Usual Adult Dose for Contraception

Formulations with placebo tablets:
1 tablet orally once a day for 21 consecutive days, then either 1 placebo tablet OR no tablet for 7 days

Formulations without placebo tablets:
1 tablet orally once a day

Comments:

• Start either the first day of menses, or the first Sunday after onset of menses.
• When switching from a different oral contraceptive, start the day a new pack of the previous medication would have been started.
• When switching from a transdermal patch, vaginal ring, or injection, start when the next application would have been due.
• When switching from an intrauterine device, start the day the device is removed.
• Tablets should be taken in the order directed on the package.
• Take at the same time every day, preferably after the evening meal or at bedtime.
• Patients should use a non-hormonal contraceptive as back up for the first 7 days.

Usual Adult Dose for Premenstrual Dysphoric Disorder

1 tablet orally once a day

Comments:

• Start either the first day of menses, or the first Sunday after onset of menses.
• When switching from a different oral contraceptive, start the day a new pack of the previous medication would have been started.
• When switching from a transdermal patch, vaginal ring, or injection, start when the next application would have been due.
• When switching from an intrauterine device, start the day the device is removed.
• Tablets should be taken in the order directed on the package.
• Take at the same time every day, preferably after the evening meal or at bedtime.
• Patients should use a non-hormonal contraceptive as back up for the first 7 days.

Use: Treatment of premenstrual dysphoric disorder in women who choose to use an oral contraceptive for contraception.

Usual Adult Dose for Acne

1 tablet orally once a day

Comments:

• Start either the first day of menses, or the first Sunday after onset of menses.
• When switching from a different oral contraceptive, start the day a new pack of the previous medication would have been started.
• When switching from a transdermal patch, vaginal ring, or injection, start when the next application would have been due.
• When switching from an intrauterine device, start the day the device is removed.
• Tablets should be taken in the order directed on the package.
• Take at the same time every day, preferably after the evening meal or at bedtime.
• Patients should use a non-hormonal contraceptive as back up for the first 7 days.

Use: Treatment of moderate acne vulgaris in women at least 14 years old and have achieved menarche, with no known contraindication to oral contraceptives, who choose to use an oral contraceptive for contraception.

Renal Dose Adjustments

Contraindicated

Liver Dose Adjustments

Contraindicated

Dose Adjustments

Missed doses:

• Take missed pills as soon as remembered.
• Consider the possibility of pregnancy if a missed period occurs.
• Missed 1 active pill at any time: take as soon as remembered, even if it means taking 2 tablets at the same time; back up birth control is not needed.
• Missed 2 pills in a row in week 1 or 2: take 2 pills on the day remembered and 2 pills the next day; use another form of birth control as back up for 7 days.
• Missed 2 pills in a row in week 3 or 4: (day 1 starter) discard the rest of the pack and start a new pack that same day; (Sunday starter) keep taking 1 pill daily until Sunday, then discard the rest of the pack and start a new pack that same day; use another form of birth control as back up for 7 days.
• Missed 3 or more active pills in a row at any time: (day 1 starter) discard the rest of the pack and start a new pack that same day; (Sunday starter) keep taking 1 pill daily until Sunday, then discard the rest of the pack and start a new pack that same day; use another form of birth control as back up for 7 days.
• Missed placebo pill(s): discard missed pills and keep taking until the pack is empty, back up birth control is not needed.

Precautions

BOXED WARNING:
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

• Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive (COC) use.
• This risk increases with age, particularly in women over 35, and with the number of cigarettes smoked.
• COCs should not be used by women over the age of 35 who smoke.

Safety and efficacy have not been established in patients younger than 14 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take at the same time every day, preferably after the evening meal or at bedtime.

Patient advice:

• Advise women on the increased venous thromboembolism risk with this product, including her current risk factors, and that the risk is highest during the first year of use.
• Advise women that hormonal contraceptives do not protect against HIV and other sexually transmitted diseases.