Champix Tablets / Film-coated
Varenicline Tartrate
0.5mg or 1mg
Pfizer Europe MA EEIG
| Pack size | 53's (11's Blister [0.5mg] + 42's Blister [1mg]) |
|---|---|
| Dispensing mode | POM |
| Source | BELGIUM |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 335.50 AED |
Available as:
Indications
Champix Tablets / Film-coated is used for:
Smoking cessation aid
Adult Dose
Smoking Cessation
Set a date to stop smoking and begin varenicline 1 week before this date
Alternatively, the patient can begin varenicline and then quit smoking between days 8 and 35 of treatment
Also see Administration
Quit smoking date regimen
Initiate regimen 1 week before quit smoking date
Days 1-3: 0.5 mg PO qDay
Days 4-7: 0.5 mg PO BID
Day 8 to end of treatment: 1 mg PO BID
If quitting is successful after 12 weeks, continue another 12 weeks at 1 mg q12hr
Gradual approach to quitting
For patients who are sure that they are not able or willing to quit abruptly, consider a gradual approach to quitting smoking with varenicline
Begin dosing and reduce smoking by 50% from baseline within the first 4 weeks, by an additional 50% in the next 4 weeks, and continue reducing with the goal of reaching complete abstinence by 12 weeks
Continue varenicline for an additional 12 weeks, for a total of 24 weeks of treatment
Encourage patients to attempt quitting sooner if they feel ready
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Renal impairment
Mild-to-moderate (CrCl ?30 mL/min): No dosage adjustment required
Severe (CrCl <30 mL/min): 0.5 mg PO qDay initially; may increase to 0.5 mg PO q12hr
ESRD on hemodialysis: Not to exceed 0.5 mg PO qDay
Administration
Taken after eating with full glass of water
Contra Indications
Documented hypersensitivity or skin reactions to drug or components of formulation. Nonsmokers.
Precautions
Monitor for signs of suicidal ideation or behaviour, or changes in behaviour. May affect performance of skilled tasks. Not recommended for use in children <18 yr. Pregnancy, lactation.
Pregnancy-Lactation
Pregnancy
Available data have not suggested increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke; smoking during pregnancy causes increased risks of orofacial clefts, premature rupture of membranes, placenta previa, placental abruption, ectopic pregnancy, fetal growth restriction and low birth weight, stillbirth, preterm delivery and shortened gestation, neonatal death, sudden infant death syndrome and reduction of lung function in infants; it is not known whether quitting smoking with varenicline during pregnancy reduces these risks
Lactation
Because there are no data on presence of varenicline in human milk and effects on breastfed infant, breastfeeding women should monitor their infant for seizures and excessive vomiting, which are adverse reactions that have occurred in adults that may be clinically relevant in breastfeeding infants
Interactions
Increased incidence of adverse effects (nausea, vomiting) w/ transdermal nicotine. Increased exposure w/ cimetidine.
Adverse Effects
Side effects of Varenicline Tartrate :
N>10%
Nausea (15-40%; dose related), Abnormal dreams, Headache, Insomnia
1-10%
Appetite changes, Chest pain, Constipation, Dry mouth, Dyspepsia, Dyspnea, Flatulence, Gastroesophageal reflux disease (GERD), Fatigue or lethargy, Pruritus, Rash, Somnolence, Rhinorrhea, Vomiting, Upper respiratory tract disorder
Frequency Not Defined (selected)
Abnormal liver function tests, Anemia, Anxiety, Arrhythmia, Arthralgia, Depression, Diarrhea, Dizziness, Epistaxis, Hypertension, Myocardial infarction (MI), Polyuria, Respiratory disorder
Mechanism of Action
Varenicline Tartrate is a partial neuronal alpha 2 beta 2 nicotinic acetylcholine receptor agonist. It works as a smoking cessation aid by preventing nicotine stimulation of mesolimbic dopamine system. It also stimulates dopamine activity but to a much lesser extent than nicotine does, resulting in reduced craving and withdrawal symptoms.
Note
Champix 0.5mg or 1mg Tablets / Film-coated manufactured by Pfizer Europe MA EEIG. Its generic name is Varenicline Tartrate. Champix is availble in United Arab Emirates.
Farmaco UAE drug index information on Champix Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.