To achieve maximum contraceptive effectiveness, Triphasil®-21 Tablets (levonorgestrel and ethinyl estradiol tablets—triphasic regimen) must be taken exactly as directed and at intervals not exceeding 24 hours.

Triphasil-21 Tablets are a three-phase preparation. The dosage of Triphasil-21 Tablets is one tablet daily for 21 consecutive days per menstrual cycle in the following order: 6 brown tablets (phase 1), followed by 5 white tablets (phase 2), and then followed by the last 10 light-yellow tablets (phase 3), according to the prescribed schedule. Tablets are then discontinued for 7 days (three weeks on, one week off). It is recommended that Triphasil-21 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 Triphasil-21 Tablet daily in the order of 6 brown, 5 white and, finally, 10 light-yellow tablets, for twenty-one (21) consecutive days, beginning on day one (1) of her menstrual cycle. (The first day of menstruation is day one.) The tablets are then discontinued for one week (7 days). Withdrawal bleeding usually occurs within 3 days following discontinuation of Triphasil-21 Tablets and may not have finished before the next pack is started. (If Triphasil-21 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 Triphasil-21 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, Triphasil-21 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 Triphasil-21 the next day. If switching from an implant or injection, the patient should start Triphasil-21 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 nonhormonal back-up method of birth control for the first 7 days of tablet-taking.

The patient begins her next and all subsequent 21-day courses of Triphasil-21 Tablets on the same day of the week that she began her first course, following the same schedule: 21 days on — 7 days off. She begins taking her brown tablets on the 8th day after discontinuance, regardless of whether or not a menstrual period has occurred or is still in progress. Any time a subsequent cycle of Triphasil-21 Tablets is started later than the 8th 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 Triphasil®-21 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 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 tablets, it will usually be transient and of no consequence.

Triphasil-21 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 Triphasil-21 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.