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TEVA-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: Teva-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…
Verbatim from this product's HC label. Tap a section to expand.
). 2 CONTRAINDICATIONS 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 components 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 Teva-Paroxetine Page 9 of 63 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 Teva-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: Teva-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 Teva-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 Teva-Paroxetine during the third trimester, the health professional should carefully consider the potential risks and benefits of treatment. The health professional may consider tapering Teva-Paroxetine in the third trimester.
2 Geriatrics Geriatrics (> 65 years of age): Evidence from clinical studies indicates that there are differences in the pharmacokinetic profile of paroxetine in the geriatric population relative to younger adults, which may be associated with differences in safety or effectiveness.
4 Geriatrics; 10 CLINICAL PHARMACOLOGY; 4 DOSAGE AND ADMINISTRATION). 2 CONTRAINDICATIONS 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 components 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). Teva-Paroxetine Page 6 of 63 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Increased risk of self-harm, harm to others, suicidal thinking and behavior with antidepressants use.
Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation-type and/or suicidal thoughts and behaviors (see 7 WARNINGS AND PRECAUTIONS, Potential Association with Behavioural and Emotional Changes, Including Self-Harm).
1 Dosing Considerations General • Teva-Paroxetine is not indicated for use in children under the age of 18 years. 1 Pregnant Women). • Due to the potential for life-threatening serotonin toxicity: - Concurrent use with MAOIs is contraindicated.
- Washout periods are necessary if switching between paroxetine and MAOIs. - Use with other serotonergic agents is not recommended (see 7 WARNINGS AND PRECAUTIONS, Serotonin Toxicity/Neuroleptic Malignant Syndrome). - Dose tapering is recommended when switching between antidepressants, including paroxetine.
• Dosing: - Reduced doses may be needed for the elderly, and those with renal impairment. - All dose changes should be gradual, including discontinuation. - Monitor for discontinuation symptoms when decreasing or stopping treatment. • Periodically reassess the need for ongoing therapy.
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 components 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). Teva-Paroxetine Page 6 of 63
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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4 Administration Teva-Paroxetine should be administered once daily in the morning and may be taken with or without Teva-Paroxetine Page 10 of 63 food. The tablet should be swallowed rather than chewed. 5 Missed Dose If a dose of Teva-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, tachycardia, hyperhidrosis, mydriasis, convulsion, paresthesia, 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. Teva-Paroxetine Page 11 of 63 A specific caution involves patients taking or recently having taken Teva-Paroxetine 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.
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 Basic Butylated Methacrylate Copolymer, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Sodium […]
Monitor for agitation, suicidal tendencies Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages, especially when initiating therapy or during any change in dose or dosage regimen.
This includes monitoring for agitation-type emotional and behavioural changes (see 7 WARNINGS AND PRECAUTIONS, Potential Association with Behavioural and Emotional Changes, Including Self-Harm). 2 Recommended Dose and Dosage Adjustment Depression • Usual Adult Dose: The administration of Teva-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 third or 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 Teva-Paroxetine should be initiated at 20 mg/day. The recommended dose of Teva-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 Teva-Paroxetine in the treatment of panic disorder is 10 mg/day. The recommended dose of Teva-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:
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.
Teva-Paroxetine Page 8 of 63 Generalized Anxiety Disorder • Usual Adult Dose:
The recommended initial dosage is 20 mg/day. • 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. Dose Adjustments Based on pharmacokinetic parameters, steady-state paroxetine plasma levels are achieved over a 7 to 14 day interval.
Hence, dosage adjustments in 10 mg increments should be […]