Misoprostol

Aka: Misoprostol, Cytotec, PGE1 Gel

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II. Indications

  1. Peptic Ulcer Disease Prevention
    1. See NSAID Gastrointestinal Adverse Effects
    2. Prevents ulcers in those on NSAIDs chronically
  2. Cervical Ripening agent in Pregnancy Labor Induction
  3. Early Pregnancy Loss (<84 days)
  4. Termination of Pregnancy (<77 days)

III. Mechanism

  1. Misoprostol is a Prostaglandin E1 Analog
    1. Misoprostol is a pro-drug, that when taken orally is de-esterified to its active acid
  2. Effects
    1. Gastric Mucosa Protection by Prostaglandin replacement
    2. Cervical Ripening and uterine contractions

IV. Medications

  1. Misoprostol (Cytotec)

V. Dosing: Prevention of NSAID-induced Peptic Ulcer Disease

  1. See NSAID Gastrointestinal Adverse Effects
  2. Option 1: 100 to 200 mcg four times daily with food
  3. Option 2: 200 mcg orally twice daily with food
    1. Better tolerated than four times per day dosing

VI. Dosing: Obstetrics and Gynecology

  1. Cervical Ripening
    1. See Cervical Ripening for pregnancy dosing
    2. Misoprostol 50 mcg per vagina every 6 hours (or 25 mcg every 3 hours)
    3. Monitor for uterine hyperstimulation and Fetal Heart Rate
    4. Avoid after prior Cesarean Section, Multigravida (>=5 prior pregnancies)
      1. Risk of Uterine Rupture
  2. Early Pregnancy Loss (<84 days) or Termination of Pregnancy (<77 days)
    1. See Early Pregnancy Loss (includes precautions and monitoring protocol)
    2. Misoprostol Dosing Protocol
      1. Vaginal (or rectal)
        1. Place 800 mcg (4 tablets) intravaginally at 24-48 hours after Mifepristone
        2. Lie supine for 30 minutes after dose
      2. Buccal Dosing may be used in place of vaginal dosing
        1. Place two of the 200 mcg Misoprostol tablets on each side of the mouth (total 800 mcg)
        2. Allow tablets to dissolve over 30 minutes
      3. Efficacy improves if followed by second dose Misoprostol 800 mcg 4 hours after first
    3. Strong uterine cramping and heavier Vaginal Bleeding follows Misoprostol dose
      1. Onset within several hours
      2. Persists for 3-5 hours
      3. Lighter Vaginal Bleeding may persist for 9-16 days
    4. Adjunctive medications
      1. NSAIDs
      2. Heating pad

VII. Pharmacokinetics

  1. Rapid oral absorption
  2. Serum level peaks within 30 min of oral dose
  3. Elimination half life (including metabolites): <2 hours

VIII. Safety

  1. Pregnancy Category X
  2. Avoid in Lactation

IX. Adverse Effects

  1. See Misoprostol Poisoning
  2. When used orally (poorly tolerated)
    1. Diarrhea
    2. Nausea
    3. Vomiting
    4. Abdominal cramping
    5. Flatulence
  3. Gynecologic symptoms (800 mcg dosing)
    1. Strong uterine cramping
    2. Vaginal Bleeding heavier than typical Menses

X. Efficacy: Peptic Ulcer Disease reduction

  1. Dosing qid: 4% Peptic Ulcer Disease recurrence
  2. Dosing bid: 8% Peptic Ulcer Disease recurrence
  3. Placebo: 16% Peptic Ulcer Disease recurrence
  4. Reference
    1. Raskin (1995) Ann Intern Med 123:344-50 [PubMed]

XI. Resources

  1. Misoprostol (DailyMed)
    1. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f15b41bd-ed36-4908-aba5-f0a019b7a26e

XII. References

  1. MacNaughton (2021) Am Fam Physician 103(8) 473-80 [PubMed]

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Related Studies

Cost: Medications

misoprostol (on 12/21/2022 at Medicaid.Gov Survey of pharmacy drug pricing)
MISOPROSTOL 100 MCG TABLET Generic $0.46 each
MISOPROSTOL 200 MCG TABLET Generic $0.74 each
FPNotebook does not benefit financially from showing this medication data or their pharmacy links. This information is provided only to help medical providers and their patients see relative costs. Insurance plans negotiate lower medication prices with suppliers. Prices shown here are out of pocket, non-negotiated rates. See Needy Meds for financial assistance information. GoodRx is another tool for finding lower drug prices.

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