General MedicationsOralBlack Box

TRI-LO-MARZIA

NORGESTIMATE AND ETHINYL ESTRADIOL

Standard Dose

2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.2 ) Take tablets in the order directed on the blister. ( 2.2 ) Do not skip or delay tablet intake. ( 2.2 ) 2.1 How to Start Tri-Lo-Marzia Tri-Lo-Marzia is dispensed in a blister [see HOW SUPPLIED/STORAGE AND HANDLING ( 16 )]. Tri-Lo-Marzia may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. 2.2 How to Take Tri-Lo-Marzia Table 1 : Instructions for Administration of Tri - Lo - Marzia Starting COCs in women not currently using hormonal contraception ( Day 1 Start or Sunday Start ) Important : Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color : ο Tri-Lo-Marzia active tablets are white to off white (Day 1 to Day 7), light blue (Day 8 to Day 15) and blue (Day 16 to Day 21) and has green inactive tablets ( Day 22 to Day 28) Day 1 Start : ο Take first active tablet without regard to meals on the first day of menses. ο Take subsequent active tablets once daily at the same time each day for a total of 21 days. ο Take one green inactive tablet daily for 7 days and at the same time of day that active tablets were taken. ο Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet) Sunday Start : ο Take first active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant , use additional non - hormonal contraception ( such as condoms and spermicide ) for the first seven days of the patient’s first cycle pack of Tri - Lo - Marzia . ο Take subsequent active tablets once daily at the same time each day for a total of 21 days. ο Take one green inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken. ο Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. Switching to Tri - Lo - Marzia from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to Tri - Lo - Marzia Start Tri - Lo - Marzia : ο Transdermal patch ο On the day when next application would have been scheduled ο Vaginal ring ο On the day when next insertion would have been scheduled ο Injection ο On the day when next injection would have been scheduled ο Intrauterine contraceptive ο On the day of removal ο If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack. ο Implant ο On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA - Approved Patient Labeling . Starting Tri-Lo-Marzia after Abortion or Miscarriage First-trimester: After a first-trimester abortion or miscarriage, Tri-Lo-Marzia may be started immediately. An additional method of contraception is not needed if Tri-Lo-Marzia is started immediately. If Tri-Lo-Marzia is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Tri-Lo-Marzia. Second-trimester: Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Tri-Lo-Marzia, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Tri-Lo-Marzia. [see CONTRAINDICATIONS ( 4 ), WARNINGS AND PRECAUTIONS ( 5.1 ), and FDA-APPROVED PATIENT LABELING.] Starting Tri-Lo-Marzia after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-Lo-Marzia following the instructions in Table 1 for women not currently using hormonal contraception. Tri-Lo-Marzia is not recommended for use in lactating women [see USE IN SPECIFIC POPULATIONS ( 8.3 )]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Tri-Lo-Marzia. [see CONTRAINDICATIONS ( 4 ), WARNINGS AND PRECAUTIONS ( 5.1 ), USE IN SPECIFIC POPULATIONS AND ( 8.1 AND 8.3 ), and FDA-APPROVED PATIENT LABELING]. Blister Pack: SET THE DAY Sunday Start: Each blister has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Day 1 Start: Six different day label strips of the week have been provided with this pack in order to accommodate a Day-1 Start regimen. Pick the day label strip that starts with the first day of your period. Place this day label strip over the area that has the days of the week (starting with Sunday) pre-printed on the blister (Refer figure below). Remove pill "1" by pushing down on the pill. The pill will come out through a hole in the back of the strip. The patient should wait 24 hours to take the next pill. Continue to take one pill each day until all the pills have been taken. When your blister is empty, you will start a new blister on the day after pill "28." The first pill in every refill will always be taken on the same day of the week, no matter when the patient's next period starts. 2.3 Missed Tablets Table 2 : Instructions for Missed Tri - Lo - Marzia Tablets Ο If one active tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. Ο If two active tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non - hormonal contraception ( such as condoms and spermicide ) should be used as backup if the patient has sex within 7 days after missing tablets . Ο If two active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3 Day 1 start : Throw out the rest of the pack and start a new pack that same day. Sunday start : Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non - hormonal contraception ( such as condoms and spermicide ) should be used as back - up if the patient has sex within 7 days after missing tablets . 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 an active tablet, handle this as a missed tablet [see FDA-APPROVED PATIENT LABELING]. wallet

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE Tri-Lo-Marzia is an estrogen/progestin COC, indicated for use by women to prevent pregnancy.

