Paroxetine is an antidepressant that belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).
It treats depression and other mental illnesses by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental and emotional balance.

Category

Chemical class: Phenylpiperidine derivative
Therapeutic class: Antidepressant, antiobsessional, antipanic

Pregnancy category: D

Indications

To treat major depression C.R.
Adults. Initial: 25 mg daily, increased as prescribed and tolerated by 12.5 mg daily every wk. Maximum: 62.5 mg daily. ORAL SUSPENSION,
Adults. Initial: 20 mg daily, increased as prescribed and tolerated by 10 mg daily every wk. Maximum: 50 mg daily. To treat obsessive-compulsive disorder ORAL SUSPENSION,
Adults. Initial: 20 mg daily, increased as prescribed and tolerated by 10 mg daily every wk. Usual: 20 to 60 mg daily. Maximum: 60 mg daily. To treat panic disorder C.R.
Adults. Initial: 12.5 mg daily, increased by 12.5 mg daily every wk as needed. Maximum: 75 mg daily. ORAL SUSPENSION,
Adults. Initial: 10 mg daily, increased as prescribed and tolerated by 10 mg daily every wk. Usual: 10 to 60 mg daily. Maximum: 60 mg daily. To treat social anxiety disorder C.R.
Adults. Initial: 12.5 mg daily, increased by 12.5 mg daily every wk as needed. Maximum: 37.5 mg daily. ORAL SUSPENSION, (HYDROCHLORIDE)
Adults. Initial: 20 mg daily, increased as prescribed and tolerated by 10 mg daily every wk. Usual: 20 to 60 mg daily. Maximum: 60 mg daily. To treat generalized anxiety disorder ORAL SUSPENSION, (HYDROCHLORIDE)
Adults. Initial: 20 mg daily, increased as prescribed and tolerated by 10 mg daily every wk. Usual: 20 to 50 mg daily. Maximum: 60 mg daily. To treat posttraumatic stress disorder ORAL SUSPENSION, (HYDROCHLORIDE)
Adults. Initial: 20 mg daily, increased as prescribed and tolerated by 10 mg daily every wk. Usual: 20 to 50 mg daily. Maximum: 50 mg daily. To treat premenstrual dysphoric disorder C.R.
Adults. Initial: 12.5 mg daily in the morning, increased as needed after 1 wk to 25 mg daily. Or, 12.5 mg daily in the morning only during luteal phase of menstrual cycle (2-wk period before onset of monthly cycle), increased as needed after 1 wk to 25 mg daily in the morning during luteal phase of menstrual cycle.
DOSAGE ADJUSTMENT For patients who are elderly, debilitated, or have creatinine clearance less than 30 ml/min/1.73 m2, initially 10 mg daily; maximum, 40 mg daily. Avoid C.R. form. For patients taking C.R. tablets with creatinine clearance less than 30 ml/ min/1.73 m2, initially 12.5 mg daily; maximum, 50 mg daily. Route Onset Peak Duration P.O. 1–4 wk Unknown Unknown

Mechanism of Action

Exerts antidepressant, antiobsessional, and antipanic effects by potentiating serotonin activity in CNS and inhibiting serotonin reuptake at presynaptic neuronal membrane. Blocked serotonin reuptake increases levels and prolongs activity of serotonin at synaptic receptor sites.

Contraindications

Hypersensitivity to paroxetine or its components,pimozide therapy,use within 14 days of an MAO inhibitor,thioridazine therapy

Interactions

antacids: Hastened release of C.R. paroxetine aspirin, NSAIDs,
warfarin: Increased anticoagulant activity and risk of bleeding astemizole: Increased risk of arrhythmias atomoxetine; risperidone; other metabolized by CYP2D6, such as amitriptyline, desipramine, fluoxetine, imipramine, phenothiazines, tamoxifen, type IC antiarrhythmics: Increased plasma levels of these barbiturates, primidone: Decreased blood paroxetine level
cimetidine: Possibly increased blood paroxetine level cisapride, isoniazid, MAO inhibitors, procarbazine: Possibly serotonin syndrome codeine, haloperidol, metoprolol, perphenazine, propranolol, risperidone, thioridazine: Decreased metabolism and increased effects of these cyproheptadine: Decreased paroxetine effects dextromethorphan: Decreased dextromethorphan metabolism and increased risk of toxicity digoxin: Possibly decreased digoxin effects encainide, flecainide, propafenone,
quinidine: Potentiated toxicity of these fosamprenavir, ritonavir: Decreased plasma paroxetine level lithium: Possibly increased blood paroxetine level, increased risk of serotonin syndrome methadone: Decreased methadone metabolism, increased risk of adverse effects
phenytoin: Possibly phenytoin toxicity pimozide: Increased risk of prolonged QT interval procyclidine: Increased blood procyclidine level and anticholinergic effects serotonergic such as linezolid, St. John’s wort, tramadol, triptans, and tryptophan: Increased risk of serotonin syndrome tamoxifen: Decreased tamoxifen effectiveness
theophylline: Possibly increased blood theophylline level and risk of toxicity thioridazine: Increased thioridazine level, possibly leading to prolonged QT interval and life-threatening ventricular arrhythmias
tramadol: Increased risk of serotonin syndrome and seizures tricyclic antidepressants: Increased metabolism and blood antidepressant levels; increased risk of toxicity, including seizures

