PAXIL paroxetine hydrochloride 30 mg Tablet, Film Coated, 30-count
Other active recalls for Paroxetine Hydrochloride (different manufacturers) — 5 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Serotonin Reuptake Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Paroxetine is used to treat depression, panic disorder (sudden, unexpected attacks of extreme fear and worry about these attacks), social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life), obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), generalized anxiety disorder (GAD; excessive worrying that is difficult to control), and posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience). Paroxetine...
Read the full MedlinePlus article ↗- It usually takes a few weeks before you notice the full benefit — that's completely normal for this type of medication. Some people notice small improvements in sleep or energy wit...
- How long before I start feeling better on paroxetine?
- Please don't stop suddenly — paroxetine is one of the antidepressants most likely to cause discontinuation symptoms if you quit cold turkey. These can include dizziness, nausea, ir...
- Can I just stop taking paroxetine if I feel better or if it bothers me?
Patient education
Supplement & herbal interactions
Paroxetine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 27NA468985
A starch derivative made from potatoes that helps tablets and capsules break down quickly in the stomach. It absorbs water and swells, causing the medication to disintegrate so it can be absorbed properly.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $10.807 | $324.22 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $11.32 | $339.58 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Paroxetine 30 mg 00378-7003-10 | Mylan | 1000 tablets | $0.094 | AB | Availability likely | save 99% |
| Paroxetine 30 mg 16714-0183-01 | NorthStar | 30 tablets | $0.094 | AB | Availability likely | save 99% |
| Paroxetine 30 mg 43547-0349-03 | Solco | 30 tablets | $0.094 | AB | Availability likely | save 99% |
| Paroxetine 30 mg 50268-0642-15 | AvPAK | 1 tablet | $0.094 | AB | Availability likely | save 99% |
| Paroxetine 30 mg 60505-0084-01 | Apotex | 30 tablets | $0.094 | AB | Availability likely | save 99% |
| Paroxetine 30 mg 62135-0543-90 | Chartwell | 90 tablets | $0.094 | AB | Availability likely | save 99% |
| Paroxetine 30 mg 68084-0046-01 | American | 1 tablet | $0.094 | AB | Availability likely | save 99% |
| paroxetine hydrochloride 30 mg 69584-0673-03 | Oxford | 30 tablets | $0.094 | AB | Availability likely | save 99% |
| Paxil 30 mgthis 60505-4519-03 | Apotex | 30 tablets | $10.807 | AB | Availability likely | — |
| Paroxetine 30 mg 00615-8173-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 30 mg 13107-0156-01 | Aurolife | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 30 mg 50090-5987-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Paroxetine 30 mg 60429-0736-10 | Golden | 1000 tablets | — | AB | FDA listed | — |
| Paroxetine 30 mg 65841-0099-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 30 mg 65862-0156-01 | Aurobindo | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 30 mg 68382-0099-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 30 mg 68788-7410-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 30 mg 69117-0026-01 | Yiling | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 30 mg 70518-1460-01 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Paroxetine 30 mg 70518-2465-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 30 mg 71335-0321-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| paroxetine hydrochloride 30 mg 71335-9650-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 30 mg 71610-0243-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Paroxetine 30 mg 76420-0718-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60505-4519-03 You're viewing this | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4519-3) | 2019-03-11 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . PAXIL is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] .
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning . Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant treated patients for clinical worsening and emergence of suicidal thoughts and behaviors.
PAXIL is not approved for use in pediatric patients.( 5.1 , 8.4 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE PAXIL is indicated in adults for the treatment of: Major depressive disorder (MDD) Obsessive compulsive disorder (OCD) Panic disorder (PD) Social anxiety disorder (SAD) Generalized anxiety disorder (GAD) Posttraumatic stress disorder (PTSD) PAXIL is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Shake oral suspension well before administration ( 2.1 ) Recommended starting and maximum daily dosage for MDD, OCD, PD, and PTSD: ( 2.2 ) Indication Starting Daily Dose Maximum Daily Dose MDD 20 mg 50 mg OCD 20 mg 60 mg PD 10 mg 60 mg PTSD 20 mg 50 mg Recommended starting dosage for SAD and GAD is 20 mg daily. ( 2.3 ) Elderly patients, patients with severe renal impairment or severe hepatic impairment: Starting dosage is 10 mg daily. Maximum dosage is 40 mg daily.
