|Systematic (IUPAC) name|
|Trade names||Paxil, Pexeva, Seroxat, Brisdelle, Rexetin|
|Licence data||US FDA:|
|Bioavailability||Extensively absorbed from the GI tract, but extensive first-pass metabolism in the liver|
|Metabolism||Extensive, hepatic (mostly CYP2D6-mediated)|
|Biological half-life||21 hours|
|Excretion||Renal (64%; 2% unchanged and 62% as metabolites), Faecal (36%; <1% unchanged)|
|Molecular mass||329.3 g/mol|
|N (what is this?)|
Paroxetine (also known by the trade names Paxil and Seroxat, among others) is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) type. Paroxetine is used to treat major depression, obsessive-compulsive disorder, panic disorder, social anxiety, posttraumatic stress disorder, generalized anxiety disorder and vasomotor symptoms (e.g. hot flashes and night sweats) associated with menopause in adult outpatients.
Differences between newer antidepressants are usually fairly subtle and mostly confined to side effects. Paroxetine shares the common side effects and contraindications of other SSRIs. Discontinuing paroxetine is associated with a high (7%) risk of withdrawal syndrome. It may be associated with a slightly increased risk of birth defects. Several studies have associated paroxetine with suicidal thinking and behavior in teenagers.
Marketing of the drug began in 1992 by the pharmaceutical company SmithKline Beecham, known since 2000 as GlaxoSmithKline. Generic formulations have been available since 2003 when the patent expired. The United States Department of Justice fined GlaxoSmithKline $3 billion in 2012, including a sum for withholding data on paroxetine, unlawfully promoting it for the under-18s, and preparing an article, following one of its clinical trials, study 329, that misleadingly reported the drug was effective in treating adolescent depression.[n 1]
- 1 Medical uses
- 1.1 Depression
- 1.2 Menopausal hot flashes
- 2 Adverse effects
- 2.1 Suicide
- 2.2 Pregnancy
- 2.3 Discontinuation syndrome
- 3 Overdose
- 4 Interactions
- 5 Pharmacology
- 6 Society and culture
- 6.1 Withdrawal symptoms
- 6.2 Off-label marketing for children
- 6.3 Sales
- 6.4 Trade names
- 7 Research
- 8 Notes
- 9 References
- 10 External links
Paroxetine is primarily used to treat major depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), panic disorder, generalized anxiety disorder (GAD), social phobia/social anxiety disorder, premenstrual dysphoric disorder (PMDD) and menopausal hot flashes.
Paroxetine was the first antidepressant formally approved in the United States for the treatment of panic attacks.
A variety of meta analyses have been conducted to evaluate the efficacy of paroxetine in depression. They have variously concluded that paroxetine is superior or equivalent to placebo and that it is equivalent or inferior to other antidepressants.
Menopausal hot flashes
On June 28, 2013 U.S. FDA approved low dose paroxetine for the treatment of moderate-to-severe vasomotor symptoms (e.g. hot flashes and night sweats) associated with menopause. Randomized controlled trials have shown modest relief in such cases. At the low dose used for menopausal hot flashes side effects are similar to placebo and dose tapering is not required for discontinuation.
Paroxetine shares many of the common adverse effects of SSRIs, including (with the corresponding rates seen in people treated with placebo in parentheses): nausea 26% (9%), diarrhea 12% (8%), constipation 14% (9%), dry mouth 18% (12%), somnolence 23% (9%), insomnia 13% (6%), headache 18% (17%), hypomania 1% (0.3%), blurred vision 4%(1%), loss of appetite 6% (2%), nervousness 5% (3%), paraesthesia 4% (2%), dizziness 13% (6%), asthenia (weakness; 15% (6%)), tremor 8% (2%), sweating 11% (2%) and sexual dysfunction (≥10% incidence). Most of these adverse effects are transient and go away with continued treatment. Central and peripheral 5-HT3 receptor stimulation is believed to result in the gastrointestinal effects observed with SSRI treatment. Compared to other SSRIs it has a lower incidence of diarrhoea, a higher incidence of anticholinergic effects (e.g. dry mouth, constipation, blurred vision, etc.), sedation/somnolence/drowsiness, sexual side effects and weight gain.
Due to reports of adverse withdrawal reactions upon terminating treatment, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency recommends to reduce gradually over several weeks or months if the decision to withdraw is made. See also Discontinuation syndrome (withdrawal).
