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PROGESTINS For Contraceptive Use (Systemic)

Some commonly used brand names are:

In the U.S.—

• Depo-Provera Contraceptive Injection ²
• depo-subQ provera 104 ²
• Micronor ³
• NORPLANT System ¹
• Nor-QD ³
• Ovrette ⁴
• Plan B ¹

In Canada—

• Depo-Provera ²
• Micronor ³
• NORPLANT System ¹

Another commonly used name is norethisterone .

Category

• Contraceptive (systemic)
• Progestational agent

Description

Progestins (proe-JES-tins) are hormones.

The low-dose progestins for contraception are used to prevent pregnancy. Other names for progestin-only oral contraceptives are minipills and progestin-only pills (POPs). Progestins can prevent fertilization by preventing a woman"s egg from fully developing.

Also, progestins cause changes at the opening of the uterus, such as thickening of the cervical mucus. This makes it hard for the partner"s sperm to reach the egg. The fertilization of the woman"s egg with her partner"s sperm is less likely to occur while she is taking, receiving, or using a progestin, but it can occur. Even so, the progestins make it harder for the fertilized egg to become attached to the walls of the uterus, making it difficult to become pregnant.

No contraceptive method is 100 percent effective. Studies show that fewer than 1 of each 100 women become pregnant during the first year of use when correctly receiving the injection on time or receiving the levonorgestrel implants. Fewer than 10 of each 100 women correctly taking progestins by mouth for contraception become pregnant during the first year of use . Methods that do not work as well include using condoms, diaphragms, or spermicides. Discuss with your health care professional what your options are for birth control.

Progestins are available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Levonorgestrel
  • Tablets (U.S.)
• Norethindrone
  • Tablets (U.S. and Canada)
• Norgestrel
  • Tablets (U.S.)

• Subdermal
• Levonorgestrel
  • Implants (U.S. and Canada)

• Parenteral
• Medroxyprogesterone
  • Intramuscular injection (U.S. and Canada)
  • Subcutaneous injection (U.S.)

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 progestins 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 progestins, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to 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—Use of progestin-only contraceptives during pregnancy is not recommended. Doctors should be told if pregnancy is suspected. When accidently used during pregnancy, progestins used for contraception have not caused problems.

Breast-feeding—Although progestins pass into the breast milk, the low doses of progestins used for contraception have not been shown to cause problems in nursing babies. Progestins used for contraception are recommended for nursing mothers when contraception is desired.

Adolescents—Progestins have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. You must take progestin-only oral contraceptives every day in order for them to work. Progestins do not protect against sexually transmitted diseases, a risk factor for teenagers. It is not known if Depo-Provera Contraceptive Injection causes problems with bone development and growth in teenagers and young women. It is important that your doctor check you regularly for growth problems, especially if you have been using this medicine for 2 years or longer.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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 a progestin, it is especially important that your health care professional know if you are taking any of the following:

• Aminoglutethimide (e.g., Cytadren) or
• Carbamazepine (e.g., Tegretol) or
• Phenobarbital or
• Phenytoin (e.g., Dilantin) or
• Rifabutin (e.g., Mycobutin) or
• Rifampin (e.g., Rifadin, Rimactane)—These medicines may decrease the effects of progestins and increase your chance of pregnancy, so use of a second form of birth control is recommended

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

• Asthma or
• Epilepsy (or history of) or
• Heart or circulation problems or
• Kidney disease (severe) or
• Migraine headaches—Progestins may cause fluid build-up and may cause these conditions to become worse

• Bleeding problems, undiagnosed, such as blood in urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult

• Breast disease (such as breast lumps or cysts) (history of)—May make this condition worse in certain types of diseases that do not react in a positive way to progestins

• Central nervous system (CNS) disorders, such as mental depression (or history of) or
• High blood cholesterol—Effects of progestins may cause these conditions or may make these conditions worse
• Diabetes mellitus (sugar diabetes)—May cause a mild increase in your blood sugar and a need to change the amount of medicine you take for diabetes

• Liver disease—Effects of some progestins may be increased and may worsen this condition

• Other conditions that increase the chances for osteoporosis (brittle bones)—Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. It is especially important that you tell your doctor about any of these risk factors if you are taking Depo-Provera Contraceptive Injection or depo-subQ provera 104 . This contraceptive may cause loss of bone mineral density. Your doctor may replace this contraceptive with a different one. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

Proper Use of This Medicine

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins for contraception usually come with patient directions. Read them carefully before taking or using this medicine.

