Paroxetine hydrochloride

[pah-ROX-eh-teen] Pregnancy Category: B Paxil [Rx]

Classification: Antidepressant, selective serotonin reuptake inhibitor

Action/Kinetics: Inhibits neuronal reuptake of serotonin in the CNS resulting in potentiation of serotonergic activity in the CNS. It appears to have weak effects on neuronal uptake of norepinephrine and dopamine. Has no anticholinergic effects, does not cause orthostatic hypotension, produces a slight sedative effect. Completely absorbed from the GI tract. Time to peak plasma levels: 5.2 hr. Peak plasma levels: 61.7 ng/mL. tV2: 21 hr. Time to reach steady state: About 10 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), and obsessive-compulsive disorders (as defined in DSM-III-R). Non-FDA Approved Uses: Headaches, diabetic neuropathy, premature ejaculation.

Contraindications: Use in clients taking MAO inhibitors. 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, and during lactation. Concurrent administration of paroxetine with lithium or digoxin should be undertaken with caution. Safety and efficacy have not been determined in children.

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 hypo-mania, dizziness, nervousness, pa-resthesia, drugged feeling, myoclo-nus, 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, hyper-tonia, incoordination, lack of emotion, manic reaction, paranoid reaction. Oral: Dry mouth, dysphagia, glossitis, increased salivation, mouth ulceration. GI: Nausea, abdominal pain, diarrhea, vomiting, constipation, decreased appetite, flatulence, oropharynx disorder ("lump" in throat, tightness in throat), dyspepsia, increased appetite, bruxism, eructation, gastritis, rectal hemorrhage, abnormal LFTs. Hematologic: Anemia, leu-kopenia, 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 upper respiratory infection), 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, myasthe-nia, 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 perver sion or loss, chills, malaise, allergic reaction, carcinoma, face edema, mon-iliasis, anorexia.

NOTE: Over 4- to 6-week period, there was evidence of adaptation to side effects such as nausea and dizziness but less adaptation to dry mouth, somnolence, and asthenia.

Drug Interactions Cimetidine / T Effect of paroxetine due to l breakdown by the liver Diazepam / T Half-life of diazepam MAO inhibitors / Possibility of serious, and sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations in VS, and mental status changes including extreme agitation progressing to delirium and coma Phenobarbital / Possible l effect of paroxetine due to T breakdown by the liver

Phenytoin / Possible l effect of pa-roxetine due to T breakdown by the liver; also, paroxetine l levels of phenytoin


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