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paroxetine hydrochloride

(pah rox' a teen)


Paxil, Paxil CR

Pregnancy Category C

Drug class
Antidepressant

Therapeutic actions
Potentiates serotonergic activity in the CNS, resulting in antidepressant effect.

Indications
• Treatment of major depressive disorder
• Treatment of obsessive-compulsive disorders
• Treatment of panic disorders
• Treatment of social anxiety disorder (social phobia)
• Treatment of generalized anxiety disorder
• Treatment of posttraumatic stress disorder
• Treatment of premenstrual dysphoric disorder (PMDD)
• Unlabeled uses: Treatment of diabetic neuropathy, headaches, premature
ejaculation

Contraindications and cautions


• Contraindicated with MAOI use.
• Use cautiously in the elderly, with renal or hepatic impairment, pregnancy,
lactation, suicidal patients.

Available forms
Tablets—10, 20, 30, 40 mg; CR tablets, 12.5, 25, 37.5 mg; suspension—10 mg/5 mL

Dosages
ADULTS
• Depression: 20 mg/day PO as a single daily dose. Range: 20–50 mg/day. Or 25–
62.5 mg/day CR tablet.
• Obsessive-compulsive disorder: 20 mg/day PO as a single dose, may increase in
10-mg/day increments; do not exceed 60 mg/day.
• Panic disorder: 10 mg/day, increase in increments of 10 mg/wk; usual range: 10–
60 mg/day. Or 12.5–75 mg/day CR tablet; do not exceed 75 mg/day.
• Social anxiety disorder: 20 mg/day PO as a single dose in the morning. May
increase up to 60 mg/day or 37.5 mg/day CR form.
• Generalized anxiety disorder: 20 mg/day PO as a single daily dose. Range: 20–
50 mg/day.
• PMDD: 12.5 mg/day PO as a single dose in the morning. Range, 12.5–25 mg/day.
• Posttraumatic stress disorder: 20 mg/day as a single dose. Range: 20–50 mg/day
PO.
• Switching to or from an MAOI: At least 14 days should elapse between
discontinuation of MAOI and initiation of paroxetine therapy; similarly, allow 14
days between discontinuing paroxetine and beginning MAOI.
PEDIATRIC PATIENTS
Safety and efficacy not established.
GERIATRIC PATIENTS OR PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT
10 mg/day PO; do not exceed 40 mg/day. Or, 12.5 mg/day PO of CR tablets; do not
exceed 50 mg/day.

Pharmacokinetics
Route Onset
Oral Slow

Metabolism: Hepatic; T1/2: 24 hr


Distribution: Crosses placenta; enters breast milk
Excretion: Urine

Adverse effects
• CNS: Somnolence, dizziness, insomnia, tremor, nervousness, headache, anxiety,
paresthesia, blurred vision
• CV: Palpitations, vasodilation, orthostatic hypotension, hypertension
• Dermatologic: Sweating, rash, redness
• GI: Nausea, dry mouth, constipation, diarrhea, anorexia, flatulence, vomiting
• GU: Ejaculatory disorders, male genital disorders, urinary frequency
• Respiratory: Yawns, pharyngitis, cough
• Other: Headache, asthenia

Interactions
Drug-drug
• Increased paroxetine levels and toxicity with cimetidine, MAOIs
• Decreased therapeutic effects of phenytoin, digoxin
• Decreased effectiveness of paroxetine with phenobarbital, phenytoin
• Increased serum levels and possible toxicity of procyclidine, tryptophane,
warfarin
• Risk of serotonin syndrome (hypertension, hyperthermia, mental status changes)
if used with SSRIs

Drug-alternative therapy
• Increased sedative-hypnotic effects with St. John's wort

Nursing considerations
Assessment
• History: Hypersensitivity to paroxetine, lactation, renal or hepatic impairment,
seizure disorder; pregnancy, lactation
• Physical: Orientation, reflexes; P, BP, perfusion; R, adventitious sounds; bowel
sounds, normal output; urinary output; liver evaluation; liver and renal function
tests

Interventions
• Administer once a day in the morning.
• Shake suspension well before using.
• Ensure that patient swallows CR tablets whole; do not cut, crush, or chew them.
• Limit amount of drug given to potentially suicidal patients.
• Abruptly discontinuing drug may result in discontinuation symptoms (agitation,
palpitations); consider tapering.
• Advise patient to avoid using if pregnant or lactating.

Teaching points
• Take this drug exactly as directed and as long as directed. Shake suspension well
before using. Swallow CR tablets whole; do not cut, crush, or chew them.
• Abruptly stopping the drug without tapering the dose may cause symptoms
including agitation and palpitations.
• This drug should not be taken during pregnancy or when nursing a baby; using
barrier contraceptives is advised.
• These side effects may occur: Drowsiness, dizziness, tremor (use caution and
avoid driving or performing other tasks that require alertness); GI upset (eat
frequent small meals, use frequent mouth care); alterations in sexual function.
• Report severe nausea, vomiting; palpitations; blurred vision; excessive sweating.

Adverse effects in Italic are most common; those in Bold are life-threatening.