Paroxetine 20 mg Tablet, Film Coated, 90-count
🆔 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 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII R8WTH25YS2
Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
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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 EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII R4OXA9G5BV
A fatty acid salt derived from palm and stearic oils. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking together.
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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 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.
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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
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💲 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 | $0.063 | $5.68 / 90 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2154 | $19.39 / 90 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2824 | $25.42 / 90 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Paroxetine 20 mg 00378-7002-10 | Mylan | 1000 tablets | $0.063 | AB | Availability likely | — |
| Paroxetine 20 mg 00904-5677-61 | Major | 1 tablet | $0.063 | AB | Availability likely | — |
| Paroxetine 20 mg 16714-0182-01 | NorthStar | 30 tablets | $0.063 | AB | Availability likely | — |
| Paroxetine 20 mgthis 43547-0348-09 | Solco | 90 tablets | $0.063 | AB | Availability likely | — |
| Paroxetine 20 mg 60505-0083-01 | Apotex | 30 tablets | $0.063 | AB | Availability likely | — |
| Paroxetine 20 mg 62135-0542-90 | Chartwell | 90 tablets | $0.063 | AB | Availability likely | — |
| Paroxetine 20 mg 68084-0045-01 | American | 1 tablet | $0.063 | AB | Availability likely | — |
| Paroxetine 20 mg 68382-0098-01 | Zydus | 100 tablets | $0.063 | AB | Availability likely | — |
| paroxetine hydrochloride 20 mg 69584-0672-03 | Oxford | 30 tablets | $0.063 | AB | Availability likely | — |
| Paxil 20 mg 60505-4518-03 | Apotex | 30 tablets | $10.737 | AB | Availability likely | +16922% |
| Paroxetine 20 mg 00615-7985-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 13107-0155-01 | Aurolife | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 43353-0554-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 43353-0713-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 50090-0850-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 55154-7999-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 55289-0972-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 60429-0735-10 | Golden | 1000 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 63187-0105-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 63187-0564-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 63187-0927-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 63629-1840-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 65841-0098-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 65862-0155-01 | Aurobindo | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 67544-0317-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 68071-2835-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 68788-8777-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 68788-9074-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 69117-0025-01 | Yiling | 30 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 70518-2387-00 | REMEDYREPACK | 1 tablet | — | AB | Discontinued | — |
| Paroxetine 20 mg 70518-2871-00 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Paroxetine 20 mg 70518-3518-00 | REMEDYREPACK | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 76420-0717-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Paroxetine 20 mg 80425-0339-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 43547-0348-03 | 30 TABLET, FILM COATED in 1 BOTTLE (43547-348-03) | $0.0631 / ea | $1.89 | 2014-11-01 | Active |
| 43547-0348-09 You're viewing this | 90 TABLET, FILM COATED in 1 BOTTLE (43547-348-09) | $0.0631 / ea | $5.68 | 2014-11-01 | Active |
| 43547-0348-11 | 1000 TABLET, FILM COATED in 1 BOTTLE (43547-348-11) | $0.0631 / ea | $63.08 | 2014-11-01 | Active |
| 43547-0348-50 | 500 TABLET, FILM COATED in 1 BOTTLE (43547-348-50) | $0.0631 / ea | $31.54 | 2014-11-01 | Active |
You're viewing one of 4 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 4 priced pack sizes ($0.0631 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 64% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 43547-0348-09?
What is the difference between NDC 43547-0348-09 and NDC 43547-0348-03?
What NDC number is used to bill for this package of Paroxetine 20 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 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 )] . Paroxetine tablets are 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.
Paroxetine tablets are not approved for use in pediatric patients. ( 5.1 , 8.4 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Paroxetine tablets are 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) Paroxetine tablets are 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 • 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 paroxetine tablets, reduce dosage gradually. ( 2.6 , 5.7 )
2.1Administration Information Administer paroxetine tablets as a single daily dose in the morning, with or without food.
2.2Recommended Dosage for MDD, OCD, PD, and PTSD The recommended starting dosages and maximum dosages of paroxetine tablets 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 Paroxetine Tablets 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 paroxetine tablets was demonstrated in patients dosed in a range of 20 mg to 60 mg daily. While the safety of paroxetine tablets 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 paroxetine tablets 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 Paroxetine Tablets Prior to initiating treatment with paroxetine tablets 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 paroxetine tablets. In addition, at least 14 days must elapse after stopping paroxetine tablets before starting an MAOI antidepressant [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] .
