Progestins (Monograph)

Brand names: Fallback Solo, Implanon, Micronor, Mirena, Next Choice One Dose, ... show all 8 brands Nor-QD, Opcicon One-Step, Plan B One-Step
Drug class: Contraceptives
ATC class: G03FA10
VA class: HS200
CAS number: 54048-10-1

Introduction

Contraceptives containing synthetic progestinic steroids.^{106 117 119 120 125 a}

Uses for Progestins

Contraception

Prevention of conception in women.^{117 119 120 125 a}

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

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.¹¹⁷

Postcoital (Emergency) Contraception

Prevention of conception after unprotected intercourse (including known or suspected contraceptive failure) as an emergency contraceptive (“morning-after” pills). ^{101 102 106 126 127 128 129 130 132 133 136 137} Postcoital (emergency) contraceptive regimens are not as effective as most other forms of long-term contraception; do not use as routine forms of contraception.^{106 126 127 132 133 137}

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; levonorgestrel generally preferred when readily available.^{101 102 126 127 128 129 136}

Progestins Dosage and Administration

Administration

Administer norethindrone orally.^{119 120}

Administer levonorgestrel orally or as an intrauterine system.^{106 117 132 133 137}

Administer etonogestrel implant by sub-Q insertion.¹²⁵

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.^{119 120}

If vomiting occurs soon after a dose, use a back-up method of contraception (e.g., condoms, foam, sponges) for 48 hours.^{119 120}

Available in a mnemonic dispensing package designed to aid the user in complying with the prescribed dosing regimen.^{119 120}

Postcoital (Emergency) Contraception

Plan B One-Step, Next Choice One Dose: Administer as soon as possible but preferably within 72 hours following unprotected sex.^{132 133 137}

Levonorgestrel 2-dose regimen: Administer the first dose as soon as possible within 72 hours of unprotected sex followed by a second dose 12 hours after the first dose.^{101 102 106}

Most data support administration of either regimen up to 120 hours^{† [off-label]} after unprotected intercourse if necessary,^{126 127 128 136} but efficacy decreases as initiation of contraception becomes more remote from unprotected intercourse.^{101 102 103 126 127 128}

May be used at any time during the menstrual cycle.^{106 132} Efficacy not established if administered >120 hours after unprotected sex.^{126 127}

Plan B One-Step, Next Choice One Dose : If vomiting occurs within 2 hours after administration, contact clinician to discuss repeating the dose.^{132 133 137}

Levonorgestrel 2-dose regimen: If vomiting occurs within 2 hours after administration of either the first or second dose, contact clinician to discuss taking another dose.¹⁰⁶

Food not effective in reducing adverse GI effects (i.e., nausea).^{126 127}

Sub-Q Administration

Insert etonogestrel implant (Implanon) subdermally in the inner aspect of the upper arm about 6–8 cm above the elbow crease.¹²⁵ Consult manufacturer’s labeling for proper method of administration and associated precautions.¹²⁵

Intrauterine Administration

Insert levonorgestrel-releasing intrauterine system (Mirena) into the uterine cavity under strict aseptic conditions.¹¹⁷ (See Intrauterine Device Considerations under Cautions.) Consult manufacturer’s labeling for proper methods of inserting and removing the intrauterine system and for associated precautions.¹¹⁷

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.^{117 119 120 125}

Adults

Contraception

Oral

Norethindrone: 0.35 mg daily.^{119 120} Take 1 tablet each day and continue daily without interruption.^{119 120} Start on the first day of the menstrual cycle.^{119 120} 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.^{119 120}

Women switching from estrogen-progestin oral contraceptives: Start norethindrone on the day after the last hormonally active tablet.^{119 120}

Women may start using norethindrone tablets on the next day after a miscarriage or an abortion.^{119 120}

Women whose infants are only partially breast-fed may begin norethindrone 3 weeks after delivery.^{119 120} Women who are exclusively breast-feeding their infants may begin 6 weeks after delivery.^{119 120}

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.^{119 120} 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.^{119 120}

Sub-Q

Etonogestrel contraceptive implant (Implanon): One 68-mg implant every 3 years.¹²⁵

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.¹²⁵

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.¹²⁵

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.¹²⁵

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.¹²⁵

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.¹²⁵

The contraceptive implant can be inserted immediately after a first-trimester abortion.¹²⁵ 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.¹²⁵

The contraceptive implant can be inserted 21–28 days after a second-trimester abortion.¹²⁵

