Generic name: LEVONORGESTREL 0.05mg, ETHINYL ESTRADIOL 0.03mg; LEVONORGESTREL 0.075mg, ETHINYL ESTRADIOL 0.04mg; LEVONORGESTREL 0.125mg, ETHINYL ESTRADIOL 0.03mg;
Dosage form: tablets
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To achieve maximum contraceptive effectiveness, Myzilra® Tablets—triphasic regimen must be taken exactly as directed and at intervals not exceeding 24 hours.
Myzilra® Tablets are a three-phase preparation plus 7 inert tablets. The dosage of Myzilra® Tablets is one tablet daily for 28 consecutive days per menstrual cycle in the following order: 6 beige tablets (phase 1), followed by 5 white tablets (phase 2), followed by 10 light-yellow tablets (phase 3), plus 7 light-green inert tablets, according to the prescribed schedule.
It is recommended that Myzilra® 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 Myzilra® Tablet daily in the order of 6 beige, 5 white, 10 light-yellow 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 light-yellow tablet. (If Myzilra® 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 Myzilra® Tablets until after the first 7 consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered.)
When switching from another oral contraceptive, Myzilra® Tablets should be started on the first day of bleeding following the last active tablet taken of the previous oral contraceptive.
The patient begins her next and all subsequent 28 day courses of Myzilra® Tablets on the same day of the week that she began her first course, following the same schedule. She begins taking her beige 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 Myzilra® 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 Myzilra® 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 (beige, white, or light-yellow) 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 beige tablets again on the proper day.
In the nonlactating mother, Myzilra® Tablets 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, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). It is to be noted that early resumption of ovulation may occur if bromocriptine mesylate has been used for the prevention of lactation.