Varenicline

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Begin varenicline tablets dosing one week before the date set by the patient to stop smoking. Alternatively, the patient can begin varenicline tablets dosing and then quit smoking between days 8 and 35 of treatment. ( 2.1 )
• Starting Week:
• 0.5 mg once daily on days 1 to 3 and 0.5 mg twice daily on days 4 to 7. ( 2.1 )
• Continuing Weeks: 1 mg twice daily for a total of 12 weeks. ( 2.1 )
• An additional 12 weeks of treatment is recommended for successful quitters to increase likelihood of long-term abstinence. ( 2.1 )
• Consider a gradual approach to quitting smoking with varenicline tablets for patients who are sure that they are not able or willing to quit abruptly. Patients should begin varenicline tablets dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continue reducing with the goal of reaching complete abstinence by 12 weeks. Continue treatment for an additional 12 weeks, for a total of 24 weeks. ( 2.1 )
• 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 undergoing hemodialysis, a maximum of 0.5 mg daily may be given if tolerated. ( 2.2 )
• Consider dose reduction for patients who cannot tolerate adverse effects. ( 2.1 )
• Another attempt at treatment is recommended for those who fail to stop smoking or relapse when factors contributing to the failed attempt have been addressed. ( 2.1 )
• Provide patients with appropriate educational materials and counseling to support the quit attempt. ( 2.1 ) 2.1 Usual Dosage for
• Adults Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support. Provide patients with appropriate educational materials and counseling to support the quit attempt. The patient should set a date to stop smoking. Begin varenicline tablets dosing one week before this date. Alternatively, the patient can begin varenicline tablets dosing and then quit smoking between days 8 and 35 of treatment. Varenicline tablets should be taken orally after eating and with a full glass of water. The recommended dose of varenicline tablets is 1 mg twice daily following a 1-week titration as follows:
• Days 1 to 3:
• 0.5 mg once daily Days 4 to 7:
• 0.5 mg twice daily Day 8 – end of treatment:
• 1 mg twice daily Patients should be treated with varenicline tablets for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with varenicline tablets are recommended to further increase the likelihood of long-term abstinence. For patients who are sure that they are not able or willing to quit abruptly, consider a gradual approach to quitting smoking with varenicline tablets. Patients should begin varenicline tablets dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continue reducing with the goal of reaching complete abstinence by 12 weeks. Continue varenicline tablets treatment for an additional 12 weeks, for a total of 24 weeks of treatment. Encourage patients to attempt quitting sooner if they feel ready [see Clinical Studies ( 14.5 )]. Patients who are motivated to quit, and who did not succeed in stopping smoking during prior varenicline tablets therapy for reasons other than intolerability due to adverse events or who relapsed after treatment, should be encouraged to make another attempt with varenicline tablets once factors contributing to the failed attempt have been identified and addressed. Consider a temporary or permanent dose reduction in patients who cannot tolerate the adverse effects of varenicline tablets. 2.2 Dosage in Special Populations Patients with Impaired Renal Function No dosage adjustment is necessary for patients with mild to moderate renal impairment. For patients with severe renal impairment (estimated creatinine clearance less than 30 mL per min), the recommended starting dose of varenicline tablets is 0.5 mg once daily. The dose may then be titrated as needed to a maximum dose of 0.5 mg twice daily. For patients with end-stage renal disease undergoing hemodialysis, a maximum dose of 0.5 mg once daily may be administered if tolerated [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )]. Elderly and Patients with Impaired Hepatic Function No dosage adjustment is necessary for patients with hepatic impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Use in Specific Populations ( 8.5 )].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

• Varenicline is not recommended for use in pediatric patients 16 years of age or younger because its efficacy in this population was not demonstrated.
• Single and multiple-dose pharmacokinetics of varenicline have been investigated in pediatric patients aged 12 to 17 years old (inclusive) and were approximately dose-proportional over the 0.5 mg to 2 mg daily dose range studied.
• Steady-state systemic exposure in adolescent patients of bodyweight >55 kg, as assessed by AUC (0 to 24) , was comparable to that noted for the same doses in the adult population.
