Paroxetine – Usages, Side effects, Risk factors, Precautions

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Paroxetine – Usages, Side effects, Risk factors, Precautions

Here in this post, we are discussing the “Prozac”. You can read usages, side effects, Risk factors, and warning information.  Keep visiting Psychology Roots.

About Paroxetine

Paroxetine is an antidepressant SSRIs. 

Brand name

Paroxetine is available with the following brand name.

  • Paxil
  • Brisdella
  • Paxil CR
  • Pexeva

 Disorder to treat

 It is used for the treatment of the following disorder.

     Depression

     OCD

     Panic Disorder

     Social Phobia

     Generalized Anxiety Disorders

     Post-traumatic stress disorder

 

Paroxetine - Usages, Side effects, Risk factors, Precautions

Paroxetine – Usages, Side effects, Risk factors, Precautions

 Forms of Paroxetine

 Paroxetine is available in the following form

     Tablets

     Capsule

     Tablet- extended release

     Oral suspension

 Tablets

 Paroxetine tablets are available in following doses:

     10mg

     20mg

     30mg

     40mg

 Capsule

 Paroxetine capsule  is available in the following dose

     7.5 mg

 Tablet, extended-release

 Paroxetine tablets, extended-release are available in following doses:

     12.5mg

     25mg

     37.5 mg

 Oral suspension

 The Oral suspension of paroxetine is available in

     10mg/5mL

 Depression

 Initially, 20 mg orally per day paroxetine is prescribed. It may increase by 10 mg per day every week. It should not exceed 50 mg per day.

 Paxil CR: Initially 25 mg orally per day. It may increase by 12.5 mg per day every week. It should not exceed 62.5 mg per day.

 Obsessive-Compulsive Disorder

 Initially 20 mg orally per day. It may increase by 10 mg every week. It should not exceed 60 mg per day

 Panic Disorder

 Initially 10 mg orally per day. It may increase by 10 mg every week (target dose 40 mg/day). It should not exceed 60 mg per day.

OR

Paxil CR: Initially 12.5 mg orally per day. It may increase by 12.5 mg every week. It should not exceed 75 mg per day

 Social Phobia

 20 mg orally per day.

OR

 Paxil CR: Initially,12.5 mg orally per day. It may increase by 12.5 mg every week. It should not exceed 37.5 mg per day.

 Generalized Anxiety Disorder

 Initially, 20 mg orally per day. It may increase by 10 mg every week, up to 50 mg per day doses have been used but no increase in benefit seen at doses >20 mg per day.

 Posttraumatic Stress Disorder

 Initially, 20 mg orally per day. It may increase by 10 mg per week, up to 50 mg per day doses have been used but no increase in benefit seen at doses >20 mg/day.

 Premenstrual Dysphoric Disorder

 Paxil CR: initially 12.5 mg orally per day. It  may increase at 1-week intervals not to exceed 25 mg per day.

 Menopausal Vasomotor Symptoms

 Brisdelle: Indicated to treat moderate-to-severe vasomotor symptoms associated with menopause

Brisdelle: 7.5 mg orally daily at bedtime.

Paxil CR (Off-label): 12.5-25 mg orally per day.

 Side effects

 There are the following side effects of paroxetine

  •  Nausea
  • Dry mouth
  • Asthenia
  • Insomnia
  • Constipation
  • Headache
  • Dizziness
  • Ejaculation disorder
  • Diarrhea
  • Tremor
  • Blurred vision
  • Impotence
  • Paresthesia
  • Anxiety
  • Hypomania
  • Decreased appetite
  • Nervousness
  • Emotional lability
  • Hypertension
  • Vertigo
  • Weight gain
  • Tachycardia
  • Arthralgia
  • Angle-closure glaucoma
  • Pruritus
  • Tinnitus

 Serious side effects

  • Depression exacerbation
  • Akathisia
  • Acute hepatitis (rare)
  • Bone fractures
  • Seizure (rare)
  • Toxic epidermal necrolysis
  • Suicidal thoughts (rare)
  • Stevens-Johnson Syndrome
  • Mania (rare)
  • Bleeding, abnormal (rare)
  • Serotonin syndrome
  • Hyponatremia (rare)
  • Suicide (rare)

 Warnings

In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses.

This increase was not seen in patients aged >24 years; a slight decrease in suicidal thinking was seen in adults >65 years.

 In children and young adults, risks must be weighed against the benefits of taking antidepressants.

 Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during the initial 1-2 months of therapy and dosage adjustments.

 The patient’s family should communicate any abrupt changes in behavior to the healthcare provider.

 Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy.

 This drug is not approved for use in pediatric patients.

 Contraindications

There are the following contraindications

     Hypersensitivity

     Concomitant administration with pimozide or thioridazine.

Cautions

 Clinical worsening and suicidal ideation may occur despite medication in adolescents and young adults (18-24 years)

 Use caution in patients with a history of seizure or suicidal thought/behavior; discontinue therapy in patients who develop seizures.

 In patients with bipolar disorder, treating a a depressive episode may precipitate a mixed/manic episode; prior to initiating treatment, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.

 Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include, nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (eg, paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures; a gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.

Life-threatening serotonin syndrome reported with SNRIs and SSRIs alone; also with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort)

The risk of mydriasis; may trigger an angle-closure attack in patients with angle-closure glaucoma with anatomically narrow angles without a patent iridectomy; avoid use in patients with untreated anatomically narrow angles.

Conflicting evidence regarding the use of SSRIs during pregnancy and increased risk of persistent pulmonary hypertension of the newborn.

Risk of complications such as feeding difficulties, irritability, and respiratory problems reported in neonates exposed to SNRIs/SSRIs late in the third trimester.

Risk of cardiovascular defects in infants whose mothers took drugs during early pregnancy.

Withdraw gradually

Use lower starting dose in renal impairment (CrCl <30 mL/min) or severe hepatic impairment.

In patients with symptomatic hyponatremia, discontinue therapy and institute appropriate medical intervention; elderly patients, patients taking diuretics, and those who are volume-depleted maybe at greater risk of developing hyponatremia with SSRIs.

May cause or exacerbate sexual dysfunction.

Inability to remain still due to feelings of agitation or restlessness reported; may occur within the first few weeks of therapy.

May impair platelet aggregation especially when used in combination with aspirin or NSAIDs; increases the risk of bleeding in patients taking anticoagulants/antiplatelets concomitantly.

Epidemiologic studies on bone fracture risk following exposure to some antidepressants, including SSRIs, have reported an association between antidepressant treatment and fractures; there are multiple possible causes for this observation and it is unknown to what extent fracture risk is directly attributable to SSRI treatment.

Bone fractures reported being associated with antidepressant use.

Consider the risk of serotonin syndrome if administered concomitantly with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort.

Pregnancy

Teratogenic effects: Epidemiologic studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations.

Use late in the third trimester associated with complications in newborns and may require prolonged hospitalization, respiratory support, and tube feeding.

A study of nearly 28,000 women taking SSRIs confirmed 5 previously reported birth defects associated with paroxetine, including heart defects, anencephaly, and abdominal wall defects.

 Persistent pulmonary hypertension of the newborn

 The potential risk of persistent pulmonary hypertension of the newborn (PPHN) when used during pregnancy.

Initial public health advisory in 2006 was based on a single published study; since then, there have been conflicting findings from new studies, making it unclear whether the use of SSRIs during pregnancy can cause PPHN.

FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.

FDA recommendation: FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy and to report any adverse events to the FDA MedWatch program.

Lactation

 Excreted in breast milk; use caution (AAP states effect on nursing infants is unknown but may be of concern)

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