Generic
Paroxetine Hydrochloride
7 brands available in the market
At a glance
Paroxetine Hydrochloride is an SSRI antidepressant used for the treatment of Major Depressive Disorder, Obsessive Compulsive Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, and Posttraumatic Stress Disorder.
Description
Paroxetine is a selective serotonin reuptake inhibitor (SSRI). Its efficacy is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin. Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake.
Indications
- Major Depressive Disorder
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Social Anxiety Disorder
- Generalized Anxiety Disorder
- Posttraumatic Stress Disorder (PTSD)
Therapeutic class
SSRIs & related anti-depressant drugs
Pharmacological class
Selective Serotonin Reuptake Inhibitor (SSRI)
Pharmacology
Paroxetine is an SSRI that increases serotonergic activity by inhibiting neuronal serotonin reuptake in the central nervous system. It has little affinity for muscarinic, alpha1, alpha2, beta adrenergic, dopamine (D2), 5-HT1, 5-HT2, and histamine (H1) receptors.
Mechanism of action
Increases serotonin levels in the brain by inhibiting neuronal serotonin reuptake.
Dosage
Adult Dose (Oral):
- Major Depressive Disorder: Initial 20 mg/day; increase by 10 mg increments up to max 50 mg/day
- OCD: Initial 20 mg/day; target 40 mg/day; max 60 mg/day
- Panic Disorder: Initial 10 mg/day; target 40 mg/day; max 60 mg/day
- SAD, GAD, PTSD: Initial 20 mg/day
- Elderly, debilitated, severe renal/hepatic impairment: 10 mg/day; max 40 mg/day
Pediatric Dose: Safety and efficacy not established.
Administration
- May be taken with or without food; preferably in the morning
- Swallow tablet whole; do not chew, crush or break
- Take at the same time each day
- Do not change dose or stop without consulting your doctor
Missed dose
If you miss a dose, take it as soon as you remember; skip if it's almost time for next dose; do not double the dose.
Side effects
Common Side Effects:
- Nausea
- Fatigue
- Dry mouth
- Loss of appetite
- Increased sweating
- Dizziness
- Nervousness
- Tremor
- Insomnia
- Constipation
- Delayed ejaculation
- Decreased libido
- Erectile dysfunction
Precautions & warnings
- May decrease alertness, affect vision, or cause sleepiness and dizziness; do not drive if these occur
- May take 2-3 weeks to start working
- Do not stop suddenly (withdrawal symptoms may occur); taper over 4 weeks under doctor supervision
- Avoid alcohol (may cause excessive drowsiness)
- Caution in epilepsy; discontinue if seizures occur
- Caution in cardiac conditions
Contraindications
- Use with or within 14 days of MAOIs
- Concurrent use with thioridazine or pimozide
- Hypersensitivity to paroxetine
Drug interactions
- Cyproheptadine, phenytoin: Decrease paroxetine levels/effects
- Carbamazepine, cimetidine, CYP2D6 inhibitors: Increase paroxetine levels/effects
- Increases levels/effects of atomoxetine, carvedilol, clozapine, CYP2B6/2D6 substrates
- Decreases levels/effects of CYP2D6 prodrug substrates (codeine, hydrocodone, oxycodone, tramadol)
- Increased risk of serotonin syndrome with amphetamines, SSRIs, meperidine, nefazodone, trazodone, serotonin agonists, sibutramine, sympathomimetics, tramadol, venlafaxine
- Increased bleeding risk with NSAIDs, aspirin, warfarin
- Neurotoxicity with lithium
- Additive hyponatraemia with loop diuretics
- Mania or hypertension with selegiline
- Potentially fatal: Fatal reactions with nonselective MAOIs
Food interactions
Take with food for better absorption; antacids do not affect absorption.
Use in pregnancy
Use in Pregnancy: Highly unsafe during pregnancy; animal and human studies have shown significant harmful effects to the developing baby.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably unsafe; limited human data suggests the drug may pass into breast milk and harm the baby.
Pediatric use
Safety and efficacy not established in children under 18 years.
Geriatric use
Elderly patients (≥65 years): Initial dose 10 mg/day; increase as needed; max 40 mg/day.
Renal / hepatic impairment
Renal Impairment: Severe renal impairment: 10 mg/day initial; max 40 mg/day.
Hepatic Impairment: Severe hepatic impairment: 10 mg/day initial; max 40 mg/day.
Overdose effects
Overdose treatment: General supportive measures; no specific antidote.
Storage conditions
Store in a cool and dry place, protected from light and moisture; keep out of reach of children.
Chemical structure
Paroxetine Hydrochloride