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Basic Drug Info
Drug Name:Nora-BE
Manufacturer:Watson Pharmaceuticals, Inc.
Other Info:

McCann M, and Potter L, Progestin-Only Oral Contraceptives: A Comprehensive Review.

Contraception, 50:60 (Suppl.1), December 1994.



Clinical Trials:


Indications and Usage

1.

Indications.

Progestin-only oral contraceptives are indicated for the prevention of pregnancy.2.

Efficacy.

If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%.

However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills.

The following table lists the pregnancy rates for users of all major methods of contraception.Table 1.

Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year.

United States. % of Women Experiencing an% of Women Unintended Pregnancy within the Continuing Use First Year of Useat One Year3 MethodTypical Use1Perfect Use2 (1)(2)(3)(4) Hatcher et al, 1998, Ref.

#1. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 Source: Trussell J, Contraceptive Efficacy.

In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition.

New York, NY: Irvington Publishers, 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any reason. 2 Among couples who initiate use of a method (not necessarily for the first time), and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percentage of women becoming pregnant noted in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant.

Among such populations, about 89% become pregnant within one year.

This estimate was lowered slightly (to 85%) to represent the percentage that would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose.

The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. Chance48585 Spermicides526640 Periodic abstinence2563 Calendar9 Ovulation Method3 Sympto-Thermal62 Post-Ovulation1 Cap7 Parous Women402642 Nulliparous Women20956 Sponge Parous Women402042 Nulliparous Women20956 Diaphragm720656 Withdrawal194 Condom8 Female (Reality)21556 Male14361 Pill571 Progestin only0.5 Combined0.1 IUDs Progesterone T2.01.581 Copper T 380A0.80.678 LNg 200.10.181 Depo-Provera0.30.370 Norplant and Norplant-20.050.0588 Female Sterilization0.50.5100 Male Sterilization0.150.10100
Contraindications
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:Known or suspected pregnancyKnown or suspected carcinoma of the breastUndiagnosed abnormal genital bleedingHypersensitivity to any component of this productBenign or malignant liver tumorsAcute liver disease
Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Liver diseases -- Pathological processes of the LIVER.

Warnings

Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes.

Women who use oral contraceptives are strongly advised not to smoke.Nora-BE 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.

The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism.

The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (POP) use to an increased risk of heart attack or stroke.The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.1.

Ectopic pregnancy.

The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years.

Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine.

Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method.

Health providers should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives.2.

Delayed follicular atresia/Ovarian cysts.

If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle.

Generally these enlarged follicles disappear spontaneously.

Often they are asymptomatic; in some cases they are associated with mild abdominal pain.

Rarely they may twist or rupture, requiring surgical intervention.3.

Irregular genital bleeding.

Irregular menstrual patterns are common among women using progestin-only oral contraceptives.

If genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out.

If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated.4.

Carcinoma of the breast and reproductive organs.

Some epidemiologic studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use.

These studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of POPs similarly increase the risk.

Women with breast cancer should not use oral contraceptives because the role of female hormone in breast cancer has not been fully determined.Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women.

However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.

There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.5.

Hepatic neoplasia.

Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States.

Rupture of benign, hepatic adenomas may cause death through intraabdominal hemorrhage.Studies from Britain and the U.S.

have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users.

However, these cancers are rare.

There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.

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