Usual Adult Dose for Contraception

Ethinyl estradiol-ethynodiol products are packaged in 21 or 28 day dosage preparations. The last seven tablets in 28 day dosage preparations are hormonally inert.

1 tablet orally at the same time once a day

• Begin on the first day of menstrual period (Day 1 start)

If the 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
• The possibility of ovulation and conception prior to initiation should be considered.

Use: This drug is indicated in women to prevent pregnancy.

Usual Pediatric Dose for Contraception

Ethinyl estradiol-ethynodiol products are packaged in 21 or 28 day dosage preparations. The last seven tablets in 28 day dosage preparations are hormonally inert.

Postpubertal adolescents:
1 tablet orally at the same time once a day

• Begin on the first day of menstrual period (Day 1 start)

If the 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
• The possibility of ovulation and conception prior to initiation should be considered.

Use: This drug is indicated in women to prevent pregnancy.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:

• Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age and with heavy smoking (15 or more cigarettes/day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

CONTRAINDICATIONS:

• Thrombophlebitis or thromboembolic disorders
• History of deep vein thrombophlebitis or thromboembolic disorders
• Current or history or cerebral vascular disease, myocardial infarction, or coronary artery disease
• Known, suspected, or history of breast cancer
• Known, suspected, or history of cancer of the female reproductive organs or estrogen-dependent neoplasia
• Undiagnosed abnormal uterine bleeding
• History of cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive use
• 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

Missed Doses:

• If 1 active 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 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 tablets are missed in a row in Week 3: 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 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.

General:

• COCs may cause fluid retention; prescribe with caution and careful monitoring in patients with conditions that might be aggravated by fluid retention such as convulsive disorders, migraine syndrome, asthma, or cardiac, hepatic, or renal dysfunction.
• Women who take oral contraceptives, should take the lowest possible dose formulation that is effective.

Monitoring:

• Monitor blood pressure
• 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 blood clots.
• Patients should understand that oral contraceptive medications do not protect against HIV-infection and other sexually transmitted infections.
• For contact lens wearers who notice a change in vision or an inability to wear contact lenses, they should contact their ophthalmologist.