Usual Adult Dose for Contraception

Intrauterine Device (IUD) insertion should be performed by a trained healthcare provider thoroughly familiar with product; product manufacturer labeling should be consulted:

Insert 1 IUD (13.5, 19.5 or 52 mg) into uterus

Timing of insertion:

• For women who are not currently using hormonal or intrauterine contraception: Insertion may occur at any time the woman is not pregnant; if inserted after the first 7 days of menstrual cycle, an additional method of contraception should be used for 7 days after insertion
• Switching from an oral, transdermal, or vaginal hormonal contraceptive: Insertion may occur at any time; if inserted during the hormone phase, continue use for 7 days after insertion or until the end of the current treatment cycle
• Switching from an injectable progestin contraceptive: Insertion may occur at any time; if inserted more than 3 months after the last injection, an additional method of contraception should be used for 7 days after insertion
• Switching from a contraceptive implant or another IUD: Insertion should occur on the same day the implant or IUD is removed
• Inserting after abortion or miscarriage:
• First trimester: May insert IUD immediately after a first trimester abortion or miscarriage
• Second trimester: Insertion of IUD should be delayed a minimum of 4 weeks or until the uterus is fully involuted; if involution is delayed, insertion should be delayed until involution is complete; consider the possibility of ovulation and conception occurring prior to insertion and advise patient on need for an additional method of contraception for 7 days after insertion
• After childbirth: Insertion of IUD should be delayed a minimum of 4 weeks after delivery, or until the uterus is fully involuted; if involution is delayed, insertion should be delayed until involution is complete; consider the possibility of ovulation and conception occurring prior to insertion and advise patient on need for an additional method of contraception for 7 days after insertion

Replacement: IUD should be replaced after the prescribed amount of time; a new IUD may be inserted for continued use

• Skyla(R): Replace after 3 years
• Kyleena(R), Mirena(R), and Liletta(R): Replace after 5 years

Comments:

• IUD may be removed at any time but must be removed by the end of the prescribed time; if continued use is desired, replace with a new IUD.

Uses: Prevention of pregnancy for up to 3 years (Skyla[R]) or 5 years (Kyleena[R], Mirena[R], and Liletta[R]); additionally, Mirena(R) is for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception.

Usual Adult Dose for Postcoital Contraception

Emergency Contraception:

Take 1.5 mg orally once or 0.75 mg orally 12 hours apart

Comments:

• Doses should be taken as soon as possible within 72 hours after unprotected intercourse or known/suspected contraception failure; the sooner it is taken the better.
• If vomiting occurs within 2 hours of taking dose, consider repeating the dose.
• This product is not intended for regular birth control.

Use: To reduce the chance or pregnancy after unprotected intercourse or a known/suspected contraceptive failure.

Usual Pediatric Dose for Contraception

Postpubertal adolescents:
Intrauterine Device (IUD) insertion should be performed by a trained healthcare provider thoroughly familiar with product; product manufacturer labeling should be consulted:

Insert 1 IUD (13.5, 19.5 or 52 mg) into uterus

Timing of insertion:

• For women who are not currently using hormonal or intrauterine contraception: Insertion may occur at any time the woman is not pregnant; if inserted after the first 7 days of menstrual cycle, an additional method of contraception should be used for 7 days after insertion
• Switching from an oral, transdermal, or vaginal hormonal contraceptive: Insertion may occur at any time; if inserted during the hormone phase, continue use for 7 days after insertion or until the end of the current treatment cycle
• Switching from an injectable progestin contraceptive: Insertion may occur at any time; if inserted more than 3 months after the last injection, an additional method of contraception should be used for 7 days after insertion
• Switching from a contraceptive implant or another IUD: Insertion should occur on the same day the implant or IUD is removed
• Inserting after abortion or miscarriage:
• First trimester: May insert IUD immediately after a first trimester abortion or miscarriage
• Second trimester: Insertion of IUD should be delayed a minimum of 4 weeks or until the uterus is fully involuted; if involution is delayed, insertion should be delayed until involution is complete; consider the possibility of ovulation and conception occurring prior to insertion and advise patient on need for an additional method of contraception for 7 days after insertion
• After childbirth: Insertion of IUD should be delayed a minimum of 4 weeks after delivery, or until the uterus is fully involuted; if involution is delayed, insertion should be delayed until involution is complete; consider the possibility of ovulation and conception occurring prior to insertion and advise patient on need for an additional method of contraception for 7 days after insertion

