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Prescribing Information
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
ORTHO MICRONOR® 28 Day Regimen
Each tablet contains 0.35 mg norethindrone. Inactive ingredients include D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, povidone and starch.
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Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:
Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke.
ORTHO MICRONOR does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives (COCs). The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks. The relationship between progestin-only oral contraceptives and these risks is not fully defined. The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.
1. General
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
2. Physical Examination and Follow up
It is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations. The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician.
3. Carbohydrate and Lipid Metabolism
Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.
Lipid metabolism is occasionally affected in that HDL, HDL2, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is usually no effect on total cholesterol, HDL 3 , LDL, or VLDL.
4. Drug Interactions
The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin. No significant interaction has been found with broad-spectrum antibiotics.
5. Interactions with Laboratory Tests
The following endocrine tests may be affected by progestin-only oral contraceptive use:
7. Pregnancy
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.
No adverse effects have been found on breastfeeding performance or on the health, growth or development of the infant. Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma of 1-6% of the levels of maternal plasma.
9. Pediatric Use
Safety and efficacy of ORTHO MICRONOR Tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
10. Fertility Following Discontinuation
The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.
11. Headache
The onset or exacerbation of migraine or development of severe headache with focal neurological symptoms which is recurrent or persistent requires discontinuation of progestin-only contraceptives and evaluation of the cause.
The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives:
Adverse reactions reported with the use of POPs include:
There have been no reports of serious ill effects from overdosage, including ingestion by children.
To achieve maximum contraceptive effectiveness, ORTHO MICRONOR must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See Detailed Patient Labeling for detailed instruction.
ORTHO MICRONOR Tablets are available in a DIALPAK® Tablet Dispenser
(NDC 0062-1411-16) containing 28 green tablets (0.35 mg norethindrone).
STORAGE: Store at 25°C (77°F); excursions permitted to 15°-30°C (59-86°F).
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McCann M, and Potter L. Progestin-Only Oral Contraceptives: A Comprehensive Review. Contraception, 50:60 (Suppl. 1), December 1994.
ORTHO MICRONOR® (norethindrone) Tablets
This product (like all oral contraceptives) is used to prevent pregnancy. It does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
ORTHO MICRONOR® 28 Day Regimen
Each tablet contains 0.35 mg norethindrone. Inactive ingredients include D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, povidone and starch.
This leaflet is about birth control pills that contain one hormone, a progestin. Please read this leaflet before you begin to take your pills. It is meant to be used along with talking with your doctor or clinic.
Progestin-only pills are often called "POPs" or "the minipill." POPs have less progestin than the combined birth control pill (or "the pill") which contains both an estrogen and a progestin.
About 1 in 200 POP users will get pregnant in the first year if they all take POPs perfectly (that is, on time, every day). About 1 in 20 "typical" POP users (including women who are late taking pills or miss pills) gets pregnant in the first year of use. Table 2 will help you compare the efficacy of different methods.
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POPs can prevent pregnancy in different ways including:
Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.
WARNING: If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your doctor or clinic immediately.
An ectopic pregnancy is a pregnancy outside the womb. Because POPs protect against pregnancy, the chance of having a pregnancy outside the womb is very low. If you do get pregnant while taking POPs, you have a slightly higher chance that the pregnancy will be ectopic than do users of some other birth control methods.
These cysts are small sacs of fluid in the ovary. They are more common among POP users than among users of most other birth control methods. They usually disappear without treatment and rarely cause problems.
Some studies in women who use combined oral contraceptives that contain both estrogen and a progestin have reported an increase in the risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. There is insufficient data to determine whether the use of POPs similarly increases this risk.
A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years. This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use.
Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives and there is insufficient data to determine whether the use of POPs increases the risk of developing cancer of the cervix.
In rare cases, combined oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer among women who use combined oral contraceptives. However, liver cancers are rare. There is insufficient data to determine whether POPs increase the risk of liver tumors.
Diabetic women taking POPs do not generally require changes in the amount of insulin they are taking. However, your physician may monitor you more closely under these conditions.
WARNING: POPs do not protect against getting or giving someone HIV (AIDS) or any other STD, such as chlamydia, gonorrhea, genital warts or herpes.
The most common side effect of POPs is a change in menstrual bleeding. Your periods may be either early or late, and you may have some spotting between periods. Taking pills late or missing pills can result in some spotting or bleeding.
Less common side effects include headaches, tender breasts, nausea and dizziness. Weight gain, acne and extra hair on your face and body have been reported, but are rare.
If you are concerned about any of these side effects, check with your doctor or clinic.
Before taking a POP, inform your health care provider of any other medication, including over-the-counter medicine, that you may be taking.
These medicines can make POPs less effective:
Medicines for seizures such as:
Medicine for TB:
Before you begin taking any new medicines be sure your doctor or clinic knows you are taking a progestin-only birth control pill.
HOW TO TAKE POPs
IMPORTANT POINTS TO REMEMBER
STARTING POPs
IF YOU ARE LATE OR MISS TAKING YOUR POPs
IF YOU ARE BREASTFEEDING
IF YOU ARE SWITCHING PILLS
If you think you are pregnant, contact your physician. Even though research has shown that POPs do not cause harm to the unborn baby, it is always best not to take any drugs or medicines that you don't need when you are pregnant.
You should get a pregnancy test:
If you want to become pregnant, simply stop taking POPs. POPs will not delay your ability to get pregnant.
If you are breastfeeding, POPs will not affect the quality or amount of your breastmilk or the health of your nursing baby.
No serious problems have been reported when many pills were taken by accident, even by a small child, so there is usually no reason to treat an overdose.
If you have any questions or concerns, check with your doctor or clinic. You can also ask for the more detailed "Professional Labeling" written for doctors and other health care providers.
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
ORTHO-McNEIL
PHARMACEUTICAL, INC.
Raritan, New Jersey 08869
©OMP 1998 REVISED JANUARY 2002 635-50-894-2