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NRA-PAROXETINE is a brand name for Paroxetine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NRA-PAROXETINE (paroxetine hydrochloride) is indicated in adults for the symptomatic treatment of: • Major Depressive Disorder (MDD) • Obsessive-Compulsive Disorder (OCD) • Panic Disorder (with or without agoraphobia) • Social Phobia (Social Anxiety Disorder) • Generalized Anxiety Disorder (GAD) • Posttraumatic Stress…
Verbatim from this product's HC label. Tap a section to expand.
). 2 CONTRAINDICATIONS NRA-PAROXETINE (paroxetine hydrochloride) is contraindicated: • Hypersensitivity: In patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
, Adverse Reactions following Discontinuation of Treatment (or Dose Reduction)). A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient’s clinical response (see 8 ADVERSE REACTIONS).
Special Patient Populations For any indication: • Pediatrics (< 18 years):
Health Canada has not authorized an indication for pediatric use. (see 7 WARNINGS AND PRECAUTIONS, Potential Association with Behavioral and Emotional Changes, Including Self-Harm). • Geriatrics (> 65 years): Administration of NRA-PAROXETINE to the elderly is associated with increased plasma levels and prolongation of the elimination half-life relative to younger adults (see 10 CLINICAL PHARMACOLOGY).
The recommended initial dose is 10 mg/day for elderly and/or debilitated patients. The dose may be increased, if indicated, up to a maximum of 40 mg daily. • Renal/Hepatic Insufficiency: NRA-PAROXETINE should be used with caution in patients with renal or hepatic impairment.
The recommended initial dose is 10 mg/day in patients with clinically significant renal or hepatic impairment. A maximum dose of 40 mg should not be exceeded (See 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY). g. ventricular and atrial septal defects), associated with the use of paroxetine.
1 Special Populations) and consideration should be given to switching to other treatment options. Treatment with NRA-PAROXETINE should only be continued for an individual patient, if the potential benefits outweigh the potential risks.
1 Special Populations). 1 Special Populations). When treating pregnant women with NRA-PAROXETINE during the third trimester, the health professional should carefully consider the potential risks and benefits of treatment. The health professional may consider tapering NRA- PAROXETINE in the third trimester.
1 Pregnant Women 05/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES...........................................................................................
2 TABLE OF CONTENTS............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
5 1 INDICATIONS ............................................................................................................. 5 2 CONTRAINDICATIONS................................................................................................
6 4 DOSAGE AND ADMINISTRATION ................................................................................ 9 5 OVERDOSAGE............................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 10 7 WARNINGS AND PRECAUTIONS ................................................................................ 1 Special Populations .................................................................................................
1 Pregnant Women .............................................................................................. 2 Breast-feeding................................................................................................... 3 Pediatrics...........................................................................................................
4 Geriatrics ........................................................................................................... 18 8 ADVERSE REACTIONS ................................................................................................
NRA-PAROXETINE (paroxetine hydrochloride) is contraindicated: • Hypersensitivity:
In patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
4 Drug- Drug Interactions). 4 Drug-Drug Interactions). 4 Drug-Drug Interactions).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Paroxetine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
4 Administration NRA-PAROXETINE should be administered once daily in the morning and may be taken with or without food. The tablet should be swallowed rather than chewed. 5 Missed Dose If a dose of NRA-PAROXETINE is missed at its usual time, it should be taken as soon as possible, unless it is too close to the time of the next dose.
The missed dose should be skipped if it is almost time for the next regular dose. Two doses should not be taken at the same tim e . NRA-PAROXETINE Page 9 of 57 5 OVERDOSAGE The largest known ingestion from which a patient has recovered is 2000 mg.
The smallest known dose of paroxetine alone associated with a fatal outcome is approximately 400 mg. Symptoms The most commonly reported adverse events subsequent to paroxetine-only overdose include: somnolence, nausea, tremor, dizziness, vomiting, diarrhea, agitation, aggression, anxiety, confused state, headache, fatigue, insomnia, tachychardia, hyperhydrosis, mydriasis, convulsion, parasthesia, serotonin syndrome, fever, blood pressure changes, involuntary muscle contraction and loss of consciousness.
It should be noted that in some cases, patients may have consumed alcohol in addition to taking an overdose of paroxetine. Some of these symptoms may also be seen with clinical use. Events such as coma and ECG changes have also been reported.
Treatment The health professional should consider contacting a poison control centre for additional information on the treatment of any overdose. No specific antidote is known. Treatment should consist of those general measures employed in the management of overdose with any antidepressant.
Establish and maintain an airway; ensure adequate oxygenation and ventilation. Induction of emesis is not recommended. Due to the large volume of distribution of paroxetine hydrochloride, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit.
Supportive care with frequent monitoring of vital signs and careful observation is indicated. An ECG should be taken and monitoring of cardiac function instituted if there is any evidence of abnormality. Patient management should be as clinically indicated, or as recommended by the national poisons centre, where available.
In managing overdosage, consider the possibility of multiple drug involvement. A specific caution involves patients taking or recently having taken paroxetine hydrochloride who might ingest, by accident or intent, excessive quantities of a tricyclic antidepressant.
In such a case, accumulation of the parent tricyclic and its active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation. For management of a suspected drug overdose, contact your regional poison control centre.
NRA-PAROXETINE Page 10 of 57 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1– Dosage Forms, Strengths and Composition Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Oral Tablet/ 10 mg, 20 mg, 30 mg Dibasic calcium phosphate dehydrate USP, Hypromellose, Sodium Starch Glycolate, Magnesium Stearate, Titanium Dioxide, Macrogol/PEG 400, […]
1 Adverse Reaction Overview .................................................................................... 2 Clinical Trial Adverse Reactions .............................................................................. 1 Clinical Trial Adverse Reactions – Pediatrics.....................................................
3 Less Common Clinical Trial Adverse Reactions ....................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data..............................................................................................................
5 Post-Market Adverse Reactions ............................................................................. 29 9 DRUG INTERACTIONS ............................................................................................... 1 Serious Drug Interactions .......................................................................................
2 Drug Interactions Overview .................................................................................... 3 Drug-Behavioural Interactions ............................................................................... 4 Drug-Drug Interactions ...........................................................................................
5 Drug-Food Interactions ........................................................................................... 6 Drug-Herb Interactions ...........................................................................................
7 Drug-Laboratory Test Interactions.......................................................................... 38 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ........................................................................................
2 Pharmacodynamics ........................................................................................... 3 Pharmacokinetics .............................................................................................. 39 11 STORAGE, STABILITY AND DISPOSAL ............................................................................
41 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 41 PART II: SCIENTIFIC INFORMATION.......................................................................................
42 13 PHARMACEUTICAL INFORMATION............................................................................ 42 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by […]