2.7Discontinuation of Treatment With Paroxetine Tablets Adverse reactions may occur upon discontinuation of paroxetine tablets [see Warnings and Precautions ( 5.7 )]. Gradually reduce the dosage rather than stopping paroxetine tablets abruptly whenever possible.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Paroxetine tablets, USP are available as: • 10-mg beige to light brown, scored tablets, debossed with ‘710’ on one side and ‘HH’ on the other side with the score line in between. • 20-mg beige to light brown, scored tablets, debossed with ‘711’ on one side and ‘HH’ on the other side with the score line in between. The above 10 mg and 20 mg strength tablets are functionally scored, each can be split into two halves. • 30-mg beige to light brown tablets, debossed with ‘712’ on one side and ‘HH’ on the other side. • 40-mg beige to light brown tablets, debossed with ‘713’ on one side and ‘HH’ on the other side. • Tablets: 10 mg, scored; 20 mg, scored; 30 mg; and 40 mg tablets.
( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Paroxetine tablets are 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 paroxetine tablets [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 paroxetine tablets. ( 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 paroxetine tablets 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: Paroxetine tablets 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 Paroxetine tablets are 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 paroxetine tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
5.2Serotonin Syndrome SSRIs, including paroxetine tablets, 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…
🤒 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 Solco Healthcare US, LLC. at 1-866-257-2597 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 paroxetine tablets are from: • 6-week clinical trials in MDD patients who received paroxetine tablets 20 mg to 50 mg once daily • 12-week clinical trials in OCD patients who received paroxetine tablets 20 mg to 60 mg once daily • 10- to 12-week clinical trials in PD patients who received paroxetine tablets 10 mg to 60 mg once daily • 12-week clinical trials in SAD patients who received paroxetine tablets 20 mg to 50 mg once daily • 8-week clinical trials in GAD patients who received paroxetine tablets 10 mg to 50 mg once daily • 12-week clinical trials in PTSD patients who received paroxetine tablets 20 mg to 50 mg once daily Adverse Reactions Leading to Discontinuation Twenty percent (1,199/6,145) of patients treated with paroxetine tablets 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 paroxetine tablets 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 paroxetine tablets compared to placebo) are presented in Table 3: Table 3: Adverse Reactions Reported as Leading to Discontinuation (≥1% of Paroxetine Tablets-Treated Patients and Greater than Placebo) in MDD, OCD, PD, SAD, GAD, and PTSD Trials MDD OCD PD SAD GAD PTSD Paroxetine Tablets % Placebo % Paroxetine Tablets % Placebo % Paroxetine Tablets % Placebo % Paroxetine Tablets % Placebo % Paroxetine Tablets % Placebo % Paroxetine Tablets % 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 — — Gastroin- testinal 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 pati…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 9 presents clinically significant drug interactions with paroxetine tablets. Table 9: Clinically Significant Drug Interactions with Paroxetine Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of SSRIs, including paroxetine tablets, and MAOIs increases the risk of serotonin syndrome. Intervention Paroxetine tablets are 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 Paroxetine tablets are contraindicated in patients taking pimozide or thioridazine [see Contraindications ( 4 )]. Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with paroxetine tablets 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 paroxetine tablets 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 paroxetine tablets may potentiate the risk of bleeding. Intervention Inform patients of the increased risk of bleeding associated with the concomitant use of paroxetine Tablets 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 Paroxetine tablets are highly bound to plasma protein. The concomitant use of paroxetine tablets with another drug that is highly bound to plasma protein may increase free concentrations of paroxetine tablets or other tightly-bound drugs in plasma .
Intervention Monitor for adverse reactions and reduce dosage of paroxetine Tablets or other protein-bound drugs as warranted. Examples Warfarin Drugs Metabolized by CYP2D6 Clinical Impact Paroxetine tablets are a CYP2D6 inhibitor [see Clinical Pharmacology ( 12.3 )]. The concomitant use of paroxetine tablets with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate.
Intervention Decrease the dosage of a CYP2D6 substrate if needed with concomitant paroxetine Tablets use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if paroxetine tablets are discontinued. Examples propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone.
Tamoxifen Clinical Impact Concomitant use of tamoxifen with paroxetine tablets 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 paroxetine Tablets significantly decreased plasma levels of paroxetine Tablets. 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 paroxetine tablets or other protein-bound drugs (e.g., warfarin) as warranted.
( 7 ) • Drugs Meta…
👥 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 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] . Paroxetine tablets are 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 paroxetine tablets 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/m 2 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/m 2 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 paroxetine tablets 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 paroxetine tablets and other SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of SSRIs or possibly a drug discont…
🤰 Pregnancy ▾
8.1Pregnancy 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] . Paroxetine tablets are 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 paroxetine tablets 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/m 2 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/m 2 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 paroxetine tablets 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 paroxetine tablets and other SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of SSRIs or possibly a drug discontinuation syndrome.
