Drug Detail:Dienogest and estradiol (Dienogest and estradiol [ dye-en-oh-jest-and-ess-tra-dye-ole ])
Drug Class: Contraceptives
Usual Adult Dose for Contraception
1 tablet orally at the same time every day
- Tablets must be taken in the order directed on the blister pack.
Comments:
- Efficacy in women with a body mass index over 30 kg/m2 has not been evaluated.
- To start: Take the first pill on the first day of the menstrual cycle; non-hormonal back-up contraceptives should be used for the first 9 days.
- Starting postpartum: Start no earlier than 4 weeks postpartum due to increased thromboembolism risk; if no period has occurred, rule out pregnancy; non-hormonal back-up contraceptives should be used for the first 9 days.
- Switching from another combination hormonal method: Take the first pill on the first day of withdrawal bleeding; if no withdrawal bleeding occurred, rule out pregnancy.
- Switching from vaginal ring or transdermal patch: Take the first pill on the day the ring/patch is removed; non-hormonal back-up contraceptives should be used for the first 9 days.
- Switching from a progestin-only method: Take the first pill on the day the next progestin-only pill would have been taken, the day of removal of an implant, or the day the next injection would have occurred; non-hormonal back-up contraceptives should be used for the first 9 days.
Uses:
- Pregnancy prevention
- Treatment of heavy menstrual bleeding without organic pathology in women who choose oral contraceptives for contraception
Renal Dose Adjustments
Data not available
- Dose adjustments are not expected to be required.
Liver Dose Adjustments
Contraindicated in liver disease or impairment if liver function values have not returned to normal
- Steroid hormones may be poorly metabolized in patients with impaired liver function.
- Acute or chronic liver function disturbances may require discontinuation of oral contraceptives until markers of liver function return to normal.
Dose Adjustments
Gastrointestinal disturbances:
- Severe vomiting or diarrhea may cause incomplete absorption; additional contraceptive measures should be taken.
- If vomiting or diarrhea occurs within 3 to 4 hours of taking a colored tablet, regard this as a missed tablet.
Missed tablets:
- Missed ONE tablet less than 12 hours late: Take missed pill as soon as it is remembered; back-up contraception is not needed.
- Missed ONE tablet, more than 12 hours late:
- If pill is from days 1 to 17: Take missed pill immediately, which may involve taking 2 pills the same day; take the next pill at the usual time; use back-up contraception for the next 9 days; continue taking one pill at the same time each day for the rest of the cycle.
- If pill is from days 18 to 24: Do not take any pills from the current blister pack and throw the pack away; take day 1 pill from a new blister pack; use back-up contraception for the next 9 days; continue taking one pill at the same time each day from the new blister pack for the rest of the cycle.
- If pill is from days 25 to 28: Take missed pill immediately, which may involve taking 2 pills the same day; take the next pill at the usual time; back-up contraception is not needed; continue taking one pill at the same time each day from the new blister pack for the rest of the cycle.
- Missed TWO tablets in a row:
- If pills are from days 1 to 17: Do not take missed pill; take the pill for the first day it was noticed a pill was missed; use back-up contraception for the next 9 days; continue taking one pill at the same time each day for the rest of the cycle. (If missed pills are days 17 and 18, follow the directions for missed days 18 to 24).
- If pill is from days 18 to 24: Do not take any pills from the current blister pack and throw the pack away; take day 3 pill from a new blister pack; use back-up contraception for the next 9 days; continue taking one pill at the same time each day from the new blister pack for the rest of the cycle. (If missed pills are days 24 and 25, follow the directions for missed days 25 to 28).
- If pill is from days 25 to 28: Do not take any pills from the current blister pack and throw the pack away; start a new pack on the same day or start a new pack the day a new pack is normally started; back-up contraception is not needed; continue taking one pill at the same time each day from the new blister pack for the rest of the cycle.
Precautions
US BOXED WARNING(S):
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 been established in women of reproductive age; efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available