• When 0.5 mg BID was given, steady-state daily exposure of varenicline was, on average, higher (by approximately 40%) in adolescent patients with bodyweight ≤ 55 kg compared to that noted in the adult population.
• The efficacy and safety of varenicline was evaluated in a randomized, double-blind, placebo-controlled study of 312 patients aged 12 to 19 years, who smoked an average of at least 5 cigarettes per day during the 30 days prior to recruitment, had a score of at least 4 on the Fagerstrom Test for Nicotine Dependence scale, and at least one previous failed quit attempt.
• Patients were stratified by age (12 to 16 years of age, n = 216 and 17 to 19 years of age, n = 96) and by body weight (≤55 kg and >55 kg).
• Patients were randomized to one of two doses of varenicline, adjusted by weight to provide plasma levels in the efficacious range (based on adult studies) and placebo.
• Patients received treatment for 12 weeks, followed by a non-treatment period of 40 weeks, along with age-appropriate counseling throughout the study.
• Results from this study showed that varenicline, at either dose studied, did not improve continuous abstinence rates at weeks 9 through 12 of treatment compared with placebo in subjects 12 to 19 years of age.
• The varenicline safety profile in this study was consistent with that observed in adult studies.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• A combined single- and multiple-dose pharmacokinetic study demonstrated that the pharmacokinetics of 1 mg varenicline given once daily or twice daily to 16 healthy elderly male and female smokers (aged 65 to 75 years) for 7 consecutive days was similar to that of younger subjects.
• No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
• Varenicline is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
• Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration ( 2.2 )].
• No dosage adjustment is recommended for elderly patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following serious adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the labeling:
• Neuropsychiatric Adverse Events including Suicidality [see Warnings and Precautions ( 5.1 )]
• Seizures [see Warnings and Precautions ( 5.2 )]
• Interaction with Alcohol [see Warnings and Precautions ( 5.3 )]
• Accidental Injury [see Warnings and Precautions ( 5.4 )]
• Cardiovascular Events [see Warnings and Precautions ( 5.5 )]
• Somnambulism [see Warnings and Precautions ( 5.6 )]
• Angioedema and Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )]
• Serious Skin Reactions [see Warnings and Precautions ( 5.8 )] In the placebo-controlled premarketing studies, the most common adverse events associated with varenicline (>5% and twice the rate seen in placebo-treated patients) were nausea, abnormal (vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting. The treatment discontinuation rate due to adverse events in patients dosed with 1 mg twice daily was 12% for varenicline, compared to 10% for placebo in studies of three months’ treatment. In this group, the discontinuation rates that are higher than placebo for the most common adverse events in varenicline-treated patients were as follows:
• nausea (3% vs. 0.5% for placebo), insomnia (1.2% vs. 1.1% for placebo), and abnormal dreams (0.3% vs. 0.2% for placebo). Smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. Most common adverse reactions (>5% and twice the rate seen in placebo-treated patients) were nausea, abnormal (e.g., vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During the premarketing development of varenicline, over 4500 subjects were exposed to varenicline, with over 450 treated for at least 24 weeks and approximately 100 for a year. Most study participants were treated for 12 weeks or less. The most common adverse event associated with varenicline treatment is nausea, occurring in 30% of patients treated at the recommended dose, compared with 10% in patients taking a comparable placebo regimen [see Warnings and Precautions ( 5.9 )]. Table 1 shows the adverse events for varenicline and placebo in the 12- week fixed dose premarketing studies with titration in the first week [Studies 2 (titrated arm only), 4, and 5]. Adverse events were categorized using the Medical Dictionary for Regulatory Activities (MedDRA, Version 7.1). MedDRA High Level Group Terms (HLGT) reported in ≥5% of patients in the varenicline 1 mg twice daily dose group, and more commonly than in the placebo group, are listed, along with subordinate Preferred Terms (PT) reported in ≥1% of varenicline patients (and at least 0.5% more frequent than placebo). Closely related Preferred Terms such as ‘Insomnia’, ‘Initial insomnia’, ‘Middle insomnia’, ‘Early morning awakening’ were grouped, but individual patients reporting two or more grouped events are only counted once. Table 1. Common Treatment Emergent AEs (%) in the Fixed-Dose, Placebo-Controlled Studies (HLGTs >5% of Patients in the 1 mg BID Varenicline Group and More Commonly than Placebo and PT ≥1% in the 1 mg BID Varenicline Group, and 1 mg BID Varenicline at Least 0.5% More than Placebo) SYSTEM ORGAN CLASS High Level Group Term Preferred Term Varenicline 0.5 mg BID N=129 Varenicline 1 mg BID N=821 Placebo N=805 GASTROINTESTINAL (GI) GI Signs and Symptoms Nausea 16 30 10 Abdominal Pain * 5 7 5 Flatulence 9 6 3 Dyspepsia 5 5 3 Vomiting 1 5 2 GI Motility/Defecation Conditions Constipation 5 8 3 Gastroesophageal reflux disease 1 1 0 Salivary Gland Conditions Dry mouth 4 6 4 PSYCHIATRIC DISORDERS Sleep Disorder/Disturbances Insomnia ** 19 18 13 Abnormal dreams 9 13 5 Sleep disorder 2 5 3 Nightmare 2 1 0 NERVOUS SYSTEM Headaches Headache 19 15 13 Neurological Disorders NEC Dysgeusia 8 5 4 Somnolence 3 3 2 Lethargy 2 1 0 GENERAL DISORDERS General Disorders NEC Fatigue/Malaise/Asthenia 4 7 6 RESPIR/THORACIC/MEDIAST Respiratory Disorders NEC Rhinorrhea 0 1 0 Dyspnea 2 1 1 Upper Respiratory Tract Disorder 7 5 4 SKIN/SUBCUTANEOUS TISSUE Epidermal and Dermal Conditions Rash 1 3 2 Pruritis 0 1 1 METABOLISM and NUTRITION Appetite/General Nutrition Disorders Increased appetite 4 3 2 Decreased appetite/ Anorexia 1 2 1 * Includes PTs Abdominal (pain, pain upper, pain lower, discomfort, tenderness, distension) and Stomach discomfort ** Includes PTs Insomnia/Initial insomnia/Middle insomnia/Early morning awakening The overall pattern and frequency of adverse events during the longer-term premarketing trials was similar to those described in Table 1, though several of the most common events were reported by a greater proportion of patients with long-term use (e.g., nausea was reported in 40% of patients treated with varenicline 1 mg twice daily in a one year study, compared to 8% of placebo-treated patients). Following is a list of treatment-emergent adverse events reported by patients treated with varenicline during all premarketing clinical trials and updated based on pooled data from 18 placebo-controlled pre- and postmarketing studies, including approximately 5,000 patients treated with varenicline. Adverse events were categorized using MedDRA, Version 16.0. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening. Blood and Lymphatic System Disorders. Infrequent:
• anemia, lymphadenopathy. Rare:
• leukocytosis, splenomegaly, thrombocytopenia. Cardiac Disorders. Infrequent:
• angina pectoris, myocardial infarction, palpitations, tachycardia. Rare:
• acute coronary syndrome, arrhythmia, atrial fibrillation, bradycardia, cardiac flutter, cor pulmonale, coronary artery disease, ventricular extrasystoles. Ear and Labyrinth Disorders. Infrequent:
• tinnitus, vertigo. Rare:
• deafness, Meniere’s disease. Endocrine Disorders. Infrequent:
• thyroid gland disorders. Eye Disorders. Infrequent:
• conjunctivitis, eye irritation, eye pain, vision blurred, visual impairment. Rare:
• blindness transient, cataract subcapsular, dry eye, night blindness, ocular vascular disorder, photophobia, vitreous floaters. Gastrointestinal Disorders. Frequent:
• diarrhea, toothache. Infrequent:
• dysphagia, eructation, gastritis, gastrointestinal hemorrhage, mouth ulceration. Rare:
• enterocolitis, esophagitis, gastric ulcer, intestinal obstruction, pancreatitis acute. General Disorders and Administration Site Conditions. Frequent:
• chest pain. Infrequent:
• chest discomfort, chills, edema, influenza-like illness, pyrexia. Hepatobiliary Disorders. Rare:
• gall bladder disorder. Investigations. Frequent:
• liver function test abnormal, weight increased. Infrequent:
• electrocardiogram abnormal. Rare:
• muscle enzyme increased, urine analysis abnormal. Metabolism and Nutrition Disorders. Infrequent:
• diabetes mellitus, hypoglycemia. Rare:
• hyperlipidemia, hypokalemia. Musculoskeletal and Connective Tissue Disorders. Frequent:
• arthralgia, back pain, myalgia. Infrequent:
• arthritis, muscle cramp, musculoskeletal pain. Rare:
• myositis, osteoporosis. Nervous System Disorders. Frequent:
• disturbance in attention, dizziness. Infrequent:
• amnesia, convulsion, migraine, parosmia, syncope, tremor. Rare:
• balance disorder, cerebrovascular accident, dysarthria, mental impairment, multiple sclerosis, VII th nerve paralysis, nystagmus, psychomotor hyperactivity, psychomotor skills impaired, restless legs syndrome, sensory disturbance, transient ischemic attack, visual field defect. Psychiatric Disorders. Infrequent:
• dissociation, libido decreased, mood swings, thinking abnormal. Rare:
• bradyphrenia, disorientation, euphoric mood. Renal and Urinary Disorders. Infrequent:
• nocturia, pollakiuria, urine abnormality. Rare:
• nephrolithiasis, polyuria, renal failure acute, urethral syndrome, urinary retention. Reproductive System and Breast Disorders. Frequent:
• menstrual disorder. Infrequent:
• erectile dysfunction. Rare:
• sexual dysfunction. Respiratory, Thoracic and Mediastinal Disorders. Frequent:
• respiratory disorders. Infrequent:
• asthma, epistaxis, rhinitis allergic, upper respiratory tract inflammation. Rare:
• pleurisy, pulmonary embolism. Skin and Subcutaneous Tissue Disorders. Infrequent:
• acne, dry skin, eczema, erythema, hyperhidrosis, urticaria. Rare:
• photosensitivity reaction, psoriasis. Vascular Disorders. Infrequent:
• hot flush. Rare:
• thrombosis. Varenicline has also been studied in postmarketing trials including (1) a trial conducted in patients with chronic obstructive pulmonary disease (COPD), (2) a trial conducted in generally healthy patients (similar to those in the premarketing studies) in which they were allowed to select a quit date between days 8 and 35 of treatment (“alternative quit date instruction trial”), (3) a trial conducted in patients who did not succeed in stopping smoking during prior varenicline therapy, or who relapsed after treatment (“re-treatment trial”), (4) a trial conducted in patients with stable cardiovascular disease, (5) a trial conducted in patients with stable schizophrenia or schizoaffective disorder, (6) a trial conducted in patients with major depressive disorder, (7) a postmarketing neuropsychiatric safety outcome trial in patients without or with a history of psychiatric disorder, (8) a non-treatment extension of the postmarketing neuropsychiatric safety outcome trial that assessed CV safety, (9) a trial in patients who were not able or willing to quit abruptly and who were instructed to quit gradually (“gradual approach to quitting smoking trial”). Adverse events in the trial of patients with COPD (1), in the alternative quit date instruction trial (2), and in the gradual approach to quitting smoking trial (9) were similar to those observed in premarketing studies. In the re-treatment trial (3), the profile of common adverse events was similar to that previously reported, but, in addition, varenicline-treated patients also commonly reported diarrhea (6% vs. 4% in placebo-treated patients), depressed mood disorders and disturbances (6% vs. 1%), and other mood disorders and disturbances (5% vs. 2%). In the trial of patients with stable cardiovascular disease (4), more types and a greater number of cardiovascular events were reported compared to premarketing studies, as shown in Table 1 and in Table 2 below. Table 2. Cardiovascular Mortality and Nonfatal Cardiovascular Events (%) with a Frequency >1% in Either Treatment Group in the Trial of Patients with Stable Cardiovascular Disease Varenicline 1 mg BID N=353 Placebo N=350 Adverse Events ≥1% in either treatment group Up to 30 days after treatment Angina pectoris 3.7 2.0 Chest pain 2.5 2.3 Peripheral edema 2.0 1.1 Hypertension 1.4 2.6 Palpitations 0.6 1.1 Adjudicated Cardiovascular Mortality (up to 52 weeks) 0.3 0.6 Adjudicated Nonfatal Serious Cardiovascular Events ≥1% in either treatment group Up to 30 days after treatment Nonfatal MI 1.1 0.3 Hospitalization for angina pectoris 0.6 1.1 Beyond 30 days after treatment and up to 52 weeks Need for coronary revascularization* 2.0 0.6 Hospitalization for angina pectoris 1.7 1.1 New diagnosis of peripheral vascular disease (PVD) or admission for a PVD procedure 1.4 0.6 *some procedures were part of management of nonfatal MI and hospitalization for angina In the trial of patients with stable schizophrenia or schizoaffective disorder (5), 128 smokers on antipsychotic medication were randomized 