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Paroxetine | CAS No: 61869-08-7 | GMP-certified suppliers
A medication that treats depression, anxiety disorders, obsessive-compulsive disorder, posttraumatic stress disorder, and menopausal vasomotor symptoms, supporting neuropsychiatric and menopausal symptom management.
Therapeutic categories
Primary indications
- Paroxetine is indicated for the management of depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, posttraumatic stress disorder
- One form of paroxetine, commercially known as Brisdelle, is used to manage mild to moderate vasomotor symptoms of menopause
- Off-label, paroxetine may be used for the treatment of premature ejaculation or irritable bowel syndrome (IBS)
Product Snapshot
- Paroxetine is available as an oral small molecule formulation primarily in tablet, capsule, solution, and suspension forms
- It is indicated for the treatment of depression, several anxiety disorders, and menopausal vasomotor symptoms, among other off-label uses
- Paroxetine is approved for use in major regulatory markets including the United States and Canada
Clinical Overview
Pharmacodynamically, paroxetine exerts its therapeutic effects by selectively inhibiting the presynaptic serotonin transporter (SERT), thereby increasing serotonin concentrations in the synaptic cleft. This action modulates serotonergic neurotransmission and contributes to symptom relief in targeted neuropsychiatric conditions. The onset of clinical effect is generally observed around six weeks after initiation of therapy. Although a potent SSRI, paroxetine has minimal affinity for other neurotransmitter receptors such as adrenergic, dopamine, histamine, and serotonin receptor subtypes, contributing to its selectivity profile. The pharmacological basis for its efficacy in alleviating menopausal vasomotor symptoms is not fully understood but may involve thermoregulatory pathways.
Paroxetine is metabolized primarily via hepatic cytochrome P450 enzymes, including CYP2D6, and acts as a strong inhibitor of CYP2D6. It also exhibits interactions with other CYP isoforms and is subject to P-glycoprotein transporter effects, necessitating consideration in polypharmacy contexts.
Safety considerations include the potential for serotonin syndrome, particularly when paroxetine is coadministered with monoamine oxidase inhibitors (MAOIs) or other serotonergic agents. A two-week washout period is recommended when transitioning between paroxetine and MAOIs. Withdrawal symptoms are relatively common due to its potent serotonin reuptake inhibition. The controlled-release formulation was developed to mitigate gastrointestinal side effects such as nausea. Paroxetine's adverse effect profile aligns with other SSRIs, with common considerations including anticholinergic effects and cardiovascular impacts like tachycardia.
From an API sourcing and quality perspective, paroxetine demands high purity standards due to its potent pharmacological activity and narrow therapeutic window. Manufacturers and procurement specialists should ensure compliance with regulatory guidelines regarding impurity profiles, polymorphic forms, and stability parameters. Supply chain verification and consistent analytical characterization are critical to maintain batch-to-batch uniformity for safe pharmaceutical formulation.
Identification & chemistry
| Generic name | Paroxetine |
|---|---|
| Molecule type | Small molecule |
| CAS | 61869-08-7 |
| UNII | 41VRH5220H |
| DrugBank ID | DB00715 |
Pharmacology
| Summary | Paroxetine is a selective serotonin reuptake inhibitor (SSRI) that increases synaptic serotonin levels by inhibiting the serotonin transporter (SERT), primarily targeting serotonergic pathways implicated in mood and anxiety disorders. It is indicated for treating depression, obsessive-compulsive disorder, various anxiety disorders, posttraumatic stress disorder, and vasomotor symptoms of menopause, with additional minor affinities for muscarinic and certain adrenergic and dopamine receptors. The therapeutic effects are mediated through modulation of serotonin neurotransmission, with a delayed onset reflecting initial autoreceptor-mediated adjustments. |
|---|---|
