PAROXETINE HYDROCHLORIDE HEMIHYDRATE

SSRI

Brand names: Paroxetine

Oral

Mechanism of Action

12.1 Mechanism of Action The mechanism of action of paroxetine tablets in the treatment of MDD, SAD, OCD, PD, GAD, and PTSD is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT).

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS Paroxetine tablets are contraindicated in patients: Taking
• or within 14 days of stopping
• MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 )
• Drug Interactions ( 7 )]. Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions ( 5.3 )
• Drug Interactions ( 7 )] Taking pimozide because of risk of QT prolongation [see Warnings and Precautions ( 5.3 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone
Meta-analyses of epidemiological studies have shown increased risk (less than 2-fold) of cardiovascular malformations with exposure during the first trimester
1 ) Increased Risk of Bleeding : Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, other antiplatelet drugs, warfarin, and other anticoagulant drugs may increase risk
There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied

Known Side Effects

11 documented side effects by frequency

Drug Not Working

1-10%

Nausea

1-10%

Dizziness

1-10%

Anxiety

1-10%

Fatigue

1-10%

Headache

1-10%

Depression

1-10%

Insomnia

1-10%

Diarrhea

1-10%

Vomiting

0.1-1%

Weight Gain

0.1-1%

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Compare With

12 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral