Varenicline
Generic medicine reference
Not yet clinically reviewed
This entry was migrated from the earlier Pharmapedia app bundle and has not been reviewed by a named clinician on this site. It is provided for educational reference only — verify dosage and safety information against current, authoritative sources and a qualified healthcare professional before any clinical use.
Overview
Varenicline is a smoking cessation aid that is used alongside education and counseling to help people stop smoking. Varenicline works by binding to nicotinic receptors, stimulating these receptors at a much lower level than nicotine, while at the same time preventing nicotine from binding to these same receptors. This decreases nicotine cravings and withdrawal symptoms that happen when people stop smoking. It belongs to the class of medicines called smoking cessation aids.
Varenicline was FDA-approved on May 10, 2006, under the brand Chantix. The Chantix brand has been discontinued, but varenicline generics are available.
Indications
Varenicline is a smoking cessation aid that is used alongside education and counseling to help people stop smoking. Varenicline works by binding to nicotinic receptors, stimulating these receptors at a much lower level than nicotine, while at the same time preventing nicotine from binding to these same receptors. This decreases nicotine cravings and withdrawal symptoms that happen when people stop smoking. It belongs to the class of medicines called smoking cessation aids.
Varenicline was FDA-approved on May 10, 2006, under the brand Chantix. The Chantix brand has been discontinued, but varenicline generics are available.
Contraindications
Do not take varenicline if you have had a serious allergic or skin reaction to varenicline, Chantix, or any inactive ingredients in the tablets. Symptoms may include:
swelling of the face, mouth (tongue, lips, gums), throat or neck trouble breathing rash, with peeling skin blisters in your mouth.
Before taking varenicline, tell your healthcare provider if you have ever had depression or other mental health problems. Also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without varenicline.
Tell your healthcare provider if you:
use other treatments to quit smoking. Using varenicline with a nicotine patch may cause nausea, vomiting, headache, dizziness, upset stomach, and tiredness to happen more often than if you just use a nicotine patch alone. have kidney problems or get kidney dialysis. Your healthcare provider may prescribe a lower dose of varenicline for you. have a history of seizures drink alcohol have heart or blood vessel problems have any other medical conditions are pregnant or planning to become pregnant are breastfeeding.
Side Effects
Nausea is the most common side effect reported with varenicline, experienced by up to 30% of people taking it. Reducing the dose may help with this side effect.
Other common side effects of varenicline affecting 5% or more people who take it include:
sleep problems (trouble sleeping or vivid, unusual, or strange dreams) constipation gas vomiting.
When you try to quit smoking, with or without varenicline, you may have symptoms that may be due to nicotine withdrawal, such as:
an urge to smoke a depressed mood trouble sleeping irritability frustration anger feeling anxious difficulty concentrating restlessness a decreased heart rate increased appetite weight gain.
Warnings
Some people have experienced the following serious side effects while taking varenicline to help them quit smoking.
New or worse mental health problems , such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions. Some people had these symptoms when they began taking varenicline, and others developed them after several weeks of treatment, or after stopping treatment. These symptoms happened more often in people who had a history of mental health problems before taking varenicline than in people without a history of mental health problems.
Stop taking varenicline and call your healthcare provider right away if you, your family, or your caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take varenicline. In many people, these symptoms went away after stopping varenicline, but in some people, symptoms continued despite stopping it. You need to follow up with your healthcare provider until your symptoms go away.
Some people have even experienced suicidal thoughts when trying to quit smoking with or without medication such as varenicline. Sometimes quitting smoking can lead to worsening mental health problems that you already have, such as depression.
Seizures . Some people have had seizures during treatment with varenicline. In most cases, the seizures have happened during the first month of treatment. If you have a seizure during treatment with varenicline, stop taking it and contact your healthcare provider right away.
New or worse heart or blood vessel (cardiovascular) problems , mostly in people, who already have cardiovascular problems. Tell your healthcare provider if you have any changes in symptoms during treatment with varenicline. Get emergency medical help right away if you have any of the following symptoms of a heart attack, including:
chest discomfort (uncomfortable pressure, squeezing, fullness, or pain) that lasts more than a few minutes, or that goes away and comes back pain or discomfort in one or both arms, back, neck, jaw, or stomach shortness of breath, sweating, nausea, vomiting, or a lightheaded feeling associated with chest discomfort.
Sleepwalking can happen with varenicline, and can sometimes lead to behavior that is harmful to you or other people, or to property. Stop taking varenicline and tell your healthcare provider if you start sleepwalking.
Allergic reactions can happen with varenicline. Some of these allergic reactions can be life-threatening.
Serious skin reactions , including rash, swelling, redness, and peeling of the skin. Some of these skin reactions can become life-threatening. Stop taking varenicline and get medical help right away if you have any of the following symptoms:
swelling of the face, mouth (tongue, lips, and gums), throat or neck trouble breathing rash with peeling skin blisters in your mouth.