Summary

Dosage and administration 2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.2 ) Take tablets in the order directed on the blister. ( 2.2 ) Do not skip or delay tablet intake. ( 2.2 ) 2.1 How to Start Tri-Lo-Marzia Tri-Lo-Marzia is dispensed in a blister [see HOW SUPPLIED/STORAGE AND HANDLING ( 16 )].

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Tri-Lo-Marzia is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraception Tri-Lo-Marzia™ Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES ( 14 )]. Dosage and administration 2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.2 ) Take tablets in the order directed on the blister. ( 2.2 ) Do not skip or delay tablet intake. ( 2.2 ) 2.1 How to Start Tri-Lo-Marzia Tri-Lo-Marzia is dispensed in a blister [see HOW SUPPLIED/STORAGE AND HANDLING ( 16 )]. Tri-Lo-Marzia may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. 2.2 How to Take Tri-Lo-Marzia Table 1 : Instructions for Administration of Tri - Lo - Marzia Starting COCs in women not currently using hormonal contraception ( Day 1 Start or Sunday Start ) Important : Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color : ο Tri-Lo-Marzia active tablets are white to off white (Day 1 to Day 7), light blue (Day 8 to Day 15) and blue (Day 16 to Day 21) and has green inactive tablets ( Day 22 to Day 28) Day 1 Start : ο Take first active tablet without regard to meals on the first day of menses. ο Take subsequent active tablets once daily at the same time each day for a total of 21 days. ο Take one green inactive tablet daily for 7 days and at the same time of day that active tablets were taken. ο Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet) Sunday Start : ο Take first active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant , use additional non - hormonal contraception ( such as condoms and spermicide ) for the first seven days of the patient’s first cycle pack of Tri - Lo - Marzia . ο Take subsequent active tablets once daily at the same time each day for a total of 21 days. ο Take one green inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken. ο Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. Switching to Tri - Lo - Marzia from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to Tri - Lo - Marzia Start Tri - Lo - Marzia : ο Transdermal patch ο On the day when next application would have been scheduled ο Vaginal ring ο On the day when next insertion would have been scheduled ο Injection ο On the day when next injection would have been scheduled ο Intrauterine contraceptive ο On the day of removal ο If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack. ο Implant ο On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA - Approved Patient Labeling . Starting Tri-Lo-Marzia after Abortion or Miscarriage First-trimester: After a first-trimester abortion or miscarriage, Tri-Lo-Marzia may be started immediately. An additional method of contraception is not needed if Tri-Lo-Marzia is started immediately. If Tri-Lo-Marzia is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Tri-Lo-Marzia. Second-trimester: Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Tri-Lo-Marzia, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Tri-Lo-Marzia. [see CONTRAINDICATIONS ( 4 ), WARNINGS AND PRECAUTIONS ( 5.1 ), and FDA-APPROVED PATIENT LABELING.] Starting Tri-Lo-Marzia after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-Lo-Marzia following the instructions in Table 1 for women not currently using hormonal contraception. Tri-Lo-Marzia is not recommended for use in lactating women [see USE IN SPECIFIC POPULATIONS ( 8.3 )]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Tri-Lo-Marzia. [see

Boxed Warning

WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Tri-Lo-Marzia is contraindicated in women over 35 years old who smoke. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. ( 4 ) 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 are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS ( 4 )].

Monitoring

• 5 WARNINGS AND PRECAUTIONS Thromboembolic Disorders and Other Vascular Problems: Stop Tri-Lo-Marzia 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 Tri-Lo-Marzia if jaundice occurs.

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 or alternative method of contraception when enzyme inducers are used with COCs.
• ( 7.1 ) Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
• No drug-drug interaction studies were conducted with Tri-Lo-Marzia.