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PMS-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.
Dosing Considerations Smoking-cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional counselling and /or support services. In the clinical trials on which approval was based, varenicline tartrate was used with supportive counselling.
Physicians should review the patient’s overall smoking-cessation plan that includes treatment with pms-VARENICLINE. The majority of clinical evidence in efficacy and safety was based on a 1 mg BID dose (see CLINICAL TRIALS). There is little clinical experience with doses above the maximum recommended dose of 1 mg BID.
There is limited data available for dose comparison. 5 mg BID (n = 253) and placebo (n = 121) were: for Weeks 9 to 12: 51%, 45%, and 12% respectively, and for Weeks 9 to 52: 23%, 19% and 4% respectively. For further information on this study, see CLINICAL TRIAL, study 1.
Based on the limited data available, it cannot be concluded that there is a difference between the two doses in the rate of serious neuropsychiatric events (see ADVERSE REACTIONS, Neuropsychiatric Adverse Events in Randomized Double Blind, Placebo-Controlled Clinical Studies of Varenicline).
pms-VARENICLINE should be taken after eating and with a full glass of water. 5 mg twice daily (see below Special Populations, Patients with Impaired Renal Function).
Recommended Dose and Dosage Adjustment Adults Setting a quit date:
There are three ways to set a quit date with pms-VARENICLINE: Fixed quit approach: The patient sets a date to stop smoking. pms-VARENICLINE dosing should start 1-2 Weeks before this date (see CLINICAL TRIALS). , between Weeks 2 and 5) (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations, Flexibility in Setting a Quit Date).
or Gradual quit approach: The patient starts taking pms-VARENICLINE with a goal to quit smoking by end of 12 weeks of treatment. The patient should gradually reduce smoking during the first 12 weeks of treatment such as 50% reduction or more by 4 weeks of treatment, 75% or more by 8 weeks to reach 100% by 12 weeks (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations).
5 mg BID or 1 mg BID. 5 mg BID or moves up to 1 mg BID. 5 mg twice daily 1 mg twice daily The choice of dosing regimen should be based on physician judgment and patient preference, following discussion with the patient (see also Dosing Considerations).
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 tartrate, including anxiety, psychosis, mood swings, depressed mood, agitation, aggression, hostility, changes in behaviour or thinking, suicidal ideation, suicidal behaviour 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 tartrate, 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 tartrate.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Once pms-VARENICLINE treatment is initiated, the dose may be changed, temporarily or permanently, according to patient and physician judgments on tolerability and efficacy. Patients who follow one of the first 2 approaches to setting a quit date (1-2 weeks after starting the treatment or between days 8 and 35 of treatment) should be treated with pms- VARENICLINE for 12 weeks.
For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with pms-VARENICLINE may be considered. No data are available on the efficacy of an additional 12 week course of treatment with varenicline tartrate for patients who have not successfully stopped smoking at the end of 12 weeks.
Patients who follow the gradual quit approach (Week 12) should be treated with pms- VARENICLINE for 24 weeks. Dose tapering may be considered. Regardless of whether the treatment course is 12 or 24 weeks, risk of smoking-cessation relapse is elevated in the period immediately following the end of drug treatment (see CLINICAL TRIALS).
, increase in irritability, urge to smoke, depression, and/or insomnia), observed in up to 3% of patients at the end of treatment. Special Populations Psychiatric Patients Patients with a history of psychiatric symptoms who are attempting to quit smoking should be monitored by their health care professional for new or worsened psychiatric events.
Those with a current condition should be clinically stable. Patients should be instructed that if they develop worsened or new symptoms, to report these to their healthcare provider, so that dose adjustments of psychiatric medications and/or pms-VARENICLINE may be considered (see also WARNINGS AND PRECAUTIONS, Special Populations, Psychiatric Patients).
Patients with Impaired Renal Function No dosage adjustment is necessary for patients with mild (estimated creatinine clearance > 50 mL/min and < 80 mL/min) to moderate (estimated creatinine clearance ≥ 30 mL/min and < 50 mL/min) renal impairment.
For patients who experience intolerable adverse events, dosing may be reduced. 5 mg twice daily. 5 mg twice daily. Based on insufficient clinical experience with varenicline tartrate in patients with end-stage renal disease, treatment is not recommended in this patient population (see also WARNINGS AND PRECAUTIONS, Special Populations: Renal Impairment).
Patients with Hepatic Impairment No dosage adjustment […]
Some cases described unusual and sometimes aggressive behaviour, and were often accompanied by amnesia for the events. , 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.
Patients should be instructed to report strongly atypical and concerning symptoms to their healthcare provider, so that dose adjustments of psychiatric medications or pms- 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 pms- pms-VARENICLINE Product Monograph Page 5 of 61 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 There have been post-marketing reports of hypersensitivity reactions, including angioedema, in patients treated with varenicline tartrate (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 pms-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 tartrate (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 tartrate.
Some patients had no history of seizures, whereas others had a history of seizure disorder that was remote or well-controlled. pms-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 pms-VARENICLINE and immediately contact a healthcare provider if they experience a seizure while on treatment (see Special Populations, Use of pms-VARENICLINE in Patients with Concomitant Conditions).
Somnambulism Cases of somnambulism have been reported post-marketing in patients taking CHAMPIX. Some cases described harmful behavior to self, others, or property. Instruct patients to discontinue pms-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 tartrate 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 tartrate 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 pms-VARENICLINE Product Monograph Page 6 of 61 total number of patients that experienced serious CV events in varenicline tartrate 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 […]