Generic name: D-norgestrel and Ethinylestradiol

Description
Oral contraceptives are known also as the Pill, OCs, BCs, BC tablets, or birth control pills. This medicine 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)

Before Using This Medicine
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.

Teenagers—This medicine is frequently used for birth control in teenage females and has not been shown to cause different side effects or problems than it does in adults. Some teenagers may need extra information on the importance of taking this medication exactly as prescribed.

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

Other medical problems—The presence of other medical problems may affect the use of oral contraceptives. Make sure you tell your doctor if you have any other medical problems, especially:

• 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

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.

Precautions While Using This Medicine
It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.

Tell the medical doctor or dentist in charge that you are taking this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue taking this medicine.

The following medicines may reduce the effectiveness of oral contraceptives. You should use an additional method of birth control during each cycle in which any of the following medicines are used:

• Ampicillin
• Barbiturates
• Carbamazepine (e.g., Tegretol)
• Griseofulvin (e.g., Fulvicin)
• Penicillin V
• Phenytoin (e.g., Dilantin)
• Primidone (e.g., Mysoline)
• Rifampin (e.g., Rifadin)
• Ritonavir (e.g., Norvir)
• Tetracyclines (medicine for infection)
• Troglitazone (e.g., Rezulin)

Check with your doctor if you have any questions about this.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier. If this should occur:

• Continue on your regular dosing schedule.
• The bleeding usually stops within 1 week.
• Check with your doctor if the bleeding continues for more than 1 week.
• After you have been taking oral contraceptives on schedule and for more than 3 months and bleeding continues, check with your doctor.

Missed menstrual periods may occur:

• If you have not taken the medicine exactly as scheduled. Pregnancy must be considered as a possibility.
• If the medicine is not the right strength or type for your needs.
• If you stop taking oral contraceptives, especially if you have taken oral contraceptives for 2 or more years.

Check with your doctor if you miss any menstrual periods so that the cause may be determined.

In some patients using estrogen-containing oral contraceptives, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums. Also, it has been shown that estrogen-containing oral contraceptives may cause a healing problem called dry socket after a tooth has been removed. If you are going to have a tooth removed, tell your dentist or oral surgeon that you are taking oral contraceptives.

Some people who take oral contraceptives may become more sensitive to sunlight than they are normally. When you begin taking this medicine, avoid too much sun and do not use a sunlamp until you see how you react to the sun, especially if you tend to burn easily. If you have a severe reaction, check with your doctor. Some people may develop brown, blotchy spots on exposed areas. These spots usually disappear gradually when the medicine is stopped.

If you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor.

If you are scheduled for any laboratory tests, tell your doctor that you are taking birth control pills.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Side Effects of This Medicine

Side Effects of This Medicine

Healthy women who do not smoke cigarettes have almost no chance of having a severe side effect from taking oral contraceptives. For most women, more problems occur because of pregnancy than will occur from taking oral contraceptives. But for some women who have special health problems, oral contraceptives can cause some unwanted effects. Some of these unwanted effects include benign (not cancerous) liver tumors, liver cancer, or blood clots or related problems, such as a stroke. Although these effects are very rare, they can be serious enough to cause death. You may want to discuss these effects with your doctor.

Smoking cigarettes during the use of oral contraceptives has been found to greatly increase the chances of these serious side effects occurring. To reduce the risk of serious side effects, do not smoke cigarettes while you are taking oral contraceptives. Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. The risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age.

The following side effects may be caused by blood clots. Get emergency help immediately if any of the following side effects occur:

• Rare
  • Abdominal or stomach pain (sudden, severe, or continuing); coughing up blood; headache (severe or sudden); loss of coordination (sudden); loss of vision or change in vision (sudden); pains in chest, groin, or leg (especially in calf of leg); shortness of breath (sudden or unexplained); slurring of speech (sudden); weakness, numbness, or pain in arm or leg (unexplained)

Check with your doctor as soon as possible if any of the following side effects occur:

• More common—usually less common after the first 3 months of oral contraceptive use
  • Changes in the uterine bleeding pattern at menses or between menses, such as decreased bleeding at menses, breakthrough bleeding or spotting between periods, prolonged bleeding at menses, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometime

• Less common
  • Headaches or migraines (although headaches may lessen in many users, in others, they may increase in number or become worse); increased blood pressure; vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge
  • For women with diabetes mellitus
    • Mild increase of blood sugar—Faintness, nausea, pale skin, or sweating
• Rare
  • Mental depression; swelling, pain, or tenderness in upper abdominal area
  • For women who smoke tobacco
    Pains in stomach, side, or abdomen; yellow eyes or skin
  • For women with a history of breast disease
    • Lumps in breast

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Abdominal cramping or bloating; acne (usually less common after first 3 months and may improve if acne already exists); breast pain, tenderness, or swelling; dizziness; nausea; swelling of ankles and feet; unusual tiredness or weakness; vomiting
• Less common
  • Brown, blotchy spots on exposed skin; gain or loss of body or facial hair; increased or decreased interest in sexual intercourse; increased sensitivity of skin to sunlight; weight gain or loss

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, oral contraceptives are used in certain patients with the following medical conditions:

• Amenorrhea (stopping of menses for several consecutive months)
• Dysfunctional uterine bleeding (abnormal uterine bleeding)
• Dysmenorrhea (painful menstrual bleeding)
• Hypermenorrhea (excessive menstrual bleeding)
• Emergency contraception within 72 hours of unprotected intercourse
• Endometriosis (painful bleeding from uterine-like tissue that can grow in different parts of the female body)
• Hirsutism in females (male-like hair growth)
• Hyperandrogenism, ovarian (excessive production of male hormones)
• Polycystic ovary syndrome (many problems that include amenorrhea, hirsutism, infertility, and many tiny cysts or sacs usually in both ovaries)

For patients taking this medicine for emergency contraception :

• Must be taken with food within 72 hours of unprotected sexual intercourse. One single course (2 doses 12 hours apart) is a one-time emergency protection. Using more than one course in a month will reduce the effectiveness.
• Because the hormones are strong, watch for danger signs. Call your doctor if you experience any severe pains in your leg, stomach, or chest; any vision or breathing changes; yellowing of skin; headaches; numbness; or trouble in speaking.
• You may experience nausea so take it with food and call your doctor if you vomit the medicine.
• Your menstrual period may start earlier than usual. If it doesn't start, call your doctor.

For patients taking this medicine for hirsutism:

• You may need to use oral contraceptives for 6 to 12 months before you see less new hair growth.

For patients taking this medicine for endometriosis :

• Sometimes instead of following the directions on the oral contraceptive's package, your doctor may ask you to follow different directions, such as taking the active tablets in the package each day without stopping for 6 to 9 months. This means that after 21 days you will start a new package of pills. If you are not sure about how to take this medicine, discuss any questions with your health care professional.
• Also, your symptoms of endometriosis may worsen at first but with continued use of the oral contraceptives your symptoms should lessen and your condition improve.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.