| Mechanism of action | Paroxetine enhances serotonergic activity via the inhibition presynaptic reuptake of serotonin by the serotonin (SERT) receptor. This inhibition raises the level of serotonin in the synaptic cleft, relieving various symptoms. This drug has been demonstrated to be a stronger inhibitor of serotonin reuptake than other members of the same drug class, including [Citalopram], [Fluoxetine], and [Fluvoxamine]. The mechanism of action of paroxetine in relieving the vasomotor symptoms of menopause is unknown, according to the Brisdelle prescribing information, but may occur due to its effects on thermoregulation. Paroxetine shows a clinically insignificant affinity for adrenergic alpha-1 and alpha-2 receptors and β-adrenergic receptors, dopamine D1 and D2 receptors, histamine H1 receptors and serotonin 5-HT1A, 5-HT2A and 5-HT2C receptors. This drug shows some affinity for muscarinic cholinergic receptors and 5-H2B receptors. The delayed onset of paroxetine therapeutic effects may be explained by the initial paroxetine actions on the 5-HT neurons. In rats, paroxetine activates 5-HT1A receptors when it is first administered, inhibiting the stimulation of the 5-HT neurons and subsequent release of serotonin at the synaptic cleft. |
| Pharmacodynamics | Paroxetine treats the symptoms of depression, various anxiety disorders, posttraumatic stress disorder, obsessive-compulsive disorder, and the vasomotor symptoms of menopause via the inhibition of serotonin reuptake. The onset of action of paroxetine is reported to be approximately 6 weeks. Due its serotonergic activity, paroxetine, like other SSRI drugs, may potentiate serotonin syndrome. This risk is especially high when monoamine oxidase (MAO) inhibitors are given within 2 weeks of paroxetine administration. Upon cessation of MAO inhibitors, a 2-week interval before paroxetine administration is recommended. Do not coadminister these agents. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium-dependent serotonin transporter | Humans | inhibitor |
| Sodium-dependent noradrenaline transporter | Humans | inhibitor |
| 5-hydroxytryptamine receptor 2A | Humans | agonist |
ADME / PK
| Absorption | Paroxetine is readily absorbed from the gastrointestinal tract. Due to the first-pass metabolism, the bioavailability ranges from 30-60%. Cmax is attained 2 to 8 hours after an oral dose. Mean Tmax is 4.3 hours in healthy patients. The steady-state concentration of paroxetine is achieved within 7 to 14 days of oral therapy. In a pharmacokinetic study, AUC in healthy patients was 574 ng·h/mL and 1053 ng·h/mL in those with moderate renal impairment. |
|---|---|
| Half-life | The mean elimination half-life of paroxetine is about 21 hours. In healthy young subjects, mean elimination half-life was found to be 17.3 hours. |
| Protein binding | Paroxetine is 95% bound to plasma proteins. |
| Metabolism | Paroxetine metabolism occurs in the liver and is largely mediated by cytochrome CYP2D6 with contributions from CYP3A4 and possibly other cytochrome enzymes. Genetic polymorphisms of the CYP2D6 enzyme may alter the pharmacokinetics of this drug. Poor metabolizers may demonstrate increased adverse effects while rapid metabolizers may experience decreased therapeutic effects. The majority of a paroxetine dose is oxidized to a catechol metabolite that is subsequently converted to both glucuronide and sulfate metabolites via methylation and conjugation. In rat synaptosomes, the glucuronide and sulfate conjugates have been shown to thousands of times less potent than paroxetine itself. The metabolites of paroxetine are considered inactive. |
| Route of elimination | About 2/3 of a single paroxetine dose is found to be excreted in the urine and the remainder is found to be excreted in feces. Almost all of the dose is eliminated as metabolites; 3% is found to be excreted as unchanged paroxetine. About 64% of a 30 mg oral dose was found excreted in the urine, with 2% as the parent drug and 62% appearing as metabolites. Approximately 36% of the dose was found to be eliminated in the feces primarily as metabolites and less than 1% as the parent compound. |
| Volume of distribution | Paroxetine has a large volume of distribution and is found throughout the body, including in the central nervous system. Only 1% of the drug is found in the plasma. Paroxetine is found in the breast milk at concentrations similar to the concentrations found in plasma. |
| Clearance | The apparent oral clearance of paroxetine is 167 L/h. The clearance of paroxetine in patients with renal failure is significantly lower and dose adjustment may be required, despite the fact that it is mainly cleared by the liver. Dose adjustments may be required in hepatic impairment. |
Formulation & handling
- Paroxetine is a low water solubility small molecule formulated exclusively for oral administration in tablet, capsule, solution, and suspension forms.
- The compound does not require specific food restrictions during administration but alcohol should be avoided due to interaction potential.
- Standard handling of this solid API should consider its phenylpiperidine structure and moderate lipophilicity (LogP 3.15) for formulation solubility and stability optimization.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is marketed in the United States and Canada, with key patent protections having expired between 2009 and 2023, indicating a mature market with potential for generic competition. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Paroxetine is manufactured by multiple originator and generic pharmaceutical companies, including both established brand holders and numerous generic manufacturers, reflecting a competitive supply landscape. Branded products are primarily marketed in the US and Canada, with widespread generic production supporting these markets. Recent patent expirations and those occurring in 2022 and 2023 indicate existing generic competition is established and may continue to expand. |
|---|
Safety
| Toxicity | The acute LD50 in mice and rats is 350 mg/kg. Overdose information The lowest dose of paroxetine reported to lead to a fatal outcome is approximately 400 mg. The largest reported paroxetine overdose from which a patient has survived and recovered is a dose of 2000 mg. Common manifestations in a paroxetine overdose include fatigue, fever, insomnia hypertension, tachycardia, nausea, vomiting, somnolence, tremor, dizziness, agitation, confusion, anxious symptoms, headache, insomnia, hyperhidrosis, dilated pupils, seizures, paresthesia, serotonin syndrome, involuntary muscle contraction, and change in mental status. It should be noted that in some cases, patients may have consumed alcohol in addition to taking an overdose of paroxetine. Some of these symptoms may also be seen with clinical use. There is no specific antidote to an overdose of paroxetine. |
|---|
- Paroxetine exhibits an acute oral LD50 of approximately 350 mg/kg in rodent models, indicating moderate acute toxicity
- Overdose manifestations can include central nervous system effects such as seizures, agitation, and serotonin syndrome, as well as cardiovascular symptoms like hypertension and tachycardia
- No specific antidote is available for paroxetine overdose
Paroxetine is a type of Selective Serotonin Reuptake Inhibitors (SSRIs)
Selective Serotonin Reuptake Inhibitors (SSRIs) are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used for the treatment of various mental health disorders, particularly depression and anxiety. SSRIs work by inhibiting the reuptake of serotonin, a neurotransmitter that plays a crucial role in regulating mood, emotions, and well-being.
These medications are designed to selectively target the serotonin transporter proteins in the brain, preventing the reabsorption of serotonin into the presynaptic neuron. By blocking the reuptake process, SSRIs increase the concentration of serotonin in the synaptic cleft, enhancing its availability for binding to postsynaptic receptors. This ultimately leads to an improved transmission of serotonin signals between neurons.
The mechanism of action of SSRIs helps to alleviate symptoms of depression and anxiety by stabilizing mood, reducing feelings of sadness, enhancing motivation, and promoting a sense of calmness. The exact therapeutic effects and onset of action may vary depending on the specific SSRIs used.
SSRIs have gained popularity due to their favorable safety profile and efficacy in treating a range of mental health conditions. Common SSRIs include fluoxetine, sertraline, citalopram, and escitalopram. These medications are typically available in oral dosage forms, such as tablets or capsules.
It's important to note that SSRIs should be prescribed and monitored by healthcare professionals, as they can have potential side effects and interactions with other medications. Individuals considering SSRIs should consult with their healthcare provider to determine the most appropriate treatment option for their specific needs.
Paroxetine API manufacturers & distributors
Compare qualified Paroxetine API suppliers worldwide. We currently have 22 companies offering Paroxetine API, with manufacturing taking place in 9 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Aesica Pharma | Producer | United Kingdom | United Kingdom | CEP, CoA, FDA, GMP, USDMF | 5 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GDP, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC, WHO-GMP | 176 products |
| AXXO GmbH | Distributor | Germany | World | CEP, CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Chemi S.p.A. | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 18 products |
| Gedeon Richter | Producer | Hungary | Unknown | CEP, CoA, FDA, GMP | 48 products |
| Glaxosmithkline | Producer | United Kingdom | United Kingdom | CoA, USDMF | 19 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Ipca Labs. | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, WC | 69 products |
| Jubilant Pharmova | Producer | India | India | BSE/TSE, CEP, CoA, GMP, ISO9001, JDMF, MSDS, USDMF | 52 products |
| Junsei Chemical | Producer | Japan | Japan | CoA, JDMF | 2 products |
| Medichem | Producer | Spain | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF | 39 products |
| Mylan | Producer | India | Unknown | CEP, CoA | 201 products |
| Osaka Synthetic Chemical ... | Producer | Japan | Japan | CoA, JDMF | 16 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Signa | Producer | Mexico | Mexico | CoA, USDMF | 42 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 762 products |
| SPC Life Sciences Pvt Ltd... | Producer | India | India | CoA | 5 products |
| Sumitomo Chemical | Producer | Japan | Japan | CoA, JDMF | 28 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Wanbury | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 15 products |
When sending a request, specify which Paroxetine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Paroxetine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
