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Check Drug InteractionsNorgestimate And Ethinyl Estradiol Prescribing Information
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 ()].
Norgestimate and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions:
• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:∘ Smoke, if over age 35[see Boxed WarningandWarnings and Precautions ]∘ Have deep vein thrombosis or pulmonary embolism, now or in the past[see Warnings and Precautions ]∘ Have inherited or acquired hyper coagulopathies[see Warnings and Precautions ]∘ Have cerebrovascular disease[see Warnings and Precautions ]∘ Have coronary artery disease[see Warnings and Precautions ]∘ Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)[see Warnings and Precautions ]∘ Have uncontrolled hypertension[see Warnings and Precautions ]∘ Have diabetes mellitus with vascular disease[see Warnings and Precautions ]∘ Have headaches with focal neurological symptoms or migraine headaches with aura[see Warnings and Precautions ]▪ Women over age 35 with any migraine headaches[see Warnings and Precautions ]
• Liver tumors, benign or malignant, or liver disease[see Warnings and Precautions ]• Undiagnosed abnormal uterine bleeding[see Warnings and Precautions ]• Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[see Warnings and Precautions ]• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations[see Warnings and Precautions]
• A high risk of arterial or venous thrombotic diseases• Liver tumors or liver disease• Undiagnosed abnormal uterine bleeding• Breast cancer• Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
Contraindications, Pregnancy (
Norgestimate and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions:
• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:∘ Smoke, if over age 35[see Boxed WarningandWarnings and Precautions ]∘ Have deep vein thrombosis or pulmonary embolism, now or in the past[see Warnings and Precautions ]∘ Have inherited or acquired hyper coagulopathies[see Warnings and Precautions ]∘ Have cerebrovascular disease[see Warnings and Precautions ]∘ Have coronary artery disease[see Warnings and Precautions ]∘ Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)[see Warnings and Precautions ]∘ Have uncontrolled hypertension[see Warnings and Precautions ]∘ Have diabetes mellitus with vascular disease[see Warnings and Precautions ]∘ Have headaches with focal neurological symptoms or migraine headaches with aura[see Warnings and Precautions ]▪ Women over age 35 with any migraine headaches[see Warnings and Precautions ]
• Liver tumors, benign or malignant, or liver disease[see Warnings and Precautions ]• Undiagnosed abnormal uterine bleeding[see Warnings and Precautions ]• Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[see Warnings and Precautions ]• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations[see Warnings and Precautions]
• A high risk of arterial or venous thrombotic diseases• Liver tumors or liver disease• Undiagnosed abnormal uterine bleeding• Breast cancer• Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
Norgestimate and ethinyl estradiol tablets are combinations of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (
Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg and Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg are indicated for use by females of reproductive potential to prevent pregnancy
[see Clinical Studies ].
Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche.
Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (
Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control
[see Clinical Studies ].
• Take one tablet daily by mouth at the same time every day. ()2.1 Recommended Dosage and AdministrationTake one tablet by mouth at the same time each day with or without food. Table 1 provides the recommended dosage and administration instructions for norgestimate and ethinyl estradiol tablets, 0.25 mg/0.035 mg and Norgestimate and ethinyl estradiol tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.
Table 1: Instructions for Administration of Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mgStarting 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:• Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg active tablets are blue (Day 1 to Day 21).• Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg active tablets are white to off-white (Day 1 to Day 7), light blue (Day 8 to Day 14) and blue (Day 15 to Day 21).• Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, and Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg both have light green inactive tablets (Day 22 to Day 28).
Day 1 Start:• Take first active tablet without regard to meals on the first day of menses.• Take subsequent active tablets once daily at the same time each day for a total of 21 days.• Take onelight greeninactive tablet daily for 7 days and at the same time of day that active tablets were taken.• 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:• 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 Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.• Take subsequent active tablets once daily at the same time each day for a total of 21 days.• Take onelightgreeninactive tablet daily for the following 7 days and at the same time of day that active tablets were taken.• 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 Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg from another oral contraceptiveStart on the same day that a new pack of the previous oral contraceptive would have started.
Switching from another contraceptive method to Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mgStart Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg:• Transdermal patch
• On the day when next application would have been scheduled
• Vaginal ring
• On the day when next insertion would have been scheduled
• Injection
• On the day when next injection would have been scheduled
• Intrauterine contraceptive
• On the day of removal• 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.
• Implant
• On the day of removal
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.Starting Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg after Abortion or MiscarriageFirst-trimester• After a first-trimester abortion or miscarriage, Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg may be started immediately. An additional method of contraception is not needed if Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are started immediately.• If Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are 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 Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.
Second-trimester• Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, 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 Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.[see ContraindicationsandWarnings and Precautions ].
Starting Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg after Childbirth• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg following the instructions in Table 1 for women not currently using hormonal contraception.• Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are 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 Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.[see Contraindications , Warnings and Precautions ,andUse in Specific PopulationsandWarnings and Precautions ].
Starting Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg after Childbirth• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg following the instructions in Table 1 for women not currently using hormonal contraception.• Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are 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 Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.[see Contraindications , Warnings and Precautions ,andUse in Specific PopulationsandWarnings and Precautions ].
Starting Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg after Childbirth• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg following the instructions in Table 1 for women not currently using hormonal contraception.• Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are 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 Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg, or Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.[see Contraindications , Warnings and Precautions ,andUse in Specific Populations ( 8.1and8.2)].
Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg are available in blister packs containing 28 tablets, in the following order:
• 21 blue, round, flat faced beveled edged, uncoated tablets, debossed with ‘A7’ on one side and plain on the other. Each blue tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP.• 7 light green, round, flat faced beveled edged, uncoated tablets debossed with ‘A2’on one side and plain on the other. Each light green tablet contains inert ingredients.
Norgestimate and Ethinyl Estradiol Tablets, USP 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are available in blister cards. Each blister card contains 28 tablets in the following order:
• 7 white to off-white, round, flat faced beveled edge, uncoated tablets, debossed with ‘A9’ on one side and plain on the other. Each white to off-white tablet contains 0.18 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP.• 7 light blue, round, flat faced beveled edge, uncoated tablets, debossed with ‘A8’ on one side and plain on the other. Each light blue tablet contains 0.215 mg norgestimate, USP and 0.035 mg of ethinyl estradiol, USP.• 7 blue, round, flat faced beveled edge, uncoated tablets, debossed with ‘A7’ on one side, and plain on the other. Each blue tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP.• 7 light green, round, flat faced beveled edge, uncoated tablets, debossed with ‘A2’ on one side and plain on the other. Each light green tablet contains inert ingredients.
Lactating women: Not recommended; can decrease milk production. (8.2)
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available