PAROXETINE HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE is an FDA-registered drug product whose active ingredient is PAROXETINE HYDROCHLORIDE. It is labelled by Apotex Corp taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 60505-1316, application NDA020936, label effective 20260916. It is one of 7 FDA drug label records sharing the active ingredient PAROXETINE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PAROXETINE HYDROCHLORIDE are most often described in connection with: paroxetine hcl, indicated adults, treatment major, depressive disorder, mdd panic, social anxiety, sad premenstrual, selective serotonin. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Paroxetine HCL CR is indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Paroxetine HCL CR is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): Major Depressive Disorder (MDD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Premenstrual Dysphoric Disorder (PMDD)

2 DOSAGE AND ADMINISTRATION Swallow tablet whole; do not chew or crush. ( 2.1 ) Recommended starting and maximum daily dosage: ( 2.2 , 2.3 ) Indication Starting Dose Maximum Dose MDD 25 mg/day 62.5 mg/day PD 12.5 mg/day 75 mg/day SAD 12.5 mg/day 37.5 mg/day PMDD 12.5 mg/day 25 mg/day For PMDD, dose continuously or intermittently (luteal phase only). ( 2.3 ) If inadequate response to starting dosage, titrate in 12.5 mg per day increments once weekly. ( 2.2 , 2.3 ) Elderly patients, patients with severe renal impairment or severe hepatic impairment: Starting dose is 12.5 mg per day. Do not exceed 50 mg per day for treatment of MDD and PD and 37.5 mg per day for treatment of SAD. ( 2.5 ) When discontinuing Paroxetine HCL CR, reduce dose gradually. ( 2.7 ) 2.1 Important Administration Instructions Administer Paroxetine HCL CR as a single daily dose in the morning, with or without food. Swallow tablets whole and do not chew or crush. 2.2 Dosage in Patients with Major Depressive Disorder, Panic Disorder, and Social Anxiety Disorder The recommended initial dosage and maximum dosage of Paroxetine HCL CR in patients with MDD, PD, and SAD are presented in Table 1. In patients with an inadequate response, dosage may be increased in increments of 12.5 mg per day at intervals of at least 1 week, depending on tolerability. Table 1: Recommended Daily Dosage of Paroxetine HCL CR in Patients with MDD, PD, and SAD Indication Starting Dose Maximum Dose MDD 25 mg 62.5 mg PD 12.5 mg 75 mg SAD 12.5 mg 37.5 mg 2.3 Dosage in Patients with Premenstrual Dysphoric Disorder The recommended starting dosage in women with PMDD is 12.5 mg per day. Paroxetine HCL CR may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only during the luteal phase of the menstrual cycle, i.e., starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing is repeated with each new cycle. In patients with an inadequate response, the dosage may be increased to the maximum recommended dosage of 25 mg per day, depending on tolerability. Institute dosage adjustments at intervals of at least 1 week. 2.4 Screen for Bipolar Disorder Prior to Starting Paroxetine HCL CR Prior to initiating treatment with Paroxetine HCL CR or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.6 )]. 2.5 Dosage Modifications for Elderly Patients, Patients with Severe Renal Impairment and Patients with Severe Hepatic Impairment The recommended initial dose of Paroxetine HCL CR is 12.5 mg per day for elderly patients, patients with severe renal impairment, and patients with severe hepatic impairment. Reduce initial dose and increase up-titration intervals if necessary. Dosage should not exceed 50 mg per day for MDD or PD and should not exceed 37.5 mg per day for SAD [see Use in Specific Populations ( 8.5 , 8.6 )]. 2.6 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of an monoamine oxidase inhibitor (MAOI) antidepressant and initiation of Paroxetine HCL CR. In addition, at least 14 days must elapse after stopping Paroxetine HCL CR before starting an MAOI antidepressant [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. 2.7 Discontinuation of Treatment with Paroxetine HCL CR Adverse reactions may occur upon discontinuation of Paroxetine HCL CR [see Warnings and Precautions ( 5.7 )] .Gradually reduce the dosage rather than stopping Paroxetine HCL CR abruptly whenever possible.