Tell your healthcare provider about side effects that bother you or do not go away.
Varenicline is not effective in children 16 years of age and under and should not be used in children.
It is not known if varenicline is safe and effective when used with other stop-smoking medicines.
These are not all the side effects of varenicline. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
High Risk Groups
Some people have experienced the following serious side effects while taking varenicline to help them quit smoking.
New or worse mental health problems , such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions. Some people had these symptoms when they began taking varenicline, and others developed them after several weeks of treatment, or after stopping treatment. These symptoms happened more often in people who had a history of mental health problems before taking varenicline than in people without a history of mental health problems.
Stop taking varenicline and call your healthcare provider right away if you, your family, or your caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take varenicline. In many people, these symptoms went away after stopping varenicline, but in some people, symptoms continued despite stopping it. You need to follow up with your healthcare provider until your symptoms go away.
Some people have even experienced suicidal thoughts when trying to quit smoking with or without medication such as varenicline. Sometimes quitting smoking can lead to worsening mental health problems that you already have, such as depression.
Seizures . Some people have had seizures during treatment with varenicline. In most cases, the seizures have happened during the first month of treatment. If you have a seizure during treatment with varenicline, stop taking it and contact your healthcare provider right away.
New or worse heart or blood vessel (cardiovascular) problems , mostly in people, who already have cardiovascular problems. Tell your healthcare provider if you have any changes in symptoms during treatment with varenicline. Get emergency medical help right away if you have any of the following symptoms of a heart attack, including:
chest discomfort (uncomfortable pressure, squeezing, fullness, or pain) that lasts more than a few minutes, or that goes away and comes back pain or discomfort in one or both arms, back, neck, jaw, or stomach shortness of breath, sweating, nausea, vomiting, or a lightheaded feeling associated with chest discomfort.
Sleepwalking can happen with varenicline, and can sometimes lead to behavior that is harmful to you or other people, or to property. Stop taking varenicline and tell your healthcare provider if you start sleepwalking.
Allergic reactions can happen with varenicline. Some of these allergic reactions can be life-threatening.
Serious skin reactions , including rash, swelling, redness, and peeling of the skin. Some of these skin reactions can become life-threatening. Stop taking varenicline and get medical help right away if you have any of the following symptoms:
swelling of the face, mouth (tongue, lips, and gums), throat or neck trouble breathing rash with peeling skin blisters in your mouth.
Tell your healthcare provider about side effects that bother you or do not go away.
Varenicline is not effective in children 16 years of age and under and should not be used in children.
It is not known if varenicline is safe and effective when used with other stop-smoking medicines.
These are not all the side effects of varenicline. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Adult Dosage
0.5 mg (0.5 (0.5)) 24 hourly PO — Day 1-3, Once daily. The patient should set a date to stop smoking. Varenicline dosing should start one week before this date. It should be taken after eating and with a full glass of water. Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support. Patients should be provided with appropriate educational materials and counseling to support the quit attempt.
1 mg (1 (1)) 12 hourly PO — on day 8, end of treatment.
Scraped Dose — Varenicline is an oral tablet that is taken twice a day. The most common way to start taking varenicline is at least one week before you quit, at a low dose (varenicline 0.5 mg), which is gradually increased over 8 days to varenicline 1 mg twice a day.
Take varenicline with food or soon after eating and with a full glass of water to minimize potential nausea from the medications. Varenicline does not contain nicotine, so it works differently than nicotine replacement medicines.
Child Dosage
No child dosage information is recorded for this medicine yet.
Neonatal Dosage
No neonatal dosage information is recorded for this medicine yet.
Drug Interactions
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider may need to change the dose of some of your medicines when you stop smoking.
You should not use varenicline while using other medicines to quit smoking. Tell your healthcare provider if you use other treatments to quit smoking. Interaction with Alcohol: Increased effects of alcohol have been reported. Instruct patients to reduce the amount of alcohol they consume until they know whether varenicline affects them. Using varenicline with a nicotine patch may cause nausea, vomiting, headache, dizziness, upset stomach, and tiredness to happen more often than if you just use a nicotine patch alone.
Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist when you get a new medicine.
Storage
Tabs Store Between 20°C-25°C.
Available Brands in Pakistan
3 active brands listed alphabetically.
NEUTOVARIC
ActiveNEUTRO PHARMA (PVT) LTD.
DML: NEUTOVARIC
Tabs
VALACLINE
ActiveVALOR PHARMACEUTICALS
DML: VALACLINE
Tabs
VARIPUF
ActiveGENIX PHARMA (PVT) LTD
DML: VARIPUF
Tabs
1 additional record is present but flagged "Unverified / Legacy" and not listed.
