DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Seasonale (Levonorgestrel / Ethinyl Estradiol) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Seasonale® tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

In a 1-year controlled clinical trial, 4 pregnancies occurred in women 18-35 years of age during 809 completed 91-day cycles of Seasonale® during which no backup contraception was utilized. This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 1.98 per 100 women-years of use.

Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® Implant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

TABLE 2
Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year: United States.
% of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing
Use at One Year 3
Method
(1)
Typical Use 1
(2)
Perfect Use 2
(3)
(4)
Chance 4 85 85
Spermicides 5 26 6 40
Periodic abstinence 25 63
Calendar 9
Ovulation method 3
Sympto-thermal 6 2
Post-ovulation 1
Withdrawal 19 4
Cap 7
Parous women 40 26 42
Nulliparous women 20 9 56
Sponge
Parous women 40 20 42
Nulliparous women 20 9 56
Diaphragm 7 20 6 56
Condom 8
Female (Reality) 21 5 56
Male 14 3 61
Pill 5 71
Progestin only 0.5
Combined 0.1
IUD:
Progesterone T 2.0 1.5 81
Copper T 380A 0.8 0.6 78
LNg 20 0.1 0.1 81
Depo Provera 0.3 0.3 70
Norplant and
Norplant-2
0.05 0.05 88
Female sterilization 0.5 0.5 100
Male sterilization 0.15 0.10 100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9
Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an unintended pregnancy during the first year if they do not stop use for any other reason.
2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an unintended pregnancy during the first year if they do not stop use for any other reason.
3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4 The percentages of women becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5 Foams, creams, gels, vaginal suppositories and vaginal film.
6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7 With spermicidal cream or jelly.
8 Without spermicides.
9 The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).
10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced or the baby reaches six months of age.

DOSAGE AND ADMINISTRATION

Although the occurrence of pregnancy is unlikely if Seasonale® is taken according to directions, if withdrawal bleeding does not occur while taking white (inactive) tablets, the possibility of pregnancy must be considered. Appropriate diagnostic measures to rule out pregnancy should be taken at the time of any missed menstrual period. Seasonale should be discontinued if pregnancy is confirmed.

The dosage of Seasonale® is one pink (active) tablet daily for 84 consecutive days, followed by 7 days of white (inert) tablets. To achieve maximum contraceptive effectiveness, Seasonale® must be taken exactly as directed and at intervals not exceeding 24 hours. Ideally, the tablets should be taken at the same time of the day on each day of active treatment. The tablets should not be removed from the protective blister packaging and outer plastic dispenser to avoid damage to the product. The plastic dispenser should be kept in the foil pouch until dispensed to the patient.

During the first cycle of medication, the patient is instructed to begin taking Seasonale® on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (pink) is taken that day. One pink tablet should be taken daily for 84 consecutive days, followed by 7 days on which a white (inert) tablet is taken. Withdrawal bleeding should occur during the 7 days following discontinuation of pink active tablets. During the first cycle, contraceptive reliance should not be placed on Seasonale® until a pink (active) tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient begins her next and all subsequent 91-day courses of tablets without interruption on the same day of the week (Sunday) on which she began her first course, following the same schedule: 84 days on which pink tablets are taken followed by 7 days on which white tablets are taken. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a pink tablet daily for 7 consecutive days.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding may be transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider.

For patient instructions regarding missed pills, see the " WHAT TO DO IF YOU MISS PILLS " section in the DETAILED PATIENT LABELING. Any time the patient misses two or more pink tablets, she should also use another method of non-hormonal back-up contraception until she has taken a pink tablet daily for seven consecutive days. If the patient misses one or more white tablets, she is still protected against pregnancy provided she begins taking pink tablets again on the proper day. The possibility of ovulation increases with each successive day that scheduled pink tablets are missed. The risk of pregnancy increases with each active (pink) tablet missed.

In the nonlactating mother, Seasonale® may be initiated no earlier than day 28 postpartum, for contraception due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered. Seasonale® may be initiated immediately after a first-trimester abortion; if the patient starts Seasonale® immediately, additional contraceptive measures are not needed.

HOW SUPPLIED

Seasonale® tablets (levonorgestrel/ethinyl estradiol tablets) 0.15 mg/0.03 mg are available in Extended-Cycle Tablet Dispensers (NDC 51285-058-66), each containing a 13-week supply of tablets: 84 pink tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 white inert tablets. The active pink tablets are round, film-coated, biconvex, unscored tablets with a debossed S on one side and 62 on the other side. The inert tablets are white, round, biconvex, unscored tablet debossed with S on one side and 197 on the other side. Store at controlled room temperature 20°-25° C (68°-77° F) [See USP].

References available upon request.

BRIEF SUMMARY PATIENT PACKAGE INSERT

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

Oral contraceptives, also known as "birth control pills" or "the pill", are taken to prevent pregnancy, and when taken correctly, have a failure rate of approximately 1.0% per year (1 pregnancy per 100 women per year of use). The typical failure rate of pill users is approximately 5% per year when women who miss pills are included.

For the majority of women, oral contraceptives can be taken safely. But for some women oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability or death. The risks associated with taking oral contraceptives increase significantly if you:

  • smoke
  • have high blood pressure, diabetes, high cholesterol or are obese
  • have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, or malignant or benign liver tumors

You should not take the pill if you are pregnant.

Although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy, non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women.

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the amount of smoking (15 or more cigarettes per day has been associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not smoke.