( 2.4 ) When discontinuing PAXIL, reduce dosage gradually. ( 2.6 , 5.7 )
2.1Administration Information Administer PAXIL as a single daily dose in the morning, with or without food. Shake the oral suspension well before administration.
2.2Recommended Dosage for MDD, OCD, PD, and PTSD The recommended starting dosages and maximum dosages of PAXIL in patients with MDD, OCD, PD, and PTSD are presented in Table 1. In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability. Table 1: Recommended Daily Dosage of PAXIL in Patients with MDD, OCD, PD, and PTSD Indication Starting Dose Maximum Dose MDD 20 mg 50 mg OCD 20 mg 60 mg PD 10 mg 60 mg PTSD 20 mg 50 mg
2.3Recommended Dosage for SAD and GAD SAD The starting and recommended dosage in patients with SAD is 20 mg daily. In clinical trials the effectiveness of PAXIL was demonstrated in patients dosed in a range of 20 mg to 60 mg daily. While the safety of PAXIL has been evaluated in patients with SAD at doses up to 60 mg daily, available information does not suggest any additional benefit for doses above 20 mg daily [see Clinical Studies ( 14.4 )] .
GAD The starting and recommended dosage in patients with GAD is 20 mg daily. In clinical trials the effectiveness of PAXIL in GAD was demonstrated in patients dosed in a range of 20 mg to 50 mg daily. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg daily [see Clinical Studies ( 14.5 )] .
In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability.
2.4Screen for Bipolar Disorder Prior to Starting PAXIL Prior to initiating treatment with PAXIL or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.6 )].
2.5Recommended Dosage for Elderly Patients, Patients with Severe Renal Impairment, and Patients with Severe Hepatic Impairment The recommended initial dosage is 10 mg per day for elderly patients, patients with severe renal impairment, and patients with severe hepatic impairment. Dosage should not exceed 40 mg/day.
2.6Switching Patients to or From a Monoamine Oxidase Inhibitor (MAOI) At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI and initiation of PAXIL. In addition, at least 14 days must elapse after stopping PAXIL before starting an MAOI antidepressant [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )].
2.7Discontinuation of Treatment With PAXIL Adverse reactions may occur upon discontinuation of PAXIL [see Warnings and Precautions ( 5.7 )] . Gradually reduce the dosage rather than stopping PAXIL abruptly whenever possible.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS PAXIL tablets are available as: 10 mg yellow, scored tablet engraved on the front with “PAXIL” and on the back with “10”. 20 mg pink, scored tablet engraved on the front with “PAXIL” and on the back with “20”. 30 mg blue tablet engraved on the front with “PAXIL” and on the back with “30”.
40 mg green tablet engraved on the front with “PAXIL” and on the back with “40”. PAXIL oral suspension is available as: 10 mg/5 mL orange colored, orange flavored suspension in bottles containing 250 mL (not currently marketed). Extended-release tablets: 10 mg, scored; 20 mg, scored; 30 mg; and 40 mg tablets.
( 3 ) Oral suspension: 10 mg/5 mL (not currently marketed). ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS PAXIL is contraindicated in patients: Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ), Drug Interactions (7)]. Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions ( 5. 3 ), Drug Interactions (7)] Taking pimozide because of risk of QT prolongation [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )].
With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or any of the inactive ingredients in PAXIL [see Adverse Reactions ( 6.1 ), ( 6.2 )]. Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOI. ( 4 , 5.3 , 7 ) Concomitant use of pimozide or thioridazine.
( 4 , 5.3 , 7 ) Known hypersensitivity to paroxetine or to any of the inactive ingredients in PAXIL. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If occurs, discontinue PAXIL and serotonergic agents and initiate supportive measures. ( 5.
2) Embryofetal Toxicity: May cause fetal harm. Meta-analyses of epidemiological studies have shown increased risk (less than 2-fold) of cardiovascular malformations with exposure during the first trimester. ( 5.4 , 8.1 ) Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, other antiplatelet drugs, warfarin, and other anticoagulant drugs may increase risk.
( 5. 5) Activation of Mania/Hypomania: Screen patients for bipolar disorder. ( 5.6 ) Seizures: Use with caution in patients with seizure disorders.
( 5.8 ) Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.9 ) Sexual Dysfunction: PAXIL may cause symptoms of sexual dysfunction. ( 5.13 )
5.1Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.
There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 2. Table 2: Risk Differences of the Number of Patients with Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients with Suicidal Thoughts and Behaviors per 1,000 Patients Treated Increases Compared to Placebo <18 years old 14 additional cases 18-24 years old 5 additional cases Decreases Compared to Placebo 25-64 years old 1 fewer case ≥65 years old 6 fewer cases PAXIL is not approved for use in pediatric patients.
