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Paroxetine mesylate

Class
Antidepressants
Subclass
Selective serotonin reuptake inhibitors
Substance name
PARoxetine
Brand names
Pexeva®
Common formulations
Film-coated tablet
See also
Paroxetine hydrochloride CR (Paxil CR®)
Paroxetine hydrochloride (Paxil®)
Dosage and administration
Adults patients
Symptomatic relief
Chronic pruritus • Off-label
•
10-20 mg PO daily
Start with 10 mg daily in elderly patients
Pruritus in patients with cancer • Off-label
•
20-40 mg PO daily
Start with 10 mg daily in elderly patients
Treatment
Generalized anxiety disorder
•
20 mg PO qAM
Increase in 10 mg increments weekly depending on tolerability in case of inadequate response. Start with 10 mg daily in elderly patients
Major depressive disorder
•
Start at: 20 mg PO qAM
•
Maintenance: 20-50 mg PO qAM
•
Maximum: 50 mg per day
Titrate in 10 mg increments weekly depending on tolerability. Start with 10 mg daily in elderly patients
OCD
•
Start at: 20 mg PO qAM
•
Maintenance: 20-60 mg PO qAM
•
Maximum: 60 mg per day
Titrate in 10 mg increments weekly depending on tolerability. Start with 10 mg daily in elderly patients
Panic disorder
•
Start at: 10 mg PO qAM
•
Maintenance: 10-60 mg PO qAM
•
Maximum: 60 mg per day
Titrate in 10 mg increments weekly depending on tolerability. Start with 10 mg daily in elderly patients
PTSD
•
Start at: 20 mg PO qAM
•
Maintenance: 20-50 mg PO qAM
•
Maximum: 50 mg per day
Titrate in 10 mg increments weekly depending on tolerability. Start with 10 mg daily in elderly patients
Social anxiety disorder
•
20 mg PO qAM
Start with 10 mg daily in elderly patients
Vasomotor symptoms • Moderate-to-severe
•
7.5 mg PO qHS
Start with 10 mg daily in elderly patients
Body dysmorphic disorder • Off-label
•
Start at: 20 mg PO daily
•
Maintenance: 20-60 mg PO daily
•
Maximum: 100 mg per day
Start with 10 mg daily in elderly patients
Premature ejaculation • Off-label
•
10-40 mg PO daily
Start with 10 mg daily in elderly patients
Alternative
•
20-40 mg PO × 1 3-4 hours before sexual intercourse
Start with 10 mg daily in elderly patients
Premenstrual dysphoric disorder • Off-label
•
Start at: 10-20 mg PO daily
•
Maintenance: 20-30 mg PO daily
•
Maximum: 40 mg per day
Start with 10 mg daily in elderly patients
Indications for use
Labeled indications
Adults
•
Treatment of generalized anxiety disorder
•
Treatment of major depressive disorder
•
Treatment of OCD
•
Treatment of panic disorder
•
Treatment of PTSD
•
Treatment of social anxiety disorder
•
Treatment of vasomotor symptoms (moderate-to-severe)
Children
•
Treatment of OCD
Off-label indications
Adults
•
Symptomatic relief of chronic pruritus
•
Symptomatic relief of pruritus in patients with cancer
•
Treatment of body dysmorphic disorder
•
Treatment of premature ejaculation
•
Treatment of premenstrual dysphoric disorder
Safety risks
Boxed warnings
Suicidal ideation
•
Use extreme caution in patients with major depressive disorder or other psychiatric disorders, particularly in children, adolescents, and young adults. Monitor closely for suicidality and unusual changes in behavior.
Contraindications
Hypersensitivity to paroxetine or its components
Concomitant use of MAOIs
•
Do not use paroxetine with or within 14 days of stopping MAOIs.
Concomitant use of thioridazine or pimozide
Warnings and precautions
Acute angle-closure glaucoma
•
Use caution in patients with untreated anatomically narrow angles.
Akathisia, cognitive difficulties, motor impairment
•
Maintain a high level of suspicion, as paroxetine has been associated with an increased risk for these adverse events.
Antidepressant discontinuation syndrome
•
Do not discontinue abruptly in patients taking the drug for a prolonged period.
Bleeding
•
Use caution in all patients, especially with concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants.
Bone fracture
•
Maintain a high level of suspicion, as antidepressants, including SSRIs, have been associated with an increased risk of bone fracture.
Decreased serum sodium
•
Use caution in all patients, especially in the elderly and in patients with volume depletion or taking diuretics.
Decreased serum tamoxifen levels
•
Use caution in patients taking tamoxifen.
Manic or mixed episodes
•
Use caution in patients with bipolar disorder.
Seizure
•
Use caution in patients with seizure disorder.
Serotonin syndrome
•
Use caution in patients taking other serotonergic agents.
Sexual dysfunction
•
Maintain a high level of suspicion, as SSRIs have been associated with decreased libido, erectile dysfunction, and ejaculatory delay or failure in males, and decreased libido and delayed or absent orgasm in females.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 30 mL/min
•
Start at dose of 10 mg daily. Maximal dose of 40 mg per day. Titrate slowly.
Renal replacement therapy
Continuous renal replacement
•
Dose as in CrCl < 30 mL/min.
Intermittent hemodialysis
•
Dose as in CrCl < 30 mL/min.
Peritoneal dialysis
•
Dose as in CrCl < 30 mL/min.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
Start at dose of 10 mg daily. Maximal dose of 40 mg per day. Titrate slowly.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Do not use. Evidence of fetal harm in humans.
Breastfeeding
Use only if benefits outweigh potential risks.
Low levels in breastfed infants (5-25%).
May potentially cause adverse effects in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Antidepressant discontinuation syndrome, ↓ serum sodium, diaphoresis, asthenia, constipation, ↓ libido, diarrhea, dizziness, dry mouth, ejaculation difficulties, headache, insomnia, nausea, somnolence, tremor
Common 1-10%
•
Lethargy, fatigue, malaise, anorgasmia, anxiety, blurred vision, erectile dysfunction, itching, mood changes, loss of appetite, nervousness, palpitations, paresthesia, skin rash, urinary frequency, tinnitus, vomiting, yawning, rhinitis
Uncommon < 1%
•
Seizure, tachycardia
Unknown frequency
•
Toxic epidermal necrolysis, syndrome of inappropriate antidiuretic hormone secretion, anaphylaxis, bone fracture, cerebral hemorrhage, tardive dyskinesia, acute angle-closure glaucoma, renal failure, priapism, pulmonary hypertension, serotonin syndrome, ventricular arrhythmia, weight loss, gastrointestinal bleeding, bleeding, akathisia, bruxism, dystonia, myoclonus, aggressive behavior, depression, hallucinations, mania, suicidal ideation
Interactions
Drug(s)
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