Mania or hypomania may occur in 1% of patients with depression and up to 12% of patients with bipolar disorder. This side effect can occur in individuals with no history of mania but it may be more likely to occur in those with bipolar or with a family history of mania.
Like other antidepressants, paroxetine may increase the risk of suicidal thinking and behaviour in children and adolescents. The FDA conducted a statistical analysis of paroxetine clinical trials in children and adolescents in 2004, finding an increase in "suicidality" and ideation as compared to placebo; the trend for increased "suicidality" was observed in both trials for depression and for anxiety disorders. In 2015 a paper published in the BMJ that reanalysed the original case notes, argued that in Study 329, assessing paroxetine and imipramine against placebo in adolescents with depression, the incidence of suicidal behavior had been under-reported and efficacy exaggerated for paroxetine.
The American College of Obstetricians and Gynecologists recommends that for pregnant women and women planning to become pregnant, "treatment with all SSRIs or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine use among pregnant women or women planning to become pregnant be avoided, if possible." According to the prescribing information "epidemiological studies have shown that infants born to women who had first trimester paroxetine exposure had an increased risk of cardiovascular malformations, primarily ventricular and atrial septal defects (VSDs and ASDs). In general, septal defects range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve spontaneously. If a patient becomes pregnant while taking paroxetine, she should be advised of the potential harm to the fetus. Unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuing paroxetine therapy or switching to another antidepressant." These conclusions are supported by multiple systematic reviews and meta-analyses that found that, on average, the use of paroxetine during pregnancy is associated with about 1.5–1.7-fold increase in congenital birth defects, in particular, heart defects.
Many psychoactive medications can cause withdrawal symptoms upon discontinuation from administration. Evidence has shown that paroxetine has among the highest incidence rates and severity of withdrawal syndrome of any medication of its class.[medical citation needed] Common withdrawal symptoms for paroxetine include nausea, dizziness, lightheadedness and vertigo; insomnia, nightmares and vivid dreams; feelings of electricity in the body, as well as crying and anxiety.[medical citation needed] Liquid formulation of paroxetine is available and allows a very gradual decrease of the dose, which may prevent discontinuation syndrome. Another recommendation is to temporarily switch to fluoxetine, which has a longer half-life and thus decreases the severity of discontinuation syndrome.
Acute overdosage is often manifested by emesis, lethargy, ataxia, tachycardia and seizures. Plasma, serum or blood concentrations of paroxetine may be measured to monitor therapeutic administration, confirm a diagnosis of poisoning in hospitalized patients or to aid in the medicolegal investigation of fatalities. Plasma paroxetine concentrations are generally in a range of 40–400 μg/L in persons receiving daily therapeutic doses and 200–2000 μg/L in poisoned patients. Postmortem blood levels have ranged from 1–4 mg/L in acute lethal overdose situations. It is usually considered, along with the other SSRIs, sertraline and fluoxetine to be a low-risk drug in cases of overdose.
Interactions with other drugs acting on the serotonin system or impairing the metabolism of serotonin may increase the risk of Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reaction. Such reactions have been observed with SNRIs and SSRIs alone, but particularly with concurrent use of triptans, MAO inhibitors, antipsychotics or other dopamine antagonists.
The prescribing information states that paroxetine should "not be used in combination with an MAOI (including linezolid, an antibiotic which is a reversible non-selective MAOI), or within 14 days of discontinuing treatment with an MAOI", and should not be used in combination with pimozide, thioridazine, tryptophan, or warfarin.
Paroxetine interacts with the following cytochrome P450 enzymes:
- CYP2D6 for which it is both a substrate and a potent inhibitor.
- CYP2B6 (strong) inhibitor.
- CYP3A4 (weak) inhibitor.
- CYP1A2 (weak) inhibitor.
- CYP2C9 (weak) inhibitor.
- CYP2C19 (weak) inhibitor.
Paroxetine is the most potent and one of the most specific selective serotonin (5-hydroxytryptamine, 5-HT) reuptake inhibitors (SSRIs). It also binds to the allosteric site of the serotonin transporter, similarly, but less potently than escitalopram. This activity of the drug on brain neurons is thought to be responsible for its antidepressant effects. Paroxetine inhibits the reuptake of norepinephrine more than the other SSRIs, just as sertraline inhibits the reuptake of dopamine more than the other SSRIs.
