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AVENTYL is a brand name for Nortriptyline, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics). • AVENTYL is contraindicated for concomitant use with MAO inhibitors (see 2 CONTRAINDICATIONS). AVENTYL should not be used within 14 days of initiating or discontinuing MAO inhibitors. • The maximum recommended daily dose is 100 mg/day.
• Clinical findings should predominate over plasma concentrations as primary determinants of dosage changes. 2 Recommended Dose and Dosage Adjustment). • The use of lower dosages for outpatients is more important than for hospitalized patients, who will be treated under close supervision.
• Dosages should be titrated, beginning at a low level and increasing gradually over several weeks, while carefully monitoring for clinical response and noting any evidence of intolerance. Improvement may not occur during the first few weeks or more of treatment.
5 Post-Market Adverse Reactions). • Following remission, maintenance medication may be required for a long period of time at the lowest dose that will maintain remission. • If a patient develops minor side effects, the dosage should be reduced.
The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur. 2 Recommended Dose and Dosage Adjustment • Adults (≥ 18 years): The recommended dose of AVENTYL is 25 mg, taken orally 3 - 4 times daily.
When initiating treatment with AVENTYL, dosage should begin at a low level and increase gradually, as required. 3 Pediatrics). • Pediatrics (< 18 years): Health Canada has not authorized an indication for pediatric use. The use of AVENTYL in children is not recommended.
When considering the use of AVENTYL (Nortriptyline Hydrochloride Capsules) Page 6 of 34 nortriptyline in adolescents, the clinical need should outweigh the potential risks and uncertainties. Dosing in adolescents should be reduced to 30 to 50 mg/day, in divided doses.
• Geriatrics: There is limited data available involving the use of nortriptyline in patients aged 65 and over. Caution should be exercised when using AVENTYL in elderly patients. 4 Geriatrics). 3 Pharmacokinetics). In patients with hepatic impairment, use caution when initiating treatment with AVENTYL.
Lower doses may be required. 4 Administration AVENTYL is administered orally, in the form of capsules. 5 Missed Dose If the patient misses a dose of AVENTYL, the patient should be instructed to skip the missed dose and take the next dose at the regular dosing schedule.
4 Drug-Drug Interactions). 4 Drug-Drug Interactions). Dependence/Tolerance Though not indicative of addiction, abrupt cessation of treatment following prolonged therapy may produce withdrawal symptoms, including flu-like symptoms, dizziness, nausea, headache, agitation, malaise, and abdominal cramping.
As with other antidepressants, sudden discontinuation of nortriptyline treatment may also increase the risk of relapse. 1 Dosing Considerations; 8 ADVERSE REACTIONS, Withdrawal). Driving and Operating Machinery Nortriptyline may cause somnolence, dizziness, and confusion.
Exercise caution when driving or operating a vehicle or potentially dangerous machinery. Endocrine and Metabolism In hyperthyroid patients or those receiving thyroid medication, NORTIPTYLINE may cause cardiac arrhythmias (see 8 ADVERSE REACTIONS, Cardiovascular).
Nortriptyline may affect blood sugar levels. Both elevation and lowering of blood sugar levels AVENTYL (Nortriptyline Hydrochloride Capsules) Page 10 of 34 have been reported with nortriptyline (see 8 ADVERSE REACTIONS, Endocrine). A case of significant hypoglycemia has been reported in a Type II diabetic patient maintained on chlorpropamide (250 mg/day) after the addition of nortriptyline (125 mg/day).
Those patients with reduced activity of drug metabolizing enzymes, such as the cytochrome P450 isoenzyme P450 2D6 (debrisoquin hydroxylase), may have higher plasma concentrations of nortriptyline when given usual doses. 3 Pharmacokinetics).
Genitourinary Due to its anticholinergic activity, nortriptyline may cause urinary retention (see 8 ADVERSE REACTIONS, Anticholinergic). Extreme caution should be used when AVENTYL is given to patients with a history of urinary retention.
4 Drug- Drug Interactions). Monitoring and Laboratory Tests Plasma concentrations are difficult to measure. Healthcare providers should consult with laboratory professional staff. 1 Dosing Considerations). Neurologic • Seizures Nortriptyline is known to lower convulsive threshold.
, Potential association with behavioural and emotional changes, including self-harm). 3 Pediatrics). • AVENTYL is contraindicated for concomitant use with MAO inhibitors (see 2 CONTRAINDICATIONS). AVENTYL should not be used within 14 days of initiating or discontinuing MAO inhibitors.
• The maximum recommended daily dose is 100 mg/day. • Clinical findings should predominate over plasma concentrations as primary determinants of dosage changes. 2 Recommended Dose and Dosage Adjustment). • The use of lower dosages for outpatients is more important than for hospitalized patients, who will be treated under close supervision.
