Generic Name: LEVONORGESTREL 0.15mg, ETHINYL ESTRADIOL 0.02mg; LEVONORGESTREL 0.15mg, ETHINYL ESTRADIOL 0.025mg; LEVONORGESTREL 0.15mg, ETHINYL ESTRADIOL 0.03mg; ETHINYL ESTRADIOL 0.01mg
Dosage Form: tablets
Drug Class: Contraceptives
How to Start and Take QUARTETTE
Begin QUARTETTE on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first light pink tablet that day.
For each 91-day course, take in the following order:
- Start the first light pink tablet on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Then take one light pink tablet once daily for a total of 42 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms and spermicide) for the first 7 days of treatment.
- One pink tablet once daily for 21 consecutive days.
- One purple tablet once daily for 21 days.
- One yellow tablet once daily for 7 days. Bleeding should occur during yellow tablet use.
Begin the next and all subsequent 91-day courses of QUARTETTE without interruption on the same day of the week (Sunday) on which the first dose of QUARTETTE was taken. Follow the same schedule as the initial 91-day course: light pink tablet once daily for 42 days, pink tablet once daily for 21 days, purple tablet once daily for 21 days, and yellow tablet once daily for 7 days. If the next pill pack is not started immediately, use a non-hormonal back-up method of contraception until a light pink tablet has been taken once daily for 7 consecutive days.
Switching to QUARTETTE from another oral hormonal contraceptive or from another contraceptive method (transdermal patch, vaginal ring, injection, intrauterine contraceptive, implant)
Start on the Sunday after the patient’s next period starts. Use additional non-hormonal contraceptive (such as condoms and spermicide) until the patient has taken 7 light pink pills (7 days).
Starting QUARTETTE after Abortion or Miscarriage
First-trimester
QUARTETTE may be started on the Sunday after an abortion or miscarriage. The patient must use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a light pink tablet for 7 days.
Second-trimester
Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start contraceptive therapy with QUARTETTE following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a light pink tablet for 7 days [see Contraindications (4) and Warnings and Precautions (5.1)].
Starting QUARTETTE after Childbirth
Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with QUARTETTE following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a light pink tablet for 7 days [see Contraindications (4) and Warnings and Precautions (5.1)].
QUARTETTE is not recommended for use in lactating women [see Use in Specific Populations (8.2)].
If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of QUARTETTE [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)].
Dosing QUARTETTE
Take one tablet by mouth at the same time every day. The dosage of QUARTETTE is one light pink tablet once daily for 42 days, one pink tablet once daily for 21 days, one purple tablet once daily for 21 days, and one yellow tablet once daily for 7 days.
To achieve maximum contraceptive effectiveness, take QUARTETTE exactly as directed, in the order directed, and at intervals not exceeding 24 hours. The failure rate may increase when pills are missed or taken incorrectly.
Missed Doses
Table 1. Instructions for Missed QUARTETTE Tablets
|
If one light pink, pink or purple tablet is missed |
Take the missed tablet as soon as possible. Take the next tablet at the regular time. Continue taking one tablet a day until the pack is finished. A back-up birth control method is not required if the patient has sex. |
|
If two light pink, pink or purple tablets in a row are missed |
Take the two missed tablets as soon as possible, and the next two tablets the next day. Continue taking one tablet a day until the pack is finished. Use additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets. |
|
If three or more light pink, pink or purple tablets in a row are missed |
Throw away the missed tablets. Continue taking one tablet every day as indicated on the pack until the pack is finished. Bleeding may occur during the week following the missed tablets. Use additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets. |
|
If any of the seven yellow tablets are missed |
Throw away the missed tablets. Continue taking the remaining tablets until the pack is finished. A backup birth control method is not needed. |
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 3-4 hours after taking a light pink, pink or purple tablet, handle this as a missed tablet [see Dosage and Administration (2.3)].