4 CONTRAINDICATIONS Paroxetine HCL CR 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)]. Paroxetine HCL CR should not be used in patients receiving medications that can prolong QT interval and are also metabolized by CYP450 2D6,such as thioridazine or pimozide [see Drug Interactions (7),Warnings and Precautions (5.3)]. With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or to any of the inactive ingredients in Paroxetine HCL CR [see Adverse Reactions ( 6.1 , 6.2 )]. Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOIs. ( 4 , 5.2 , 7 ) Concomitant use of pimozide or thioridazine. ( 4 , 5.3 , 7 ) Known hypersensitivity to paroxetine or to any of the inactive ingredients in Paroxetine HCL CR. ( 4 )

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 and Neonatal 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) in placebo-controlled MDD, PD, SAD, and PMDD clinical trials: abnormal ejaculation, abnormal vision, asthenia, constipation, decreased appetite, diarrhea, dizziness, dry mouth, female genital disorder, impotence, insomnia, libido decreased, nausea, somnolence, sweating, tremor. ( 6.1 ) 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 . 6.1 Clinical 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. Safety data for Paroxetine HCL CR is from 11 short-term, placebo‑controlled clinical trials including 3 studies in patients with major depressive disorder (MDD) (Studies 1, 2, and 3), 3 studies in patients with panic disorder (PD) (Studies 4, 5, and 6), 1 study in patients with social anxiety disorder (SAD) (Study 7), and 4 studies in female patients with premenstrual dysphoric disorder (PMDD) (Studies 8, 9, 10, and 11) [see Clinical Studies ( 14 )]. These 11 trials included 1627 patients treated with Paroxetine HCL CR. Studies 1 and 2 were 12-week studies that enrolled patients 18 to 65 years old who received Paroxetine HCL CR at doses ranging from 25 mg to 62.5 mg once daily. Study 3 was a 12-week study in patients 60 to 88 years old who received Paroxetine HCL CR at doses ranging from 12.5 mg to 50 mg once daily. Studies 4, 5, and 6 were 10-week studies in patients 19 to 72 years old who received Paroxetine HCL CR at doses ranging from 12.5 mg to 75 mg once daily. Study 7 was a 12-week study that enrolled adult patients who received Paroxetine HCL CR at doses ranging from 12.5 mg to 37.5 mg once daily. Studies 8, 9, and 10 were 12‑week, placebo‑controlled trials in female patients 18 to 46 years old who received Paroxetine HCL CR at doses of 12.5 mg or 25 mg once daily. Study 11 was a 12-week placebo‑controlled trial in patients 18 to 46 years old who received Paroxetine HCL CR 2 weeks prior to the onset of menses (luteal phase dosing) at doses of 12.5 mg or 25 mg once daily. Adverse Reactions Leading to Discontinuation in Patients with MDD, PD, SAD, and PMDD In pooled studies in patients with MDD, PD and SAD, the most common adverse reactions leading to study withdrawal were: nausea (up to 4% of patients), asthenia, headache, depression, insomnia, and abnormal liver function tests (each occurring in up to 2% of patients), and dizziness, somnolence, and diarrhea (each occurring in up to 1% of patients). In pooled studies for PMDD, the most common adverse reactions leading to study withdrawal were: nausea (occurring in up to 6% of patients), asthenia (occurring in up to 5% of patients), somnolence (occurring in up to 4% of patients), insomnia (occurring in approximately 2% of patients); and impaired concentration, dry mouth, dizziness, decreased appetite, sweating, tremor, yawn and diarrhea (occurring in less than or equal to 2% of patients). Adverse Reactions in MDD, PD, and SAD Table 3 presents the most common adverse reactions in Paroxetine HCL CR-treated patients (incidence ≥5% and greater than placebo within at least 1 of the indications) in controlled trials in patients with MDD, PD, and