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.¹²⁵ The implant can be inserted after the fourth postpartum week in women who are exclusively breast-feeding their infant.¹²⁵ If implant insertion occurs >4 weeks postpartum, use back-up method of contraception for 7 days.¹²⁵

Remove implant 3 years after insertion.¹²⁵ At time of implant removal, may insert another implant to continue therapy.¹²⁵

Intrauterine

Levonorgestrel-releasing intrauterine contraceptive system (Mirena): One system containing 52 mg every 5 years.¹¹⁷

To initiate therapy, insert the intrauterine contraceptive system within 7 days of menses onset.¹¹⁷

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.¹¹⁷

Do not insert the intrauterine contraceptive system until 6 weeks postpartum or after involution of the uterus is complete.¹¹⁷

Remove the intrauterine contraceptive system after 5 years of use (contraceptive efficacy >5 years not established).¹¹⁷ 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.¹¹⁷

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.¹¹⁷ 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.¹¹⁷

Postcoital (Emergency) Contraception

Oral

Levonorgestrel one-dose regimen (e.g., Plan B One-Step, Next Choice One Dose): Single 1.5-mg dose taken as soon as possible within 72 hours of unprotected intercourse.^{132 133 137}

Levonorgestrel 2-dose regimen: 0.75-mg dose taken as soon as possible within 72 hours of unprotected intercourse, followed by a second 0.75-mg dose 12 hours after the first dose.^{101 102 106 126 127}

If necessary, the first dose of either the single or 2-dose regimen can be administered up to120 hours^{† [off-label]} after unprotected intercourse,^{126 127 128} but efficacy decreases the longer initiation of contraception is delayed.^{101 102 103 126 127 128 129}

Repeated postcoital (emergency) contraception use indicates need for counseling about other contraceptive options.^{126 131} Safety of recurrent use not established but risk appears low, even within same menstrual cycle.^{126 127} Consider possibility that risk of adverse effects (e.g., menstrual irregularities) may be increased with frequently repeated postcoital contraception.¹²⁶

FDA has approved Plan B One-Step for OTC status for women of childbearing potential regardless of age.^{133 134 135 136} Next Choice One Dose is a prescription-only preparation for women <17 years of age and an OTC preparation for women ≥17 years of age.^{132 137}

Cautions for Progestins

Contraindications

• Known or suspected pregnancy.^{106 117 119 120 125 132 133 137}

• Undiagnosed vaginal bleeding.^{117 119 120 125}

• Known or suspected breast cancer.^{117 119 120 125}

• Benign or malignant liver tumor.^{117 119 120 125}

• Liver disease.^{117 119 120 125}

• Current or past history of thrombosis or thromboembolic disorders.¹²⁵

• Levonorgestrel-releasing intrauterine contraceptive system also is contraindicated in women with uterine abnormalities that distort the uterine cavity (e.g., fibroids), PID or history of PID (unless there has been a subsequent intrauterine pregnancy), postpartum endometritis or infected abortion in the past 3 months, untreated acute cervicitis or vaginosis, conditions associated with immune compromise (e.g., HIV, leukemia, IV drug abuse), a previously inserted IUD still in place, genital actinomycosis, history of ectopic pregnancy or predisposition for ectopic pregnancy, known or suspected uterine or cervical neoplasia, abnormal Papanicolaou test (Pap smear), and in women with multiple sexual partners or whose partners have multiple sexual partners.¹¹⁷

• Postcoital (emergency) contraception: Currently no real contraindication to postcoital (emergency) contraception with recommended levonorgestrel regimens and benefits generally outweigh any theoretical or proven risk.^{126 127 131}

• Hypersensitivity to the drug or any ingredient in the formulation.^{117 119 120 125 133 137}

Warnings/Precautions

Warnings

Ectopic Pregnancy

Consider the possibility of ectopic pregnancy if pregnancy or severe lower abdominal pain occurs in women using progestin contraception, including those using postcoital (emergency) regimens.^{106 117 119 120 125 132 133 137} Follow-up physical or pelvic examination recommended if there are questions about general health or pregnancy status of women after levonorgestrel administration.^{106 132} Current evidence does not support increased risk of ectopic pregnancy after use of levonorgestrel for postcoital (emergency) contraception in the general population; rather, preventing pregnancy overall actually reduces absolute risk.¹²⁶ Postcoital contraception with levonorgestrel can be used in women with history of ectopic pregnancy.^{106 131 132}

Existing Pregnancy

Levonorgestrel 0.75 or 1.5 mg used for postcoital (emergency) contraception is not effective in terminating an existing pregnancy.^{106 132 133 137}

