General MedicationsOralBlack Box

Charlotte 24Fe

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Standard Dose

2 DOSAGE AND ADMINISTRATION • One tablet daily chewed and swallowed or swallowed whole taken at the same time of day. Follow with 8 ounces of water ( 2.1 ) • Take one tablet by mouth at the same time every day for 28 days (2.1 ) • Take tablets in the order directed on the blister pack (2.1 ) • Tablets may be administered without regard to meals ( 12.3 ) 2.1 How to Take Charlotte 24 Fe To achieve maximum contraceptive effectiveness, Charlotte 24 Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The tablet may be chewed and swallowed or swallowed whole. The patient should drink a full glass (8 ounces) of water immediately after the white to off-white tablets are chewed or swallowed whole. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets. Charlotte 24 Fe may be administered without regard to meals [see Clinical Pharmacology ( 12.3 )]. 2.2 How to Start Charlotte 24 Fe Instruct the patient to begin taking Charlotte 24 Fe either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start). Day 1 Start During the first cycle of Charlotte 24 Fe use, instruct the patient to take one white to off-white Charlotte 24 Fe tablet daily, beginning on Day one (1) of her menstrual cycle (the first day of menstruation is Day one). She should take one white to off-white Charlotte 24 Fe tablet daily for 24 consecutive days, followed by one brown to dark brown tablet daily on days 25 through 28. Charlotte 24 Fe should be taken in the order directed on the package at the same time each day. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Charlotte 24 Fe on a day other than the first day of her menstrual cycle. The possibility of ovulation and conception prior to initiation of medication should be considered. Sunday Start During the first cycle of Charlotte 24 Fe use, instruct the patient to take one white to off-white Charlotte 24 Fe tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one white to off-white Charlotte 24 Fe tablet daily for 24 consecutive days, followed by one brown to dark brown tablet daily on days 25 through 28. Charlotte 24 Fe should be taken in the order directed on the package at the same time each day. Charlotte 24 Fe should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should begin her next and all subsequent 28-day regimens of Charlotte 24 Fe on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her white to off-white Charlotte 24 Fe tablets on the next day after ingestion of the last brown to dark brown tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Charlotte 24 Fe is started later than the day following administration of the last brown to dark brown tablet, the patient should use another method of contraception until she has taken a white to off-white Charlotte 24 Fe tablet daily for 7 consecutive days. For postpartum women who do not breastfeed or after a second trimester abortion, start Charlotte 24 Fe no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Charlotte 24 Fe postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Charlotte 24 Fe for 7 consecutive days. Charlotte 24 Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Charlotte 24 Fe immediately, additional contraceptive measures are not needed. Switching from another Hormonal Method of Contraception If the patient is switching from a combination hormonal method such as: • Another pill • Vaginal ring • Patch • Instruct her to take the first white to off-white Charlotte 24 Fe tablet on the day she would have taken her next COC pill. She should not continue taking the tablets from her previous birth control pack, and should not skip any days between packs. If she does not have a withdrawal bleed, rule out pregnancy before starting Charlotte 24 Fe. • If she previously used a vaginal ring or transdermal patch, she should start using Charlotte 24 Fe on the day she would have resumed the previous product. If the patient is switching from a progestin-only method such as a: • Progestin-only pill • Implant • Intrauterine system • Injection • She may switch any day from a progestin-only pill; instruct her to take the first white to off-white Charlotte 24 Fe tablet on the day she would have taken her next progestin-only pill. She should use a non-hormonal method of contraception for 7 consecutive days. • If switching from an implant or injection, start the first white to off-white Charlotte 24 Fe tablet on the day her next injection would have been due or on the day of removal of her implant. • If switching from an IUD, depending on the timing of removal, back-up contraception may be needed. 2.3 Missed Doses Table 1. Instructions for Missed Charlotte 24 Fe Tablets If one white to off-white 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 white to off-white 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 white to off-white tablets are missed in Week 3 or Week 4 of the tablet pack Day 1 Starter: Throw out the rest of the tablet pack and start a new pack that same day. Sunday Starter: Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that 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 white to off-white tablets in a row are missed Day 1 Starter: Throw out the rest of the tablet pack and start a new pack that same day. Sunday Starter: Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day. 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 to dark 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 If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a white to off-white Charlotte 24 Fe tablet), she should follow the instructions in the “What to Do if You Miss Tablets” section [see 2.3 Missed Doses ] .

