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7/8/2022

Levonorgestrel Oral Tablets (Emergency Contraception)

Products Affected - Description

    • Afterpill tablet, Syzygy Healthcare Solutions, 1.5 mg, 1 count, NDC 64122-0605-01
    • Econtra One-Step tablet, Afaxys Pharma, 1.5 mg, 3 count, NDC 50102-0211-13
    • Econtra One-Step tablet, Afaxys Pharma, 1.5 mg, 6 count, NDC 50102-0211-16
    • My Way tablet, Lupin, 1.5 mg, 1 count, NDC 68180-0852-11
    • Levonorgestrel tablet, Rugby Laboratories, 1.5 mg, 1 count, NDC 00536-1142-63

Reason for the Shortage

    • Afaxys Pharma did not provide a reason for the shortage.
    • Lupin did not provide a reason for the shortage.
    • Rugby did not provide a reason for the shortage.
    • Syzygy Healthcare Solutions did not provide a reason for the shortage.
    • Additional over-the-counter levonorgestrel oral tablets (emergency contraception) may be available from store brands. These companies do not provide availability information.

Available Products

    • Aftera tablet, Foundation Consumer Healthcare, 1.5 mg, 1 count, NDC 69536-0103-88
    • Fallback Solo tablet, Lupin, 1.5 mg, 1 count, NDC 68180-0853-11
    • Option 2 tablet, Perrigo, 1.5 mg, 1 count, NDC 00113-2003-12
    • Plan B One-Step tablet, Foundation Consumer Healthcare, 1.5 mg, 1 count, NDC 69536-0146-19
    • Take Action tablet, Foundation Consumer Healthcare, 1.5 mg, 1 count, NDC 69536-0200-88
    • Levonorgestrel tablet, Xiromed, 1.5 mg, 1 count, NDC 70700-0164-06

Estimated Resupply Dates

    • Afaxys Pharma has Econtra One-Step in 3 and 6 count on back order and the company estimates release dates of mid-August 2022.
    • Lupin has My Way on back order and the company estimates a release date of late-July 2022.
    • Rugby has levonorgestrel 1.5 mg tablets on back order and the company cannot estimate a release date.
    • Syzygy Healthcare Solutions has Afterpill on intermittent back order and the company is allocating to current customers.

Alternative Agents & Management

    • Alternatives to Levonorgestrel for Emergency Contraception1-4
    • Ulipristal (Ella) - prescription only
    • 1. Oral progestin receptor modulator labeled for emergency contraception.
    • 2. Take 30 mg as soon as possible, but within 5 days of unprotected intercourse or contraceptive failure.
    • Ethinyl Estradiol and levonorgestrel combined oral contraceptive pill (off-label use)
    • 1. Safe and effective alternative method for the management of emergency contraception when other methods are not available.
    • 2. Increased adverse effects and decreased efficacy compared with other methods.
    • 3. Take 1 dose followed by a second dose 12 hours later. Begin treatment as soon as possible, but within 5 days of unprotected intercourse or contraceptive failure.
    • 4. Each dose should contain a minimum of ethinyl estradiol 100 mcg (0.1 mg) and levonorgestrel 0.5 mg (eg, 5 tablets containing ethinyl estradiol 0.02 mg and levonorgestrel 0.1 mg once followed by an additional 5 tablets 12 hours later or 4 tablets containing ethinyl estradiol 0.03 mg and levonorgestrel 0.15 once followed by an additional 4 tablets 12 hours later).
    • Copper IUD (off-label use) - prescription only
    • 1. Insert within 5 days of unprotected intercourse or contraceptive failure. May also be inserted beyond 5 days of unprotected intercourse as long as insertion does not occur more than 5 days after ovulation.

References

    1. Curtis KM, Tepper NK, Jatlaoui TC, et al. US medical eligibility criteria for contraceptive use, 2016. MMWR Recomm Rep. 2016b;65(3):1â103.
    2. American College of Obstetricians and Gynecologists (ACOG). Practice bulletin no. 152: emergency contraception. Obstet Gynecol. 2015;126(3):e1-e11.
    3. Upadhya KK; Committee on Adolescence. Emergency contraception. Pediatrics. 2019;144(6):e20193149.
    4. Lexicomp Online: Wolters Kluwer Clinical Drug Information, Inc; 2019.

Updated

Created July 8, 2022 by Anthony Trovato, PharmD, BCPS. © 2022, Drug Information Service, University of Utah, Salt Lake City, UT.

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