It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes.
Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing PAXIL, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
5.2Serotonin Syndrome SSRIs, including PAXIL, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] .
Serotonin syndrome can also occur when these drugs are used alone. Serotonin syndrome symptoms may include mental status changes (…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are included in more detail in other sections of the prescribing information: Hypersensitivity reactions to paroxetine [see Contraindications ( 4 )] Suicidal Thoughts and Behaviors [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Embryofetal Toxicity [see Warnings and Precautions ( 5.4 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.5 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.6 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.7 )] Seizures [see Warnings and Precautions ( 5.8 )] Angle-closure Glaucoma [see Warnings and Precautions ( 5.9 )] Hyponatremia [see Warnings and Precautions ( 5.10 )] Bone Fracture [see Warnings and Precautions ( 5.12 )] Sexual Dysfunction [see Warnings and Precautions ( 5.13 )] Most common adverse reactions (≥5% and at least twice placebo) are abnormal ejaculation, asthenia, constipation, decreased appetite, diarrhea, dizziness, dry mouth, female genital disorder, impotence, infection, insomnia, libido decreased, male genital disorder, nausea, nervousness, somnolence, sweating, tremor, yawn.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data for PAXIL are from: 6‑week clinical trials in MDD patients who received PAXIL 20 mg to 50 mg once daily 12-week clinical trials in OCD patients who received PAXIL 20 mg to 60 mg once daily 10‑ to 12‑week clinical trials in PD patients who received PAXIL 10 mg to 60 mg once daily 12-week clinical trials in SAD patients who received PAXIL 20 mg to 50 mg once daily 8‑week clinical trials in GAD patients who received PAXIL 10 mg to 50 mg once daily 12‑week clinical trials in PTSD patients who received PAXIL 20 mg to 50 mg once daily Adverse Reactions Leading to Discontinuation Twenty percent (1,199/6,145) of patients treated with PAXIL in clinical trials in MDD and 16.1% (84/522), 11.8% (64/542), 9.4% (44/469), 10.7% (79/735), and 11.7% (79/676) of patients treated with PAXIL in clinical trials in SAD, OCD, PD, GAD, and PTSD, respectively, discontinued treatment due to an adverse reaction.
The most common adverse reactions (≥1%) associated with discontinuation (i.e., those adverse reactions associated with dropout at a rate approximately twice or greater for PAXIL compared to placebo) are presented in Table 3: Table 3: Adverse Reactions Reported as Leading to Discontinuation (≥1% of PAXIL-Treated Patients and Greater than Placebo) in MDD, OCD, PD, SAD, GAD, and PTSD Trials MDD OCD PD SAD GAD PTSD PAXIL % Placebo % PAXIL % Placebo % PAXIL % Placebo % PAXIL % Placebo % PAXIL % Placebo % PAXIL % Placebo % CNS Somnolence 2.3 0.7 --- 1.9 0.3 3.4 0.3 2.0 0.2 2.8
0.6Insomnia --- --- 1.7 0 1.3 0.3 3.1 0 --- --- Agitation 1.1 0.5 --- --- --- Tremor 1.1 0.3 --- 1.7 0 1.0
0.2Anxiety --- --- --- 1.1 0 --- --- Dizziness --- --- 1.5 0 1.9 0 1.0 0.2 --- --- Gastrointestinal Constipation --- 1.1 0 --- --- Nausea 3.2 1.1 1.9 0 3.2 1.2 4.0 0.3 2.0 0.2 2.2
0.6Diarrhea 1.0 0.3 --- Dry mouth 1.0 0.3 --- --- --- Vomiting 1.0 0.3 --- 1.0 0 --- --- Flatulence 1.0 0.3 --- --- Other Asthenia 1.6 0.4 1.9 0.4 2.5 0.6 1.8 0.2 1.6
0.2Abnormal Ejaculation a 1.6 0 2.1 0 4.9 0.6 2.5 0.5 --- --- Sweating 1.0 0.3 --- 1.1 0 1.1 0.2 --- --- Impotence a --- 1.5 0 --- --- Libido Decreased 1.0 0 --- --- Where numbers are not provided the incidence of the adverse reactions in patients treated with PAXIL was not >1% or was not greater than or equal to 2 times the incidence of placebo. a. Incidence corrected for gender. Most Common Adverse Reactions The most commonly ob…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 9 presents clinically significant drug interactions with PAXIL. Table 9 : Clinically Significant Drug Interactions with PAXIL Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of SSRIs, including PAXIL, and MAOIs increases the risk of serotonin syndrome. Intervention PAXIL is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.5 ), Contraindications ( 4 ), Warnings and Precautions ( 5.2 )].
Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide and Thioridazine Clinical Impact Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention PAXIL is contraindicated in patients taking pimozide or thioridazine [see Contraindications ( 4 )]. Other Serotonergic Drugs Clinical Impac t The concomitant use of serotonergic drugs with PAXIL increases the risk of serotonin syndrome.
Intervention Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of PAXIL and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.2 )]. Examples other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St.
John’s Wort. Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact The concurrent use of an antiplatelet agent or anticoagulant with PAXIL may potentiate the risk of bleeding. Intervention Inform patients of the increased risk of bleeding associated with the concomitant use of PAXIL and antiplatelet agents and anticoagulants.
For patients taking warfarin, carefully monitor the international normalized ratio [see Warnings and Precautions ( 5.5 )]. Examples aspirin, clopidogrel, heparin, warfarin Drugs Highly Bound to Plasma Protein Clinical Impact PAXIL is highly bound to plasma protein. The concomitant use of PAXIL with another drug that is highly bound to plasma protein may increase free concentrations of PAXIL or other tightly-bound drugs in plasma.
Intervention Monitor for adverse reactions and reduce dosage of PAXIL or other protein-bound drugs as warranted. Examples warfarin Drugs Metabolized by CYP2D6 Clinical Impact PAXIL is a CYP2D6 inhibitor [see Clinical Pharmacology ( 12.3 )]. The concomitant use of PAXIL with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate.
Intervention Decrease the dosage of a CYP2D6 substrate if needed with concomitant PAXIL use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if PAXIL is discontinued. Examples propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone.
Tamoxifen Clinical Impact Concomitant use of tamoxifen with PAXIL may lead to reduced plasma concentrations of the active metabolite (endoxifen) and reduced efficacy of tamoxifen Intervention Consider use of an alternative antidepressant with little or no CYP2D6 inhibition [see Warnings and Precautions ( 5.11 )]. Fosamprenavir/Ritonavir Clinical Impact Co-administration of fosamprenavir/ritonavir with PAXIL significantly decreased plasma levels of PAXIL. Intervention Any dose adjustment should be guided by clinical effect (tolerability and efficacy).
Drugs Highly Bound to Plasma Protein: Monitor for adverse reactions and reduce dosage of PAXIL or other protein-bound drugs (e.g., warfarin) as warranted. ( 7 ) Drugs Metabolized by CYP2D6: Reduce dosage of drugs metabolized by CYP2D6 as warranted. ( 7 ) Concomitant use with tamoxifen : Consider use of an alternative antidepressant with little or no CYP2D6 inhibition.
( 5.11 , 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: SSRI use, particularly later in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, irritability) in the neonate. ( 8.1 )
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including PAXIL, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.5 ) and Clinical Considerations] .
Paxil is associated with a less than 2-fold increase in cardiovascular malformations when administered to a pregnant woman during the first trimester. While individual epidemiological studies on the association between paroxetine use and cardiac malformations have reported inconsistent findings, some meta-analyses of epidemiological studies have identified an increased risk of cardiovascular malformations ( see Data ). There are risks of persistent pulmonary hypertension of the newborn (PPHN) ( see Data ) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including PAXIL during pregnancy.
There also are risks associated with untreated depression in pregnancy (see Clinical Considerations ). For women who intend to become pregnant or who are in their first trimester of pregnancy, paroxetine should be initiated only after consideration of the other available treatment options. No evidence of treatment related malformations was observed in animal reproduction studies, when paroxetine was administered during the period of organogenesis at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits.
These doses are approximately 8 (rat) and less than 2 (rabbit) times the maximum recommended human dose (MRHD – 60 mg) on an mg/m2 basis. When paroxetine was administered to female rats during the last trimester of gestation and continued through lactation, there was an increase in the number of pup deaths during the first four days of lactation. This effect occurred at a dose of 1 mg/kg/day which is less than the MRHD on an mg/m2 basis ( See Data ).
The background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryofetal risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study of 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and the postpartum.
