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Indications & Uses
Varenicline Tartrate is a nicotinic receptor partial agonist. Doctors prescribe it as an aid to smoking cessation treatment.
Pharmacology
Varenicline binds with high affinity and selectivity to α4β2 neuronal nicotinic acetylcholine receptors. Its effect in helping people stop smoking is believed to come from its action at the α4β2 sub-type of the nicotinic receptor. There it produces agonist activity, and at the same time it stops nicotine from binding to these receptors.
In vitro electrophysiology studies and in vivo neurochemical studies have shown that varenicline binds to α4β2 neuronal nicotinic acetylcholine receptors and stimulates receptor-mediated activity, but at a much lower level than nicotine does. Varenicline also blocks nicotine from activating the α4β2 receptors, so it blocks the stimulation of the central nervous mesolimbic dopamine system. This system is believed to be the neuronal mechanism behind the reinforcement and reward a person feels when smoking.
Varenicline is highly selective. It binds more potently to α4β2 receptors than to other common nicotinic receptors (>500-fold for α3β4, >3,500-fold for α7, >20,000-fold for α1βγδ) or to non-nicotinic receptors and transporters (>2,000-fold). It also binds with moderate affinity (Ki = 350 nM) to the 5-HT3 receptor.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Start Varenicline one week before the date the patient has set for stopping smoking. The other way is to start Varenicline first and let the patient quit smoking between days 8 and 35 of treatment.
In the starting week, the dose is 0.5 mg once daily on days 1 to 3, then 0.5 mg twice daily on days 4 to 7. In the continuing weeks, the dose is 1 mg twice daily, for a total of 12 weeks. For people who manage to quit, another 12 weeks of treatment is recommended to increase the likelihood of long-term abstinence.
Some patients are sure they can't or won't quit all at once. For them, consider a gradual approach with Varenicline. The patient starts the medicine and cuts smoking by 50% from baseline within the first four weeks, then by another 50% over the next four weeks. After that they keep reducing, with the goal of complete abstinence by 12 weeks. Treatment then continues for another 12 weeks, making 24 weeks in all.
Severe renal impairment (estimated creatinine clearance less than 30 mL/min): begin with 0.5 mg once daily and titrate to 0.5 mg twice daily. For patients with end-stage renal disease on hemodialysis, a maximum of 0.5 mg daily may be given if tolerated.
Consider a lower dose for patients who can't tolerate the adverse effects.
If a patient fails to stop smoking or relapses, another attempt at treatment is recommended once the factors behind the failed attempt have been addressed.
Provide patients with suitable educational materials and counseling to support the quit attempt.
Pediatric use: Varenicline is not recommended for patients 16 years of age or younger, because its efficacy in this group was not demonstrated.
Side Effects
The most common side effects of Varenicline Tartrate were nausea, abnormal dreams (such as vivid, unusual or strange dreams), constipation, flatulence and vomiting. These were reported by more than 5% of patients, and at more than twice the rate seen in patients given a placebo.
Cautions & Contraindications
Warnings & Precautions
Neuropsychiatric Adverse Events Serious or clinically significant neuropsychiatric events have been reported after Varenicline Tartrate came into use. These include changes in mood (depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety and panic, as well as suicidal ideation, suicide attempt and completed suicide. Watch patients who are trying to quit smoking with the medicine for any of these symptoms. Tell them to stop taking it and contact a doctor if such events occur. Seizures New or worsening seizures have been seen in patients taking Varenicline Tartrate. Use it with caution in patients who have a history of seizures or other factors that can lower the seizure threshold. Interaction with Alcohol Increased effects of alcohol have been reported. Tell patients to drink less alcohol until they know whether the medicine affects them. Accidental Injury Accidental injuries, such as traffic accidents, have been reported. Tell patients to take care when driving or operating machinery until they know how the medicine may affect them. Cardiovascular Events Patients who already have cardiovascular (CV) disease may be at higher risk of CV events. This concern has to be balanced against the health benefits of quitting smoking. Tell patients to inform their doctor about any new or worsening CV symptoms, and to get medical attention immediately if they have signs and symptoms of myocardial infarction (MI) or stroke. Somnambulism Cases of somnambulism (sleepwalking) have been reported in patients taking Varenicline Tartrate. Some of these cases involved harmful behaviour towards the patient, other people or property. Tell patients to stop the medicine and inform their doctor if they experience somnambulism. Angioedema and Hypersensitivity Reactions These reactions, including angioedema, have been reported, and they have infrequently been life-threatening. Tell patients to stop the medicine and seek medical care immediately if symptoms occur. Serious Skin Reactions Rare skin reactions, which can be life-threatening, have been reported. Tell patients to stop the medicine and contact a doctor immediately when a skin rash with mucosal lesions first appears. Nausea Nausea is the most common adverse reaction, with an incidence of up to 30%. Reducing the dose may help.
Contraindications
Don't use Varenicline Tartrate if you have ever had a serious allergic reaction or a serious skin reaction to it.
Pregnancy & Breastfeeding
The data we have so far don't show a higher risk of major birth defects when women take varenicline during pregnancy, compared with women who smoke. Smoking in pregnancy carries its own risks for the mother, the baby before birth and the newborn.
For breastfeeding, nobody knows yet whether varenicline passes into human milk, what it might do to a breastfed infant, or whether it affects milk production. In animal studies, varenicline was found in the milk of lactating rats.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Store Varenicline Tartrate below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Champix 0.5 mg
What is Champix 0.5 mg Tablet?
Champix 0.5 mg Tablet is a medicine that contains Varenicline Tartrate. It is made by Janata Traders. It belongs to the Drugs used in substance dependence group of medicines.
What is Champix used for?
Varenicline Tartrate is a nicotinic receptor partial agonist. Doctors prescribe it as an aid to smoking cessation treatment.
What are the side effects of Champix?
The most common side effects of Varenicline Tartrate were nausea, abnormal dreams (such as vivid, unusual or strange dreams), constipation, flatulence and vomiting. These were reported by more than 5% of patients, and at more than twice the rate seen in patients given a placebo.
Can I take Champix during pregnancy or while breastfeeding?
The data we have so far don't show a higher risk of major birth defects when women take varenicline during pregnancy, compared with women who smoke. Smoking in pregnancy carries its own risks for the mother, the baby before birth and the newborn. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Champix?
Store Varenicline Tartrate below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Champix?
Some medicines can interact with Varenicline Tartrate, for example: Insulin (Human) 30/70, Theophylline, Warfarin Sodium, Nicotine. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Champix?
Champix is a prescription (Rx) medicine. Take it as your doctor advises.