• Dosages should be titrated, beginning at a low level and increasing gradually over several weeks, while carefully monitoring for clinical response and noting any evidence of intolerance. Improvement may not occur during the first few weeks or more of treatment.
5 Post-Market Adverse Reactions). • Following remission, maintenance medication may be required for a long period of time at the lowest dose that will maintain remission. • If a patient develops minor side effects, the dosage should be reduced.
The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur. 2 Recommended Dose and Dosage Adjustment • Adults (≥ 18 years): The recommended dose of AVENTYL is 25 mg, taken orally 3 - 4 times daily.
When initiating treatment with AVENTYL, dosage should begin at a low level and increase gradually, as required. 3 Pediatrics). • Pediatrics (< 18 years): Health Canada has not authorized an indication for pediatric use. The use of AVENTYL in children is not recommended.
When considering the use of AVENTYL (Nortriptyline Hydrochloride Capsules) Page 6 of 34 nortriptyline in adolescents, the clinical need should outweigh the potential risks and uncertainties. Dosing in adolescents should be reduced to 30 to 50 mg/day, in divided doses.
AVENTYL is contraindicated: • in patients with hypersensitivity 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.
Cross- sensitivity between nortriptyline and other dibenzazepines is a possibility. 4 Drug-Drug Interactions; 5 OVERDOSAGE). • during the acute recovery period following myocardial infarction.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nortriptyline 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.
Extreme caution should be exercised when using AVENTYL in patients with a history of seizures. Patients should be followed closely when nortriptyline is administered in these patients. Troublesome patient hostility may be aroused by the use of nortriptyline.
Epileptiform seizures may accompany its administration, as may happen with other drugs of its class. • Serotonin toxicity/Serotonin syndrome Serotonin toxicity, also known as serotonin syndrome, is a potentially life-threatening condition and has been reported with tricyclic antidepressants.
g. g. anxiety, agitation, hypomania). 4 Drug-Drug Interactions). If serotonin toxicity is suspected, discontinuation of the serotonergic agents should be considered. • Electroconvulsive Therapy (ECT) There is limited clinical experience in the concurrent administration of ECT and antidepressant drugs.
When it is essential, AVENTYL may be administered concurrently with ECT, if such treatment is essential. However, the possibility of increased risk, relative to benefits, should be considered. Discontinue the drug for several days, if possible, prior to ECT.
Ophthalmologic Due to anticholinergic activity, nortriptyline may cause an increase in intraocular pressure. 4 Drug-Drug Interactions). 4 Drug-Drug Interactions). Psychiatric All patients being treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behaviour, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
Symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania and mania have been reported in adults, adolescents and children being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.
Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation-type AVENTYL (Nortriptyline Hydrochloride Capsules) Page 12 of 34 and/or suicidal thoughts and […]
• Geriatrics: There is limited data available involving the use of nortriptyline in patients aged 65 and over. Caution should be exercised when using AVENTYL in elderly patients. 4 Geriatrics). 3 Pharmacokinetics). In patients with hepatic impairment, use caution when initiating treatment with AVENTYL.
Lower doses may be required. 4 Administration AVENTYL is administered orally, in the form of capsules. 5 Missed Dose If the patient misses a dose of AVENTYL, the patient should be instructed to skip the missed dose and take the next dose at the regular dosing schedule.
5 OVERDOSAGE Overdose of tricyclic antidepressants may manifest with doses as small as 50 mg in a child. Of patients who are alive at initial presentation, a mortality rate of between 0% and 15% has been reported. Symptoms of overdose of tricyclic antidepressants may begin within several hours of oral ingestion.
1 Adverse Reaction Overview). An effect on cardiac conduction, similar to that of quinidine, may be seen with slowing of conduction, prolongation of the QRS complex and QT intervals, right bundle branch and AV block, ventricular tachyarrhythmias (including Torsade de pointes and fibrillation), and death.
1 seconds is predictive of more severe toxicity. The absence of sinus tachycardia does not ensure a benign course. - adrenergic blockade, and cardiac depression. In a healthy young person, prolonged resuscitation may be effective; one patient was reported to survive 5 hours of cardiac massage.
AVENTYL (Nortriptyline Hydrochloride Capsules) Page 7 of 34 In managing overdose, consider the possibility of multiple drug overdose, interactions among drugs, and unusual drug kinetics in your patients. Protect the patient's airway and support ventilation and perfusion.
Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying.
Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal. Ventricular arrhythmias, especially when accompanied by lengthened QRS intervals, may respond to alkalinization by hyperventilation or administration of sodium bicarbonate.
It is important to monitor and manage serum electrolyte levels. Refractory arrhythmias may respond to propranolol, bretylium, or lidocaine. 4 Drug-Drug Interactions). Seizures may respond to diazepam. Phenytoin has pharmacologic properties that may be helpful in dealing with both the […]