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE Charlotte 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies ( 14 )] .

Summary

Indications and usage 1 INDICATIONS AND USAGE Charlotte 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies ( 14 )] .

The efficacy of Charlotte 24 Fe in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. • Charlotte 24 Fe is a combination of norethindrone acetate, 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 of more than 35 kg/m 2 has not been evaluated ( 1 , 8.8 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION • One tablet daily chewed and swallowed or swallowed whole taken at the same time of day.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Charlotte 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies ( 14 )] . The efficacy of Charlotte 24 Fe in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. • Charlotte 24 Fe is a combination of norethindrone acetate, 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 of more than 35 kg/m 2 has not been evaluated ( 1 , 8.8 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION • One tablet daily chewed and swallowed or swallowed whole taken at the same time of day. Follow with 8 ounces of water ( 2.1 ) • Take one tablet by mouth at the same time every day for 28 days (2.1 ) • Take tablets in the order directed on the blister pack (2.1 ) • Tablets may be administered without regard to meals ( 12.3 ) 2.1 How to Take Charlotte 24 Fe To achieve maximum contraceptive effectiveness, Charlotte 24 Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The tablet may be chewed and swallowed or swallowed whole. The patient should drink a full glass (8 ounces) of water immediately after the white to off-white tablets are chewed or swallowed whole. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets. Charlotte 24 Fe may be administered without regard to meals [see Clinical Pharmacology ( 12.3 )]. 2.2 How to Start Charlotte 24 Fe Instruct the patient to begin taking Charlotte 24 Fe either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start). Day 1 Start During the first cycle of Charlotte 24 Fe use, instruct the patient to take one white to off-white Charlotte 24 Fe tablet daily, beginning on Day one (1) of her menstrual cycle (the first day of menstruation is Day one). She should take one white to off-white Charlotte 24 Fe tablet daily for 24 consecutive days, followed by one brown to dark brown tablet daily on days 25 through 28. Charlotte 24 Fe should be taken in the order directed on the package at the same time each day. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Charlotte 24 Fe on a day other than the first day of her menstrual cycle. The possibility of ovulation and conception prior to initiation of medication should be considered. Sunday Start During the first cycle of Charlotte 24 Fe use, instruct the patient to take one white to off-white Charlotte 24 Fe tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one white to off-white Charlotte 24 Fe tablet daily for 24 consecutive days, followed by one brown to dark brown tablet daily on days 25 through 28. Charlotte 24 Fe should be taken in the order directed on the package at the same time each day. Charlotte 24 Fe should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should begin her next and all subsequent 28-day regimens of Charlotte 24 Fe on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her white to off-white Charlotte 24 Fe tablets on the next day after ingestion of the last brown to dark brown tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Charlotte 24 Fe is started later than the day following administration of the last brown to dark brown tablet, the patient should use another method of contraception until she has taken a white to off-white Charlotte 24 Fe tablet daily for 7 consecutive days. For postpartum women who do not breastfeed or after a second trimester abortion, start Charlotte 24 Fe no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Charlotte 24 Fe postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Charlotte 24 Fe for 7 consecutive days. Charlotte 24 Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Charlotte 24 Fe immediately, additional contraceptive measures are not needed. Switching from another Hormonal Method of Contraception If the patient is switching from a combination hormonal method such as: • Another pill • Vaginal ring • Patch • Instruct her to take the first

Boxed Warning

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 & Precautions ( 5.1 )]. 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 Charlotte 24 Fe ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use (4)

Monitoring

• 5 WARNINGS AND PRECAUTIONS • Vascular risks: Stop norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets if a thrombotic event occurs.
• Stop at least 4 weeks before 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 ( 5.2 ) • High blood pressure: Do not prescribe for women with uncontrolled hypertension or hypertension with vascular disease ( 5.4 ) • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets.
• Consider an alternative contraceptive method for women with uncontrolled dyslipidemia (5.6) • Headache: Evaluate significant change in headaches and discontinue if indicated (5.7) • Uterine bleeding: Evaluate irregular bleeding or amenorrhea (5.8) 5.1 Thromboembolic Disorders and Other Vascular Problems Stop norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets if an arterial or deep venous thrombotic event (VTE) occurs.

Interaction Notes

• 7 DRUG INTERACTIONS Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations.
• No drug-drug interaction studies were conducted with norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets.
• • 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 ) 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding.