrel, ethinyl estradiol)

  1. Take one pill at the same time every day until you have taken the last pill in the tablet dispenser.
    •  Do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea).
    •  Do not skip pills even if you do not have sex very often.
  2. When you finish a tablet dispenser
    • After taking the last yellow pill, start taking the first light blue-green pill from a new Extended-Cycle Tablet Dispenser the very next day (this should be on a Sunday) regardless of when your period started.
  3. If you miss your scheduled period when you are taking the yellow pills, contact your healthcare provider because you may be pregnant. If you are pregnant, you should stop taking Seasonique (levonorgestrel, ethinyl estradiol) .

What To Do If You Miss Pills

If you MISS 1 light blue-green pill:

  1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.
  2. You do not need to use a back-up birth control method if you have sex.

If you MISS 2 light blue-green pills in a row:

  1. Take 2 pills on the day you remember, and 2 pills the next day.
  2. Then take 1 pill a day until you finish the pack.
  3. You could become pregnant if you have sex in the 7 days after you miss two pills. You MUST use another birth control method (such as condoms or spermicide) as a back up for the 7 days after you restart your pills.

If you MISS 3 OR MORE light blue-green pills in a row:

  1. Do not take the missed pills. Keep taking 1 pill every day as indicated on the pack until you have completed all of the remaining pills in the pack. For example: If you resume taking the pill on Thursday, take the pill under "Thursday" and do not take the missed pills. You may experience bleeding during the week following the missed pills.
  2. You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills.
  3. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up when you miss pills and for the first 7 days after you restart your pills. If you do not have your period when you are taking the yellow pills, call your healthcare provider because you may be pregnant.

If you MISS ANY of the 7 yellow pills:

  1. Throw away the missed pills.
  2. Keep taking the scheduled pills until the pack is finished.
  3. You do not need a back-up method of birth control.

Finally, if you are still not sure what to do about the pills you have missed

  1. Use a back-up method anytime you have sex.
  2. Keep taking one pill each day until you contact your healthcare provider.

Who Should Not Take Seasonique (levonorgestrel, ethinyl estradiol) ?

Your healthcare provider will not give you Seasonique (levonorgestrel, ethinyl estradiol) if you have:

  • Ever had breast cancer or any cancer that is sensitive to female hormones
  • Liver disease, including liver tumors
  • Ever had blood clots in your arms, legs, or lungs
  • Ever had a stroke
  • Ever had a heart attack
  • Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
  • An inherited problem with your blood that makes it clot more than normal
  • High blood pressure that medicine can't control
  • Diabetes with kidney, eye, or blood vessel damage
  • Certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision

Also, do not take birth control pills if you:

  • Smoke and are over 35 years old
  • Are pregnant

Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy.

What Else Should I Know About Taking Seasonique (levonorgestrel, ethinyl estradiol) ?

Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.

Do not skip any pills, even if you do not have sex often.

Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.

If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Seasonique (levonorgestrel, ethinyl estradiol) , may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk.

Tell your healthcare provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including:

  • barbiturates
  • bosentan
  • carbamazepine
  • felbamate
  • griseofulvin
  • oxcarbazepine
  • phenytoin
  • rifampin
  • St. John's wort
  • topiramate

Consider using another birth control method when you take medicines that may make birth control pills less effective.

Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your physician may need to adjust the dose of lamotrigine.

If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms or a spermicide, until you check with your healthcare provider.

What Are The Most Serious Risks Of Taking Birth Control Pills?

Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age > 35. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

Women who take birth control pills may get:

  • High blood pressure
  • Gallbladder problems
  • Rare cancerous or noncancerous liver tumors All of these events are uncommon in healthy women.

Call your healthcare provider right away if you have:

  • Persistent leg pain
  • Sudden shortness of breath
  • Sudden blindness, partial or complete
  • Severe pain in your chest
  • Sudden, severe headache unlike your usual headaches
  • Weakness or numbness in an arm or leg, or trouble speaking
  • Yellowing of the skin or eyeballs

What Are Common Side Effects Of Birth Control Pills?

The most common side effects of birth control pills are:

  • Spotting or bleeding between menstrual periods
  • Nausea
  • Breast tenderness
  • Headache

These side effects are usually mild and usually disappear with time.

Less common side effects are:

  • Acne
  • Less sexual desire
  • Bloating or fluid retention
  • Blotchy darkening of the skin, especially on the face
  • High blood sugar, especially in women who already have diabetes
  • High fat levels in the blood
  • Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.
  • Problems tolerating contact lenses
  • Weight changes

This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.

No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.

Do Birth Control Pills Cause Cancer?

Birth control pills do not appear to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What Should I Know About My Period When Taking Seasonique (levonorgestrel, ethinyl estradiol) ?

When you take Seasonique (levonorgestrel, ethinyl estradiol) , which has a 91-day extended dosing cycle, you should expect to have 4 scheduled periods per year (bleeding when you are taking the 7 yellow pills). Each period is likely to last about 3 days. However, you will probably have more bleeding or spotting between your scheduled periods than if you were using a birth control pill with a 28-day dosing cycle. During the first Seasonique (levonorgestrel, ethinyl estradiol) 91-day treatment cycle, about 3 in 10 women may have 20 or more days of unplanned bleeding or spotting. This bleeding or spotting tends to decrease with time. Do not stop taking Seasonique (levonorgestrel, ethinyl estradiol) because of this bleeding or spotting. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, call your healthcare provider.

What If I Miss My Scheduled Period When Taking Seasonique (levonorgestrel, ethinyl estradiol) ?

You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking yellow tablets). Since scheduled periods are less frequent when you are taking Seasonique (levonorgestrel, ethinyl estradiol) , notify your healthcare provider that you have missed your period and that you are taking Seasonique (levonorgestrel, ethinyl estradiol) . Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant. Stop taking Seasonique (levonorgestrel, ethinyl estradiol) if it is determined that you are pregnant.

What If I Want To Become Pregnant?

You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.

General Advice About Seasonique (levonorgestrel, ethinyl estradiol)

Your healthcare provider prescribed Seasonique (levonorgestrel, ethinyl estradiol) for you. Do not share Seasonique (levonorgestrel, ethinyl estradiol) with anyone else. Keep Seasonique (levonorgestrel, ethinyl estradiol) out of the reach of children.

If you have concerns or questions, ask your healthcare provider. You may also ask your healthcare providers for a more detailed label written for medical professionals.

Last reviewed on RxList: 8/30/2010
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Seasonique Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LEVONORGESTREL/ETHINYL ESTRADIOL-EE 13 WEEK CONTRACEPTIVE - ORAL

(LEE-voe-nor-jes-trel/ETH-in-il es-tra-DYE-ole)

COMMON BRAND NAME(S): Seasonique

WARNING: Smoking cigarettes/using tobacco while using hormonal birth control (pill/patch/ring) increases your risk of heart problems and stroke. Do not smoke. The risk of heart problems increases with age (especially in women over 35) and with frequent smoking (15 or more cigarettes a day).

USES: This medication is a combination of 2 hormones (an estrogen and a progestin) and is used to prevent pregnancy. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also can work by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and by changing the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body.

Besides preventing pregnancy, birth control pills have been shown to help make your periods more regular, decrease blood loss and painful periods (dysmenorrhea), and decrease your risk of ovarian cysts. While you are taking the combination pills continuously for 12 weeks, this medication will decrease the number of periods you have.

Using this medication does not protect you or your partner against sexually transmitted diseases (e.g., HIV, gonorrhea).

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information about when to take your pills and what to do if you miss a dose. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth once daily or as directed by your doctor. Pick a time of day that is easy for you to remember, and take your pill at the same time each day.

Begin taking this medication on the first Sunday following the beginning of your period (menstruation). If your period begins on a Sunday, begin taking this medication on that day. The pill pack contains 84 estrogen/progestin pills and 7 estrogen-only pills. Take one estrogen/progestin pill daily for 84 days in a row. The day after you finish all the combination pills, start taking one estrogen-only pill daily for 7 days in a row. You should have your period during the week you are taking the estrogen-only pills. The day after you take the last estrogen-only pill, take the first estrogen/progestin combination pill in a new pack to start a new cycle.

It is very important to continue taking this medication exactly as prescribed by your doctor, even if you have spotting or irregular bleeding (see also Side Effects section). Take the pills in the correct order. Do not skip any doses. Pregnancy is more likely if you miss pills, start a new pack late, or take your pill at a different time of the day than usual.

