Some commonly used TRIPHASIL Brand Names are:

In the U.S.—

In Canada—

Other commonly used names are: Ethinylestradiol[Ethinyl estradiol] Ethinyloestradiol [Ethinyl estradiol] Ethynodiol[Ethynodiol diacetate] Etynodiol[Ethynodiol diacetate] Etynodiol acetate[Ethynodiol diacetate] Norethindrone[Norethisterone]

• Antiacne agent, systemic --Norgestimate and Ethinyl Estradiol, triphasic formulation only; Norethindrone and Ethinyl Estradiol, triphasic formulation only
• Antiendometriotic --Desogestrel and Ethinyl Estradiol; Ethynodiol Diacetate and Ethinyl Estradiol; Levonorgestrel and Ethinyl Estradiol; Norethindrone and Ethinyl Estradiol; Norethindrone and Mestranol; Norethindrone Acetate and Ethinyl Estradiol; Norgestimate and Ethinyl Estradiol; Norgestrel and Ethinyl Estradiol
• Contraceptive, postcoital, systemic --Levonorgestrel and Ethinyl Estradiol; Norgestrel and Ethinyl Estradiol
• Contraceptive, systemic --Desogestrel and Ethinyl Estradiol; Ethynodiol Diacetate and Ethinyl Estradiol; Levonorgestrel and Ethinyl Estradiol ; Norethindrone and Ethinyl Estradiol; Norethindrone and Mestranol; Norethindrone Acetate and Ethinyl Estradiol; Norgestimate and Ethinyl Estradiol; Norgestrel and Ethinyl Estradiol
• Estrogen-progestin --Desogestrel and Ethinyl Estradiol; Ethynodiol Diacetate and Ethinyl Estradiol; Levonorgestrel and Ethinyl Estradiol; Norethindrone and Ethinyl Estradiol; Norethindrone and Mestranol; Norethindrone Acetate and Ethinyl Estradiol; Norgestimate and Ethinyl Estradiol; Norgestrel and Ethinyl Estradiol
• Gonadotropin inhibitor, female, noncontraceptive use --Desogestrel and Ethinyl Estradiol; Ethynodiol Diacetate and Ethinyl Estradiol; Levonorgestrel and Ethinyl Estradiol; Norethindrone and Ethinyl Estradiol; Norethindrone and Mestranol; Norethindrone Acetate and Ethinyl Estradiol; Norgestimate and Ethinyl Estradiol; Norgestrel and Ethinyl Estradiol

Oral contraceptives are known also as the Pill, OCs, BCs, BC tablets, or birth control pills. TRIPHASIL usually contains two types of hormones, estrogens (ES-troh-jenz ) and progestins ( proh-JES-tins) and, when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented. Although oral contraceptives have other effects that help prevent a pregnancy from occurring, this is the main action.

Sometimes a woman's egg can still develop even though the medication is taken once each day, especially when more than 24 hours pass between two doses. In almost all cases when the medicine was taken properly and an egg develops, fertilization can still be stopped by oral contraceptives. This is because oral contraceptives also thicken cervical mucus at the opening of the uterus. This makes it hard for the partner's sperm to reach the egg. In addition, oral contraceptives change the uterus lining just enough so that an egg will not stop in the uterus to develop. All of these effects make it difficult to become pregnant when properly taking an oral contraceptive.

No contraceptive method is 100 percent effective. Studies show that fewer than one of each one hundred women correctly using oral contraceptives becomes pregnant during the first year of use. Birth control methods such as having surgery to become sterile or not having sex are more effective. Using condoms, diaphragms, progestin-only oral contraceptives, or spermicides is not as effective as using oral contraceptives containing estrogens and progestins. Discuss with your health care professional your options for birth control.

The triphasic cycle product of norgestimate and ethinyl estradiol (the brand name Ortho Tri-Cyclen) and norethindrone acetate and ethinyl estradiol (the brand name Estrostep ) can be used for the treatment of moderate acne only if the patient is at least 15 years old, has acne that has not improved with topical anti-acne medicines, has gotten approval from her doctor, has begun to have menstrual periods, desires an oral contraceptive for birth control, and plans to stay on it for at least 6 months.

Sometimes these preparations can be used for other conditions as determined by your doctor.

Oral contraceptives are available only with your doctor's prescription, in the following dosage forms:

Oral
• Desogestrel and Ethinyl Estradiol
  • Tablets (U.S. and Canada)
• Ethynodiol Diacetate and Ethinyl Estradiol
  • Tablets (U.S. and Canada)
• Levonorgestrel and Ethinyl Estradiol
  • Tablets (U.S. and Canada)
• Norethindrone Acetate and Ethinyl Estradiol
  • Tablets (U.S. and Canada)
• Norethindrone and Ethinyl Estradiol
  • Tablets (U.S. and Canada)
• Norethindrone and Mestranol
  • Tablets (U.S. and Canada)
• Norgestimate and Ethinyl Estradiol
  • Tablets (U.S. and Canada)
• Norgestrel and Ethinyl Estradiol
  • Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. If you are using oral contraceptives for contraception you should understand how their benefits and risks compare to those of other birth control methods. This is a decision you, your sexual partner, and your doctor will make. For oral contraceptives, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to estrogens or progestins. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Pregnancy—Oral contraceptives are not recommended for use during pregnancy and should be discontinued if you become pregnant or think you are pregnant. When oral contraceptives were accidently taken early in pregnancy, problems in the fetus did not occur. Women who are not breast-feeding may begin to take oral contraceptives two weeks after having a baby.

