Paroxetine

Indications
 Oral
Depression
Adult: 20 mg daily, increase gradually, if necessary, by 10-mg increments wkly; max: 50 mg/day.
Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily.
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Oral
Obsessive compulsive disorder
Adult: Initially, 20 mg daily, increase wkly in 10-mg increments. Maintenance: 40-60 mg daily.
Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily.
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Oral
Panic disorder with or without agoraphobia
Adult: Initially, 10 mg daily, increase wkly in 10-mg increments according to clinical response. Maintenance: 40-60 mg daily.
Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily.
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Oral
Social anxiety disorder
Adult: Initially, 20 mg daily, increase after several wk by 10-mg increments; max dose: 50-60 mg/day.
Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily.
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Oral
Anxiety
Adult: Initially, 20 mg daily, increase in wkly increments of 10 mg; max dose: 50 mg/day.
Elderly: Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily.
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Oral
Posttraumatic stress disorder
Adult: 20 mg daily, may be increased in 10-mg increments if necessary; max dose: 50 mg/day.
Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily.
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Oral
Premenstrual dysphoric disorder
Adult: As hydrochloride, modified-release preparation: Initially, 12.5 mg once daily, usually in the morning; may increase up to 25 mg once daily after at least 1 wk, if necessary; given throughout the menstrual cycle or limited to the luteal phase.
Elderly: Initially, 10 mg daily, increase if needed by 10 mg/day at 1 wk intervals; max: 40 mg daily.
Renal impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.
Hepatic impairment: Hepatic impairment: Severe: 10 mg daily, increase to a max of 40 mg daily as necessary.

Special Populations: Patient with severe renal/hepatic impairment: 10 mg daily.
Contraindications
 Use with or within 14 days of MAOIs; concurrent use with thioridazine or pimozide.
Warnings / Precautions
 Epilepsy, glaucoma, history of mania, cardiac disease, DM, history of bleeding disorders, on drugs with increased risk of bleeding; renal and hepatic impairment; patients receiving electroconvulsive therapy; achlorhydria or high gastric pH (reduced absorption of oral suspension). Pregnancy and lactation. The risk of suicidal behaviour may be higher in young adults, closely monitor. May impair ability to drive or perform tasks. Avoid abrupt withdrawal.
Adverse Reactions
 Somnolence, insomnia, headache, dizziness; decreased libido; nausea, xerostomia, constipation, diarrhoea; ejaculatory disturbances; weakness, tremor, diaphoresis; vasodilation, chest pain, palpitation, hypertension, tachycardia, nervousness, anxiety , agitation, abnormal dreams, impaired concentration, yawning, depersonalisation, amnesia, emotional lability, vertigo, confusion, chills; rash, pruritus; orgasmic disturbance, dysmenorrhoea; anorexia, decreased appetite, dyspepsia, flatulence, abdominal pain, appetite increased, vomiting, taste perversion, weight gain; impotence, genital disorder, urinary frequency, UTI; paresthesia, myalgia, back pain, myoclonus, myopathy, myasthenia, arthralgia; blurred vision, abnormal vision; tinnitus; respiratory disorder, pharyngitis, sinusitis, rhinitis; infection.
Overdose Reactions
 Somnolence, nausea, vomiting, hepatic dysfunction, drowsiness, sinus tachycardia, urinary retention, renal failure (acute), dilated pupils, convulsions, status epilepticus, ventricular arrhythmias (including torsade de pointes), serotonin syndrome and manic reaction. No specific antidotes; treatment is supportive; cardiac monitoring is recommended.
Drug Interactions
 Levels/effects inhibited by cyproheptadine, phenytoin. Levels/effects increased by carbamazepine, cimetidine, CYP2D6 inhibitors (e.g. chlorpromazine, delavirdine, fluoxetine, miconazole, pergolide, quinidine, quinine, ritonavir, ropinirole). Increases levels/effects of atomoxetine, carvedilol, clozapine, CYP2B6 substrates (e.g. bupropion, promethazine, propofol, selegiline, sertraline), CYP2D6 substrates (e.g. amphetamines, selected beta-blockers, dextromethorphan, fluoxetine, lidocaine, mirtazapine, nefazodone, risperidone, ritonavir, thioridazine, TCAs, venlafaxine), duloxetine, galantamine, mexilitine, pimozide, procyclidine, propafenone. Decreases levels/effects of CYP2D6 prodrug substrates (e.g. codeine, hydrocodone, oxycodone, tramadol). Inhibits the metabolism of dextromethorphan, haloperidol, thioridazine. Enhances bradycardic effect of beta-blockers. Enhances toxic effects of other CNS depressants. Increased risk of serotonin syndrome with amphetamines, SSRIs, meperidine, nefazodone, trazodone, serotonin agonists, sibutramine, sympathomimetics, tramadol, venlafaxine. Increases risk of bleeding with NSAIDs, aspirin, warfarin, or other drugs affecting coagulation. Increases sensitivity to amphetamines. Neurotoxicity with lithium. Additive hyponatraemia with loop diuretics. Mania or hypertension with selegiline.
Potentially Fatal: Fatal reactions with nonselective MAOI.
See Below for More paroxetine Drug Interactions
Food Interactions
 Peak concentration increased; bioavailability not significantly altered. Avoid valerian, St John's wort, SAMe, kava kava. Ethanol may increase CNS depression.
Mechanism of Actions
 Paroxetine selectively inhibits the reuptake of serotonin. It has limited direct action at other neurotransmitter sites including muscarinic receptors.
Absorption: Absorbed readily from the GI tract (oral); peak plasma concentrations after 5 hr.
Distribution: Enters breast milk. Protein-binding: 95%.
Metabolism: Extensive hepatic first-pass metabolism; by oxidation followed by methylation then formation of glucuronide and sulfate conjugates.
Excretion: Via urine (64%) and faeces (36%), mainly as metabolites; elimination half-life: 21 hr.
Administration
 May be taken with or without food. (May be taken w/ meals to minimise GI upset.)
Storage Conditions
 Oral: Store at ≤25°C for suspensions or 15-30°C for tablets.
ATC Classification
 N06AB05 - paroxetine ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Storage
 Oral: Store at ≤25°C for suspensions or 15-30°C for tablets.
Available As
  • Paroxetine 10 mg
  • Paroxetine 12.5 mg
  • Paroxetine 20 mg
  • Paroxetine 25 mg
  • Paroxetine 30 mg
  • Paroxetine 37.5 mg
  • Paroxetine 40 mg

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