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ZDS-VARENICLINE is a brand name for Varenicline, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .................................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Psychiatric Symptoms (in Patients with and without Pre-existing Psychiatric Disorder or Symptoms) (see also ADVERSE REACTIONS, Post-Marketing Experience) There have been post-marketing reports of serious neuropsychiatric symptoms in patients being treated with varenicline, including anxiety, psychosis, mood swings, depressed mood, agitation, aggression, hostility, changes in behavior or thinking, suicidal ideation, suicidal behavior and suicide, as well as worsening of pre-existing psychiatric disorder (previously diagnosed or not).
Not all patients had stopped smoking at the time of onset of symptoms, and not all patients had known pre-existing psychiatric illness, or were using concomitant CNS drugs.
Randomized Study Data:
A large randomized, double-blind, active and placebo-controlled study (“EAGLES” study) was conducted to compare the risk of serious neuropsychiatric events in patients with and without a history of psychiatric disorder treated for smoking cessation with varenicline, bupropion, nicotine replacement therapy patch (NRT) or placebo.
The primary safety endpoint was a composite of neuropsychiatric adverse events that have been reported in post-marketing experience. The findings were that the use of varenicline, in patients with or without a history of psychiatric disorder, was not associated with an increased risk of serious neuropsychiatric adverse events in the composite primary endpoint compared with placebo (See ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Neuropsychiatric Safety Study in Subjects with and without a History of Psychiatric Disorder).
Recommendations:
Clinicians should be aware of the possible emergence of serious neuropsychiatric symptoms in patients attempting to quit smoking, with or without treatment.
Alcohol Intake:
There have been post-marketing reports of patients experiencing increased intoxicating effects of alcohol while taking varenicline. Some cases described unusual and sometimes aggressive behaviour, and were often accompanied by amnesia for the events.
g. depression, anxiety). Patients with a history of psychiatric symptoms should be monitored for worsening or new symptoms when attempting to quit smoking, regardless of how well controlled symptoms may be when starting smoking cessation treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Varenicline 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.
Patients should be instructed to report strongly atypical and concerning symptoms to their healthcare provider, so that dose adjustments of psychiatric medications or ZDS-Varenicline may be considered.
General:
Patients should be informed that if they experience thoughts, moods or behaviours that are strongly atypical and concerning while on smoking-cessation medication, including ZDS -Varenicline, the medication should be discontinued immediately, with urgent medical help sought as needed, and the symptoms reported to their healthcare provider.
Angioedema and Hypersensitivity reactions ZDS-Varenicline Product Monograph Page 5 of 62 There have been post-marketing reports of hypersensitivity reactions, including angioedema, in patients treated with varenicline (see ADVERSE REACTIONS, Post-Marketing Experience).
Clinical signs included swelling of the face, mouth (tongue, lips and gums), neck (pharynx and larynx) and extremities. There were rare reports of life-threatening angioedema requiring urgent medical attention due to respiratory compromise.
Patients experiencing these symptoms should be instructed to discontinue treatment with ZDS-Varenicline and contact a healthcare provider immediately. Serious Skin Reactions There have also been post-marketing reports of rare but severe cutaneous reactions, including Stevens-Johnson syndrome and erythema multiforme, in patients using varenicline (see ADVERSE REACTIONS, Post-Marketing Experience).
As these skin reactions can be life- threatening, patients should be instructed to discontinue treatment at the first sign of rash or skin reaction and contact a healthcare provider immediately. Seizures In clinical trials and post-marketing experience there have been reports of seizures in patients treated with varenicline.
Some patients had no history of seizures, whereas others had a history of seizure disorder that was remote or well-controlled. ZDS-Varenicline should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Advise patients to discontinue ZDS-Varenicline and immediately contact a healthcare provider if they experience a seizure while on treatment (see Special Populations, Use of ZDS-Varenicline in Patients with Concomitant Conditions).
Somnambulism Cases of somnambulism have been reported post-marketing in patients taking varenicline. Some cases described harmful behavior to self, others, or property. Instruct patients to discontinue ZDS-Varenicline and notify their healthcare provider if they experience somnambulism.
Cardiovascular Events In a placebo-controlled smoking cessation clinical trial in patients with stable cardiovascular disease (CVD), patients were treated with varenicline 1 mg BID or placebo for 12 weeks, and then followed for another 40 weeks.
There were approximately 350 patients per arm. Serious cardiovascular (CV) events that were reported more frequently in varenicline compared to placebo (difference > 2 subjects) were: non-fatal myocardial infarctions (4 vs. 1, on- treatment phase) and need for coronary revascularization (7 vs.
2, post-treatment phase). The total number of patients that experienced serious CV events in varenicline compared to placebo was: 10 vs. 9 on treatment phase, 16 vs. 11 post-treatment phase, for a total of 25 vs. 20 over the 52 week duration.
The serious CV events occurring during the treatment and post- treatment phases were adjudicated by an independent blinded committee. The study was […]