Ovarian Follicles

Possible delayed atresia of ovarian follicles, resulting in follicular enlargement.^{117 119 120 125} Follicular enlargement generally is asymptomatic or associated with mild abdominal pain and resolves spontaneously; in rare cases, surgery may be required.^{117 119 120 125}

Bleeding Irregularities

Possible breakthrough bleeding or irregular vaginal bleeding.^{117 119 120 125} Perform adequate diagnostic tests in patients with undiagnosed vaginal bleeding.^{117 119 120 125} Rule out pregnancy in patients with amenorrhea.^{117 119 120 125} If pregnancy occurs, discontinue therapy.^{117 119 120 125}

Postcoital (emergency) contraception: Irregular vaginal bleeding also possible with postcoital contraceptive regimens;^{106 126 132} rule out pregnancy if menses is delayed >7 days after anticipated onset.^{106 132}

Carcinoma of Breast and Reproductive Organs

Insufficient data to determine whether use of progestin-only contraceptives is associated with an increased risk of breast cancer or cervical carcinoma.^{117 119 120 125} (See Contraindications under Cautions.)

Hepatic Effects

Insufficient data to determine whether use of progestin-only contraceptives is associated with increased risk of hepatocellular carcinoma.^{119 120} (See Contraindications and also see Hepatic Impairment under Cautions.)

Implant Considerations

Carefully follow recommended procedures for insertion and removal of implant to minimize potential for complications.¹²⁵

If infection develops at insertion site, initiate appropriate treatment; if infection persists, remove the implant.¹²⁵

Intrauterine Device Considerations

Evaluate women for suitability (i.e., exclude pregnancy; evaluate for genital infections, risk for ectopic pregnancy, and/or PID) prior to insertion of levonorgestrel-releasing intrauterine device.¹¹⁷ Insert the device under strict aseptic conditions.¹¹⁷

Possible complications include intrauterine pregnancy with the device in place; if this occurs, remove device to reduce possibility of complications to the woman (e.g., septicemia, septic shock, death) and fetus (e.g., miscarriage, sepsis, premature labor, premature delivery).¹¹⁷ Long-term effects unknown if pregnancy is continued with the intrauterine device in place.¹¹⁷ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Sepsis following insertion of the device reported rarely.¹¹⁷ Increased risk of infective endocarditis in women with valvular or congenital heart disease and in those with surgically constructed systemic-pulmonary shunts; prophylactic anti-infective therapy recommended at time of insertion for women with congenital heart disease.¹¹⁷

Other complications include penetration or embedment of the device in the myometrium and perforation of the uterus or cervix.¹¹⁷

Fetal/Neonatal Morbidity and Mortality

Congenital abnormalities reported infrequently in neonates born to women with a levonorgestrel-releasing intrauterine device in place during the pregnancy.¹¹⁷

Thromboembolic Disorders

Thromboembolic events (i.e., pulmonary embolism, stroke) reported in patients using etonogestrel implant (Implanon).¹²⁵

General Precautions

Physical Examination and Follow-up

Annual medical history and physical examination advised with long-term progestin therapy.^{117 119 120 125} Physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician.^{119 120} Physical examination not required prior to initiating therapy with oral levonorgestrel for postcoital (emergency) contraception.^{106 126 132} Perform complete medical examination prior to initiating therapy with etonogestrel implant or levonorgestrel-releasing intrauterine system.^{117 125} Exercise particular care in women with family history of breast cancer or those who have breast nodules.¹²⁵

Metabolic Effects

Slight deterioration in glucose tolerance and increases in plasma insulin reported.^{117 119 120 125} Monitor prediabetic and diabetic patients.^{106 117 119 120 125}

Altered lipid metabolism (decreased HDL, HDL₂, apolipoprotein A-I and A-II; increased hepatic lipase) noted; no change in total cholesterol, LDL, VLDL, or HDL₃ observed.^{119 120} Closely monitor women with hyperlipidemia.¹²⁵

Ocular Effects

Obtain ophthalmologist assessment for contact lens wearers who develop visual disturbances or changes in lens tolerance.¹²⁵

Depression

Exercise caution in women with a history of depression; discontinue if severe depression recurs during use.¹²⁵

Headache

Discontinue contraceptive and evaluate cause if migraine occurs or is exacerbated, or when new headache pattern develops that is recurrent, persistent, or severe.^{119 120}