It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions ( 5.2 )] . Data Human Data Published epidemiological studies on the association between first trimester paroxetine use and cardiovascular malformati…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of paroxetine tablets in pediatric patients have not been established [see Box Warning]. Effectiveness was not demonstrated in three placebo-controlled trials in 752 paroxetine tablets-treated pediatric patients with MDD. Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions ( 5.1 )] .
Decreased appetite and weight loss have been observed in association with the use of SSRIs. In placebo-controlled clinical trials conducted with pediatric patients, the following adverse reactions were reported in at least 2% of pediatric patients treated with paroxetine tablets and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation.
Adverse reactions upon discontinuation of treatment with paroxetine tablets in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients and at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain.
🧓 Geriatric Use ▾
8.5Geriatric Use In premarketing clinical trials with paroxetine tablets, 17% of patients treated with paroxetine tablets (approximately 700) were 65 years of age or older. Pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; however, no overall differences in safety or effectiveness were observed between elderly and younger patients [see Dosage and Administration ( 2.4 ), Clinical Pharmacology ( 12.3 )]. SSRIs including paroxetine tablets, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions ( 5.7 )].
🆘 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 paroxetine tablets 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 paroxetine tablets. 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 T ½ 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.
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 paroxetine tablets. 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 paroxetine metabolism also suggests pot…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of paroxetine tablets 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).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Paroxetine tablets, USP are capsule-shaped tablets supplied as: Tablet Strength Color Engraved Descriptors Package Configuration NDC Number 10 mg beige to light brown scored tablets, debossed with ‘710’ on one side and ‘HH’ on the other side with the score line in between Bottles of 30 Bottles of 90 Bottles of 500 Bottles of 1,000 NDC 43547-347-03 NDC 43547-347-09 NDC 43547-347-50 NDC 43547-347-11 20 mg beige to light brown scored tablets, debossed with ‘711’ on one side and ‘HH’ on the other side with the score line in between Bottles of 30 Bottles of 90 Bottles of 500 Bottles of 1,000 NDC 43547-348-03 NDC 43547-348-09 NDC 43547-348-50 NDC 43547-348-11 30 mg beige to light brown debossed with ‘712’ on one side and ‘HH’ on the other side Bottles of 30 Bottles of 90 Bottles of 500 Bottles of 1,000 NDC 43547-349-03 NDC 43547-349-09 NDC 43547-349-50 NDC 43547-349-11 40 mg beige to light brown debossed with ‘713’ on one side and ‘HH’ on the other side Bottles of 30 Bottles of 90 Bottles of 500 Bottles of 1,000 NDC 43547-350-03 NDC 43547-350-09 NDC 43547-350-50 NDC 43547-350-11 Store tablets at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]
📋 Description ▾
11 DESCRIPTION Paroxetine tablets contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans -4 R -(4'-fluorophenyl)-3 S -[(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, USP is an odorless, off-white powder, having a melting point range of 120 o to 138 o C and a solubility of 5.4 mg/mL in water. Paroxetine Tablets Paroxetine 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 glyceryl behenate, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycols and titanium dioxide. picture1
💬 Information for Patients ▾
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 paroxetine tablets 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 paroxetine tablets 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 paroxetine tablets and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when paroxetine tablets are discontinued [See Warnings and Precautions ( 5.7 )]. Sexual Dysfunction Advise patients that use of paroxetine tablets 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 )] . 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 paroxetine tablets.
Advise women of risks associated with first trimester use of paroxetine tablets 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 paroxetine tablets during pregnancy [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 )].
Lactation Advise breastfeeding women using paroxetine tablets 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 paroxetine tablets may affect sperm quality, which may impair ferti…
💬 Medication Guide ▾
Medication Guide Dispense with Medication Guide available at: www.solcohealthcare.com/medguide/paroxetine-tablets.pdf MEDICATION GUIDE Paroxetine Tablets USP (PA-rox-eh-tine) What is the most important information I should know about paroxetine tablets? Paroxetine tablets can cause serious side effects, including: • Increased risk of suicidal thoughts or actions. Paroxetine tablets 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 .
Paroxetine tablets are not for use in children. o 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? o 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. o 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. o 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: o attempts to commit suicide o acting on dangerous impulses o acting aggressive or violent o thoughts about suicide or dying o new or worse depression o new or worse anxiety or panic attacks o feeling agitated, restless, angry, or irritable o trouble sleeping o an increase in activity and talking more than what is normal for you o other unusual changes in behavior or mood What are Paroxetine Tablets?
Paroxetine tablets are 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 Paroxetine Tablets 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 paroxetine tablets.
See the end of this Medication Guide for a complete list of ingredients in paroxetine tablets. 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 paroxetine tablets.
Before taking paroxetine tablets, 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. Paroxetine tablets may harm your unborn baby. o Taking paroxetine tablets 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. o Taking paroxetine tablets 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 u…