II. Background

  1. As of 2013 may be purchased by anyone, at any age without a prescription
  2. Previously available from the pharmacy counter without a prescription if age 17 years or older
  3. Ella (ulipristal acetate) still requires a prescription
  4. Generic single dose and split dose Levonorgestrel
    1. Require a prescription for <17 years old (and are kept behind counter for age 17 and over)

III. Indications

  1. Intercourse within last 5 days (<72 hours offers best efficacy)
    1. Sexual Assault
    2. Failure of ongoing contraceptive method (e.g. broken Condom)
    3. Unprotected Intercourse

IV. Mechanism

  1. Semen remain viable for up to 7 days after ejaculation
  2. Emergency Contraception effects
    1. Suppresses Ovulation (Follicular Phase <12 days)
    2. Interception by preventing nidation (post Ovulation)
  3. No impact on implanted fetus!
    1. No increase in Spontaneous Abortion rate
    2. No increase in birth defects
    3. No increase in Ectopic Pregnancy
    4. No Teratogenic or other toxic effects

V. Contraindications

  1. Ongoing Pregnancy (No benefit to use)
  2. Past history of thrombosis
    1. Consider Progesterone only option
  3. Concurrent Focal Migraine
  4. Concurrent Lactation (relative contraindication)

VI. Protocol: Approach

  1. Precautions
    1. FDA and CDC do not direct Emergency Contraception based on weight or BMI (as of 2016)
    2. Guidelines are to offer any of these options
      1. Plan B within 3 days of intercourse OR
      2. Ulipristal within 5 days of intercourse OR
      3. Copper-T IUD
    3. Recommendations listed below are based on expert opinion and differ from FDA and CDC Guidelines
  2. Intercourse not near time of Ovulation AND BMI < 25 AND weight <165 lb
    1. Single dose Plan B - Levonorgestrel method within 3 days of intercourse
  3. Intercourse near time of Ovulation
    1. Single dose Plan B - Levonorgestrel method within 3 days of intercourse AND
    2. Offer copper-T IUD
  4. Body Mass Index (BMI) >25 (but body weight <165 lb)
    1. Single dose Plan B - Levonorgestrel method within 3 days of intercourse AND
    2. Offer copper-T IUD AND
    3. Offer Ulipristal within 5 days of intercourse
  5. Body weight >165 lb
    1. Offer copper-T IUD AND
    2. Offer Ulipristal within 5 days of intercourse
  6. References
    1. Nordt and Swadron in Herbert (2014) EM:Rap 14(8):6

VII. Doses: New single dose Plan B - Levonorgestrel method (preferred)

  1. Preferred
    1. Levonorgestrel 1.5 mg orally for 1 dose (see below)
  2. Efficacy
    1. As effective as Levonorgestrel 0.75 mg x2 doses
  3. Adverse Effects
    1. Fewer side effects than traditional method (below)
    2. Bleeding (up to 31%)
    3. Nausea (15%)
    4. Fatigue (15%)
    5. Abdominal Pain (15%)
    6. Headache (10%)
  4. Precautions
    1. See protocol above
    2. Less effective near Ovulation
    3. Less effective if BMI>25 (and not recommended if weight >165 pounds)
  5. References
    1. von Hertzen (2002) Lancet 360:1803-10 [PubMed]

