IV. Background

V. Safety

  1. Pregnancy
    1. Most commonly used SSRI in pregnancy, and preferred agent
    2. Low first trimester pregnancy risk
      1. But has been associated with increased risk of atrial and ventricular defects and Craniosynostosis
      2. BĂ©rard (2015) Am J Obstet Gynecol 212(6):795.e1-795.e12 +PMID: 25637841 [PubMed]
  2. Lactation
    1. Consider safe in Lactation (poorly secreted into Breast Milk)

VI. Preparations

  1. Tablets (Scored): 25, 50, 100 mg
  2. Oral concentrate: 20 mg/ml (60 ml bottle)

VII. Dosing

  1. Start
    1. Children (ages 6-12 years of age): 25 mg orally each morning
    2. Adults (and children over age 12): 50 mg orally each morning
    3. Elderly: 25 mg orally each morning
  2. Titrate
    1. Adults: Increase by 50 mg every 2 weeks
    2. Maximum: 200 mg per day

VIII. Drug Interactions

  1. Significantly raises Pimozide levels
    1. Concurrent use with Pimozide is contraindicated
  2. Metabolized by Cytochrome P450 2C9, 2C19, 2D6 and 3A4
  3. Moderate Cytochrome P450-2D6 Inhibitor
  4. Also inhibits Cytochrome P450-2C and P450-3A4
    1. Clinically Significant interactions are uncommon
  5. Highly Protein bound
    1. Interacts with other Protein bound medications (but does not appear to significantly affect their drug levels)
  6. Absorption affected by food intake
  7. Raises Tricyclic Antidepressant levels
  8. Allow two week wash-out prior to starting MAO Inhibitor

IX. Pharmacokinetics

  1. Half Life: 1 to 4 days
  2. Therapeutic Blood level 9.5 to 56 ng/ml

X. Adverse Effects

  1. See Antidepressant Adverse Effects
  2. Increased risk of Gastrointestinal Bleeding
  3. Neutral on the sedation to excitation continuum
    1. Less sedating than Paxil or Luvox
  4. Anxiety, Insomnia or other sleep disturbance
    1. Less stimulating than Prozac
    2. Consider Trazodone (Desyrel) at bedtime
  5. Diarrhea or gastrointestinal upset
    1. Diarrhea more common than with Fluoxetine
    2. Usually resolves within 2 weeks
  6. Sexual Dysfunction may be more common
    1. Includes decreased libido
    2. See Antidepressant Induced Sexual Dysfunction
  7. Antidepressant Withdrawal symptoms on stopping
    1. Taper 50 mg per every 5-7 days
    2. Taper to 25-50 mg daily before stopping

XII. References

  1. (2023) Med Lett Drugs Ther 62(1592): 25-32
  2. Olson (2020) Clinical Pharmacology, Medmaster Miami, p. 38-9
  3. Hamilton (2020) Tarascon Pocket Pharmacopoeia

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