2:1 to varenicline (1 mg twice daily) or placebo for 12 weeks with 12-week non-drug follow-up. The most common treatment emergent adverse events reported in this trial are shown in Table 3 below. Table 3. Common Treatment Emergent AEs (%) in the Trial of Patients with Stable Schizophrenia or Schizoaffective Disorder Varenicline 1 mg BID N=84 Placebo N=43 Adverse Events ≥10% in the varenicline group Nausea 24 14 Headache 11 19 Vomiting 11 9 Psychiatric Adverse Events ≥5% and at a higher rate than in the placebo group Insomnia 10 5 For the trial of patients with major depressive disorder (6), the most common treatment emergent adverse events reported are shown in Table 4 below. Additionally, in this trial, patients treated with varenicline were more likely than patients treated with placebo to report one of events related to hostility and aggression (3% vs. 1%). Table 4. Common Treatment Emergent AEs (%) in the Trial of Patients with Major Depressive Disorder Varenicline 1 mg BID N=256 Placebo N=269 Adverse Events ≥10% in either treatment group Nausea 27 10 Headache 17 11 Abnormal dreams 11 8 Insomnia 11 5 Irritability 11 8 Psychiatric Adverse Events ≥2% in any treatment group and not included above Depressed mood disorders and disturbances 11 9 Anxiety 7 9 Agitation 7 4 Tension 4 3 Hostility 2 0.4 Restlessness 2 2 In the trial of patients without or with a history of psychiatric disorder (7), the most common adverse events in subjects treated with varenicline were similar to those observed in premarketing studies. Most common treatment-emergent adverse events reported in this trial are shown in Table 5 below. Table 5. Treatment Emergent Common AEs (%) in the Trial of Patients without or with a History of Psychiatric Disorder Varenicline 1 mg BID Placebo Adverse Events ≥10% in the varenicline group Entire study population, N 1982 1979 Nausea 25 7 Headache 12 10 Psychiatric Adverse Events ≥2% in any treatment group Non-psychiatric cohort, N 975 982 Abnormal dreams 8 4 Agitation 3 3 Anxiety 5 6 Depressed mood 3 3 Insomnia 10 7 Irritability 3 4 Sleep disorder 3 2 Psychiatric cohort, N 1007 997 Abnormal dreams 12 5 Agitation 5 4 Anxiety 8 6 Depressed mood 5 5 Depression 5 5 Insomnia 9 7 Irritability 5 7 Nervousness 2 3 Sleep disorder 3 2 In the non-treatment extension of the postmarketing neuropsychiatric safety outcomes trial that assessed CV safety (8), the most common adverse events in subjects treated with varenicline and occurring up to 30 days after last dose of treatment were similar to those observed in premarketing studies. 6.2 Postmarketing Experience The following adverse events have been reported during post-approval use of varenicline. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. There have been reports of depression, mania, psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide in patients attempting to quit smoking while taking varenicline [see Warnings and Precautions ( 5.1 )]. There have been postmarketing reports of new or worsening seizures in patients treated with varenicline [see Warnings and Precautions ( 5.2 )]. There have been postmarketing reports of patients experiencing increased intoxicating effects of alcohol while taking varenicline. Some reported neuropsychiatric events, including unusual and sometimes aggressive behavior [see Warnings and Precautions ( 5.1 ) and ( 5.3 )]. There have been reports of hypersensitivity reactions, including angioedema [see Warnings and Precautions ( 5.7 )]. There have also been reports of serious skin reactions, including Stevens-Johnson Syndrome and erythema multiforme, in patients taking varenicline [see Warnings and Precautions ( 5.8 )]. There have been reports of myocardial infarction (MI) and cerebrovascular accident (CVA) including ischemic and hemorrhagic events in patients taking varenicline. In the majority of the reported cases, patients had pre-existing cardiovascular disease and/or other risk factors. Although smoking is a risk factor for MI and CVA, based on temporal relationship between medication use and events, a contributory role of varenicline cannot be ruled out [see Warnings and Precautions ( 5.5 )]. There have been reports of hyperglycemia in patients following initiation of varenicline. There have been reports of somnambulism, some resulting in harmful behavior to self, others, or property in patients treated with varenicline [see Warnings and Precautions ( 5.6 )].

