Uses

Contraception

Prevention of conception in women.

Predominantly used by women who are breastfeeding and in those who do not tolerate estrogens or in whom estrogens are contraindicated.

Levonorgestrel-releasing intrauterine system (Mirena^®): Intended for women who have had ≥1 child; are in a stable, mutually monogamous relationship; have no history of pelvic inflammatory disease (PID); and have no history of ectopic pregnancy or any condition that would predispose to ectopic pregnancy.

Postcoital (Emergency) Contraception

Prevention of conception after unprotected intercourse (including known or suspected contraceptive failure) as an emergency contraceptive (“morning-after” pills). Postcoital (emergency) contraceptive regimens are not as effective as most other forms of long-term contraception and should not be used as routine forms of contraception.

An emergency contraceptive regimen employing a progestin alone (levonorgestrel) appears to be more effective and better tolerated than a common estrogen-progestin emergency contraceptive (“Yuzpe”) regimen when the regimens are initiated within 72 hours of unprotected intercourse, and therefore, generally is preferred when readily available.

Dosage and Administration

Administration

Administer norethindrone orally.

Administer levonorgestrel orally or as an intrauterine system.

Administer etonogestrel implant by sub-Q insertion.

Oral Administration

Contraception

Take as near as possible to the same time each day (i.e., at regular 24-hour intervals) and continue daily without interruption to ensure maximum contraceptive efficacy.

If vomiting occurs soon after a dose, use a back-up method of contraception (e.g., condoms, foam, sponges) for 48 hours.

Available in a mnemonic dispensing package designed to aid the user in complying with the prescribed dosing regimen.

Postcoital (Emergency) Contraception

Administer first contraceptive dose of levonorgestrel (Plan B^®) as soon as possible but preferably within 72 hours following unprotected sex. Most data support administration of the first dose up to 120 hours† after unprotected intercourse if necessary, but efficacy decreases as initiation of contraception becomes more remote from unprotected intercourse.

Manufacturer recommends repeating dose 12 hours after the first dose. However, administering both doses at one time (i.e., as a single 1.5-mg dose)† appears comparably effective and tolerated and more convenient.

May be used at any time during the menstrual cycle. Efficacy not established if administered >120 hours after unprotected sex.

Manufacturer states that if vomiting occurs within 1 hour after administration, the woman should contact her healthcare provider to discuss repeating the dose. Many experts recommend repeating the dose if vomiting occurs within 2 hours after administration.

Food not effective in reducing adverse GI effects (i.e., nausea).

Sub-Q Administration

Insert etonogestrel implant (Implanon^®) subdermally in the inner aspect of the upper arm about 6–8 cm above the elbow crease. Consult manufacturer’s labeling for proper method of administration and associated precautions.

Intrauterine Administration

Insert levonorgestrel-releasing intrauterine system (Mirena^®) into the uterine cavity under strict aseptic conditions. (See Intrauterine Device Considerations under Cautions.) Consult manufacturer’s labeling for proper methods of inserting and removing the intrauterine system and for associated precautions.

Dosage

When switching contraceptive methods, initiate new therapy in a manner that ensures continuous contraceptive coverage based on the mechanism of action of both methods.

Adults

Contraception

Oral

Norethindrone: 0.35 mg daily. Take 1 tablet each day and continue daily without interruption. Start on the first day of the menstrual cycle. If the first dose is taken on another day, use back-up method of contraception (e.g., condom, spermicide) for each sexual encounter for the next 48 hours.

Women switching from estrogen-progestin oral contraceptives: Start norethindrone on the day after the last hormonally active tablet.

Women may start using norethindrone tablets on the next day after a miscarriage or an abortion.

Women whose infants are only partially breast-fed may begin norethindrone 3 weeks after delivery. Women who are exclusively breast-feeding their infants may begin 6 weeks after delivery.

When a dose is taken >3 hours late or if one or more consecutive doses are missed, take the missed dose as soon as remembered, then resume regular schedule; use a back-up method of contraception (e.g., condom, spermicide) for 48 hours. If unsure of what drug regimen to take as a result of missed tablets, use a back-up method of contraception for each sexual encounter and take one tablet daily until clinician contacted.

