21 white Ovral tablets, each containing 0.5 mg of norgestrel ( dl -13-beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.05 mg of ethinyl estradiol (19-nor-17(alpha)-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and 7 pink inert tablets. The inactive ingredients present are cellulose, D&C Red 30, lactose, magnesium stearate, and polacrilin potassium.
See LO/OVRAL®.
See OVRAL®.
See LO/OVRAL.
See OVRAL.
See LO/OVRAL.
Drug Interactions: See LO/OVRAL.
Carcinogenesis: See LO/OVRAL.
Pregnancy: See LO/OVRAL.
Nursing Mothers: See LO/OVRAL.
Information for the Patient: See LO/OVRAL.
See LO/OVRAL.
See LO/OVRAL.
See LO/OVRAL
To achieve maximum contraceptive effectiveness, Ovral-28 must be taken exactly as directed and at intervals not exceeding 24 hours.
The dosage of Ovral-28 is one white tablet daily for 21 consecutive days, followed by one pink inert tablet daily for 7 consecutive days, according to prescribed schedule.
It is recommended that Ovral-28 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 begin taking Ovral-28 on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days followed by one pink inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets. During the first cycle, contraceptive reliance should not be placed on Ovral-28 until a white tablet has been taken daily for 7 consecutive days. The possibility of ovulation and conception prior to initiation of medication should be considered.
The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days on white tablets--7 days on pink inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself by using another method of birth control until she has taken a white tablet daily for 7 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-28 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 white tablets, she should also use another method of contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more pink tablets, she is still protected against pregnancy provided she begins taking white tablets again on the proper day.
If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. While there is little likelihood of ovulation occurring if only one or two white tablets are missed, the possibility of ovulation increases with each successive day that scheduled white tablets are missed.
In the nonlactating mother, Ovral-28 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.
Ovral®-28 Tablets (0.5 mg norgestrel and 0.05 mg ethinyl estradiol) are available in packages of 6 PILPAK® dispensers, each containing 28 tablets as follows:
21 active tablets, NDC 0008-0056, white, round tablet marked "WYETH" and "56".
7 inert tablets, NDC 0008-0445, pink, round tablet marked "WYETH" and "445".
Store at room temperature, approx. 25°C (77°F).
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Brief Summary Patient Package Insert: See LO/OVRAL.
DETAILED PATIENT LABELING: See OVRAL.
Manufactured by:
Wyeth Laboratories
A Wyeth-Ayerst Company
Philadelphia, PA 19101.
CI 4258-4 March 14, 1997