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• See FDA-approved patient labeling (Medication Guide) Initiate Treatment and Continue to Attempt to Quit if Lapse Instruct patients to set a date to quit smoking and to initiate varenicline tablets treatment one week before the quit date.
• Alternatively, the patient can begin varenicline tablets dosing and then set a date to quit smoking between days 8 and 35 of treatment.
• Encourage patients to continue to attempt to quit if they have early lapses after quit day [see Dosage and Administration ( 2.1 )].
• For patients who are sure that they are not able or willing to quit abruptly, a gradual approach to quitting smoking with varenicline tablets may be considered.
• Patients should begin varenicline tablets dosing and reduce smoking during the first 12 weeks of treatment, then quit by the end of that period and continue treatment for an additional 12 weeks for a total of 24 weeks [see Dosage and Administration ( 2.1 )].
• Encourage patients who are motivated to quit and who did not succeed in stopping smoking during prior varenicline tablets therapy for reasons other than intolerability due to adverse events, or who relapsed after treatment to make another attempt with varenicline tablets once factors contributing to the failed attempt have been identified and addressed [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.6 )].
• How to Take Advise patients that varenicline tablets should be taken orally after eating, and with a full glass of water [see Dosage and Administration ( 2.1 )].
• Starting Week Dosage Instruct patients on how to titrate varenicline tablets, beginning at a dose of 0.5 mg/day.
• Explain that one 0.5 mg tablet should be taken daily for the first three days, and that for the next four days, one 0.5 mg tablet should be taken in the morning and one 0.5 mg tablet should be taken in the evening [see Dosage and Administration ( 2.1 )].
• Continuing Weeks Dosage Advise patients that, after the first seven days, the dose should be increased to one 1 mg tablet in the morning and one 1 mg tablet in the evening [see Dosage and Administration ( 2.1 )].
• Dosage Adjustment for Varenicline Tablets or Other Drugs Inform patients that nausea and insomnia are side effects of varenicline tablets and are usually transient; however, advise patients that if they are persistently troubled by these symptoms, they should notify the prescribing physician so that a dose reduction can be considered.
• Inform patients that some drugs may require dose adjustment after quitting smoking [see Dosage and Administration ( 2.1 )].
• Counseling and Support Provide patients with educational materials and necessary counseling to support an attempt at quitting smoking [see Dosage and Administration ( 2.1 )].
• Neuropsychiatric Adverse Events Inform patients that some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation and suicide when attempting to quit smoking while taking varenicline tablets.
• Instruct patients to discontinue varenicline tablets and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.2 ) ].
• History of Psychiatric Illness Encourage patients to reveal any history of psychiatric illness prior to initiating treatment.
• Nicotine Withdrawal Inform patients that quitting smoking, with or without varenicline tablets, may be associated with nicotine withdrawal symptoms (including depression or agitation) or exacerbation of pre-existing psychiatric illness.
• Seizures Encourage patients to report any history of seizures or other factors that can lower seizure threshold.
• Instruct patients to discontinue varenicline tablets and contact a healthcare provider immediately if they experience a seizure while on treatment [see Warnings and Precautions ( 5.2 )].
• Interaction with Alcohol Advise patients to reduce the amount of alcohol they consume while taking varenicline tablets until they know whether varenicline tablets affects their tolerance for alcohol [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.2 )].
