Usual Adult Dose for Contraception

1 tablet orally once a day

Usual Adult Dose for Acne

1 tablet orally once a day

Comments: Not all preparations are indicated for the treatment of acne; the manufacturer product information should be consulted.

Usual Pediatric Dose for Contraception

1 tablet orally once a day

Usual Pediatric Dose for Acne

15 years or older: 1 tablet orally once a day

Comments:

• Not all preparations are indicated for the treatment of acne; the manufacturer product information should be consulted.
• Use should be reserved for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Use: For the treatment of moderate acne vulgaris in females at least 15 years of age with no know contraindications to oral contraceptive therapy and who have achieved menarche

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Contraindicated

Dose Adjustments

Elderly patients: Not indicated in postmenopausal women.

Changing from another oral contraceptive: Start on the same day that a new pack of the previous oral contraceptive would have started.

Changing from a transdermal patch: Start on the day when the next application would have been scheduled.

Changing from a vaginal ring: Start on the day when the next insertion would have been scheduled.

Changing from an injectable formulation: Start on the day when the next injection would have been scheduled

Changing from an intrauterine system (IUS) contraceptive:

• Start on the day of the removal of the IUS
• If the IUS is not removed on the first day of the menstrual cycle, additional nonhormonal contraceptives (e.g., condoms and spermicide) is needed for the first 7 days of the first cycle pack.

Changing from an implant: Start on the day when the implant is removed.

Following a first trimester abortion or miscarriage:

• May be started immediately; an additional method of contraception is not required if started immediately.
• If not started within 5 days after termination of pregnancy, an additional nonhormonal method of contraception (e.g., condoms and spermicide) is to be used for the first 7 days of the first cycle pack.

Following a second trimester abortion or miscarriage:

• Do not start until 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolic disease.
• Follow the instructions for Day 1 or Sunday start, as desired; if using Sunday start, use additional non-hormonal contraception (e.g., condoms and spermicide) for the first 7 days of the patient's first cycle pack.

Following childbirth:

• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease.
• Follow the instructions for women not currently using hormonal contraception.
• Not recommended for use in lactating women
• If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use.

Precautions

US BOXED WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR ADVERSE EFFECTS:

• Cigarette smoking increases the risk of serious cardiovascular side effects 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.

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:

• The manufacturer product information should be consulted.
• If severe vomiting or diarrhea occurs, 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.
• No hormonal contraceptive use in preceding cycle: Decide between a day 1 start or Sunday start as desired; 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 the first active pill on the Sunday after the onset of menses, even if the patient is still bleeding; if the period begins on a Sunday, start the pack the same day.
• A backup form of birth control (e.g., condoms) should be used from the Sunday the pills are started to the next Sunday (7 days) for the first cycle.
• Take all subsequent pills once a day at the same time each day.

Day 1 Start:

• Take the first active pill during the first 24 hours of starting the period.
• Take all subsequent pills once a day at the same time each day.
• A backup method of birth control will not be necessary with the Day 1 start.
• Take all subsequent pills once a day at the same time each day.

Missed Pills:

• If 1 active pill is missed in weeks 1, 2, or 3, take it as soon as it is remembered and continue taking 1 tablet once a day the pack is finished.
• If 2 active pills are missed in a row on week 1 or week 2 of the pack, take 2 pills on the day they are remembered and 2 pills the next day, then 1 pill each day until the pack is finished; a form of nonhormonal back-up birth control is necessary for the next 7 days
• If 2 active pills are missed in a row on Week 3, or 3 or more pills are missed in a row in weeks 1, 2, or 3, the rest of the pill pack should be thrown out and a new pack started the same day for day 1 starters; for Sunday starters, keep taking 1 tablet every day until Sunday, then on Sunday, throw out the rest of the pack and start a new pack of pills the same day; nonhormonal back-up birth control is necessary for the next 7 days.

Storage Requirements:

• Protect from light.

Monitoring:

• Cardiovascular: Regularly monitor blood pressure throughout therapy
• General: Women using this drug should have a yearly visit with a healthcare provider for a blood pressure check and other indicated healthcare.

Patient Advice: Consult the Patient Information and Instructions for Use.