Apo-Paroxetine

Paroxetine HCl

Symptomatic relief of depressive illness, generalized social phobia (social anxiety disorder) & in patients w/ generalized anxiety disorder (GAD). Symptomatic treatment of obsessive compulsive disorder (OCD), panic disorder (w/ or w/o agoraphobia) & post-traumatic stress disorder (PTSD).

Adult Depression Initially 20 mg once daily in the morning, may be gradually increased to 40 mg once daily in the morning. Max: 50 mg daily. OCD Initially 20 mg once daily in the morning. Recommended dose: 40 mg once daily in the morning. Max: 60 mg daily. Panic disorder Initially 10 mg once daily in the morning. Recommended dose: 40 mg once daily in the morning. Gradual dose increments may be considered. Max: 60 mg daily. Social phobia/social anxiety disorder, GAD & PTSD Initially 20 mg once daily in the morning, may be gradually increased in 10-mg daily increments. Max: 50 mg daily. Elderly &/or debilitated patients, renal or hepatic impairment Initially 10 mg once daily in the morning. Max: 40 mg daily.

May be taken with or without food: May be taken w/ meals to minimise GI upset. Swallow whole, do not chew.

Hypersensitivity. Combination w/ MAOI or w/in 2 wk of terminating treatment w/ MAOIs; thioridazine, pimozide.

Long-term use. Rigorously monitor patients for suicidal ideation or potential suicidal behaviour including agitation-type emotional & behavioural changes. Avoid abrupt discontinuation of therapy. Sexual dysfunction symptoms. Patients w/ other psychiatric disorders; epilepsy; history of seizures or mania/hypomania. Akathisia may occur w/in the 1st few wk of treatment. Discontinue treatment & initiate supportive symptomatic treatment if serotonin syndrome & neuroleptic malignant syndrome occurs; not to be used w/ serotonin-precursors. Patients at risk of hyponatraemia. Patients w/ history of bleeding disorders or conditions which may predispose to bleeding; metabolic & hemodynamic diseases; w/ recent history of MI or unstable heart disease; narrow-angle glaucoma or history of glaucoma. Patients w/ known bleeding tendency or those w/ predisposing conditions. Concomitant use w/ drugs that increase bleeding risk (eg, anticoagulants, NSAIDs & acetylsalicylic acid); electroconvulsive therapy; neuroleptics. May impair ability to drive or operate machinery. Renal & hepatic impairment. Pregnancy & lactation. Childn <18 yr. Elderly.

Nausea, somnolence, sweating, tremor, asthenia, dizziness, dry mouth, insomnia, constipation, diarrhea, decreased appetite & male sexual dysfunction.

Possible reactions including hyperthermia, rigidity, myoclonus, autonomic instability w/ possible rapid fluctuations of vital signs & mental status changes that include extreme agitation progressing to delirium & coma w/ MAOIs. Prolonged QTc interval w/ thioridazine. Risk of serious ventricular arrhythmias & sudden death potentially associated w/ elevated plasma levels of thioridazine. Risk of serotonergic syndrome w/ serotonin-precursors (eg, MAOIs, L-tryptophan, oxitriptan). Increased levels w/ cimetidine. Decreased plasma levels & potential increased incidence of adverse experiences w/ anticonvulsants (eg, carbamazepine, phenytoin, Na valproate). Avoid alcohol intake. Decreased systemic availability by phenobarb. Increased bioavailability w/ procyclidine. Potential increased free conc resulting in adverse events w/ highly protein-bound drugs. Caution during co-administration w/ lithium & sumatriptan. Elevated levels of theophylline. Increased adverse effects w/ St. John's Wort.

Antidepressants

N06AB05 - paroxetine ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.

POM