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BIO-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: Bio-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 Bio-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). 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).
2 Recommended Dose and Dosage Adjustment Depression • Usual Adult Dose: The administration of Bio-PAROXETINE should be initiated at 20 mg daily. For most patients,20 mg daily will also be the optimum dose. The therapeutic response may be delayed until the thirdor fourth week of treatment.
• Dose Range: For those patients who do not respond adequately to the 20 mg daily dose, a gradual increase in dosage up to 40 mg daily may be considered. The maximum recommended daily dose is 50 mg.
Obsessive-Compulsive Disorder • Usual Adult Dose:
The administration of Bio-PAROXETINE should be initiated at 20 mg/day. The recommended dose of Bio-PAROXETINE in the treatment of OCD is 40 mg daily. • Dose Range: For those patients who do not respond adequately to the 40 mg daily dose, a gradual increase in dosage may be considered.
The maximum recommended daily dose is 60 mg.
Panic Disorder • Usual Adult Dose:
The recommended starting dose of Bio-PAROXETINE in the treatment of panic disorder is10 mg/day. The recommended dose of Bio-PAROXETINE in the treatment of panic disorder is 40 mg daily. • Dose Range: For those patients who do not respond adequately to the 40 mg daily dose, a gradual increase in dosage may be considered.
The maximum recommended daily dose is 60 mg.
Social Phobia (Social Anxiety Disorder) • Usual Adult Dose:
1 Pregnant Women 02/2025 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 1 INDICATIONS .........................................................................................................................
5 2 CONTRAINDICATIONS ............................................................................................................ 5 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............................................................................................................ 1 Adverse Reaction Overview ................................................................................................
Bio-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.
• Monoamine Oxidase Inhibitors: In patients receiving serotonin reuptake inhibitors (SSRIs) in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with Bio-PAROXETINE PM Page 6 of 53 possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma.
These reactions have also been reported in patients who have recently discontinued SSRI treatment and have begun treatment on a MAOI. Some cases presented with features resembling serotonin syndrome or neuroleptic malignant syndrome (see 7 WARNINGS AND PRECAUTIONS, Neurologic, Serotonin Toxicity/Neuroleptic Malignant Syndrome).
Therefore, paroxetine hydrochloride should not be used in combination with MAOIs [including linezolid, an antibiotic which is a reversible non-selective MAOI and methylthioninium chloride (methylene blue)] or within a minimum of 2 weeks of terminating treatment with MAOIs.
Treatment with paroxetine hydrochloride should then be initiated cautiously and dosage increased gradually until optimal response is reached. 4 Drug- Drug Interactions). 4 Drug-Drug Interactions). At least 2 weeks should be allowed after discontinuing paroxetine hydrochloride therapy before initiating treatment with thioridazine.
Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsade de pointes-type arrhythmias, and sudden death. This effect appears to be dose-related.
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.
The recommended initial dosage is 20 mg/day. No clear dose-relationship has been demonstrated over a 20 to 60 mg/day dose range. • Dose Range: Some patients not responding adequately to a 20 mg dosage may benefit from gradual dosage increases, in 10 mg/day increments, up to a maximum of 50 mg/day.
Generalized Anxiety Disorder • Usual Adult Dose:
The recommended initial dosage is 20 mg/day.
Bio-PAROXETINE PM Page 8 of 53 • Dose Range:
Some patients not responding adequately to a 20 mg dosage may benefit from gradual dosage increases, in 10 mg/day increments, up to a maximum of 50 mg/day.
Posttraumatic Stress Disorder • Usual Adult Dose:
The recommended starting dosage is 20 mg/day. • Dose Range: Some patients not responding adequately to a 20 mg/day dosage may benefit from gradual dosage increases, in 10 mg/day increments, up to a maximum of 50 mg/day.
Special Patient Populations For any indication: • Pediatrics (< 18 years):
Health Canada has not authorized an indication for pediatric use. (see 1 INDICATIONS and 7 WARNINGS AND PRECAUTIONS, General, POTENTIAL ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM). • Geriatrics (> 65 years): Administration of paroxetine hydrochloride to the elderly is associated with increased plasmalevels 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: Paroxetine hydrochloride 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 renalor hepatic impairment. A maximum dose of 40 mg should not be exceeded (See 7 WARNINGS ANDPRECAUTIONS and 10 CLINICAL PHARMACOLOGY). g. ventricular and atrial septal defects), associated with the use of paroxetine.
1 Special Populations) and considerationshould be given to switching to other treatment options. Treatment with Bio- 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 Bio-PAROXETINE during the third trimester, the health professional should carefully consider the potential risks and benefits of treatment. The health professional may consider tapering Bio-PAROXETINE in the third trimester.
4 Administration Bio-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 Bio-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 time. 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, […]
2 Clinical Trial Adverse Reactions .......................................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics .......................................................................
3 Less Common Clinical Trial Adverse Reactions ................................................................... 5 Post-Market Adverse Reactions..........................................................................................
28 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 ......................................................................................
34 10 CLINICAL PHARMACOLOGY................................................................................................... 1 Mechanism of Action ..........................................................................................................
2 Pharmacodynamics ............................................................................................................. 3 Pharmacokinetics................................................................................................................
34 11 STORAGE, STABILITY AND DISPOSAL ..................................................................................... 36 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................................
36 PART II: SCIENTIFIC INFORMATION ................................................................................................... 37 13 PHARMACEUTICAL INFORMATION […]
• Pimozide: With concomitant use of pimozide, as paroxetine hydrochloride has been shown to increase plasma pimozide levels. 4 Drug-Drug Interactions).