Maternal Adverse Reactions Use of PAXIL in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.5 )] . Fetal/Neonatal adverse reactions Neonates exposed to PAXIL and other SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can ar…
🆘 Overdosage ▾
10 OVERDOSAGE The following have been reported with paroxetine tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.
Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a paroxetine overdose. Consider contacting a poison center (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of PAXIL in the treatment of MDD, SAD, OCD, PD, GAD, and PTSD is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5‑hydroxy‑tryptamine, 5‑HT).
12.2Pharmacodynamics Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake (SSRI) and has only very weak effects on norepinephrine and dopamine neuronal reuptake.
12.3Pharmacokinetics Nonlinearity in pharmacokinetics is observed with increasing doses of PAXIL. In a meta-analysis of paroxetine from 4 studies done in healthy volunteers following multiple dosing of 20 mg/day to 40 mg/day, males did not exhibit a significantly lower C max or AUC than females. Absorption Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt.
In a study in which normal male subjects (n = 15) received 30 mg tablets daily for 30 days, steady‑state paroxetine concentrations were achieved by approximately 10 days for most subjects, although it may take substantially longer in an occasional patient. At steady state, mean values of C max , T max , C min , and T½ were 61.7 ng/mL (CV 45%), 5.2 hr. (CV 10%), 30.7 ng/mL (CV 67%), and 21 hours (CV 32%), respectively.
The steady‑state C max and C min values were about 6 and 14 times what would be predicted from single‑dose studies. Steady‑state drug exposure based on AUC 0-24 was about 8 times greater than would have been predicted from single-dose data in these subjects. The excess accumulation is a consequence of the fact that 1 of the enzymes that metabolizes paroxetine is readily saturable.
Paroxetine is equally bioavailable from the oral suspension and tablet. Effect of Food The effects of food on the bioavailability of paroxetine were studied in subjects administered a single dose with and without food. AUC was only slightly increased (6%) when drug was administered with food but the C max was 29% greater, while the time to reach peak plasma concentration decreased from 6.4 hours post‑dosing to 4.9 hours.
Distribution Paroxetine distributes throughout the body, including the CNS, with only 1% remaining in the plasma. Approximately 95% and 93% of paroxetine is bound to plasma protein at 100 ng/mL and 400 ng/mL, respectively. Under clinical conditions, paroxetine concentrations would normally be less than 400 ng/mL.
Paroxetine does not alter the in vitro protein binding of phenytoin or warfarin. Elimination Metabolism The mean elimination half-life is approximately 21 hours (CV 32%) after oral dosing of 30 mg tablets daily for 30 days of PAXIL. In steady‑state dose proportionality studies involving elderly and nonelderly patients, at doses of 20 mg to 40 mg daily for the elderly and 20 mg to 50 mg daily for the nonelderly, some nonlinearity was observed in both populations, again reflecting a saturable metabolic pathway.
In comparison to C min values after 20 mg daily, values after 40 mg daily were only about 2 to 3 times greater than doubled. Paroxetine is extensively metabolized after oral administration. The principal metabolites are polar and conjugated products of oxidation and methylation, which are readily cleared.
Conjugates with glucuronic acid and sulfate predominate, and major metabolites have been isolated and identified. Data indicate that the metabolites have no more than 1/50 the potency of the parent compound at inhibiting serotonin uptake. The metabolism of paroxetine is accomplished in part by CYP2D6.
Saturation of this enzyme at clinical doses appears to account for the nonlinearity of paroxetine kinetics with increasing dose and increasing duration of treatment. The role of this enzyme in paroxet…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING PAXIL (paroxetine) tablets are oval shaped tablets supplied as: Tablet Strength Color Engraved Descriptors Package Configuration NDC Number 10 mg yellow Scored, “PAXIL” on front and “10” on back Bottles of 30 NDC 60505-4517-3 20 mg pink Scored, “PAXIL” on front and “20” on back Bottles of 30 NDC 60505-4518-3 30 mg blue “PAXIL” on front and “30” on back Bottles of 30 NDC 60505-4519-3 40 mg green “PAXIL” on front and “40” on back Bottles of 30 NDC 60505-4520-3 Store tablets between 15° and 30°C (59° and 86°F).
PAXIL (paroxetine) oral suspension is supplied as: Strength Color/Flavor Package Configuration NDC Number 10 mg/5 mL Orange/orange Bottles containing 250 mL NDC 60505-0402-5 Store suspension at or below 25°C (77°F). The oral suspension is not currently marketed.
📋 Description ▾
11 DESCRIPTION PAXIL contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans -4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19 H 20 FNO 3 ·HCl·1/2H 2 O. The molecular weight is 374.8 (329.4 as free base).