VIII. Doses: Traditional Yuzpe Method

  1. Background
    1. Levonorgestrel is key component for Contraception
      1. Most options below contain Levonorgestrel
      2. Each Norgestrel pill contains 50% Levonorgestrel
    2. Oral Contraceptive: 2 doses, 12 hours apart
      1. Progesterone: Norgestrel, Levonorgestrel 0.5-0.6 mg
      2. Estrogen is not necessary in Emergency Contraception
  2. General
    1. Do not use Placebo pills!
    2. Start dosing so that both doses are during awake time
  3. Option 1: 100 mcg Estrogen/dose (2 tabs q12h x2 doses)
    1. Ovral 2 white pills (0.5 mg Levonorgestrel/dose)
    2. Ogestrel 2 pills (0.5 mg Levonorgestrel/dose)
    3. Preven 2 blue pills (0.5 mg Levonorgestrel/dose)
      1. Contains a total of 4 Ovral tablets
      2. Least expensive option and includes home UPT
  4. Option 2: 120 mcg Estrogen/dose (4 tabs q12h x2 doses)
    1. Lo/Ovral 4 white pills (0.6 mg Levonorgestrel/dose)
    2. Low-Ogestrel 4 tablets (0.5 mg Levonorgestrel/dose)
    3. Nordette 4 light-orange (0.3 mg Levonorgestrel/dose)
    4. Levlen 4 light-orange (0.3 mg Levonorgestrel/dose)
    5. Triphasil 4 Yellow (0.25 mg Levonorgestrel/dose)
    6. Tri-Levlen 4 Yellow (0.25 mg Levonorgestrel/dose)
    7. Levora 4 white pills (0.3 mg Levonorgestrel/dose)
  5. Option 3: 100 mcg Estrogen/dose (5 tabs q12h x2 doses)
    1. Alesse 5 pink pills (0.25 mg Levonorgestrel/dose)
    2. Levlite 5 pink pills (0.25 mg Levonorgestrel/dose)
  6. Pre-packaged kit
    1. Preven (see Option 1 above)
  7. Antiemetic 1 hour before dose
    1. Used for Estrogen induced Nausea
    2. Over the counter
      1. Meclizine (Dimenhydrinate)
      2. Diphenhydramine (Benadryl)
    3. Presciption Antiemetics
      1. Meclizine (Antivert)
      2. Metoclopramide (Reglan)
      3. Promethazine (Phenergan)
      4. Trimethobenzamide (Tigan)

IX. Preparations: Levonorgestrel only

  1. Available as pre-packaged kit
  2. Plan B (Levonorgestrel only, without Estrogen)
    1. Contains 2 white 0.75 Levonorgestrel tablets
    2. One 0.75 mg tablet taken every 12 hours for 2 doses or two 0.75 tablets once
    3. Available OTC for the trade name Levonorgestrel (and behind the counter for the generic single dose option)
    4. Single dose Levonorgestrel is as effective as divided dose
      1. Cheng (2012) Cochrane Database Syst Rev (8): CD001324 [PubMed]

X. Preparations: Alternative agents

  1. Mifepristone
    1. Dose: 10 mg orally for 1 dose
    2. Less effective than Levonorgestrel
  2. Copper-T Intrauterine Device (IUD)
    1. Placed within 7 days of intercourse
    2. Failure rate is <0.1%
    3. Interferes with fertilization and implantation
    4. Risk includes infection as well as high cost of device and insertion (but no higher risk than standard insertion risks)
    5. Consider for patients wanting both Emergency Contraception as well as long term Contraception
    6. Avoid if high risk for STD such as with Sexual Assault
    7. Mirena IUD, which is Levonorgestrel-releasing, is surprisingly not effective for Emergency Contraception
  3. Ella (ulipristal acetate)
    1. Selective Progesterone receptor modulator (SPRM)
      1. Delays Ovulation as much as 5 days
      2. Effective independent of LH peak (unlike Levonorgestrel)
    2. Dose 30 mg tablet within 5 days of intercourse
    3. Effective in preventing pregnancy in 60%
    4. Consider in Overweight women (especially if over 165-175 pounds)
    5. As effective as Levonorgestrel single dose or split dose if taken within 72 hours of intercourse
    6. More effective than Levonorgestrel when taken at 72 to 120 hours from time of intercourse (but earliest time is best)
    7. Decreased efficacy in BMI >30% (but more effective than Levonorgestrel in that cohort)
    8. Side effects include Headache, Fatigue and Dysmenorrhea
    9. References
      1. Fine (2010) Obstet Gynecol 115(2 pt 1): 257-63 [PubMed]
      2. Glasier (2010) Lancet 375(9714):555-62 [PubMed]