Progestins do not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence is recommended for protection from these diseases.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered . To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

When using the levonorgestrel subdermal dosage form :

• For insertion:
  • Six implants are inserted under the skin of your upper arm by a health care professional. This usually takes about 15 minutes. No pain should be felt from the insertion process because you will receive a small injection from your doctor of a medicine that will numb your arm.
• For care of insertion site:
  • Keep the gauze wrap on for 24 hours after the insertion. Then, you should remove it. The sterile strips of tape should be left over the area for 3 days.
  • Be careful not to bump the site or get that area wet for at least 3 days after the procedure. Do not do any heavy lifting for 24 hours. Swelling and bruising are common for a few days.
• For contraceptive protection:
  • Full protection from pregnancy begins within 24 hours, if the insertion is done within 7 days of the beginning of your menstrual period. Otherwise, use another birth control method for the rest of your first cycle. Protection using implants lasts for 5 years or until removal, whichever comes first.
• For removal:
  • The implants need to be removed after 5 years. However, you may have them removed by a health care professional at any time before that.
  • If you want to continue using this form of birth control after 5 years, your health care professional may insert new implants in the same area where the old ones were or into the other arm.
  • After a local injection numbs the area on your arm, removal of the medication usually takes 20 minutes or longer. If the implants are hard to remove, your health care professional may want you to return another day to complete the removal process.
  • Keep a gauze wrap on for 24 hours after the removal. The sterile strips of tape underneath the gauze wrap should be left over the area for 3 days. Be careful not to bump the site or get that area wet until the area is healed.

When using levonorgestrel tablet dosage form for emergency contraception :

• The tablets may be taken at any time during the menstrual cycle.

When using medroxyprogesterone injection dosage form for contraception :

• Your injection is given by a health care professional every 3 months.
• To stop using medroxyprogesterone injection for contraception, simply do not have another injection.
• Full protection from pregnancy begins immediately if you receive the first injection within the first 5 days of your menstrual period or within 5 days after delivering a baby if you will not be breast-feeding. If you are going to breast-feed, you may have to wait for 6 weeks from your delivery date before receiving your first injection. If you follow this schedule, you do not need to use another form of birth control. Protection from that one injection ends at 3 months. You will need another injection every 3 months to have full protection from becoming pregnant. However, if the injection is given later than 5 days from the first day of your last menstrual period, you will need to use another method of birth control as directed by your doctor.

When using an oral progestin dosage form :

• Take a tablet every 24 hours each day of the year. Taking the medicine at the same time each day helps to reduce the possibility of side effects and makes it work as expected. Taking your tablet 3 hours late is the same as missing a dose and can cause the medicine to not work properly.
• Keep the tablets in the container in which you received them to help you to keep track of your dosage schedule.
• When switching from estrogen and progestin oral contraceptives, you should take the first dose of the progestin-only contraceptive the next day after the last active pill of the estrogen and progestin oral contraceptive has been taken. This means you will not take the last 7 days (placebo or nonactive pills) of a 28-day cycle of the estrogen and progestin oral contraceptive pack. You will begin a new pack of progestin-only birth control pills on the 22nd day.
• Also, when switching, full protection from pregnancy begins after 48 hours if the first dose of the progestin-only contraceptive is taken on the first day of the menstrual period. If the birth control is begun on other days, full protection may begin 3 weeks after you begin taking the medicine for the first time. You should use a second method of birth control for at least the first 3 weeks to ensure full protection . You are not fully protected if you miss pills. The chances of your getting pregnant are greater with each pill that is missed.