The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride is an odorless, off‑white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. PAXIL Tablets PAXIL tablets are for oral administration. Each film‑coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively.
Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, titanium dioxide, and 1 or more of the following: D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No.
2 aluminum lake, FD&C Yellow No. 6 aluminum lake. PAXIL Oral Suspension PAXIL oral suspension is for oral administration.
Each 5 mL contains 10 mg of paroxetine equivalent to 11.1 mg of paroxetine hydrochloride. The oral suspension is not currently marketed. Inactive ingredients consist of citric acid (anhydrous), FD&C yellow No.
6, flavorings, glycerin, methylparaben, microcrystalline cellulose and carboxymethylcellulose sodium, polacrilin potassium, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion and sodium citrate (dihydrate).
💬 Patient Medication Information ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions ( 5.1 )] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of PAXIL with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St.
John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7 )]. Concomitant Medications Advise patients to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for drug-drug interactions [see Warning and Precautions ( 5.3 ), Drug Interactions ( 7 )].
Increased Risk of Bleeding Inform patients about the concomitant use of PAXIL with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the counter medications that increase the risk of bleeding [see Warnings and Precautions ( 5.5 )]. Activation of Mania/Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions ( 5.6 )] .
Discontinuation Syndrome Advise patients not to abruptly discontinue PAXIL and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when PAXIL is discontinued [See Warnings and Precautions ( 5.7 )]. Sexual Dysfunction Advise patients that use of PAXIL may cause symptoms of sexual dysfunction in both male and female patients.
Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions ( 5.13 )] . Administration Information for Oral Suspension Instruct patients to shake the oral suspension well before administration [see Dosage and Administration ( 2.1 )]. Allergic Reactions Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions ( 6.1 , 6.2 )].
Embryo-Fetal Toxicity Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with PAXIL. Advise women of risks associated with first trimester use of PAXIL and that use later in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN) [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 )] .
Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to PAXIL during pregnancy [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 )] . Lactation Advise breastfeeding women using PAXIL to monitor infants for agitation, irritability, poor feeding, and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations ( 8.2 )] . Females and Males of Reproductive Potential Advise men that PAXIL may affect sperm…
💬 Medication Guide ▾
Medication Guide PAXIL ® (PAX-il) (paroxetine) tablets oral suspension What is the most important information I should know about PAXIL? PAXIL can cause serious side effects, including: Increased risk of suicidal thoughts or actions. PAXIL and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
PAXIL is not for use in children. Depression or other mental illnesses are the most important causes of suicidal thoughts and actions. How can I watch for and try to prevent suicidal thoughts and actions?
Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the does is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions.
Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: attempts to commit suicide acting aggressive or violent new or worse depression feeling agitated, restless, angry, or irritable an increase in activity and talking more than what is normal for you acting on dangerous impulses thoughts about suicide or dying new or worse anxiety or panic attacks trouble sleeping other unusual changes in behavior or mood What is PAXIL?
PAXIL is a prescription medicine used in adults to treat: A certain type of depression called Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD) Do not take PAXIL if you: take a monoamine oxidase inhibitor (MAOI) have stopped taking an MAOI in the last 14 days are being treated with the antibiotic linezolid or the intravenous methylene blue are taking pimozide are taking thioridazine are allergic to paroxetine or any of the ingredients in PAXIL.
See the end of this Medication Guide for a complete list of ingredients in PAXIL. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue. Do not start taking an MAOI for at least 14 days after you stop treatment with PAXIL.
Before taking PAXIL, tell your healthcare provider about all your medical conditions, including if you: have heart problems have or had bleeding problems have, or have a family history of, bipolar disorder, mania or hypomania have or had seizures or convulsions have glaucoma (high pressure in the eye) have low sodium levels in your blood have bone problems have kidney or liver problems are pregnant or plan to become pregnant. PAXIL may harm your unborn baby. Taking PAXIL during your first trimester of pregnancy may cause your baby to be at an increased risk of having a heart problem (cardiac malformations) at birth.
Taking PAXIL during your third trimester of pregnancy may cause your baby to have breathing, temperature, and feeding problems, low muscle tone, and irritability after birth and may cause your baby to be at an increased risk of a serious lung problem at birth. Talk to your healthcare provider about the risk to your unborn baby if you take PAXIL during pregnancy. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with PAXIL.
There is a pregnancy registry for females who are exposed to PAXIL during pregnancy. The purpose of the registry is to collect information about the health of females exposed to PAXIL and their baby…