Drug Class: Contraceptives
Usual Adult Dose for Acne
1 tablet orally at the same time once a day
- Begin on the first day of menstrual period (Day 1 start)
If start date of the initial cycle is any day other than the first day of the menstrual cycle, this drug should not be considered effective as a contraceptive until after the first 7 consecutive days of administration have been completed; a non-hormonal contraceptive should be used as back-up during these first 7 days
Comments:
- This drug should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid; may take with or without food.
- The possibility of ovulation and conception prior to initiation should be considered.
- The effectiveness for symptoms of premenstrual dysphoric disorder (PMDD) for more than 3 menstrual cycles has not been evaluated; this drug has not been evaluated for the treatment of premenstrual syndrome (PMS).
Uses: This drug is indicated in women to prevent pregnancy. In women who choose to use an oral contraceptive as their method of contraception this drug is also indicated:
- For the treatment of symptoms of PMDD
- For the treatment of moderate acne vulgaris
- For folate supplementation, to reduce the risk of neural tube defect in pregnancy conceived while taking this drug or shortly after discontinuing
Usual Adult Dose for Contraception
1 tablet orally at the same time once a day
- Begin on the first day of menstrual period (Day 1 start)
If start date of the initial cycle is any day other than the first day of the menstrual cycle, this drug should not be considered effective as a contraceptive until after the first 7 consecutive days of administration have been completed; a non-hormonal contraceptive should be used as back-up during these first 7 days
Comments:
- This drug should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid; may take with or without food.
- The possibility of ovulation and conception prior to initiation should be considered.
- The effectiveness for symptoms of premenstrual dysphoric disorder (PMDD) for more than 3 menstrual cycles has not been evaluated; this drug has not been evaluated for the treatment of premenstrual syndrome (PMS).
Uses: This drug is indicated in women to prevent pregnancy. In women who choose to use an oral contraceptive as their method of contraception this drug is also indicated:
- For the treatment of symptoms of PMDD
- For the treatment of moderate acne vulgaris
- For folate supplementation, to reduce the risk of neural tube defect in pregnancy conceived while taking this drug or shortly after discontinuing
Usual Adult Dose for Premenstrual Dysphoric Disorder
1 tablet orally at the same time once a day
- Begin on the first day of menstrual period (Day 1 start)
If start date of the initial cycle is any day other than the first day of the menstrual cycle, this drug should not be considered effective as a contraceptive until after the first 7 consecutive days of administration have been completed; a non-hormonal contraceptive should be used as back-up during these first 7 days
Comments:
- This drug should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid; may take with or without food.
- The possibility of ovulation and conception prior to initiation should be considered.
- The effectiveness for symptoms of premenstrual dysphoric disorder (PMDD) for more than 3 menstrual cycles has not been evaluated; this drug has not been evaluated for the treatment of premenstrual syndrome (PMS).
Uses: This drug is indicated in women to prevent pregnancy. In women who choose to use an oral contraceptive as their method of contraception this drug is also indicated:
- For the treatment of symptoms of PMDD
- For the treatment of moderate acne vulgaris
- For folate supplementation, to reduce the risk of neural tube defect in pregnancy conceived while taking this drug or shortly after discontinuing
Usual Pediatric Dose for Acne
For postpubertal women:
- For use in the treatment of moderate acne vulgaris, women should be at least 14 years of age
1 tablet orally at the same time once a day
- Begin on the first day of menstrual period (Day 1 start)
Comments:
- This drug should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid; it may be taken without regard to meals.
- The possibility of ovulation and conception prior to initiation should be considered.
- The effectives of using this drug for symptoms of premenstrual dysphoric disorder (PMDD) for more than 3 menstrual cycles has not been evaluated; this drug has not been evaluated for the treatment of premenstrual syndrome (PMS).
Uses: This drug is indicated in women to prevent pregnancy. In women who choose to use an oral contraceptive as their method of contraception this drug is also indicated:
- For the treatment of symptoms of PMDD
- For the treatment of moderate acne vulgaris in women at least 14 years of age
- For folate supplementation, to reduce the risk of neural tube defect in pregnancy conceived while taking this drug or shortly after discontinuing
Usual Pediatric Dose for Contraception
For postpubertal women:
- For use in the treatment of moderate acne vulgaris, women should be at least 14 years of age
1 tablet orally at the same time once a day
- Begin on the first day of menstrual period (Day 1 start)
Comments:
- This drug should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid; it may be taken without regard to meals.
- The possibility of ovulation and conception prior to initiation should be considered.
- The effectives of using this drug for symptoms of premenstrual dysphoric disorder (PMDD) for more than 3 menstrual cycles has not been evaluated; this drug has not been evaluated for the treatment of premenstrual syndrome (PMS).
Uses: This drug is indicated in women to prevent pregnancy. In women who choose to use an oral contraceptive as their method of contraception this drug is also indicated:
- For the treatment of symptoms of PMDD
- For the treatment of moderate acne vulgaris in women at least 14 years of age
- For folate supplementation, to reduce the risk of neural tube defect in pregnancy conceived while taking this drug or shortly after discontinuing
Usual Pediatric Dose for Premenstrual Dysphoric Disorder
For postpubertal women:
- For use in the treatment of moderate acne vulgaris, women should be at least 14 years of age
1 tablet orally at the same time once a day
- Begin on the first day of menstrual period (Day 1 start)
Comments:
- This drug should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid; it may be taken without regard to meals.
- The possibility of ovulation and conception prior to initiation should be considered.
- The effectives of using this drug for symptoms of premenstrual dysphoric disorder (PMDD) for more than 3 menstrual cycles has not been evaluated; this drug has not been evaluated for the treatment of premenstrual syndrome (PMS).