Dosing—Follow your doctor"s orders or the directions on the label . Also, follow your health care professional"s orders to schedule the proper time to remove the implants or receive an injection of progestins for contraception. You and your health care professional may choose to replace the implants sooner or begin a new method of birth control. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

• For levonorgestrel
• For subdermal dosage form (implants):
  • For preventing pregnancy:
    • Adults and teenagers—Six implants (a total dose of 216 milligrams [mg]) inserted under the skin of the upper arm in a fan-like pattern. From this total dose, about 30 mcg is released every day for 5 years.
• For oral dosage form (tablet):
  • For emergency contraception for preventing pregnancy:
    • Adults and teenagers—The first dose of 0.75 milligram (mg) should be taken as soon as possible within 72 hours of intercourse. The second dose must be taken 12 hours later.

• For medroxyprogesterone
• For muscular injection dosage form:
  • For preventing pregnancy:
    • Adults and teenagers—150 milligrams injected into a muscle in the upper arm or in the buttocks every three months (13 weeks).
• For subcutaneous injection dosage form:
  • For preventing pregnancy:
    • Adults and teenagers—104 milligrams injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks).

• For norethindrone
• For oral dosage form (tablets):
  • For preventing pregnancy:
    • Adults and teenagers—0.35 milligrams (mg) every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding begins or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.

• For norgestrel
• For oral dosage form (tablets):
  • For preventing pregnancy:
    • Adults and teenagers—75 micrograms (mcg) every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding occurs or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.

Missed dose—

• For oral dosage form (tablets): When you miss 1 day"s dose of oral tablets or are 3 hours or more late in taking your dose, many doctors recommend that you take the missed dose immediately, continue your normal schedule, and use another method of contraception for 2 days. This is different from what is done after a person misses a dose of birth control tablets that contain more than one hormone.
• For injection dosage form: If you miss having your next injection and it has been longer than 13 weeks since your last injection, your doctor may want you to stop receiving the medicine. Use another method of birth control until your period begins or until your doctor determines that you are not pregnant.
• If your doctor has other directions, follow that advice. Any time you miss a menstrual period within 45 days after a missed or delayed dose you will need to be tested for a possible pregnancy .

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat. Light will fade some tablet colors but will not change the tablets" effect.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Keep the injectable form of this medicine from freezing.
• 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 health care professional check your progress at regular visits . This will allow your dosage to be adjusted to your changing needs, and will allow any unwanted effects to be detected. These visits are usually every 12 months when you are taking progestins by mouth for birth control.

• If you are receiving the medroxyprogesterone injection for contraception, a physical exam is needed only every 12 months, but you need an injection every 3 months. Your doctor will also want to check you for any bone development or growth problems, especially if you are a teenager or young adult.
• If you are using the levonorgestrel implants, your doctor will want to check the area where they were placed within 30 days after they are put into or removed from your arm. After that, a visit every 12 months usually is all that is needed.

Progestins may cause some people to become dizzy . Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is not unusual and does not mean you should stop the medicine. This is sometimes called spotting when the bleeding is slight, or breakthrough bleeding when it is heavier. If this occurs, continue on your regular dosing schedule. Check with your doctor :

• If vaginal bleeding continues for an unusually long time.
• If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should call your doctor immediately .

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

The following medicines might reduce the effectiveness of progestins for contraception:

• Aminoglutethimide (e.g., Cytadren)
• Carbamazepine (e.g., Tegretol)
• Phenobarbital
• Phenytoin (e.g., Dilantin)
• Rifabutin (e.g., Mycobutin)
• Rifampin (e.g., Rifadin)

If you vomit your oral progestin-only contraceptive for any reason within hours of taking it, do not take another dose. Return to your regular dosing schedule and use an additional back-up method of birth control for 48 hours.

If you are receiving levonorgestrel tablets for emergency contraception and vomiting occurs within 1 hour of taking either dose of the medicine, contact your physician to discuss whether the dose should be repeated.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Incidence not known—for patients taking Depo-Provera Contraceptive Injection .

Cough; decrease in height; difficulty swallowing; fast heartbeat; hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips or tongue; pain in back, ribs, arms, or legs; shortness of breath; pain or swelling in arms or legs without any injury; skin rash; tightness in chest; wheezing

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:

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

Delayed return to fertility; stopping of menstrual periods; unusual menstrual bleeding (continuing)

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

Revised: 04/14/2005

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