Paroxetine – Usages, Side effects, Risk factors, Precautions
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Paroxetine is an antidepressant SSRIs.
Paroxetine is available with the following brand name.
- Paxil CR
Disorder to treat
It is used for the treatment of the following disorder.
● Panic Disorder
● Social Phobia
● Generalized Anxiety Disorders
● Post-traumatic stress disorder
Forms of Paroxetine
Paroxetine is available in the following form
● Tablet- extended release
● Oral suspension
Paroxetine tablets are available in following doses:
Paroxetine capsule is available in the following dose
● 7.5 mg
Paroxetine tablets, extended-release are available in following doses:
● 37.5 mg
The Oral suspension of paroxetine is available in
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.
Initially 20 mg orally per day. It may increase by 10 mg every week. It should not exceed 60 mg per day
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.
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
20 mg orally per day.
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.
There are the following side effects of paroxetine
- Dry mouth
- Ejaculation disorder
- Blurred vision
- Decreased appetite
- Emotional lability
- Weight gain
- Angle-closure glaucoma
Serious side effects
- Depression exacerbation
- 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)
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.
There are the following contraindications
● Concomitant administration with pimozide or thioridazine.
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.
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.
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.
Excreted in breast milk; use caution (AAP states effect on nursing infants is unknown but may be of concern)
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