SAD. Table 3. Adverse Reactions (≥5% of Patients Treated with Paroxetine HCL CR and Greater than Placebo) in 10 to 12 Week Studies of MDD, PD, and SAD MDD 18 to 65 year olds MDD ≥60 years old Panic Disorder Social Anxiety Disorder Body System/ Adverse Reaction Paroxetine HCL CR (N=212) % Placebo (N=211) % Paroxetine HCL CR (N=104) % Placebo (N=109) % Paroxetine HCL CR (N=444) % Placebo (N=445) % Paroxetine HCL CR (N=186) % Placebo (N=184) % Body as a Whole Headache 27 20 17 13 NA NA 23 17 Asthenia 14 9 15 14 15 10 18 7 Abdominal Pain 7 4 - - 6 4 5 4 Back Pain 5 3 - - NA NA 4 1 Digestive System Nausea 22 10 - - 23 17 22 6 Diarrhea 18 7 15 9 12 9 9 8 Dry Mouth 15 8 18 7 13 9 3 2 Constipation 10 4 13 5 9 6 5 2 Flatulence 6 4 - - NA NA NA NA Decreased Appetite 4 2 12 5 8 6 1 <1 Dyspepsia NA NA 13 10 NA NA 2 <1 Musculoskeletal System Myalgia NA NA - - 5 3 NA NA Nervous System Somnolence 22 8 21 12 20 9 9 4 Insomnia 17 9 10 8 20 11 9 4 Dizziness 14 4 9 5 NA NA 7 4 Libido Decreased 7 3 8 <1 9 4 8 1 Nervousness NA NA - - 8 7 NA NA Tremor 7 1 7 0 8 2 4 2 Anxiety NA NA - - 5 4 2 1 Respiratory System Sinusitis NA NA - - 8 5 NA NA Yawn 5 0 - - 3 0 2 0 Skin and Appendages Sweating 6 2 10 <1 7 2 14 3 Special Senses Abnormal Vision a 5 1 - - 3 <1 2 0 Urogenital System Abnormal Ejaculation b,c 26 1 17 3 27 3 15 1 Female Genital Disorder b,d 10 <1 - - 7 1 3 0 Impotence b 5 3 9 3 10 1 9 0 Hyphen = the reaction listed occurred in <5% of patients treated with Paroxetine HCL CR NA = the adverse reaction listed did not occur in this group of patients a Mostly blurred vision b Based on the number of males or females c Mostly anorgasmia or delayed ejaculation d Mostly anorgasmia or delayed orgasm Other Adverse Reactions Observed During the Premarketing Evaluation of Paroxetine HCL CR Adverse reactions from studies in MDD (not including Study 3 in elderly patients), PD, and SAD that occurred between 1% and 5% of patients treated with Paroxetine HCL CR and at a rate greater than in placebo-treated patients include:, allergic reaction, tachycardia, vasodilatation, hypertension, migraine, vomiting, weight loss, weight gain, hypertonia, paraesthesia, agitation, confusion, myoclonus, concentration impaired, depression, rhinitis, cough increased, bronchitis, photosensitivity, eczema, taste perversion, UTI, menstrual disorder, urinary frequency, urination impaired, and vaginitis. Adverse Reactions in Patients with PMDD Table 4 displays adverse reactions that occurred (incidence of 5% or more and greater than placebo within at least 1 of the studies) in patients treated with Paroxetine HCL CR in Studies 8, 9, 10, and 11. Table 4. Adverse Reactions (≥5% of Patients Treated with Paroxetine HCL CR and Greater than Placebo) in Pooled Studies PMDD (Studies 8, 9, 11), and in Study 10 a,b,c Body System/ Adverse Reaction % Reporting Adverse Reaction Continuous Dosing Luteal Phase Dosing Paroxetine HCL CR (n = 681) % Placebo (n = 349)% Paroxetine HCL CR (n = 246)% Placebo (n = 120)%% Body as a Whole Asthenia 17 6 15 4 Headache 15 12 NA NA Infection 6 4 NA NA Digestive System Nausea 17 7 18 2 Diarrhea 6 2 6 0 Constipation 5 1 2 <1 Nervous System Libido Decreased 12 5 9 6 Somnolence 9 2 3 <1 Insomnia 8 2 7 3 Dizziness 7 3 6 3 Tremor 4 <1 5 0 Skin and Appendages Sweating 7 <1 6 <1 Urogenital System Female Genital Disorders c 8 1 2 0 NA= the adverse reaction information is not available in this population. a <1% means greater than zero and less than 1%. b The luteal phase and continuous dosing PMDD trials were not designed for making direct comparisons between the 2 dosing regimens. c Mostly anorgasmia or difficulty achieving orgasm. Dose Dependent Adverse Reactions Comparison of the incidence of adverse reactions (placebo vs. 12.5 mg Paroxetine HCL CR vs. 25 mg Paroxetine HCL CR) from studies 8, 9, 10 showed the following adverse reactions to be dose-related: Nausea, somnolence, sweating, dry mouth, dizziness, decreased appetite, tremor, impaired concentration, yawn, paresthesia, hyperkinesia, and vaginitis. Male and Female Sexual Dysfunction Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence. The percentage of patients reporting symptoms of sexual dysfunction in the Studies 1 and 2 (nonelderly patients with MDD), 4, 5, 6, 7, 8, 9, 10, and 11 are presented in Table 5: Table 5. Adverse Reactions Related To Sexual Dysfunction In Patients Treated With Paroxetine HCL CR in Pooled 10-12 Week Studies of MDD, PD, SAD, and PMDD Studies 1 and 2 % Studies 4, 5 and 6 % Study 7 % Studies 8, 9 and 11 (continuous Dosing) % Study 10 (Luteal Phase Dosing) % Paroxetine HCL CR Placebo Paroxetine HCL CR Placebo Paroxetine HCL CR Placebo Paroxetine HCL CR Placebo Paroxetine HCL CR Placebo n (males) 78 78 162 194 88 97 NA NA NA NA Decreased Libido 10 5 9 6 13 1 NA NA NA NA Abnormal ejaculation 26 1 27 3 15 1 NA NA NA NA Impotence 5 3 10 1 9 0 NA NA NA NA n (females) 134 133 282 251 98 87 681 349 246 120 Decreased Libido 4 2 8 2 4 1 12 5 9 6 Orgasmic Disturbance 10 <1 7 1 3 0 8 1 2 0 NA = the adverse reaction listed did not occur in this group of patients. Paroxetine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae. Less Common Adverse Reactions The following adverse reactions occurred during the clinical studies of Paroxetine HCL CR and are not included elsewhere in the labeling. Reactions are categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent adverse reactions are those occurring on 1 or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare reactions are those occurring in fewer than 1/1,000 patients. Cardiovascular System : Infrequent was postural hypotension. Hemic and Lymphatic System: Rare was thrombocytopenia. Metabolic and Nutritional Disorders: Infrequent were generalized edema and hypercholesteremia. Nervous System : Infrequent were convulsion, akathisia, and manic reaction. Psychiatric: Infrequent were hallucinations. Skin and Appendages : Frequent was rash; infrequent was urticaria; rare was angioedema and erythema multiforme. Urogenital System: Infrequent was urinary retention; rare was urinary incontinence. 6.2 Postmarketing Experience The following reactions have been identified during post approval use of paroxetine. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain‑Barré syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), priapism, syndrome of inappropriate ADH secretion (SIADH), prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, dystonia, hypertonia, trismus; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anosmia, hyposmia, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome (RLS), ventricular fibrillation, ventricular tachycardia (including torsade de pointes), hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), and vasculitic syndromes (such as Henoch‑Schönlein purpura).

FDA lists 7 drug label records with PAROXETINE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is PAROXETINE HYDROCHLORIDE used for?
1 INDICATIONS AND USAGE Paroxetine HCL CR is indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Paroxetine HCL CR is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): Major Depressive Disorder (MDD) Panic Disorder (PD) Social Anxiety …

Who makes PAROXETINE HYDROCHLORIDE?
Apotex Corp is the labeler of record for PAROXETINE HYDROCHLORIDE. 7 FDA label records share the active ingredient PAROXETINE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does PAROXETINE HYDROCHLORIDE come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is PAROXETINE HYDROCHLORIDE prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PAROXETINE HYDROCHLORIDE?
Yes. 7 FDA drug label records list PAROXETINE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has PAROXETINE HYDROCHLORIDE been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.