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PROGESTINS For Noncontraceptive Use (Systemic)
Some commonly used brand names are:
In the U.S.—
Another commonly used name is norethisterone .
Progestins (proe-JES-tins) are hormones. They are used by both men and women for different purposes.
Progestins are prescribed for several reasons:
Progestins may also be used for other conditions as determined by your doctor.
Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.
Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.
Progestins are available only with your doctor"s prescription, in the following dosage forms:
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. This is a decision you and your health care professional will make. For progestins, the following should be considered:
Allergies—Tell your doctor if you have ever had any unusual reaction to progestins. If using progesterone capsules or injection, tell your doctor if you are allergic to peanuts. 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—Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.
Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.
Breast-feeding—Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother"s breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.
Children—Although there is no specific information comparing use of progestins in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.
Adolescents—Although there is no specific information comparing use of progestins in teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in teenagers than it does in adults.
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:
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:
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 usually come with patient directions. Read them carefully before taking or using this medicine.
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.
Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.
Dosing—The dose of these medicines will be different for different patients. Follow your doctor"s orders or the directions on the label . 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.
The number of tablets, injections, or suppositories that you take, receive, or use depends on the strength of the medicine. Also, the number of doses you take or use each day, the time allowed between doses, and the length of time you take or use the medicine depend on the medical problem for which you are taking progestins .
Missed dose—For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of this medicine, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.
Storage—To store this medicine:
Precautions While Using This Medicine
It is very important that your doctor 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 will usually be every 6 to 12 months, but some doctors require them more often.
Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. 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.
Unusual or unexpected 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 menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor :
Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking this medicine immediately and call your doctor . Your doctor will let you know if you should continue taking the progestin.
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.
In some patients, 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.
You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active .
If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.
Side Effects of This Medicine
Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.
The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention. Get emergency help immediately if any of the following side effects occur:
Symptoms of blood clotting problems, usually severe or sudden , such as headache or migraine; loss of or change in speech, coordination, or vision; numbness of or pain in chest, arm, or leg; unexplained shortness of breath
Also, check with your doctor as soon as possible if any of the following side effects occur:
Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods); symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst)
Mental depression; skin rash; unexpected or increased flow of breast milk
For megestrol—During chronic treatment
Backache; dizziness; filling or rounding out of the face; irritability; mental depression; unusual decrease in sexual desire or ability in men; nausea or vomiting; unusual tiredness or weakness
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:
Abdominal pain or cramping; bloating or swelling of ankles or feet; blood pressure increase (mild); dizziness; drowsiness (progesterone only); headache (mild); mood changes; nervousness; pain or irritation at place of injection site; swelling of face, ankles, or feet; unusual or rapid weight gain
Acne; breast pain or tenderness; brown spots on exposed skin, possibly long-lasting; hot flashes; loss or gain of body, facial, or scalp hair; loss of sexual desire; trouble in sleeping
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 the following side effect:
Delayed return to fertility; stopping of menstrual periods; unusual menstrual bleeding (continuing)
Dizziness; nausea or vomiting; unusual tiredness or weakness
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
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, progestins are used in certain patients with the following medical conditions:
Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.
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