Generic Name
Paroxetine HydrochlorideTherapeutic Class: Drugs of Nervous System (SSRIs & related anti-depressant drugs)
Indications:
Paroxetine is indicated for Major Depressive Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder and Posttraumatic Stress Disorder
Presentation:
Paroxetine: Each film-coated tablet contains Paroxetine Hydrochloride Hemihydrate BP equivalent to Paroxetine 20 mg.
Description:
The efficacy of paroxetine in the treatment of major depressive disorder, social anxiety disorder, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, and posttraumatic stress disorder is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin. Studies demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitro radioligand binding studies indicate that paroxetine has little affinity for muscarinic, alpha1-, alpha2-, beta-adrenergic-, dopamine (D2)-, 5-HT1-, 5-HT2-, and histamine (H1)-receptors.
Dosage & Administration:
Major Depressive Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder and Posttraumatic Stress Disorder- Initial dose 20 mg/day, maximum up to 50 mg/day
Obsessive Compulsive Disorder and Panic Disorder- Initial dose 20 mg/day, Maintenance dose: 40 mg/day, Maximum dose: 60 mg/day
Side Effects:
Most common adverse reactions include-somnolence, insomnia, agitation, tremor, anxiety, dizziness, constipation, nausea, diarrhea, dry mouth, flatulence etc. Other rare side-effects include- asthenia, abnormal ejaculation, sweating, impotence, decreased libido etc.
Paroxetine is indicated for Major Depressive Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder and Posttraumatic Stress Disorder
Presentation:
Paroxetine: Each film-coated tablet contains Paroxetine Hydrochloride Hemihydrate BP equivalent to Paroxetine 20 mg.
Description:
The efficacy of paroxetine in the treatment of major depressive disorder, social anxiety disorder, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, and posttraumatic stress disorder is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin. Studies demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitro radioligand binding studies indicate that paroxetine has little affinity for muscarinic, alpha1-, alpha2-, beta-adrenergic-, dopamine (D2)-, 5-HT1-, 5-HT2-, and histamine (H1)-receptors.
Dosage & Administration:
Major Depressive Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder and Posttraumatic Stress Disorder- Initial dose 20 mg/day, maximum up to 50 mg/day
Obsessive Compulsive Disorder and Panic Disorder- Initial dose 20 mg/day, Maintenance dose: 40 mg/day, Maximum dose: 60 mg/day
Side Effects:
Most common adverse reactions include-somnolence, insomnia, agitation, tremor, anxiety, dizziness, constipation, nausea, diarrhea, dry mouth, flatulence etc. Other rare side-effects include- asthenia, abnormal ejaculation, sweating, impotence, decreased libido etc.
Interaction:
- Food/antacids: The absorption and pharmacokinetics of Paroxetine are not affected by food or antacids.
- Tryptophan: As with other 5-HT reuptake inhibitors, animal studies indicate that an interaction between Paroxetine and Tryptophan may occur, resulting in a ‘serotonin syndrome’ suggested by a combination of agitation, restlessness and gastrointestinal symptoms including diarrhoea.
- Drug metabolizing enzyme inducers /inhibitors: The metabolism and pharmacokinetics of Paroxetine may be affected by drugs, which induce or inhibit hepatic drug-metabolizing enzymes. When Paroxetine is to be coadministered with a known drug-metabolizing inhibitor, consideration should be given to using doses at the lower end of the range. No initial dosage adjustment of paroxetine is considered necessary when it is to be co-administered with known drug-metabolizing enzyme inducers. Any subsequent dosage adjustment should be guided by clinical effect (tolerability and efficacy).
- Alcohol: Although Paroxetine does not increase the impairment of mental and motor skill caused by alcohol, the concomitant use of Paroxetine and alcohol in depressed patients is not advised.
- Haloperidol/amylobarbitone/oxazepam: Experience in a limited number of healthy subjects has shown that Paroxetine did not increase the sedation and drowsiness associated with haloperidol, amylobarbitone or oxazepam when given in combination.
- MAOIs: As with other 5-HT reuptake inhibitors, animal studies indicate that an interaction between Paroxetine and monoamine oxidase (MAO) inhibitors may occur.
- Lithium: Since there is little clinical experience, and there have been reports of the interaction of lithium with other 5-HT re-uptake inhibitors, the concurrent administration of Paroxetine and lithium should be undertaken with caution.
- Lithium levels should be monitored. Phenytoin/anticonvulsants: Co-administration of Paroxetine and phenytoin is associated with decreased plasma concentrations of Paroxetine and increased adverse experiences. Co-administration of Paroxetine with other anticonvulsants may also be associated with an increased incidence of adverse experiences.
- Warfarin: Preliminary data suggest that there may be a pharmacodynamic interaction between Paroxetine and warfarin, which may result in increased bleeding in the presence of unaltered prothrombin times. Paroxetine should therefore be administered with great caution to patients receiving oral anticoagulants.
Precautions:
All patients being treated with paroxetine for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
Pregnancy & Lactation:
Pregnancy: Pregnancy Category D.
Nursing mothers: Paroxetine is excreted in human milk. Caution should be exercised when paroxetine is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established.
Use in elderly, renal and hepatic impaired patients
The recommended initial dose is 10 mg/day for elderly patients, and/or patients with severe renal or hepatic impairment. Dosage should not exceed 40 mg/day.
Overdose Effects:
Commonly reported adverse events associated with paroxetine overdosage include somnolence, coma, nausea, tremor, tachycardia, confusion and dizziness.
All patients being treated with paroxetine for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
Pregnancy & Lactation:
Pregnancy: Pregnancy Category D.
Nursing mothers: Paroxetine is excreted in human milk. Caution should be exercised when paroxetine is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established.
Use in elderly, renal and hepatic impaired patients
The recommended initial dose is 10 mg/day for elderly patients, and/or patients with severe renal or hepatic impairment. Dosage should not exceed 40 mg/day.
Overdose Effects:
Commonly reported adverse events associated with paroxetine overdosage include somnolence, coma, nausea, tremor, tachycardia, confusion and dizziness.
Keep out of the reach of children. Store at a cool and dry place. Protect from light and moisture.
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