Most side effects of the pill are not serious. The most common are nausea, vomiting, bleeding or spotting between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. Some of these side effects, especially nausea and vomiting, may subside within the first 3 months of use.

The serious side effects of the pill occur very infrequently, especially if you are in good health and do not smoke. However, you should know that the following medical conditions have been associated with or made worse by the pill:

  1. Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris) or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences. Women with migraine also may be at increased risk of stroke when taking the pill.
  2. Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.
  3. High blood pressure, although blood pressure usually returns to normal when the pill is stopped.

The symptoms associated with these serious side effects are discussed in the detailed patient information leaflet. Notify your healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, and herbal preparations containing St. John's Wort (hypericum perforatum) may decrease oral contraceptive effectiveness.

Breast cancer has been diagnosed slightly more often in women who use the pill than in women of the same age who do not use the pill. This very small increase in the number of breast cancer diagnoses gradually disappears during the 10 years after stopping use of the pill. It is not known whether the difference is caused by the pill. It maybe that women taking the pill were examined more often, so that breast cancer was more likely to be detected. You should have regular breast examinations by a healthcare provider and examine your own breasts monthly. Tell your healthcare provider if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram. Women who currently have or have had breast cancer should not use hormonal contraceptives because breast cancer is usually a hormone-sensitive tumor.

Some studies have found an increase in the incidence of cancer or precancerous lesions of the cervix in women who use the pill. However, this finding may be related to factors other than the use of the pill.

Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is appropriate to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient information leaflet gives you further information, which you should read and discuss with your healthcare provider.

WHAT YOU SHOULD KNOW ABOUT YOUR MENSTRUAL CYCLE WHEN TAKING SEASONALE®

When you take Seasonale®, which has a 91-day treatment cycle, you should expect to have 4 menstrual periods per year (bleeding when you are taking the 7 white pills). However, you also should expect to have more bleeding or spotting between your menstrual periods than if you were taking an oral contraceptive with a 28-day treatment cycle. During the first Seasonale® treatment cycle, about 1 in 3 women may have 20 or more days of unplanned bleeding or spotting (bleeding when you are taking pink pills). This bleeding or spotting tends to decrease during later cycles. Do not stop Seasonale® because of the bleeding. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, call your healthcare provider.

IF YOU MISS YOUR MENSTRUAL PERIOD WHEN TAKING SEASONALE

You should consider the possibility that you are pregnant if you miss your menstrual period (no bleeding on the days that you are taking white tablets). Since scheduled menstrual periods are less frequent when you are taking Seasonale®, notify your healthcare provider that you have missed your period and are taking Seasonale®. 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 Seasonale® if it is determined that you are pregnant.

HOW TO TAKE SEASONALE®

IMPORTANT POINTS TO REMEMBER BEFORE YOU START TAKING SEASONALE®

  1. BE SURE TO READ THESE DIRECTIONS:
    • Before you start taking your pills.
    • Anytime you are not sure what to do.
  2. THE RIGHT WAY TO TAKE SEASONALE® IS TO 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.
  3. MANY WOMEN MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST FEW WEEKS OF TAKING PILLS.
    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.
  4. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING DURING THE FIRST FEW MONTHS OF TAKING SEASONALE®. Do not stop taking your pills even if you are having irregular bleeding. If the bleeding lasts for more than 7 consecutive days, talk to your healthcare provider.
  5. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
  6. IF YOU HAVE VOMITING OR DIARRHEA, or IF YOU TAKE SOME MEDICINES, including some antibiotics and the herbal supplement St. John's Wort, Seasonale may not work as well. Use a back-up method (such as condoms or spermicides) until you check with your healthcare provider.
  7. IF YOU HAVE TROUBLE REMEMBERING TO TAKE SEASONALE®, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.
  8. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your healthcare provider.

BEFORE YOU START TAKING SEASONALE®

  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 pink pills (active pills with hormones) and 7 white pills (inactive pills without hormone). Trays 1 and 2 each contain 28 pink pills (4 rows of 7 pills). Tray 3 contains 35 pills consisting of 28 pink pills (4 rows of 7 pills) and 7 white pills (1 row of 7 pills).


  3. 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).
  4. BE SURE YOU HAVE READY AT ALL TIMES ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicides), to use as a back-up in case you miss pills.

WHEN TO START SEASONALE®

  1. Take the first "active" pink pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first pink pill that same day.
  2. Use another method of birth control (such as condom or spermicide) as a back-up method if you have sex anytime from the Sunday you start your first pink pill until the next Sunday (first 7 days).

HOW TO TAKE SEASONALE®

  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 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 white pill, start taking the first pink pill from a new Extended-Cycle Tablet Dispenser the very next day regardless of when your period started. This should be on a Sunday.
  3. If you miss your period when you are taking the white pills, call your healthcare provider because you may be pregnant.

WHAT TO DO IF YOU MISS PILLS

If you MISS 1 pink "active" 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 pink "active" 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 restart your pills. You MUST use another birth control method (such as condoms or spermicide) as a back-up on the 7 days after you restart your pills.

If you MISS 3 OR MORE pink "active" pills in a row:

  1. Do not remove the missed pills from the pack as they will not be taken. 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 miss your period when you are taking the white pills, call your healthcare provider because you may be pregnant.

If you MISS ANY of the 7 white inactive 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.

DETAILED PATIENT LABELING

This product (like all oral contraceptives) is intended to prevent pregnancy. Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017