Side Efect

CNS: Agitation, akathisia, asthenia, confusion, decreased concentration, dizziness, drowsiness, emotional lability, hallucinations, headache, insomnia, mania, neuroleptic malignant syndrome, psychomotor agitation, restlessness, serotonin syndrome, somnolence, suicidal ideation, tremor
CV: Palpitations, tachycardia
EENT: Blurred vision, dry mouth, rhinitis, taste perversion
GI: Abdominal cramps or pain, anorexia, constipation, diarrhea, flatulence, nausea, vomiting
GU: Decreased libido, difficult ejaculation, impotence, sexual dysfunction, urine retention
MS: Back pain, myalgia, myasthenia, myopathy
SKIN: Diaphoresis, rash
Other: Weight gain or loss

Cautions

Shake oral suspension well. Measure with an oral syringe or calibrated device.

Don’t give enteric-coated form with antacids.

Watch for akathisia (inner sense of restlessness) and psychomotor agitation, especially during the first few weeks of therapy.

Watch patient closely (especially children, adolescents, and young adults), for suicidal tendencies, particularly when therapy starts and dosage changes, because depression may worsen temporarily during these times, possibly leading to suicidal ideation.

Watch for mania, which may result from any antidepressant in a susceptible patient.

Monitor patient closely for evidence of GI bleeding, especially if patient also takes a drug known to cause GI bleeding, such as aspirin, an NSAID, or warfarin.
WARNING Monitor patient closely for serotonin syndrome exhibited by agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, or diarrhea. Notify prescriber immediately because serotonin syndrome may be lifethreatening, and provide supportive care.
WARNING Be aware that serotonin syndrome in its most severe form may resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, and autonomic instability with possibly rapid changes in vital signs and mental status. Stop drug immediately, and provide supportive care.

To minimize

Side Efect

, expect to taper drug rather than stopping abruptly.

PATIENT SAFTY

Advise patient to take paroxetine in the morning to minimize insomnia and to take it with food if adverse GI reactions develop.

Instruct patient to avoid taking C.R. paroxetine within 2 hours of an antacid.

Tell patient to swallow C.R. tablets whole and not to cut, crush, or chew them.

Suggest that patient avoid hazardous activities until drug’s CNS effects are known.

Tell family or caregiver to observe patient closely for suicidal tendencies, especially when therapy starts or dosage changes and especially if patient is a child, teenager, or young adult.

Explain that full effect may take 4 weeks.

Urge patient to avoid alcohol during therapy; effects with paroxetine are unknown. paroxetine 795 P

Tell patient not to take aspirin or NSAIDs during therapy because they increase the risk of bleeding. If patient takes warfarin, tell her to use bleeding precautions and to notify prescriber at once if bleeding occurs.

Inform patient that episodes of acute depression may persist for months or longer and that they require continued follow-up.

Instruct patient not to stop drug abruptly but to taper dosage as instructed.

Alert female patients of childbearing age that paroxetine may cause birth defects and persistent pulmonary hypertension in the newborn if taken during the first trimester of pregnancy. Stress the need for effective contraception and to notify prescriber if pregnancy occurs or is suspected.

Caution patient to alert all prescribers about paroxetine therapy because of potentially serious drug interactions.

Trade Name & Company Name

Trade name	Company name
SEROXAT TAB 20MG	SMIITHKLINE BEECHAM
PAROXAT 10 MG FC TABLETS	SPIMACO
PAROXAT 20 MG FC TABLETS	SPIMACO
PAROXAT 30MG FC TABLETS	SPIMACO

effect of Paroxetine in Pregnancy, Fetal Health and Breast feeding

Pregnancy

. Depression is common during and after pregnancy, but typically goes unrecognized.

