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Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol

LEVONORGESTREL AND ETHINYL ESTRADIOL

Standard Dose
2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack. ( 2 ) 2.1 How to Start and Take levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets Begin levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first orange tablet that day. For each 91-day course, take in the following order: Take one orange tablet daily for 84 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms or spermicide) until an orange tablet has been taken daily for 7 consecutive days. Then take one mustard tablet for 7 consecutive days. A scheduled period should occur during the 7 days that the mustard tablets are taken. Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, following the same schedule: 84 days taking an orange tablet followed by 7 days taking a mustard tablet. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken an orange tablet daily for 7 consecutive days. Switching to levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 an orange tablet for 7 consecutive days. Starting levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets after Abortion or Miscarriage First-trimester Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 an orange tablet for 7 consecutive 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 levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 an orange tablet for 7 consecutive days [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ]. Starting levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 an orange tablet for 7 consecutive days [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablet [ see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 ) ]. 2.2 Dosing levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets Take one tablet by mouth at the same time every day. The dosage of levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets is one orange tablet daily for 84 consecutive days, followed by one mustard tablet daily for 7 days. To achieve maximum contraceptive effectiveness, levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets must be taken 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. 2.3 Missed Doses Table 1. Instructions for Missed levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol Tablets If one orange 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 orange 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 orange tablets in a row are missed Throw away the missed pills. 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. Additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets. If any of the seven mustard 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. 2.4 Advice in Case of Gastrointestinal Disturbances In case of prolonged vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken.
Max Dose
See official label
Primary Use
1 INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.( 1 ) Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive potential to prevent pregnancy.
Summary

Indications and usage 1 INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.( 1 ) Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive potential to prevent pregnancy.

Dosage and administration 2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack. ( 2 ) 2.1 How to Start and Take levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets Begin levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets on the first Sunday after the onset of menstruation.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.( 1 ) Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive potential to prevent pregnancy. Dosage and administration 2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack. ( 2 ) 2.1 How to Start and Take levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets Begin levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first orange tablet that day. For each 91-day course, take in the following order: Take one orange tablet daily for 84 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms or spermicide) until an orange tablet has been taken daily for 7 consecutive days. Then take one mustard tablet for 7 consecutive days. A scheduled period should occur during the 7 days that the mustard tablets are taken. Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, following the same schedule: 84 days taking an orange tablet followed by 7 days taking a mustard tablet. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken an orange tablet daily for 7 consecutive days. Switching to levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 an orange tablet for 7 consecutive days. Starting levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets after Abortion or Miscarriage First-trimester Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 an orange tablet for 7 consecutive 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 levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 an orange tablet for 7 consecutive days [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ]. Starting levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 an orange tablet for 7 consecutive days [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablet [ see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 ) ]. 2.2 Dosing levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets Take one tablet by mouth at the same time every day. The dosage of levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets is one orange tablet daily for 84 consecutive days, followed by one mustard tablet daily for 7 days. To achieve maximum contraceptive effectiveness, levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets must be taken 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. 2.3 Missed Doses Table 1. Instructions for Missed levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol Tablets If one orange tablet is missed Take the missed tab

Boxed Warning

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Levonorgestrel and ethinyl estradiol tablet and ethinyl estradiol tablet is contraindicated in women over 35 years old who smoke. ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, are contraindicated in women who are over 35 years of age and smoke. [ See Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ]

Monitoring

  • 5 WARNINGS AND PRECAUTIONS Vascular risks: Stop if a thrombotic or thromboembolic event occurs.
  • Stop at least 4 weeks before and through 2 weeks after major surgery.
  • Start no earlier than 4 weeks after delivery, in women who are not breastfeeding.
  • Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years.

Interaction Notes

  • 7 DRUG INTERACTIONS Enzyme inducers (e.g., CYP3A4): May decrease the effectiveness of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablet or increase breakthrough bleeding.
  • Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets.
  • ( 7.1 ) The sections below provide information on substances for which data on drug interactions with COCs are available.
  • There is little information available about the clinical effect of most drug interactions that may affect COCs.
Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol (LEVONORGESTREL AND ETHINYL ESTRADIOL) | Drug Monograph | MedicHelpline