HIV and STDs

Does not protect against HIV infection or other sexually transmitted diseases (STDs).^{106 127 131 132 133 137}

Fertility Following Use

Rapid return of fertility likely following levonorgestrel use for emergency contraception.^{106 132} Continue or initiate routine methods of contraception as soon as possible following levonorgestrel to ensure ongoing pregnancy prevention.^{106 132}

Specific Populations

Pregnancy

Levonorgestrel-releasing intrauterine contraceptive system (Mirena): Category X.¹¹⁷

Rule out pregnancy prior to initiating therapy.^{117 119 120 125} Rule out pregnancy in patients with amenorrhea.^{117 119 120 125} If pregnancy occurs, discontinue therapy.^{117 119 120 125}

Postcoital (emergency) contraception: No need to rule out pregnancy with postcoital contraceptive regimens.^{126 127 128 136} Postcoital contraceptive regimens (i.e., levonorgestrel, estrogen-progestins regimens) do not exhibit abortifacient properties^{126 127 128} and do not interrupt pregnancy once endometrial implantation has occurred.^{106 126 127 128 132} No known harm to pregnant woman, course of pregnancy, or fetus from postcoital contraceptive regimens.^{126 127 128 131 136}

Most studies have revealed no effects on fetal development associated with long-term use of oral progestin contraceptives.^{106 119 120 126 127 128}

Lactation

Small amounts of progestins are distributed into milk.^{106 117 119 120 125 132} Adverse effects, such as jaundice, reported rarely in infants.¹²⁰

Postcoital (emergency) contraception: Breast-feeding can continue without restriction during postcoital contraceptive regimens.¹³¹

Pediatric Use

Safety and efficacy of progestin contraceptives established in women of reproductive age.^{106 117 119 120 125 132} Safety and efficacy of long-term progestin contraceptives expected to be identical for postpubertal adolescents <16 years of age and women ≥16 years of age.^{119 120 125 128} Safety and efficacy of progestin emergency contraceptives expected to be identical for postpubertal adolescents <17 years of age and women ≥17 years of age.^{106 132} Not indicated before menarche.^{106 117 119 120 125 132}

Geriatric Use

Progestin contraceptives not evaluated in women >65 years of age; not indicated for use in postmenopausal women.^{106 117 125 132}

Hepatic Impairment

Steroid hormones (including oral contraceptives) may be poorly metabolized in patients with hepatic dysfunction; use with caution in those individuals.¹²⁵ (See Contraindications under Cautions.)

Postcoital (emergency) contraception: No precautions appear necessary with short-term postcoital contraceptive regimens; benefits outweigh any theoretical or known risk.^{126 131}

Common Adverse Effects

Norethindrone tablets: Bleeding irregularities (e.g., frequent or irregular bleeding), headache, breast tenderness, nausea, dizziness.^{119 120}

Levonorgestrel tablets: Nausea, abdominal pain, fatigue, headache, menstrual changes (e.g., heavier or lighter menstrual bleeding), dizziness, breast tenderness.^{106 126 127 128 129 132} Postcoital (emergency) contraceptive regimens better tolerated with levonorgestrel than with estrogen-progestins.^{126 127 128 129 136}

Etonogestrel implants: Bleeding irregularities (e.g., frequent, heavy, or prolonged bleeding, spotting).¹²⁵

Levonorgestrel-releasing intrauterine system: Abdominal pain, leukorrhea, headache, vaginitis, back pain, breast pain, acne, depression, hypertension, upper respiratory infection, nausea, nervousness, dysmenorrhea, weight increase, skin disorder, decreased libido, abnormal Pap smear, sinusitis.¹¹⁷

Drug Interactions

Specific Drugs

Progestins Pharmacokinetics

Absorption

Bioavailability

Levonorgestrel: Rapidly absorbed following oral administration with peak plasma concentrations achieved in 1.6–1.7 hours.^{106 132} Bioavailability is about 100%.¹⁰⁶

Norethindrone: Rapidly absorbed following oral administration with peak plasma concentrations achieved in 1–2 hours.^{119 120}

Etonogestrel: Approximately 100% bioavailable following sub-Q administration.¹²⁵ Following sub-Q insertion of etonogestrel implant, the drug is released at a rate of 60–70 mcg/day at week 5–6, 35–45 mcg/day at the end of year one, 30–40 mcg/day at the end of year two, and 25–30 mcg/day at the end of year three.¹²⁵ Peak serum concentrations achieved in a few weeks following insertion of the implant.¹²⁵