XI. Efficacy

  1. Unprotected intercourse randomly in cycle: >4% pregnancy risk
    1. Risk of pregnancy with Yuzpe method: 2% (on average)
    2. Number Needed to Treat 50 to prevent one pregnancy (43 with the Levonorgestrel only option)
    3. Leung (2012) Phamacotherapy 32(3): 210-21 [PubMed]
  2. Emergency Contraception efficacy depends on dose timing
    1. Dose taken <12 hours from intercourse: 0.5% pregnancy
    2. Dose taken <24 hours from intercourse: 1.5% pregnancy
    3. Dose taken <36 hours from intercourse: 1.8% pregnancy
    4. Dose taken <48 hours from intercourse: 2.5% pregnancy
    5. Dose taken <60 hours from intercourse: 3.1% pregnancy
    6. Dose taken >60 hours from intercourse: 4.0% pregnancy
    7. Piaggio (1999) Lancet 353:721 [PubMed]
  3. Progestin only method is more effective than OCP method
    1. Example: Plan B (Levonorgestrel only)
    2. (1999) Lancet 352:428-33 [PubMed]
  4. Advance EC does not increase unprotected intercourse
    1. Gold (2004) J Pediatr Adolesc Gynecol 17:87-96 [PubMed]
  5. Levonorgestrel has decreased efficacy in weight >165 pounds (and ineffective in weight >175 pounds)
    1. Consider alternative agents listed above
    2. Glasier (2011) Contraception 84(4):363-7 [PubMed]

XII. Adverse Effects

  1. No evidence for Teratogenicity in case of pregnancy
  2. Most adverse effects associated with Estrogen dose
  3. Nausea (30-54%)
  4. Vomiting (15-20%)
  5. Breast tenderness (12-30%)
  6. Other effects
    1. Headache
    2. Fluid retention
    3. Dizziness
    4. Fatigue
  7. Menstrual effects

XIII. Follow-up

  1. Pregnancy Test in 3 weeks if no Menses
  2. Longterm Hormonal Contraception may be initiated following Emergency Contraception
  3. Barrier Contraception (e.g. Condoms) should be used for the first month after taking Ella (ulipristal acetate)

XIV. Patient Information

  1. Consider educating patients about Emergency Contraception at routine health visits
  2. Princeton Hotline in English, Spanish
    1. http://not-2-late.com
    2. 1-800-Not-2-Late
  3. Preven
    1. http://www.preven.com
    2. 1-888-Preven2
  4. Emergency Contraception Newsletters
    1. http://cecinfo/html/updates.htm

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Related Studies (from Trip Database) Open in New Window

Ontology: Emergency Contraception (C0558252)

Concepts Therapeutic or Preventive Procedure (T061)
MSH D044363
SnomedCT 169557001, 146787003, 275813002
English Contraception, Emergency, Emergency Contraception, emergency contraception, contraception emergency, Emergency contraception (procedure), Emergency contraception, Emergency contraception (finding)
French Contraception d'urgence
Norwegian Nødprevensjon, Angrepille, Dagen-derpå-pille
Italian Contraccezione di emergenza
Spanish anticoncepción de urgencia (hallazgo), anticoncepción de urgencia

Ontology: Morning After pill used as contraceptive (C0851160)

Concepts Therapeutic or Preventive Procedure (T061)
SnomedCT 275814008, 146748003, 169514006, 169515007, 146775005, 169542008, 146747008, 102954005
English "Morning after pill, Prescribed postcoital OCP, Contraception;morn after pill, morning after pill, after morning pill, after morning pills, Morning After pill used as contraceptive, "Morning after" pill, "Morning after" pills given (situation), Morning-after pill, Prescribed postcoital oral contraceptive pill (procedure), Prescribed postcoital oral contraceptive pill (finding), Morning after pill (finding), "Morning after" pills given, Morning after pill, Morning after pill method of contraception, Prescribed postcoital oral contraceptive pill, Postcoital pill, Morning after pill method of contraception (finding), Post coital pills given, morning after pill contraception
Dutch morning-afterpil
French Pilule du lendemain
German Morning-after-Pille
Italian Pillola del giorno dopo
Portuguese Pílula do dia seguinte
Spanish Píldora del día siguiente, píldora poscoital, píldora del día después, píldora del día después (hallazgo), píldora del día siguiente como método anticonceptivo (hallazgo), píldora del día siguiente como método anticonceptivo, píldora poscoital como método anticonceptivo
Japanese 性交後用経口避妊薬, セイコウゴヨウケイコウヒニンヤク
Czech Postkoitální antikoncepce
Hungarian Esemény utáni tabletta