• Driving or Operating Machinery Advise patients to use caution driving or operating machinery until they know how quitting smoking and/or varenicline may affect them [see Warnings and Precautions ( 5.4 )].
• Cardiovascular Events Patients should be instructed to notify their healthcare providers of symptoms of new or worsening cardiovascular events and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke [see Warnings and Precautions ( 5.5 ), Adverse Reactions ( 6.1 )].
• Somnambulism Patients should be instructed to discontinue varenicline tablets and notify their healthcare providers if they experience somnambulism [see Warnings and Precautions ( 5.6 )].
• Angioedema Inform patients that there have been reports of angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise.
• Instruct patients to discontinue varenicline tablets and immediately seek medical care if they experience these symptoms [see Warnings and Precautions ( 5.7 ), Adverse Reactions ( 6.2 )].
• Serious Skin Reactions Inform patients that serious skin reactions, such as Stevens-Johnson Syndrome and erythema multiforme, were reported by some patients taking varenicline tablets.
• Advise patients to stop taking varenicline tablets at the first sign of rash with mucosal lesions or skin reaction and contact a healthcare provider immediately [see Warnings and Precautions ( 5.8 ), Adverse Reactions ( 6.2 )].
• Vivid, Unusual, or Strange Dreams Inform patients that they may experience vivid, unusual or strange dreams during treatment with varenicline tablets.
• Pregnancy and Lactation Patients who are pregnant or breastfeeding or planning to become pregnant should be advised of:
• the risks of smoking to a pregnant mother and her developing baby, the potential risks of varenicline tablets use during pregnancy and breastfeeding, and the benefits of smoking cessation with and without varenicline tablets.
• Advise breastfeeding women to monitor the infant for seizures and vomiting [see Use in Specific Populations ( 8.1 and 8.2 )].
• Manufactured for: Camber Pharmaceuticals, Inc.
• Piscataway, NJ 08854 By: HETERO TM HETERO LABS LIMITED 22-110, I.
• D.
• A., Jeedimetla, Hyderabad-500 055, India.
• Revised: 10/2023 vareniclinecamberlogo

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Varenicline tablets 0.5 mg:
• Pink, capsular, biconvex, film coated tablets debossed with "H" on one side and "V23" on the other side.
• Varenicline tablets 1 mg:
• Yellow, capsular, biconvex, film coated tablets debossed with "H" on one side and "V24" on the other side.
• Tablets: 0.5 mg and 1 mg (3)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Varenicline tablets are supplied for oral administration in two strengths and are supplied in the following package configurations:
• Varenicline tablets 0.5 mg:
• Pink, capsular, biconvex, film coated tablets debossed with "H" on one side and "V23" on the other side.
• Bottle of 56 Tablets NDC 31722-678-56 Starting Month Box:
• 0.5 mg x 11 tablets and 1 mg x 42 tablets NDC 31722-690-31 Varenicline tablets 1 mg:
• Yellow, capsular, biconvex, film coated tablets debossed with "H" on one side and "V24" on the other side.
• Bottle of 56 Tablets NDC 31722-679-56 Continuing Month Box:
• 1 mg x 56 tablets NDC 31722-679-31
• Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

• Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4 β 2 nicotinic acetylcholine receptor subtypes.
• Varenicline, as the tartrate salt, is a powder which is an off-white to light brown powder with the following chemical name:
• 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino [2,3-h] [3] benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1).
• It is soluble in water.
• Varenicline tartrate has a molecular weight of
• 361.35 Daltons, and a molecular formula of C 17 H 19 N 3 O 6 .
• The chemical structure is:
• Varenicline tablets are supplied for oral administration in two strengths:
• a 0.5 mg pink, capsular, biconvex, film coated tablets debossed with "H" on one side and "V23" on the other side and a 1 mg yellow, capsular, biconvex, film coated tablets debossed with "H" on one side and "V24" on the other side.
• Each 0.5 mg varenicline tablet contains 0.855 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base.
• The following inactive ingredients are included in the tablets:
• anhydrous dibasic calcium phosphate, croscarmellose sodium, stearic acid.
• The film coating contains hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, titanium dioxide and triacetin. vareniclinestructure

Quoted from the official label, section “Description”.

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

55 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Varenicline Tartrate