Uses: This drug is indicated in women to prevent pregnancy. In women who choose to use an oral contraceptive as their method of contraception this drug is also indicated:
- For the treatment of symptoms of PMDD
- For the treatment of moderate acne vulgaris in women at least 14 years of age
- For folate supplementation, to reduce the risk of neural tube defect in pregnancy conceived while taking this drug or shortly after discontinuing
Renal Dose Adjustments
Use is contraindicated
Liver Dose Adjustments
Use is contraindicated in women with liver disease
Dose Adjustments
Switching from Another Oral Contraceptive:
- Start on the same day that a new pack of the previous oral contraceptive would have been started
Switching from a Method Other Than an Oral Contraceptive:
- When switching from a transdermal patch or vaginal ring, start when the next application would have been due
- When switching from an injection, start when the next dose would have been due
- When switching from an intrauterine contraceptive or an implant, start on day of removal
For Postpartum Women Who Do Not Breastfeed or After a Second Trimester Abortion:
- Start therapy no earlier than 4 weeks postpartum due to the increased risk of thromboembolism; if patient has not yet had a period, evaluate for possible pregnancy, and use an additional method of contraception until this drug has been taken for 7 consecutive days
In Case of Gastrointestinal Disturbances:
- In case of severe vomiting or diarrhea, additional contraceptive measures should be taken; if vomiting occurs within 3 to 4 hours after tablet-taking, this can be regarded as a missed tablet (see Administration Advice)
Precautions
US BOXED WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS:
- 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 should not be used by women who are over 35 years of age and smoke.
CONTRAINDICATIONS:
- Renal impairment
- Adrenal insufficiency
- High risk of arterial or venous thrombotic disease, e.g. smokers over 35 years old; history or current DVT or PE; cerebrovascular disease; coronary artery disease; thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation); inherited or acquired hypercoagulopathies; uncontrolled hypertension; diabetes with vascular disease; headaches with focal neurological symptoms or migraines with or without aura if over age 35 years
- Undiagnosed abnormal uterine bleeding
- Known, suspected, or history of breast cancer or other estrogen or progestin-sensitive cancer
- Liver disease
- Liver tumors, benign or malignant
- Pregnancy
- Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir due to the potential for ALT elevations
Safety and efficacy have been established in female patients of reproductive age; use prior to menarche is not indicated.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Take orally once a day at the same time every day; preferably after the evening meal or at bedtime with some liquid
- May be taken with or without food
- Take pills in the order directed on the blister pack
Missed Doses:
- If 1 active (pink) tablet is missed: Take the missed dose as soon as possible and continue taking 1 tablet once a day until packet is finished
- If 2 active (pink) tablets are missed in a row in Week 1 or Week 2: Take 2 tablets on the day remembered and 2 tablets the next day, then 1 tablet once a day until pack is finished; ADDITIONALLY, non-hormonal contraception (e.g. condoms or spermicide) must be used as back-up for intercourse within 7-days after missing tablets
- If 2 active (pink) tablets are missed in a row in Week 3 or Week 4: For day 1 starters (started on day 1 of menstrual period); Throw out rest of the pack and start a new pack; For Sunday starters (started on Sunday after menstrual period): Continue taking 1 pill every day until Sunday, on Sunday, start a new pack; ADDITIONALLY, non-hormonal contraception (e.g. condoms or spermicide) must be used as back-up for intercourse within 7-days after restarting. A woman may miss her period this month, but if a period is missed for 2 months in a row, pregnancy should be ruled out.
- If 3 active (pink) tablets are missed in a row in any week: For day 1 starters (started on day 1 of menstrual period); Throw out rest of the pack and start a new pack; For Sunday starters (started on Sunday after menstrual period): Continue taking 1 pill every day until Sunday, on Sunday, start a new pack; ADDITIONALLY, non-hormonal contraception (e.g. condoms or spermicide) must be used as back-up for intercourse within 7-days after restarting. A woman may miss her period this month, but if a period is missed for 2 months in a row, pregnancy should be ruled out.
- If one or more folate (light orange) tablets are missed: Skip the missed dose and continue taking 1 tablet once a day until packet is finished
In Case of Gastrointestinal Disturbances: If vomiting occurs within 3 to 4 hours after tablet-taking, this can be regarded as a missed tablet: additional contraceptive measures should be taken.
General:
- Pregnancy should be considered in patients whose scheduled bleeding does not occur:
- If patient has not been adherent (e.g. missed 1 or 2 active tablets or started later than day 1), pregnancy should be considered at the time of the first missed period and ruled out.
- If patient has been adherent but missed 2 consecutive periods, pregnancy should be ruled out.
- Ensure folate supplementation is maintained if a woman discontinues this drug due to pregnancy.
Monitoring:
- Monitor blood pressure
- Patients receiving medications that may increase serum potassium concentrations should have their serum potassium checked prior to starting treatment and during the first treatment cycle
- Consider serum potassium monitoring in high-risk patients taking strong CYP450 3A4 inhibitors long-term and concomitantly
- Patients with diabetes may require additional glycemic monitoring
- Observe patients with history of depression for recurrence or worsening depression
Patient advice:
- Patients should be instructed to read the US FDA-approved patient labeling.
- Patients should be informed that there are drug interactions with this drug and they should discuss all medications they are taking, including herbal supplements with their healthcare provider.
- Patients should be instructed to seek medical help promptly if they experience signs or symptoms of high potassium levels or blood clots.
- Patients should understand that oral contraceptive medications do not protect against HIV-infection and other sexually transmitted infections.
