Paroxetine hydrochloride
Paroxetine hydrochloride (Paxil)
Paroxetine hydrochloride
(pah- ROX-eh-teen)
Pregnancy Category: B Paxil Paxil CR (Rx)

Classification: Antidepressant

See Also: See also Selective Serotonin Reuptake Inhibitors.

Action/Kinetics: Completely absorbed from the GI tract. Time to peak plasma levels: 5.2 hr. Peak plasma levels: 61.7 ng/mL. t 1/2: 21-24 hr. Time to reach steady state: 7-14 days. Plasma levels are increased in impaired renal and hepatic function as well as in geriatric clients. Extensively metabolized in the liver to inactive metabolites. Approximately two-thirds of the drug is excreted through the urine and one-third is excreted in the feces.

Uses: Treatment of major depressive episodes, panic disorder with or without agoraphobia (as defined in DSM-IV), obsessive-compulsive disorders (as defined in DSM-IV), and social anxiety disorder (social phobia, as defined in DSM-IV). The Controlled Release is only for depression. Investigational: Headaches, diabetic neuropathy, premature ejaculation.

Additional Contraindications: Use of alcohol.

Special Concerns: Use with caution and initially at reduced dosage in elderly clients as well as in those with impaired hepatic or renal function, with a history of mania, with a history of seizures, in clients with diseases or conditions that could affect metabolism or hemodynamic responses. Concurrent administration of paroxetine with lithium or digoxin should be undertaken with caution.

Side Effects: The side effects listed were observed with a frequency up to 1 in 1,000 clients.
CNS: Headache, somnolence, insomnia, agitation, seizures tremor, anxiety, activation of mania or hypomania, dizziness, nervousness, paresthesia, drugged feeling, myoclonus, CNS stimulation, confusion, amnesia, impaired concentration, depression, emotional lability, vertigo, abnormal thinking, akinesia, alcohol abuse, ataxia, convulsions, possibility of a suicide attempt depersonalization, hallucinations, hyperkinesia, hypertonia, incoordination, lack of emotion, manic reaction, paranoid reaction. GI: Nausea, abdominal pain, diarrhea, dry mouth, vomiting, constipation, decreased appetite, flatulence, oropharynx disorder (``lump'' in throat, tightness in throat), dyspepsia, increased appetite, bruxism, dysphagia, eructation, gastritis, glossitis, increased salivation, mouth ulceration, rectal hemorrhage abnormal LFTs. Hematologic: Anemia, leukopenia, lymphadenopathy, purpura. CV: Palpitation, vasodilation, postural hypotension, hypertension, syncope, tachycardia, bradycardia, conduction abnormalities, abnormal ECG, hypotension, migraine, peripheral vascular disorder. Dermatologic: Sweating, rash, pruritus, acne, alopecia, dry skin, ecchymosis, eczema, furunculosis, urticaria. Metabolic/Nutritional: Edema, weight gain, weight loss, hyperglycemia, peripheral edema, thirst. Respiratory: Respiratory disorder (cold symptoms or URI), pharyngitis, yawn, increased cough, rhinitis, asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu, sinusitis. GU: Abnormal ejaculation (usually delay), erectile difficulties, sexual dysfunction, impotence, urinary frequency, urinary difficulty or hesitancy, decreased libido, anorgasmia in women, difficulty in reaching climax/orgasm in women, abortion, amenorrhea, breast pain, cystitis, dysmenorrhea, dysuria, menorrhagia, nocturia, polyuria, urethritis, urinary incontinence, urinary retention, vaginitis. Musculoskeletal: Asthenia, back pain, myopathy, myalgia, myasthenia, neck pain, arthralgia, arthritis. Ophthalmologic: Blurred vision, abnormality of accommodation, eye pain, mydriasis. Otic: Ear pain, otitis media, tinnitus. Miscellaneous: Fever, chest pain, trauma, taste perversion or loss, chills, malaise, allergic reaction, carcinoma face edema, moniliasis, anorexia.

Overdose Management: Symptoms: N&V, drowsiness, sinus tachycardia, dilated pupils. Treatment: Establish and maintain an airway. Ensure adequate oxygenation and ventilation. Induction of emesis, lavage, or both; following evacuation, 20-30 g activated charcoal may be given q 4-6 hr during the first 24-48 hr after ingestion. Take an ECG and monitor cardiac function if there is any evidence of abnormality. Provide supportive care with monitoring of VS.

Additional Drug Interactions Antiarrhythmics, Type IC / Possible effect R/T liver breakdown Cimetidine / Paroxetine effect R/T liver breakdown Digoxin / Possible plasma levels Phenobarbital / Possible Paroxetine effect R/T liver breakdown Phenytoin / Possible Paroxetine effect R/T liver breakdown; also, phenytoin levels Procyclidine / Procyclidine dose due to significant anticholinergic effects St. John's wort / Possible CNS depression Theophylline / Theophylline levels

How Supplied: Suspension: 10 mg/5 mL; Tablet: 10 mg, 20 mg, 30 mg, 40 mg; Tablet, Controlled Release: 12.5 mg, 25 mg

Dosage
?Suspension, Tablets Depression.
Adults: 20 mg/day, usually given as a single dose in the morning. Some clients not responding to the 20-mg dose may benefit from increasing the dose in 10-mg/day increments, up to a maximum of 50 mg/day. Make dose changes at intervals of at least 1 week. Maintenance: Doses average about 30 mg/day.
Panic disorders.
Adults, initial: 10 mg/day usually given in the morning; then increase by 10-mg increments each week until a dose of 40 mg/day is reached. Maximum daily dose: 60 mg.
Obsessive-compulsive disorders.
Adults, initial: 20 mg/kg; then increase by 10-mg increments a day in intervals of at least 1 week until a dose of 40 mg/kg is reached. Maximum daily dose: 60 mg.
Social anxiety disorder.
Adults, initial: 20 mg/day, given as a single dose with or without food, usually in the morning. Dose range is 20-60 mg/day.
Headaches.
10-50 mg/day.
Diabetic neuropathy.
10-60 mg/day.
Premature ejaculation in men.
20 mg/day.

NOTE: Geriatric or debilitated clients, those with severe hepatic or renal impairment initial: 10 mg/day, up to a maximum of 40 mg/day for all uses.