To achieve maximum contraceptive effectiveness, Amethyst™ (levonorgestrel and ethinyl estradiol tablets) 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. Women who do not wish to become pregnant after discontinuation should be advised to immediately use another method of birth control. The dosage of Amethyst™ is one white tablet daily without any tablet-free interval.
It is recommended that Amethyst™ tablets be taken at the same time each day.
Initiation of Therapy
Instructions for beginning Amethyst™ are provided in Table 4 below.
| Table 4 |
| Current contraceptive therapy |
Amethyst™ start day |
Nonhormonal back-up method of birth control needed when correctly starting Amethyst™? |
| None |
Day 1 of patient’s menstrual cycle
(during the first 24 hours of her period) |
No |
| 21-day COC regimen OR 28-day COC regimen |
Day 1 of patient’s withdrawal bleed, at the latest 7 days after her last active tablet |
No |
| Progestin-only pill |
Day after taking a
progestin-only pill |
Yes, for the first 7 days of
Amethyst™ tablet-taking |
| Implant |
Day of implant removal |
Yes, for the first 7 days of
Amethyst™ tablet-taking |
| Injection |
Day the next injection is due |
Yes, for the first 7 days of
Amethyst™ tablet-taking |
If spotting or unscheduled 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. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. 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. Hormonal contraception must be discontinued if pregnancy is confirmed.
The risk of pregnancy increases with each tablet missed. For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below.
Amethyst™ may be initiated 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). 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 Amethyst™ immediately, additional contraceptive measures are not needed.