Replacement: IUD should be replaced after the prescribed amount of time; a new IUD may be inserted for continued use

• Skyla(R): Replace after 3 years
• Kyleena(R), Mirena(R), and Liletta(R): Replace after 5 years

Comments:

• IUD may be removed at any time but must be removed by the end of the prescribed time; if continued use is desired, replace with a new IUD.

Uses: Prevention of pregnancy for up to 3 years (Skyla[R]) or 5 years (Kyleena[R], Mirena[R], and Liletta[R]); additionally, Mirena(R) is for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception.

Usual Pediatric Dose for Postcoital Contraception

Emergency Contraception:

Postpubertal adolescents:
Take 1.5 mg orally once or 0.75 mg orally 12 hours apart

Comments:

• Doses should be taken as soon as possible within 72 hours after unprotected intercourse or known/suspected contraception failure; the sooner it is taken the better.
• If vomiting occurs within 2 hours of taking dose, consider repeating the dose.
• This product is not intended for regular birth control.

Use: To reduce the chance or pregnancy after unprotected intercourse or a known/suspected contraceptive failure.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Intrauterine Device:

• Acute liver disease or liver tumor: Contraindicated

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Known or suspected pregnancy

Intrauterine Device (IUD) is contraindicated if one or more of the following conditions exist:

• Acute liver disease or liver tumor (benign or malignant)
• Uterine bleeding of unknown etiology
• Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past
• Congenital or acquired uterine anomaly, including fibroids, that distorts uterine cavity and would be incompatible with correct placement
• Acute pelvic inflammatory disease (PID) or a history of PID unless there has been subsequent intrauterine pregnancy
• Postpartum endometritis or infected abortion in past 3 months
• Known or suspected uterine or cervical neoplasia
• Untreated acute cervicitis or vaginitis, including bacterial vaginosis, known chlamydial or gonococcal cervical infection, or other lower genital tract infections until infection is controlled
• Conditions associated with increased susceptibility to pelvic infections
• Use as post-coital contraception
• A previously inserted intrauterine device that has not been removed

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:
Emergency Contraception:

• Take as soon as possible up to 72 hours after unprotected sex; the sooner it is taken the better it will work.
• If vomiting occur within 2 hours after taking dose, dose should be repeated

Intrauterine Device (IUD):

• Insertion should be performed by a trained healthcare provider thoroughly familiar with product; product manufacturer labeling should be consulted

Timing of IUD Removal:

• If pregnancy is desired, the IUD may be removed at any time.
• If IUD is to be removed and pregnancy is not desired, a new contraception method should be started prior to removal of the IUD.

Storage requirements:

• IUD: For single use only; store pouch in outer carton until use to protect from light

Monitoring:

• IUD Follow-up: Re-examine patient 4 to 6 weeks following IUD insertion and once a year thereafter, or more frequently if clinically indicated.
• Emergency Contraception Follow-up: Physical or pelvic exam is recommended if there is any doubt concerning general health or pregnancy status of any woman after use for postcoital contraception.

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Patients should understand that this drug does not protect against HIV infection and other sexually transmitted infections.
• Counsel patients on the risks of becoming pregnant if intercourse occurs in the 7-day period after insertion as well as before removal of IUD.
• Contact healthcare provider promptly if you become pregnant with IUD intact due to the risk of ectopic pregnancy.
• Report any signs/symptoms of lower abdominal pain, long-lasting or heavy bleeding, painful intercourse, chills, or fever.
• Report severe pain or fever following IUD insertion due to the risk of infection.

Frequently asked questions

• Can Plan B make your period late or cause bleeding?
• Can you drink alcohol after taking Plan B?
• What's the weight limit for Plan B?
• How effective is Plan B and how late can you take it?
• How many times can you take Plan B?
• Mirena, Kyleena, Skyla & Liletta - What's the difference?