Generic name: LEVONORGESTREL 0.050mg, ETHINYL ESTRADIOL 0.030mg; LEVONORGESTREL 0.075mg, ETHINYL ESTRADIOL 0.040mg; LEVONORGESTREL 0.125mg, ETHINYL ESTRADIOL 0.030mg;
Dosage form: tablets
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To achieve maximum contraceptive effectiveness, Enpresse Tablets (levonorgestrel and ethinyl estradiol tablets USP—triphasic regimen) must be taken exactly as directed and at intervals not exceeding 24 hours.
Enpresse Tablets are a three-phase preparation plus 7 inert tablets. The dosage of Enpresse Tablets is one tablet daily for 28 consecutive days per menstrual cycle in the following order: 6 pink tablets (phase 1), followed by 5 white tablets (phase 2), followed by 10 orange tablets (phase 3), plus 7 light-green inert tablets, according to the prescribed schedule.
It is recommended that Enpresse 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 should be instructed to take one Enpresse Tablet daily in the order of 6 pink, 5 white, 10 orange tablets, and then 7 light-green inert tablets for twenty-eight (28) consecutive days, beginning on day one (1) of her menstrual cycle. (The first day of menstruation is day one.) Withdrawal bleeding usually occurs within 3 days following the last orange tablet and may not have finished before the next pack is started. (If Enpresse Tablets are first taken later than the first day of the first menstrual cycle of medication or postpartum, contraceptive reliance should not be placed on Enpresse Tablets until after the first 7 consecutive days of administration and a nonhormonal 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.)
When switching from another oral contraceptive, Enpresse Tablets should be started on the first day of bleeding following the last active tablet taken of the previous oral contraceptive.
The patient may switch any day from a progestin-only pill and should begin Enpresse the next day. If switching from an implant or injection, the patient should start Enpresse 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.
The patient begins her next and all subsequent 28-day courses of Enpresse Tablets on the same day of the week that she began her first course, following the same schedule. She begins taking her pink tablets on the next day after ingestion of the last light-green tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Any time a subsequent cycle of Enpresse Tablets is started later than the next 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 Enpresse Tablets are 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.
The risk of pregnancy increases with each active (pink, white, or orange) tablet missed. For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING below. If breakthrough bleeding occurs following missed active tablets, it will usually be transient and of no consequence. If the patient misses one or more light-green tablets, she is still protected against pregnancy provided she begins taking pink tablets again on the proper day.
Enpresse Tablets may be initiated no earlier than day 28 postpartum in the non-lactating mother or after a second trimester abortion due to the increased risk for thromboembolism (see “CONTRAINDICATIONS”,“WARNINGS” and “PRECAUTIONS” concerning thromboembolic disease). The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period. In the case of first-trimester abortion, if the patient starts Enpresse immediately, additional contraceptive measures are not needed. It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.