II. Mechanism
III. Indications
IV. Safety
- Unknown safety in Lactation (per AAP)
- However, undetectable in Breast Milk
- Considered ACOG L2 (safer), but often avoided due to Teratogenic effect if patient becomes pregnant
- Pregnancy Category D
- Anencephaly (Odds Ratio 3.2)
- Gastroschisis (Odds Ratio 2.5)
- Omphalocele (Odds Ratio 3.5)
- Right Ventricular Outflow Obstruction (OR 2.4)
- Increased Atrial and Ventricular Septal Defects (Odds Ratio1.8)
- Associated with first trimester exposure
- (2006) Obstet Gynecol 108:1601-3 [PubMed]
- Neonatal antedepressant withdrawal risk
- References
V. Background
VI. Preparations
- Paxil (Paroxetine hydrochloride)
- Generic Paxil is available in United States in 2003
- Tablets (lower doses scored): 10, 20, 30, and 40 mg
- Oral Suspension: 10 mg/5 ml
- Paxil CR Tablets: 12.5, 25, and 37.5 mg
- Marketed as reducing GI upset with standard Paxil
- Must be swallowed whole without chewing
- Brisdelle Capsule (Paroxetine): 7.5 mg
- Released in 2013 specifically targeting Hot Flushes
- Paroxetine 10 mg generic tablet daily is nearly equivalent (at 6% of the Brisdelle cost)
- Pexeva (Paroxetine mesylate)
- Likely has similar activity to Paxil but not proven
- Was significantly less expensive than original trade name Paxil
VII. Dosing: Paroxetine HCl Immediate Release
- Start
- Adults: 20 mg orally at bedtime
- Elderly: 10 mg orally at bedtime
- Titrate
- Adults: Increase by 10 mg every 2 weeks
- Maximum: 60 mg daily
- Limit max to 40 mg daily in elderly, debilitated or severe liver or kidney Impairment
VIII. Dosing: Other Formulations
- Paroxetine Controlled Release (CR)
- Start 12.5 mg orally at bedtime
- May gradually titrate to 25 to 75 mg at bedtime
- Pexeva (Paroxetine mesylate)
- Start 20 mg orally at bedtime
- Titrate to 20 to 50 mg at bedtime
IX. Mechanism
- Selective Serotonin Reuptake Inhibitor (SSRI)
- Increased Norepinephrine reuptake inhibitor activity
- Increased Anticholinergic activity
X. Pharmacokinetics
- Half Life: 1 day (shorter than most other SSRIs)
XI. Drug Interactions
- Metabolized by P450-2D6
- Highly Protein bound
- Interacts with other Protein bound medications
- Strong Cytochrome P450-2D6 Inhibitor
- Contraindicated with MAO Inhibitors (including Linezolid)
- Allow 2 week wash-out prior to starting MAO Inhibitor
- Also contraindicated with Thioridazine, Pimozide, and Tryptophan
- Raises Warfarin (Coumadin) levels and associated INR
- Raises Tricyclic Antidepressant levels
- Cimetidine raises Paroxetine levels
- Paroxetine decreases Phenytoin and Digoxin levels
- Also Exercise caution with Barbiturates, Theophylline, Risperidone, Atomoxetine
- Contraindicated with MAO Inhibitors (including Linezolid)
XII. Adverse Effects
- See Antidepressant Adverse Effects
- Increased risk of Gastrointestinal Bleeding
-
Anticholinergic side effects (Sedation, Constipation)
- Avoid in elderly with cognitive disorders
- Sedating on the sedation to excitation continuum
- Most sedating of the SSRIs (administer at bedtime)
- Some patients may have paradoxical activation
-
Sexual Dysfunction (inhibits nitric oxide synthetase)
- See Antidepressant Induced Sexual Dysfunction
- More common than with Fluoxetine or Sertraline
- Dysesthesia (skin Paresthesias)
- Dry Mouth
- Constipation
-
Antidepressant Withdrawal on stopping medication
- Reduce dose by 10 mg per day every 5-7 days
- Taper down to 5-10 mg before discontinuing
- Less anxiety (more Anxiolytic) than other SSRIs
- Similar to Serzone on this spectrum
- Weight gain
- More common than with Fluoxetine or Sertraline
XIII. Precautions
- Use caution in Pediatric Depression
- Use may be associated with higher Suicide Risk
XIV. Resources
XV. References
- (2023) Med Lett Drugs Ther 62(1592): 25-32
- Olson (2020) Clinical Pharmacology, Medmaster Miami, p. 38-9
- Hamilton (2020) Tarascon Pocket Pharmacopoeia
Images: Related links to external sites (from Bing)
Related Studies
| paroxetine (on 12/21/2022 at Medicaid.Gov Survey of pharmacy drug pricing) | ||
| PAROXETINE CR 12.5 MG TABLET | Generic | $0.84 each |
| PAROXETINE CR 25 MG TABLET | Generic | $0.82 each |
| PAROXETINE CR 37.5 MG TABLET | Generic | $0.72 each |
| PAROXETINE ER 12.5 MG TABLET | Generic | $0.84 each |
| PAROXETINE ER 25 MG TABLET | Generic | $0.82 each |
| PAROXETINE ER 37.5 MG TABLET | Generic | $0.72 each |
| PAROXETINE HCL 10 MG TABLET | Generic | $0.07 each |
| PAROXETINE HCL 20 MG TABLET | Generic | $0.08 each |
| PAROXETINE HCL 30 MG TABLET | Generic | $0.12 each |
| PAROXETINE HCL 40 MG TABLET | Generic | $0.12 each |
| PAROXETINE MESYLATE 7.5 MG CAP | Generic | $3.93 each |
| paxil (on 10/29/2022 at Medicaid.Gov Survey of pharmacy drug pricing) | ||
| PAXIL 10 MG/5 ML SUSPENSION | $1.71 per ml | |
| PAXIL CR 25 MG TABLET | Generic | $0.82 each |