If you have any stomach upset or nausea with this medication, it may help to take it after your evening meal or at bedtime. You may choose to take this medication at another time of day that is easier for you to remember. No matter what dosing schedule you use, it is very important that you take this medication at the same time each day, 24 hours apart. Ask your doctor or pharmacist if you have any questions.

If this is the first time you are using this medication and you are not switching from another form of hormonal birth control (e.g., patch, other birth control pills), use an additional form of non-hormonal birth control (e.g., condoms, spermicide) for the first 7 days to prevent pregnancy until the medication has enough time to work. If you take all the pills correctly, you will only need to use a back-up method for the first week of the first cycle.

Ask your doctor or pharmacist for information about how to switch from other forms of hormonal birth control (e.g., patch, other birth control pills) to this product. If any of this information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

Disclaimer

Seasonique Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, headache, stomach cramping/bloating, dizziness, vaginal discomfort/irritation, increased vaginal fluids, or breast tenderness/enlargement may occur. Acne may improve or get worse. Vaginal bleeding between periods (spotting) may occur, especially during the first few months of use. If any of these effects persist or worsen, tell your doctor promptly.

You should not have your period during the 3 months that you are taking the combination pills. Instead, you will have your period once every 3 months during the week that you are taking the estrogen-only pills. This effect is normal with this product. However, if you do not have your period while taking the estrogen-only pills, contact your doctor for a pregnancy test.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods while taking the estrogen-only pills), problem wearing contact lenses, dark patches on the skin (melasma), unwanted facial/body hair, swelling of the ankles/feet/hands, weight changes (gain or loss).

This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping), unusual tiredness, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Seasonique (levonorgestrel, ethinyl estradiol) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or levonorgestrel; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), severe high blood pressure, abnormal breast exam, cancer (especially endometrial and breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches, history of heart disease (e.g., heart attack, chest pain), heart valve disease, liver problems (e.g., liver tumor, active liver disease), current or suspected pregnancy, recent major surgery, long periods of sitting or lying down (e.g., immobility such as being bedridden), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, unexplained vaginal bleeding, heavy tobacco use (especially if 35 or over).

Before using this product, tell your doctor your medical history, especially of: high blood pressure, high cholesterol or triglyceride (blood fat) levels, depression, diabetes, swelling (edema), gallbladder problems, kidney disease, migraine, obesity, irregular/missed/very light periods, recent pregnancy, thyroid problems.

Do not smoke cigarettes or use tobacco. Hormonal birth control (e.g., pills, injections, devices) combined with smoking significantly increases your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. For more details, ask your doctor or pharmacist, or consult the Patient Information Leaflet that comes with this product.

If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and of any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions.

This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

It may take longer for you to have regular periods or become pregnant after you stop taking birth control pills. Consult your doctor.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.

This medication passes into breast milk. This may affect how much milk you make and may also have undesirable effects on the nursing infant. Consult your doctor before breast-feeding.

Disclaimer

Seasonique Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: aromatase inhibitors (e.g., anastrazole, exemestane), raloxifene, sodium tetradecyl sulfate, tamoxifen, medication for underactive thyroid (hypothyroidism), drugs that may increase blood levels of this drug (such as acetaminophen, vitamin C, atorvastatin, azole antifungals such as itraconazole/ketoconazole/vaginal miconazole).

Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.

Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This drug can speed up or slow down the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include acetaminophen, certain beta blockers (e.g., metoprolol), clofibrate, cyclosporine, morphine, corticosteroids such as prednisolone, certain benzodiazepines such as lorazepam/temazepam, theophylline, and tizanidine, among others. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.

This medication can affect the results of certain lab tests (e.g., blood tests for clotting factors, thyroid). Make sure laboratory personnel and all your doctors know you use this medication.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe nausea/vomiting. Females may experience sudden/unusual vaginal bleeding.

NOTES: Do not share this medication with others.

Keep all appointments with your doctor and the laboratory. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.

MISSED DOSE: Read the package information for advice on missed doses. You may need to use back-up birth control (e.g., condoms or spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.

If you often forget to take the pill as directed, contact your doctor to discuss switching to another form of birth control.

STORAGE: Store the tablets in their blister package until ready to use. Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2012. Copyright(c) 2012 First Databank, Inc.

