Drug Detail:Low-ogestrel (Ethinyl estradiol and norgestrel [ eth-in-il-ess-tra-dye-ol-and-nor-jess-trel ])
Generic Name: ETHINYL ESTRADIOL 0.03mg, NORGESTREL 0.3mg;
Dosage Form: tablets
Drug Class: Contraceptives
To achieve maximum contraceptive effectiveness, Low-Ogestrel (norgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Low-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 Low-Ogestrel tablets be taken by mouth at the same time each day.
How to Start Low-Ogestrel
Consider the possibility of ovulation and conception prior to initiation of medication.
Instruct the patient to begin taking Low-Ogestrel on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. The patient should take one white tablet daily for 21 consecutive days followed by one peach inert tablet daily for 7 consecutive days. Withdrawal bleeding will usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle, the patient should not rely on Low-Ogestrel for contraception until a white tablet has been taken daily for 7 consecutive days and she should use a non-hormonal back-up method of birth control during those 7 days.
After the first cycle of use
The patient is to begin 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 of white tablets, followed by 7 days of peach inert tablets. If in any cycle the patient starts tablets later than the proper day, instruct her to 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.
Switching from another hormonal method of contraception
- When the patient is switching from a 21-day regimen of tablets, instruct her to wait 7 days after her last tablet before she starts Low-Ogestrel. She will probably experience withdrawal bleeding during that week. Instruct her not to let more than 7 days pass after her previous 21-day regimen before she starts Low-Ogestrel.
- When the patient is switching from a 28-day regimen of tablets, instruct her to start her first pack of Low-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 Low-Ogestrel the next day. If switching from an implant or injection, instruct the patient to start Low-Ogestrel on the day of implant removal or the day the next injection would be due. If switching from a contraceptive vaginal ring or transdermal patch instruct the patient to start Low-Ogestrel on the day they would have inserted the next ring or applied the next patch. If switching from an Intrauterine Device (IUD) or Intrauterine System (IUS), instruct the patient to start Low-Ogestrel on the day of IUD/IUS removal. If the IUD/IUS is not removed on the first day of the patient's menstrual cycle, instruct her to use a non-hormonal back-up method of birth control for the first 7 days of tablet-taking.
Use after pregnancy, abortion, or miscarriage
- Initiate Low-Ogestrel no earlier than day 28 postpartum in the nonlactating mother or after a second-trimester abortion due to the increased risk for thromboembolism (see Contraindications, Warnings and Precautions concerning thromboembolic disease). Advise the patient to use a non-hormonal back-up method for the first 7 days of tablet-taking.
- Low-Ogestrel may be initiated immediately after a first-trimester abortion or miscarriage. If the patient starts Low-Ogestrel immediately, back-up contraception is not needed.
If spotting or breakthrough bleeding occurs
If spotting or breakthrough bleeding occurs, instruct the patient to continue on the same regimen. This type of bleeding is usually transient and without significance; however, advise the patient to consult her healthcare provider if the bleeding is persistent or prolonged.
Missed Tablets
The possibility of ovulation and pregnancy increases with each successive day that scheduled white tablets are missed. If withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (if she missed one or more tablets or started taking them on a day later than she should have), consider the probability of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.
For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in FDA-Approved Patient Labeling below.
Advice in Case of Gastrointestinal Disturbances
In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].
