Oral contraceptive products such as Ovral or Ovral®-28, which contain 50 mcg of estrogen, should not be used unless medically indicated.

Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

TABLE I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
% of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use
Method	Lowest Expected *	Typical **
(No Contraception)	(85)	(85)
Oral contraceptives		3
combined	0.1	N/A ***
progestin only	0.5	N/A ***
Diaphragm with spermicidal cream or jelly	6	18
Spermicides alone (foams and vaginal suppositories)	3	21
Vaginal Sponge
nulliparous	6	18
multiparous	9	28
DEPO-PROVERA®
(injectable progestogen)	0.3	0.3
NORPLANT® SYSTEM (implants)	0.2 #	0.2 #
IUD		3
progesterone	2	N/A ***
copper T 380A	0.8	N/A ***
Condom without spermicides	2	12
Periodic abstinence (all methods)	1-9	20
Female sterilization	0.2	0.4
Male sterilization	0.1	0.15
Adapted from J. Trussell et al., Table 1, Studies in Family Planning, 21(1) : Jan.-Feb. 1990.
* The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop use for any other reason.
** This term represents "typical" couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
*** N/A--Data not available
# This data is based on NORPLANT® SYSTEM clinical trials.

CONTRAINDICATIONS

PRECAUTIONS

ADVERSE REACTIONS

OVERDOSAGE

NONCONTRACEPTIVE HEALTH BENEFITS

DOSAGE AND ADMINISTRATION

The dosage of Ovral is one tablet daily for 21 consecutive days per menstrual cycle according to prescribed schedule. Tablets are then discontinued for 7 days (three weeks on, one week off).

It is recommended that Ovral tablets be taken at the same time each day, preferably after the evening meal or at bedtime.

During the first cycle of medication, the patient is instructed to take one Ovral tablet daily for twenty-one consecutive days, beginning on the first day (Day 1 Start) of her menstrual cycle or on the Sunday after her period begins (Sunday Start). (The first day of menstruation is day one.) The tablets are then discontinued for one week (7 days). Withdrawal bleeding should usually occur within 3 days following discontinuation of Ovral. (For Day 1 Start: If Ovral is first taken later than the first day of the first menstrual cycle of medication or postpartum, contraceptive reliance should not be placed on Ovral until after the first seven consecutive days of administration. For Sunday Start: Contraceptive reliance should not be placed on Ovral until after the first seven consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered.) The patient begins her next and all subsequent 21-day courses of Ovral tablets on the same day of the week that she began her first course, following the same schedule: 21 days on--7 days off. She begins taking her tablets on the 8th day after discontinuance, regardless of whether or not a menstrual period has occurred or is still in progress. Any time a new cycle of Ovral is started later than the 8th day, the patient should be protected by another means of contraception until she has taken a tablet daily for seven consecutive days.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. Although the occurrence of pregnancy is highly unlikely if Ovral is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING for LO/OVRAL.

Any time the patient misses two or more tablets, she should also use another method of contraception until she has taken a tablet daily for seven consecutive days. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. While there is little likelihood of ovulation occurring if only one or two tablets are missed, the possibility of ovulation increases with each successive day that scheduled tablets are missed.

In the nonlactating mother, Ovral may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see " Contraindications ," " ," and "Precautions " concerning thromboembolic disease). It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.

HOW SUPPLIED

Ovral® Tablets (0.5 mg norgestrel and 0.05 mg ethinyl estradiol) are available in packages of 6 PILPAK® dispensers with 21 tablets each as follows:

PRODUCT PHOTO(S):

References available upon request.

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

You should not use Ovral or Ovral-28, which contain higher doses of estrogen than other oral contraceptives, unless specifically recommended by your health-care provider. Any woman who considers using oral contraceptives (the birth-control pill or the pill) should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your health-care provider. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your revisits. You should also follow your health-care provider's advice with regard to regular check-ups while you are on the pill.

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.