Sub-Q

Etonogestrel contraceptive implant (Implanon^®): One 68-mg implant every 3 years.

To initiate therapy in women who did not use hormonal contraception in the preceding month, insert the contraceptive implant on or before day 5 of the cycle; a back-up method of contraception is not needed.

Women switching from estrogen-progestin oral contraceptives, contraceptive transdermal system, or vaginal contraceptive ring: Insert the contraceptive implant within 7 days of the last hormonally active tablet, removal of a transdermal patch, or removal of the vaginal ring; a back-up method of contraception is not needed.

Women switching from progestin-only oral contraceptives: Insert the contraceptive implant on any day of the month (without skipping any day between receiving the last progestin oral contraceptive and the initial administration of the implant); a back-up method of contraception is not needed.

Women switching from a progestin-only contraceptive injection: Insert the contraceptive implant on the same day as the next contraceptive injection would have been due; a back-up method of contraception is not needed.

Women switching from a progestin-containing intrauterine device: Insert the contraceptive implant on the same day as the intrauterine device is removed; a back-up method of contraception is not needed.

The contraceptive implant can be inserted immediately after a first-trimester abortion. If therapy with the contraceptive insert is not initiated within 5 days of a first-trimester abortion, follow the instructions for women who did not use hormonal contraception in the preceding month.

The contraceptive implant can be inserted 21–28 days after a second-trimester abortion.

The contraceptive implant can be inserted 21–28 days postpartum in women who are not exclusively breast-feeding; a back-up method of contraception is not needed. The implant can be inserted after the fourth postpartum week in women who are exclusively breast-feeding their infant. If implant insertion occurs >4 weeks postpartum, use back-up method of contraception for 7 days.

Remove implant 3 years after insertion. At time of implant removal, may insert another implant to continue therapy.

Intrauterine

Levonorgestrel-releasing intrauterine contraceptive system (Mirena^®): One system containing 52 mg every 5 years.

To initiate therapy, insert the intrauterine contraceptive system within 7 days of menses onset.

The intrauterine contraceptive system can be inserted immediately after a first-trimester abortion; delay insertion until involution of the uterus is complete after a second-trimester abortion.

The intrauterine contraceptive system should not be inserted until 6 weeks postpartum or after involution of the uterus is complete.

Remove the intrauterine contraceptive system after 5 years of use (contraceptive efficacy >5 years not established). At time of system removal, may insert another intrauterine contraceptive system to continue therapy; removal and replacement with a new system can be done at any time during the menstrual cycle.

For women with regular menstrual cycles who wish to initiate an alternative contraceptive method, remove the intrauterine system during the first 7 days of a menstrual cycle and start new method. For those with irregular cycles or amenorrhea or for those in whom the system is removed after the seventh day of the menstrual cycle, initiate the new contraceptive method at least 7 days before removal of the intrauterine system.

Postcoital (Emergency) Contraception

Oral

For optimal efficacy, take the first 0.75-mg dose as soon as possible within 72 hours of unprotected intercourse, and the second 0.75-mg dose 12 hours later. Alternatively to improve compliance, take a single 1.5-mg dose† (two 0.75-mg tablets) within 72 hours of unprotected intercourse. If necessary, the first dose can be administered up to120 hours† after unprotected intercourse, but efficacy decreases the longer initiation of contraception is delayed.

Repeated postcoital (emergency) contraception use indicates need for counseling about other contraceptive options. Safety of recurrent use not established but risk appears low, even within same menstrual cycle. Consider possibility that risk of adverse effects may be increased with frequently repeated postcoital contraception.

The FDA has approved Plan B^® for nonprescription (OTC) status for women ≥18 years of age; the contraceptive is a prescription-only preparation for women <18 years of age. To ensure appropriate use, Plan B^® is available with an educational and distribution monitoring program (CARE; convenient access responsible education program). The CARE program is designed to limit availability of Plan B^® to pharmacies and clinics with licensed health-care professionals, to educate health-care professionals and consumers about the appropriate use of the preparation, and to monitor the effectiveness of the program.