Seasonique Patient Information Including Side Effects

Brand Names: Jolessa, LoSeasonique, Quasense, Seasonale, Seasonique

Generic Name: ethinyl estradiol and levonorgestrel (extended-cycle) (Pronunciation: ETH in ill ess tra DYE ol and lee voe nor JESS trel)

What is ethinyl estradiol and levonorgestrel extended-cycle (Seasonique)?

Ethinyl estradiol and levonorgestrel extended-cycle contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and levonorgestrel extended-cycle are used as contraception to prevent pregnancy.

Ethinyl estradiol and levonorgestrel extended-cycle may also be used for other purposes not listed in this medication guide.

Seasonale

round, imprinted with LOGO, 46

What are the possible side effects of ethinyl estradiol and levonorgestrel extended-cycle (Seasonique)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a change in the pattern or severity of migraine headaches;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet; or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

  • mild nausea, vomiting, bloating, stomach cramps;
  • breast pain, tenderness, or swelling;
  • freckles or darkening of facial skin;
  • increased hair growth, loss of scalp hair;
  • changes in weight or appetite;
  • problems with contact lenses;
  • vaginal itching or discharge;
  • changes in your menstrual periods, decreased sex drive; or
  • headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the Seasonique (levonorgestrel, ethinyl estradiol) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about ethinyl estradiol and levonorgestrel extended-cycle (Seasonique)?

Do not use ethinyl estradiol and levonorgestrel extended-cycle if you are pregnant or recently had a baby.

Do not use this medication if you have: a history of stroke or blood clot, circulation problems, breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control when you first start using this medication.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use.

Side Effects Centers

Seasonique Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking ethinyl estradiol and levonorgestrel extended-cycle (Seasonique)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding).

Do not use this medication if you have:

  • a history of a stroke or blood clot;
  • circulation problems (especially if caused by diabetes);
  • a hormone-related cancer such as breast or uterine cancer;
  • abnormal vaginal bleeding;
  • liver disease or liver cancer;
  • severe high blood pressure;
  • severe migraine headaches;
  • a heart valve disorder; or
  • a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions.

  • high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
  • high cholesterol or if you are overweight;
  • a history of depression;
  • gallbladder disease;
  • diabetes;
  • seizures or epilepsy;
  • a history of irregular menstrual cycles; or
  • a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take ethinyl estradiol and levonorgestrel extended-cycle (Seasonique)?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

You will not have a menstrual period every month while you are taking an extended-cycle birth control pill. Instead, your period should occur every 12 weeks.

The 91-day birth control pack contains three trays with cards that hold 84 "active" pills and seven "reminder" pills. You must use the pills in a certain order to keep you on a regular cycle. Trays 1 and 2 each hold 28 pills. Tray 3 holds 35 pills, including the 7 reminder pills. Your period should begin while you are using these reminder pills.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

You may have breakthrough bleeding while taking birth control pills. Tell your doctor if this bleeding continues or is very heavy.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat.

Side Effects Centers

Seasonique Patient Information including If I Miss a Dose

What happens if I miss a dose (Seasonique)?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss three "active" pills in a row, do not take the missed pills. Continue taking 1 pill per day on schedule according to the pill package and leave the missed pills in the package. You may have some bleeding or spotting if you miss three pills in a row. Use back-up birth control for at least the next 7 days.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill. If your period does not start while you are taking the reminder pills, call your doctor because you might be pregnant.

What happens if I overdose (Seasonique)?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking ethinyl estradiol and levonorgestrel extended-cycle (Seasonique)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What other drugs will affect ethinyl estradiol and levonorgestrel extended-cycle (Seasonique)?

The following drugs can make birth control pills less effective, which may result in pregnancy:

  • acetaminophen (Tylenol) or ascorbic acid (vitamin C);
  • phenylbutazone (Azolid, Butazolidin);
  • prednisolone (Orapred);
  • theophylline (Respbid, Theo-Dur);
  • cyclosporine (Neoral, Sandimmune, Gengraf);
  • St. John's wort;
  • antibiotics such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), griseofulvin (Grisactin, Grifulvin, Fulvicin), minocycline (Minocin), penicillin (Veetids, Pen Vee K, Bicillin), rifampin (Rifadin), rifabutin (Mycobutin), tetracycline, and others;
  • seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), topiramate (Topamax), or primidone (Mysoline);
  • a barbiturate such as butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
  • HIV medicines such as indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept), and others.

This list is not complete and there may be other drugs that can interact with birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and levonorgestrel.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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