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General MedicationsOralBlack Box

Kaitlib Fe

NORETHINDRONE AND ETHINYL ESTRADIOL

Standard Dose
2 DOSAGE AND ADMINISTRATION Chew one tablet without water at the same time every day. ( 2.1 ) Take tablets in the order directed on the blister pack. ( 2.1 ) 2.1 How to Take Kaitlib Fe To achieve maximum contraceptive effectiveness, Kaitlib Fe must be taken exactly as directed. Chew and swallow one tablet without water at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. Kaitlib Fe may be administered without regard to meals [see CLINICAL PHARMACOLOGY ( 12.3 )]. 2.2 How to Start Kaitlib Fe Instruct the patient to begin taking Kaitlib Fe on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). One light green tablet should be taken daily for 24 consecutive days followed by one brown tablet daily for 4 consecutive days . Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Kaitlib Fe other than on the first day of her menstrual cycle. For postpartum women who do not breastfeed or after a second trimester abortion, Kaitlib Fe may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When combined oral contraceptives (COCs) are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. The possibility of ovulation and conception before starting COCs should also be considered. If the patient is switching from a combination hormonal method such as: o Another pill o Vaginal ring o Patch Instruct her to take the first light green pill on the day she would have started a new cycle of her previous birth control pack (Day 1). If she previously used a vaginal ring or transdermal patch, she should start using Kaitlib Fe on the day she would have restarted the ring or patch. Instruct the patient to use a non-hormonal back-up method such as a condom and spermicide for the first 7 days. If the patient is switching from a progestin-only method such as: o Progestin-only pill o Implant o Intrauterine system o Injection Instruct her to take the first light green pill on the day she would have taken her next progestin-only pill or on the day of removal of her implant or intrauterine system or on the day when she would have had her next injection. Instruct the patient to use a non-hormonal back-up method such as a condom and spermicide for the first 7 days. 2.3 Missed Doses Table 1. Instructions for Missed Kaitlib Fe Tablets If one light green 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. Additional nonhormonal contraception (such as condoms) is not needed. If two light green tablets in a row are missed in Week 1 or Week 2 of the tablet pack 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) until hormonal tablets have been taken for 7 days after missing tablets. If two light green tablets in a row are missed in Week 3 or Week 4 of the tablet pack Throw away the remainder of the tablet pack. Start a new tablet pack the same day. Use additional nonhormonal contraception (such as condoms) until hormonal tablets have been taken for 7 days after missing tablets. If three or more light green 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) until hormonal tablets have been taken for 7 days after missing tablets. If any of the four brown tablets are missed Throw away the missed tablets. Continue taking the remaining tablets until the pack is finished. Additional nonhormonal contraception (such as condoms) is not needed. 2.4 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 to 4 hours after taking a light green tablet, this can be regarded as a missed tablet. [see DOSAGE and ADMINISTRATION ( 2.3 ).]
Max Dose
See official label
Primary Use
1 INDICATIONS AND USAGE Kaitlib Fe is a combination of norethindrone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
Summary

Indications and usage 1 INDICATIONS AND USAGE Kaitlib Fe is a combination of norethindrone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) The efficacy in females of reproductive potential with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. ( 1 , 8.8 ) Kaitlib™ Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is indicated for use by women to prevent pregnancy.

The efficacy of Kaitlib Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Kaitlib Fe is a combination of norethindrone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) The efficacy in females of reproductive potential with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. ( 1 , 8.8 ) Kaitlib™ Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is indicated for use by women to prevent pregnancy. The efficacy of Kaitlib Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated. Dosage and administration 2 DOSAGE AND ADMINISTRATION Chew one tablet without water at the same time every day. ( 2.1 ) Take tablets in the order directed on the blister pack. ( 2.1 ) 2.1 How to Take Kaitlib Fe To achieve maximum contraceptive effectiveness, Kaitlib Fe must be taken exactly as directed. Chew and swallow one tablet without water at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. Kaitlib Fe may be administered without regard to meals [see CLINICAL PHARMACOLOGY ( 12.3 )]. 2.2 How to Start Kaitlib Fe Instruct the patient to begin taking Kaitlib Fe on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). One light green tablet should be taken daily for 24 consecutive days followed by one brown tablet daily for 4 consecutive days . Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Kaitlib Fe other than on the first day of her menstrual cycle. For postpartum women who do not breastfeed or after a second trimester abortion, Kaitlib Fe may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When combined oral contraceptives (COCs) are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. The possibility of ovulation and conception before starting COCs should also be considered. If the patient is switching from a combination hormonal method such as: o Another pill o Vaginal ring o Patch Instruct her to take the first light green pill on the day she would have started a new cycle of her previous birth control pack (Day 1). If she previously used a vaginal ring or transdermal patch, she should start using Kaitlib Fe on the day she would have restarted the ring or patch. Instruct the patient to use a non-hormonal back-up method such as a condom and spermicide for the first 7 days. If the patient is switching from a progestin-only method such as: o Progestin-only pill o Implant o Intrauterine system o Injection Instruct her to take the first light green pill on the day she would have taken her next progestin-only pill or on the day of removal of her implant or intrauterine system or on the day when she would have had her next injection. Instruct the patient to use a non-hormonal back-up method such as a condom and spermicide for the first 7 days. 2.3 Missed Doses Table 1. Instructions for Missed Kaitlib Fe Tablets If one light green 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. Additional nonhormonal contraception (such as condoms) is not needed. If two light green tablets in a row are missed in Week 1 or Week 2 of the tablet pack 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) until hormonal tablets have been taken for 7 days after missing tablets. If two light green tablets in a row are missed in Week 3 or Week 4 of the tablet pack Throw away the remainder of the tablet pack. Start a new tablet pack the same day. Use additional nonhormonal contraception (such as condoms) until hormonal tablets have been taken for 7 days after missing tablets. If three or more light green 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) until hormonal tablets have been taken for 7 days after missing tablets. If any of the four brown tablets are missed Throw away the missed tablets. Continue taking the remaining tablets until the pack is finished. Additional nonhormonal contraception (such as condoms) is not needed. 2.4 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 to 4 hours after taking a light green tablet, this

Boxed Warning

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Women over 35 years old who smoke should not use Kaitlib Fe. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 ) WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (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 should not be used by 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 Kaitlib Fe if a thrombotic 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.( 5.1 ) Liver disease: Discontinue if jaundice occurs.
  • • ( 5.3 ) High blood pressure: Do not prescribe for women with uncontrolled hypertension or hypertension with vascular disease.

Interaction Notes

  • • 7 DRUG INTERACTIONS Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding.
  • • Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs.
  • • ( 7.1 ) No drug-drug interaction studies were conducted with Kaitlib Fe.
  • • 7.1 Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception.