Paroxetine Tablets

Each scored film coated tablet contains

Paroxetine hydrochloride is the salt of a phenylpiperidine compound, it is an oral psychotropic agent with a chemical structure that is unrelated to other selective serotonin inhibitors. Its antidepressant action is thought to be related to its potent and selective inhibition of serotonin (5- hydroxytryptamine, 5-HT) reuptake in brain neurons.

• Paroxetine is indicated for the treatment of:
• Major depressive disorder (MDD)
• Obsessive compulsive disorder (OCD)
• Generalized anxiety disorder (GAD)
• Panic disorder (PD)
• Social anxiety disorder (SAD)
• Post traumatic stress disorder (PTSD)

• In patients who are hypersensitive to any of the product's ingredients
• Contraindicated in patients on MAOIs, pimozide or thioridazine, also drugs that may cause coagulation such as Aspirin, NSAIDs are associated with a risk of bleeding if concomitantly administered with Paroxetine.
• In pregnancy, benefits should outweigh the risks of using Paroxetine where an increased risk of cardiovascular malformations may occur during the first trimester.

Commonly observed adverse effects associated with the use of Paroxetine are mainly: asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, tremor, nervousness and ejaculatory changes (in clinical trials Paroxetine 20 mg/day exerted a strong delay in intravaginal latency time).

Paroxetine is usually administered in the morning as a single daily dose with or without food according to the following recommended regimen:

• MDD: initially 20 mg with possibility of increasing  10 mg increments per day up to a maximum of 50 mg at an interval of at least one week. Maintenance dose is averaged as 30 mg for a period of up to one year.
• OCD: initially 20 mg with possibility of increasing  10 mg increments per day up to a maximum of 60 mg at an interval of at least one week. Patients are periodically re-assessed to determine the therapeutic regimen.
• PD: initially 10 mg with possibility of increasing 10 mg increments per day up to a maximum of 60 mg at an interval of at least one week. Patients are periodically re-assessed to determine the therapeutic regimen especially discontinuation of therapy in responding patients.
• SAD: initial recommended dosage is 20 mg/ day and up to 60 mg according to severity.
• GAD & PTSD: initially 20 mg with possibility of increasing 10 mg increments per day up to a maximum of 50 mg at an interval of at least one week.

Paroxetine should be used with caution when administered with drugs that may affect the seretonergic neurotransmitter systems, tricyclic antidepressants, phenobarbital, phenytoin, lithium, digoxin, theophylline, fosaprenavir, ritonavir, triptans, cimetidine, drugs affecting hepatic metabolism, drugs metabolized by CYP2D6 and cytochrome CYP344, those highly bound to plasma protein and concomitant use of alcohol.

• Used with caution in patients with a history of mania & suicidal behavior, use of Paroxetine in children and adolescents with MDD & other psychiatric disorders should be closely monitored for unusual behavioral changes.
• Should be discontinued according to a gradual withdrawal regimen in patients who develop seizures. Symptoms associated with drug withdrawal should be carefully monitored by physician and resuming therapy with dosage re-adjustment is considered if necessary.
• Should be carefully monitored if hyponatremia is reported.
• Used with caution in patients with diseases that could affect metabolism or patients with narrow angle glaucoma, recent history of myocardial infarction, severe renal or hepatic impairment.
• Caution should be exercised in patients treated with Paroxetine who operate hazardous machinery until otherwise proven that treatment with the product does not impair their psychomotor performance.

• Store in a cool dry place below 30°C.
• Keep out of reach of children

Boxes of two blisters each contain 10 tablets.