Ogestrel 0.5/50 Dosage
Generic name: NORGESTREL 0.5mg, ETHINYL ESTRADIOL 0.05mg;
Dosage form: tablets
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To achieve maximum contraceptive effectiveness, Ogestrel must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered.
The dosage of Ogestrel is one white tablet daily for 21 consecutive days, followed by one peach inert tablet daily for 7 consecutive days, according to prescribed schedule.
It is recommended that Ogestrel tablets be taken at the same time each day.
During the first cycle of medication, the patient is instructed to begin taking Ogestrel 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 peach inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Ogestrel until a white tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control should be used during those 7 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 peach inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.
When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Ogestrel. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Ogestrel on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Ogestrel the next day. If switching from an implant or injection, the patient should start Ogestrel on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection, or implant, the patient should be advised to use a non-hormonal back-up method of birth control for the first 7 days of tablet taking.
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 health care professional. Although pregnancy is unlikely if Ogestrel 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. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.
For additional patient instructions regarding missed tablets, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING below.
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 peach 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. The possibility of ovulation increases with each successive day that scheduled white tablets are missed.
Ogestrel may be initiated no earlier than day 28 postpartum in the nonlactating mother due to the increased risk for thromboembolism (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered.
In the case of first-trimester abortion, if the patient starts Ogestrel immediately,additional contraceptive measures are not needed.