Its affinities are as follows:
- SERT (Ki = 0.08 nM)
- NET (Ki = 56.7 nM)
- DAT (Ki = 573.7 nM)
- The following muscarinic acetylcholine receptors (mAChRs):
- M1 (Ki=186 nM)
- M2 (Ki=340 nM)
- M3 (Ki=80 nM)
- M4 (Ki=320 nM)
- M5 (Ki=650 nM)
- α1 adrenoceptor (Ki>100,000 nM)
- Histamine H1 receptor (Ki=22,000 nM)
Society and culture
GlaxoSmithKline has paid substantial fines, paid settlements in class action lawsuits, and become the subject of several highly critical books in relation to its marketing of paroxetine, in particular the off-label marketing of paroxetine for children, the suppression of negative research results relating to its use in children, and allegations that it failed to warn consumers of substantial withdrawal effects associated with use of the drug.
In 2002 the U.S. FDA published a warning regarding "severe" discontinuation symptoms among those terminating paroxetine treatment, including paraesthesia, bad dreams, and dizziness. The Agency also warned of case reports describing agitation, sweating, and nausea. In connection with a Glaxo spokesperson's statement that withdrawal reactions occur only in 0.2% of patients and are "mild and short-lived", the International Federation of Pharmaceutical Manufacturers Associations said GSK had breached two of the Federation's codes of practice.
Paroxetine prescribing information posted at GlaxoSmithKline now acknowledges the occurrence of a discontinuation syndrome, including serious discontinuation symptoms.
Off-label marketing for children
In early 2004, GSK agreed to settle charges of consumer fraud for $2.5 million. The legal discovery process also uncovered evidence of deliberate, systematic suppression of unfavorable Paxil research results. One of GSK's internal documents had said, "It would be commercially unacceptable to include a statement that efficacy [in children] had not been demonstrated, as this would undermine the profile of paroxetine".
In 2012 the U.S. Justice Department announced that GSK had agreed to plead guilty and pay a $3 billion fine, in part for promoting the use of Paxil for children.
In 2007, paroxetine was ranked 94th on the list of bestselling drugs, with over $1 billion in sales. In 2006, paroxetine was the fifth-most prescribed antidepressant in the United States retail market, with more than 19.7 million prescriptions. In 2007, sales had dropped slightly to 18.1 million but paroxetine remained the fifth-most prescribed antidepressant in the U.S.
Aropax, Brisdelle, Deroxat, Paxil, Pexeva, Paxtine, Paxetin, Paroxat, Paraxyl, Sereupin and Seroxat.
Several studies have suggested that paroxetine can be used in the treatment of premature ejaculation. In particular, intravaginal ejaculation latency time (IELT) was found to increase with 6–13-fold, which was somewhat longer than the delay achieved by the treatment with other SSRIs (fluvoxamine, fluoxetine, sertraline, and citalopram). However, paroxetine taken acutely ("on demand") 3–10 hours before coitus resulted only in a "clinically irrelevant and sexually unsatisfactory" 1.5-fold delay of ejaculation and was inferior to clomipramine, which induced a fourfold delay.
There is also evidence that paroxetine may be effective in the treatment of compulsive gambling and hot flashes.
Benefits of paroxetine prescription for diabetic neuropathy or chronic tension headache are uncertain.
Although the evidence is conflicting, paroxetine may be effective for the treatment of dysthymia, a chronic disorder involving depressive symptoms for most days of the year.
- United States Department of Justice, July 2012: "The United States alleges that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy."
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|Wikimedia Commons has media related to Paroxetine.|
- List of international brand names for paroxetine
- Detailed Paroxetine Consumer Information: Uses, Precautions, Side Effects from medlibrary.org
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- 1. 成人における双極性障害：抗うつ剤による大うつ病の治療 bipolar disorder in adults treating major depression with antidepressants
- 2. 成人における単一恐怖に対する薬物療法 pharmacotherapy for specific phobia in adults
- 3. 成人における初期治療に不応の線維筋痛症の治療 treatment of fibromyalgia in adults not responsive to initial therapies
- 4. 成人における単極性うつ病および選択的セロトニン再取り込み阻害剤（SSRIs）：
薬理学、投与方法、および副作用 unipolar depression in adults and selective serotonin reuptake inhibitors ssris pharmacology administration and side effects
- 5. 妊娠女性におけるうつ病：管理 depression in pregnant women management
- Involvement of organic cation transporter 2 inhibition in potential mechanisms of antidepressant action.
