Usual Adult Dose for Contraception

Take 1 tablet orally once a day at the same time each day

Start Dates:

• When there is no current use of hormonal contraception: Day 1 start is the first day of menses
• When switching from a combined oral contraceptive: Start on the day when the new pack of the previous combined oral contraceptive would have started
• When switching from a transdermal patch: Start on the day the next application would have been scheduled
• When switching from a vaginal ring: Start on the day the next insertion would have been scheduled
• When switching from an injection: Start on the day the next injection would have been scheduled
• When switching from an intrauterine contraceptive: Start on the day of removal
• When switching from an implant: Start is the day of removal

• Consider the possibility of ovulation and conception prior to initiation of therapy.
• Active tablets are white, inactive tablets are green; take 1 white tablet daily for the first 24 days, then 1 green tablet during the next 4 days.
• Tablets should be taken at about the same time each day so the interval between tablets is always 24 hours.

Usual Pediatric Dose for Contraception

Post Pubertal Females:
Take 1 tablet orally once a day at the same time each day

Start Dates:

• When there is no current use of hormonal contraception: Day 1 start is the first day of menses
• When switching from a combined oral contraceptive: Start on the day when the new pack of the previous combined oral contraceptive would have started
• When switching from a transdermal patch: Start on the day the next application would have been scheduled
• When switching from a vaginal ring: Start on the day the next insertion would have been scheduled
• When switching from an injection: Start on the day the next injection would have been scheduled
• When switching from an intrauterine contraceptive: Start on the day of removal
• When switching from an implant: Start is the day of removal

• Consider the possibility of ovulation and conception prior to initiation of therapy.
• Active tablets are white, inactive tablets are green; take 1 white tablet daily for the first 24 days, then 1 green tablet during the next 4 days.
• Tablets should be taken at about the same time each day so the interval between tablets is always 24 hours.

Renal Dose Adjustments

Contraindicated

Liver Dose Adjustments

Contraindicated

Dose Adjustments

Gastrointestinal Disturbances:

• If nausea or vomiting occurs within 3 to 4 hours of dosing, the tablet scheduled for the following day should be taken as soon as possible (within 12 hours of usual dose, if possible)
• If more than 2 tablets are missed, backup non-hormonal contraception should be used as described above.

Precautions

CONTRAINDICATIONS:

• Renal Impairment
• Adrenal insufficiency
• Presence or history of cervical cancer or progestin sensitive cancers
• Liver tumors, benign or malignant, or hepatic impairment
• Undiagnosed abnormal uterine bleeding

Dialysis

Contraindicated

Other Comments

Administration advice:

• Take orally once a day at the same time every day; take pills in the order directed on the blister pack
• Swallow whole

• If 1 active (white) 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 or more active (white) tablets are missed: Take the last missed tablet as soon as possible and continue 1 tablet once a day until pack is finished; ADDITIONALLY, non-hormonal contraception (e.g. condoms or spermicide) should be used as back-up for intercourse within 7-days after missing tablets
• If one or more inert (green) tablets are missed: Skip the missed dose and continue taking 1 tablet once a day until packet is finished

• 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.

• 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
• Monitor potassium in patients at risk for hyperkalemia
• Patients with diabetes may require additional glycemic monitoring
• Observe patients with history of depression for recurrence or worsening depression

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• 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.