Pregnancy

is not a reason a priori to discontinue psychotropic drugs. There are no adequate reports or well-controlled studies of paroxetine in pregnant women. About 2=3 of women taking SSRIs during

Pregnancy

for major depression must increase their dose to maintain efficacy. Women should not feel compelled to stop paroxetine when they become pregnant if therapy is indeed indicated. If, after receiving appropriate evidence-based information, they decide to stop, it should be tapered gradually to avoid the abrupt discontinuation syndrome. There is growing clinical experience with the use of paroxetine for the treatment of postpartum depression. Paroxetine is also effective for the treatment of menopause-associated hot flashes.

Fetal Health

There are no adequate reports or well-controlled studies in human fetuses. Paroxetine crosses the human placenta, achieving a mean F:M ratio approximating 0.5, a value significantly 852 lower than that observed with citalopram and fluoxetine. Neonatal withdrawal symptoms are documented. Epidemiologic studies are somewhat mixed and suggest confounding factors are at play. Some larger studies suggest an increase in CV malformations after 1st trimester exposure to paroxetine. The effect is however small, appears dose-dependent (only above a daily dose of 25mg) and the most recent large epidemiological study found no such association. However, the risks may not be only structural. In one follow-up study, blunted facial-action responses were observed among infants exposed prenatally to SSRIs, whereas both prenatal and postnatal exposure was associated with reduced parasympathetic withdrawal and increased parasympathetic cardiac modulation during recovery after an acute noxious event. Given that postnatal exposure via breast milk is extremely low and altered biobehavioral pain reactivity is not associated with levels of maternal reports of depression, these findings suggest possible sustained neurobehavioral outcomes beyond the newborn period. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically.

Breastfeeding

There are no adequate reports or well-controlled studies in nursing women. Paroxetine is excreted into human breast milk with the highest concentrations in the hind milk. However, the levels are variable, and no breastfed child studied to date has had clinically relevant levels detected, suggesting paroxetine is a good selection for Breastfeeding women.

the follwing drugs will increse Paroxetine by inhepiting cyp450

abiraterone ; amiodarone ; bupropion ; celecoxib ; chlorpromazine ; cimetidine ; cinacalcet ; citalopram ; clemastine ; clobazam ; clomipramine ; cocaine ; diethyl-dithiocarbamate ; diphenhydramine ; disulfiram ; doxepin ; duloxetine ; escitalopram ; fluoxetine ; halofantrine ; haloperidol ; hydroxyzine ; levomepromazine ; lorcaserin ; methadone ; metoclopramide ; midodrine ; moclobemide ; panobinostat ; paroxetine ; perphenazine ; promethazine ; quercetin ; quinidine ; ritonavir ; rolapitant ; sertraline ; terbinafine (oral) ; ticlopidine ; tripelennamine ; vemurafenib ;

the follwing drugs will decrease Paroxetine by inhancing cyp450

ethanol ; isoniazid ;

Selective serotonin reuptake inhibitors

Occasional moods of discouragement or sadness are normal and usually pass quickly.
But more severe depression, accompanied by despair, lethargy, loss of sex...

Gen name	Trade name	Catagory name
paroxetine	Brisdelle	Selective serotonin reuptake inhibitors
paroxetine	Paxil	Selective serotonin reuptake inhibitors
paroxetine	Paxil CR	Selective serotonin reuptake inhibitors
paroxetine	Pexeva	Selective serotonin reuptake inhibitors
Paroxetine	PAROXAT 10 MG FC TABLETS
Paroxetine	PAROXAT 20 MG FC TABLETS
Paroxetine	PAROXAT 30MG FC TABLETS
Paroxetine	SEROXAT TAB 20MG

Gen name	trade name	catogry
escitalopram	Lexapro	Selective serotonin reuptake inhibitors
sertraline	Zoloft	Selective serotonin reuptake inhibitors
fluoxetine	Prozac	Selective serotonin reuptake inhibitors
paroxetine	Paxil	Selective serotonin reuptake inhibitors
citalopram	Celexa	Selective serotonin reuptake inhibitors
fluvoxamine	Luvox	Selective serotonin reuptake inhibitors
paroxetine	Paxil CR	Selective serotonin reuptake inhibitors
paroxetine	Brisdelle	Selective serotonin reuptake inhibitors
fluoxetine	Sarafem	Selective serotonin reuptake inhibitors
fluvoxamine	Luvox CR	Selective serotonin reuptake inhibitors
fluoxetine	Prozac Weekly	Selective serotonin reuptake inhibitors
paroxetine	Pexeva	Selective serotonin reuptake inhibitors
fluoxetine	Selfemra	Selective serotonin reuptake inhibitors
fluoxetine	Rapiflux	Selective serotonin reuptake inhibitors