Breast-feeding—Oral contraceptives pass into the breast milk and can change the content or lower the amount of breast milk. Also, they may shorten a woman's ability to breast-feed by about 1 month, especially when the mother is only partially breast-feeding. Because the amount of hormones is so small in low-dose contraceptives, your doctor may allow you to begin using an oral contraceptive after you have been breast-feeding for a while. However, it may be necessary for you to use another method of birth control or to stop breast-feeding while taking oral contraceptives.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking oral contraceptives, it is especially important that your health care professional know if you are taking any of the following:

• Amiodarone (e.g., Cordarone) or
• Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g., Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
• Androgens (male hormones) or
• Anti-infectives by mouth or by injection (medicine for infection) or
• Barbiturates or
• Carbamazepine (e.g., Tegretol) or
• Carmustine (e.g., BiCNU) or
• Dantrolene (e.g., Dantrium) or
• Daunorubicin (e.g., Cerubidine) or
• Disulfiram (e.g., Antabuse) or
• Divalproex (e.g., Depakote) or
• Estrogens (female hormones) or
• Etretinate (e.g., Tegison) or
• Gold salts (medicine for arthritis) or
• Griseofulvin (e.g., Fulvicin) or
• Hydroxychloroquine (e.g., Plaquenil) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Methyldopa (e.g., Aldomet) or
• Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine [e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine [e.g., Temaril]) or
• Phenylbutazone (e.g., Butazolidin) or
• Phenytoin (e.g., Dilantin) or
• Plicamycin (e.g., Mithracin) or
• Primidone (e.g., Mysoline) or
• Rifabutin (e.g., Mycobutin) or
• Rifampin (e.g., Rifadin) or
• Troleandomycin (e.g., TAO)—These medicines may increase the chance of liver problems if taken with oral contraceptives; also, these medicines may decrease the effect of oral contraceptives and increase your chance of pregnancy. Use of an additional form of birth control is recommended unless directed otherwise by your health care professional

• Corticosteroids (cortisone-like medicine) or
• Theophylline—Oral contraceptives may increase the effects of these medicines and increase the chance of problems occurring

• Cyclosporine—Oral contraceptives increase the effect of cyclosporine and increase the chance of problems occurring

• Ritonavir (e.g., Norvir) or
• Troglitazone (e.g., Rezulin)—These medicines may decrease the effect of oral contraceptives and increase your chance of pregnancy. Use of an additional form of birth control is recommended unless directed otherwise by your health care professional

• Smoking, tobacco—Smoking may decrease the effect of oral contraceptives and increase the chance of causing serious blood clot, vein, or heart problems

• Abnormal changes in menstrual or uterine bleeding or
• Endometriosis or
• Fibroid tumors of the uterus—Oral contraceptives usually improve these female conditions but sometimes they can make them worse or make the diagnosis of these problems more difficult

• Blood clots (or history of) or
• Heart or circulation disease or
• Stroke (or history of)—If these conditions are already present, oral contraceptives may have a greater chance of causing blood clots or circulation problems, especially in women who smoke tobacco. Otherwise, oral contraceptives may help prevent circulation and heart disease if you are healthy and do not smoke

• Breast disease (not involving cancer)—Oral contraceptives usually protect against certain breast diseases, such as breast cysts or breast lumps; however, your doctor may want to follow your condition more closely

• Cancer, including breast cancer (or history of or family history of)—Oral contraceptives may worsen some cancers, especially when breast, cervical, or uterine cancers already exist. Use of oral contraceptives is not recommended if you have any of these conditions. If you have a family history of breast disease, oral contraceptives may still be a good choice but you may need to be tested more often

• Chorea gravidarum or
• Gallbladder disease or gallstones (or history of) or
• High blood cholesterol or
• Liver disease (or history of, including jaundice during pregnancy or oral contraceptive use) or
• Mental depression (or history of)—Oral contraceptives may make these conditions worse or, rarely, cause them to occur again. Oral contraceptives may still be a good choice but you may need to be tested more often

• Diabetes mellitus (sugar diabetes)—Use of oral contraceptives may cause an increase, usually only a small increase, in your blood sugar and usually does not affect the amount of diabetes medicine that you take. You or your doctor will want to test for any changes in your blood sugar for 12 to 24 months after starting to take oral contraceptives in case the dose of your diabetes medicine needs to be changed

• Epilepsy (seizures) (or history of) or
• Heart or circulation problems or
• High blood pressure (hypertension) or
• Migraine headaches—Oral contraceptives may cause fluid build-up and may cause these conditions to become worse; however, some people have fewer migraine headaches when they use oral contraceptives

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 TRIPHASIL 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 TRIPHASIL. 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 TRIPHASIL:

• 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.