Levonorgestrel: Following insertion of a levonorgestrel-containing intrauterine system, drug is released into the uterine cavity at a rate of 20 mcg/day; rate of drug release decreases over time to about 10 mcg/day after 5 years of use.¹¹⁷

Food

Effect of food on oral bioavailability not studied.^{106 120 132}

Distribution

Extent

Distributed into human milk.^{117 119 120 125}

Plasma Protein Binding

Levonorgestrel: About 97.5–99% bound to serum proteins, mainly sex hormone binding globulin (SHBG) and to a lesser extent, albumin.^{106 132}

Norethindrone: 61% bound to albumin and 36% bound to SHBG.¹²⁰

Etonogestrel: 66% bound to albumin and 32% bound to SHBG.¹²⁵

Elimination

Metabolism

Etonogestrel is metabolized in the liver by CYP3A4.¹²⁵

Norethindrone is metabolized mainly by reduction, followed by sulfate and glucuronide conjugation.¹²⁰

Elimination Route

Progestins are excreted in urine and feces, principally as metabolites and glucuronide and sulfate conjugates.^{106 117 119 120 125 132}

Half-life

Levonorgestrel (single oral dose): 24.4–27.5 hours.^{106 132}

Norethindrone (single oral dose): Approximately 8 hours.¹²⁰

Etonogestrel: Approximately 25 hours.¹²⁵

Stability

Storage

Oral

Tablets

Levonorgestrel: 20–25°C.^{106 132 133 137}

Norethindrone: 25°C (may be exposed to 15–30°C).^{119 120}

Implant

Etonogestrel implant (Implanon): 25°C (may be exposed to 15–30°C).¹²⁵ Protect from light; avoid direct sunlight.¹²⁵

Actions

• Progestin contraceptives produce contraceptive effects by suppressing ovulation, thickening cervical mucus (thus inhibiting sperm migration into the uterus), lowering mid-cycle LH and FSH peaks, slowing ovum movement through the fallopian tubes, and/or alteration of the endometrium.^{117 119 120 125 126 127 a}

• Progestin contraceptives administered after intercourse (postcoital) produce contraceptive effects by inhibiting or delaying ovulation or fertilization.^{106 126 132} Recent evidence suggests that any endometrial effects are insufficient to prevent implantation.^{126 127} Effects on ovulation alone cannot explain efficacy of postcoital (emergency) contraceptive; interference of sperm transport or penetration and/or impairment of corpus luteum function proposed as contributing factors.^{126 127} Only effective before pregnancy is established; not effective after implantation of a fertilized ovum.^{106 126 127 128 132}

Advice to Patients

• Importance of reading the manufacturer’s patient information.^{106 117 119 120 125 132}

• Importance of taking progestin-only oral contraceptives at the same time each day, without interruption (including during all bleeding episodes).^{119 120}

• Importance of using a backup method of contraception (e.g., condoms, spermicides) for each sexual encounter during the next 48 hours when a progestin-only oral contraceptive dose is ≥3 hours late.^{119 120}

• Levonorgestrel 2-dose regimen for postcoital (emergency) contraception: Importance of scheduling the initial dose as soon as possible (within 72 hours after intercourse) and of taking the second dose 12 hours after the initial dose.¹⁰⁶

• Postcoital (emergency) contraception: Therapy can be initiated up to 120 hours^{† [off-label]} after intercourse if necessary, but advise of decreased efficacy as time from intercourse to initiation of contraception increases.^{126 127 128}

• Postcoital (emergency) contraception: Importance of consulting clinician about alternative methods of contraception if postcoital contraception is used repeatedly.^{126 127 131}

• Importance of informing women that progestin-only contraceptives, like all nonbarrier contraceptive methods, do not protect against HIV infection or other sexually transmitted diseases.^{106 117 119 120 125 132 133 137}

• Importance of advising patients of anticipated menstrual effects.^{117 119 120 125}

• Importance of women informing a clinician if prolonged (i.e., >8 days) or unusually heavy bleeding, amenorrhea, or severe abdominal pain occurs.^{117 119 120 125}

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.^{117 119 120 125} Nursing women can continue to breast-feed without restriction during postcoital (emergency) contraceptive regimens.¹³¹

• Importance of women informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.^{117 119 120 125}

• Importance of informing patients of other important precautionary information.^{117 119 120 125} (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

FDA has approved Next Choice One Dose for OTC status for women ≥17 years of age;¹³⁷ the contraceptive remains a prescription-only preparation for women <17 years of age.¹³²

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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