- Wang K1, Sun S1, Li L1, Tu M1, Jiang H2.
- Progress in neuro-psychopharmacology & biological psychiatry.Prog Neuropsychopharmacol Biol Psychiatry.2014 Aug 4;53:90-8. doi: 10.1016/j.pnpbp.2014.03.005. Epub 2014 Mar 20.
- Novel antidepressants or treatment strategies that may offer a more rapid onset of action, improved efficacy, and greater tolerability are in desperate need. Because current clinically utilized antidepressants, which target high-affinity transporters for serotonin and norepinephrine, fail to provide
- PMID 24657329
- Acute toxicity of 8 antidepressants: What are their modes of action?
- Minguez L1, Farcy E2, Ballandonne C3, Lepailleur A3, Serpentini A4, Lebel JM4, Bureau R3, Halm-Lemeille MP3.
- Chemosphere.Chemosphere.2014 Aug;108:314-9. doi: 10.1016/j.chemosphere.2014.01.057. Epub 2014 Feb 14.
- Currently, the hazard posed by pharmaceutical residues is a major concern of ecotoxicology. Most of the antidepressants belong to a family named the Cationic Amphipathic Drugs known to have specific interactions with cell membranes. The present study assessed the impact of eight antidepressants belo
- PMID 24534154
- An investigation of Temperament and Character Inventory items for predicting the response to paroxetine treatment in patients with major depressive disorder.
- Tomita T1, Ishioka M1, Kaneda A1, Sugawara N1, Nakagami T1, Nakamura K1, Yasui-Furukori N2.
- Journal of affective disorders.J Affect Disord.2014 Aug;165:109-13. doi: 10.1016/j.jad.2014.04.076. Epub 2014 May 4.
- BACKGROUND: Previous studies have reported associations between Temperament and Character Inventory (TCI) dimension scores and the response to treatment in patients with major depressive disorder (MDD). We aimed to determine which TCI items could predict the response to treatment with paroxetine in
- PMID 24882186
- 宿輪 哲生,石川 博士
- 日本皮膚科学会雑誌 121(8), 1601-1606, 2011-08
- NAID 40018897472
- 石蔵 文信
- 心身医学 51(7), 644-649, 2011-07-01
- … 男性更年期外来を受診する患者は,気分障害や不安障害を伴うことが多い.そこで,当院の男性更年期外来を受診し,paroxetine(SSRI)を長期投与した患者108例の経過について,1年以内に治療が終了した症例(短期終了群),1年以上治療後に終了した症例(長期終了群),現在も治療中である症例(継続群)に分けて検討した.各群の患者背景については,Self-rating Depression Scale(SDS)スコアが長期終了群で他の群より有意に低かったが,年齢,特性不 …
- NAID 110008673141
- 中込 私も大学病院ですが、私の施設では単剤治療を重視していますから、 Paroxetine の用量については十分量である30mg以上、は使おうということで、20mgでしばらく待つ ということはあまりない。ただうつ病の場合、効果があ ...
- Summary The metabolism of paroxetine is accomplished in part by cytochrome CYP2D6. Coadministration of paroxetine with other drugs that are metabolized by this isozyme should be approached with caution. Due to the risk of ...
- Paroxetine is a prescription medication used to treat depression, panic disorder, hot flashes related to menopause, and... ... Tell your doctor about all the medicines you take including prescription and non-prescription medicines ...
|拡張検索||「paroxetine hydrochloride hydrate」|
- 1. 本剤の成分に対し過敏症の既往歴のある患者
- 2. MAO阻害剤を投与中あるいは投与中止後２週間以内の患者(「相互作用」及び「重大な副作用」の項参照)
- 3. チオリダジンを投与中の患者
- 4. ピモジドを投与中の患者
三環系抗うつ薬 tricyclic antidepressant
- 1. (急性作用)シナプス前膜におけるノルアドレナリン、セロトニンの再取り込み↓→シナプス間隙における薬剤濃度↑
- 2. (慢性作用)(2週間後)シナプス後膜における受容体の数↓
- 非定型抗うつ薬 atypical agent
- some degree of sexual dysfunction
- GI distress
- serotonin syndrome: rare but dangeraous elevation of 5HT： can occur when both an SSRI and a monoamine oxidase inhibitor are administered simultaneously.
- hyperthermia, muscle rigidity, myoclonus, and rapid fluctuations in mental status and vital signs.