Estrogens and Progestins Oral Contraceptives (Systemic)

Brand name(s): Alesse

Proper Use of This Medicine

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

A paper with information for the patient will be given to you with your filled prescription, and will provide many details concerning the use of oral contraceptives. Read this paper carefully and ask your health care professional if you need additional information or explanation.

Take this medicine with food to help prevent nausea that might occur during the first few weeks. Nausea usually disappears with continued use or if the medicine is taken at bedtime.

When you begin to use oral contraceptives, your body will require at least 7 days to adjust before a pregnancy will be prevented. You will need to use an additional birth control method for at least 7 days. Some doctors recommend using an additional method of birth control for the first cycle (or 3 weeks) to ensure full protection. Follow the advice of your doctor or other health care professional.

Try to take the doses no more than 24 hours apart to reduce the possibility of side effects and to prevent pregnancy. Since one of the most important factors in the proper use of oral contraceptives is taking every dose exactly on schedule, you should never let your tablet supply run out. When possible, try to keep an extra month's supply of tablets on hand and replace it monthly.

It is very important that you keep the tablets in their original container and take the tablets in the same order that they appear in the container. The containers help you keep track of which tablets to take next. Different colored tablets in the same package contain different amounts of hormones or are placebos (tablets that do not contain hormones). The effectiveness of the medicine is reduced if the tablets are taken out of order.

• Monophasic (one-phase) cycle dosing schedule: Most available dosing schedules are monophasic. If you are taking tablets of one strength (color) for 21 days, you are using a monophasic schedule. For the 28-day monophasic cycle you will also take an additional 7 inactive tablets, which are another color. If you are taking the brand name Mircette, the last seven tablets of the 28-day cycle contains two inactive tablets (for Days 22 and 23) and five tablets (for Days 24 through 28) that contain a low dose of estrogen. Taking the last 7 tablets is not required for full protection against pregnancy but they do help to replace estrogen.
• Biphasic (two-phase) cycle dosing schedule: If you are using a biphasic twenty-one-day schedule, you are taking tablets of one strength (color) for either seven or ten days, depending on the medication prescribed (the first phase). You then take tablets of a second strength (color) for the next eleven or fourteen days, depending on the medication prescribed (the second phase). At this point, you will have taken a total of twenty-one tablets. For the twenty-eight-day biphasic cycle you will also take an additional seven inactive tablets, which are a third color.
• Triphasic (three-phase) cycle dosing schedule: If you are using a triphasic twenty-one-day schedule, you are taking tablets of one strength (color) for five, six or seven days, depending on the medicine prescribed (the first phase). You then take tablets of a second strength (color) for the next five, seven, or nine days, depending on the medicine prescribed (the second phase). After that, you take tablets of a third strength (color) for the next five, seven, nine, or ten days, depending on the medicine prescribed (the third phase). At this point, you will have taken a total of twenty-one tablets. For the twenty-eight-day triphasic cycle you will also take an additional seven inactive tablets, which are a fourth color.

If you are taking one of the brand name products Estrostep Fe or Loestrin Fe each of the last seven tablets that you will take on Days 21 through 28 of your cycle contains iron. These tablets are also a different color from the other tablets in your package. They help to replace some of the iron you lose when you have a menstrual period.

Dosing-

Your health care professional may begin your dose on the first day of your menstrual period (called Day-1 start) or on Sunday (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even when you miss a dose . Do not change your schedule on your own. If the schedule that you have been put on is not convenient, check with your health care professional about changing schedules.

• For oral dosage forms (monophasic, biphasic, or triphasic tablets):
  • For contraception:
    • Adults and teenagers:
      • For the twenty-one-day cycle: Take 1 tablet a day for twenty-one days. Skip seven days. Then repeat the cycle.
      • For the twenty-eight-day cycle: Take 1 tablet a day for twenty-eight days. Then repeat the cycle.

• For oral dosage forms (norethindrone acetate and ethinyl estradiol triphasic tablets and norgestimate and ethinyl estradiol triphasic tablets :
  • To treat acne:
    • Adults and teenagers 15 years of age and over:
      • For the twenty-one-day cycle: Take 1 tablet a day for twenty-one days. Skip seven days. Then repeat the cycle.
      • For the twenty-eight-day cycle: Take 1 tablet a day for twenty-eight days. Then repeat the cycle.
    • Teenagers up to 15 years of age-Use and dose must be determined by your doctor.

Missed dose-

Follow your doctor's orders or the directions on the label if you miss a dose of this medicine. The following information includes only some of the ways to handle missed doses. Your health care professional may want you to stop taking the medicine and use other birth control methods for the rest of the month until you have your menstrual period. Then your health care professional can tell you how to begin taking your medicine again.

For monophasic, biphasic, or triphasic cycles:

• If you miss the first tablet of a new cycle-Take the missed tablet as soon as you remember and take the next tablet at the usual time. You may take 2 tablets in one day. Then continue your regular dosing schedule. Also, use another birth control method until you have taken seven days of your tablets after the last missed dose.
• If you miss 1 tablet during the cycle-Take the missed tablet as soon as you remember. Take the next tablet at the usual time. You may take 2 tablets in one day. Then continue your regular dosing schedule.
• If you miss 2 tablets in a row in the first or second week-Take 2 tablets on the day that you remember and 2 tablets the next day. Then continue taking 1 tablet a day. Also use another birth control method until you begin a new cycle.
• If you miss 2 tablets in a row in the third week; or
• If you miss 3 or more tablets in a row at any time during the cycle-
  • Using a Day-1 start: Throw out your current cycle and begin taking a new cycle. Also, use another birth control method until you have taken seven days of your tablets after the last missed dose. You may not have a menstrual period this month. But if you miss two menstrual periods in a row, call your health care professional.
  • Using a Sunday start: Keep taking one tablet a day from your current pack until Sunday. Then, on Sunday, throw out your old pack and begin a new pack. Also use another birth control method until you have taken seven days of your tablets after the last missed dose. You may not have a menstrual period this month. But if you miss two menstrual periods in a row, call your health care professional.

If you miss any of the last seven (inactive) tablets of a twenty-eight-day cycle, there is no danger of pregnancy. However, the first tablet (active) of the next month's cycle must be taken on the regularly scheduled day, in spite of any missed doses, if pregnancy is to be avoided. The active and inactive tablets are colored differently for your convenience.

Storage-

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat and moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Last Revised: 03/15/2004

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