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Drug overview for VARENICLINE TARTRATE (varenicline tartrate):
Generic name: VARENICLINE TARTRATE (var-EN-i-kleen)
Drug class: Smoking Deterrents - Nicotinic or Bupropion (NDRI)-Type
Therapeutic class: Chemical Dependency, Agents to Treat
Varenicline is a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist.
No enhanced Uses information available for this drug.
Generic name: VARENICLINE TARTRATE (var-EN-i-kleen)
Drug class: Smoking Deterrents - Nicotinic or Bupropion (NDRI)-Type
Therapeutic class: Chemical Dependency, Agents to Treat
Varenicline is a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist.
No enhanced Uses information available for this drug.
DRUG IMAGES
VARENICLINE 0.5 MG TABLET
VARENICLINE 1 MG TABLET
The following indications for VARENICLINE TARTRATE (varenicline tartrate) have been approved by the FDA:
Indications:
Smoking cessation
Professional Synonyms:
Smoking cessation assistance
Indications:
Smoking cessation
Professional Synonyms:
Smoking cessation assistance
The following dosing information is available for VARENICLINE TARTRATE (varenicline tartrate):
Dosage of varenicline tartrate is expressed in terms of varenicline.
Varenicline is administered orally. The drug should be taken after eating and with a full glass of water.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| VARENICLINE 0.5 MG TABLET | Maintenance | Adults take 1 tablet (0.5 mg) with glass of water by oral route 2 times per day after meals for 3 days |
| VARENICLINE 1 MG TABLET | Maintenance | Adults take 1 tablet (1 mg) with glass of water by oral route 2 times per day after meals |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| VARENICLINE 0.5 MG TABLET | Maintenance | Adults take 1 tablet (0.5 mg) with glass of water by oral route 2 times per day after meals for 3 days |
| VARENICLINE 1 MG TABLET | Maintenance | Adults take 1 tablet (1 mg) with glass of water by oral route 2 times per day after meals |
| APO-VARENICLINE 0.5 MG TABLET | Maintenance | Adults take 1 tablet (0.5 mg) with glass of water by oral route 2 times per day after meals for 3 days |
| APO-VARENICLINE 1 MG TABLET | Maintenance | Adults take 1 tablet (1 mg) with glass of water by oral route 2 times per day after meals |
| VARENICLINE 1 MG CONT MONTH BX | Maintenance | Adults take 1 tablet (1 mg) with glass of water by oral route 2 times per day after meals |
The following drug interaction information is available for VARENICLINE TARTRATE (varenicline tartrate):
There are 0 contraindications.
There are 0 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Ethyl Alcohol/Varenicline SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The mechanism of this interaction has not been described. CLINICAL EFFECTS: Concurrent use of varenicline and alcohol-containing products may result in increased intoxicating effects of alcohol, aggressive behavior and/or amnesia.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients should be advised that varenicline can change the way they react to alcohol. Case reports have described decreased alcohol tolerance, sometimes associated with aggressive behavior and/or amnesia with alcohol consumption which was previously tolerated. Patients and providers should be aware of unsuspected sources of alcohol such as medications. Reduce the use of non-essential alcohol containing drugs (e.g. cough and cold products) when possible. Alcohol is used to improve docetaxel and paclitaxel solubility. - The quantity of alcohol in paclitaxel injection formulations (0.385-0.396 grams/mL) is similar across manufacturers. A paclitaxel 200 mg dose contains approximately 13 grams of alcohol. - The quantity of alcohol in docetaxel formulations varies approximately 3-fold depending upon the manufacturer. FDA data on alcohol content (2): Product Manufacturer Alcohol/200 mg dose Docetaxel Inj. Pfizer 6.4 grams Docetaxel Inj. Sandoz 5.5 grams Docetaxel Inj. Accord 4.0 grams Taxotere-one vial Sanofi 4.0 grams formulation Docetaxel Inj. Hospira 3.7 grams Docefrez Sun Pharma 2.9 grams Taxotere-two vial Sanofi 2.0 grams formulation - For comparison, the US National Institute on Alcohol Abuse and Alcoholism definition of a Standard Drink (e.g. 12oz of 5% beer, 5oz of 12% wine) contains 14 grams of alcohol. DISCUSSION: A search of the FDA Adverse Event Reporting System (FAERS) identified 48 cases of adverse events due to the combination of varenicline and alcohol.(1) Aggressive behavior was described in 37 cases. In these cases, the amount of alcohol consumed was insufficient to explain the event. More than half of the patients involved described their behavior as a significant change from their behavior prior to varenicline treatment. In 16 of the 37 cases, patients reported no or impaired memory of the event; most of these cases were also associated with physical harm to a person and/or property. Decreased alcohol tolerance was observed in 11 cases in patients who consumed quantities of alcohol which previously did not cause adverse effects. Outcomes included an automobile accident leading to arrest and a significant facial injury. Most of the patients in these cases described poor memory of their experience. |
ALCOHOL,DEHYDRATED |
The following contraindication information is available for VARENICLINE TARTRATE (varenicline tartrate):
Drug contraindication overview.
Varenicline is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to the drug.
Varenicline is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to the drug.
There are 0 contraindications.
There are 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Bipolar disorder |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Depression |
| Schizophrenia |
| Seizure disorder |
| Suicidal ideation |
There are 9 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Acute coronary syndrome |
| Acute myocardial infarction |
| Alcohol intoxication |
| Alcohol use disorder |
| Angina |
| Cerebrovascular accident |
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
| Peripheral vascular disease |
| Transient cerebral ischemia |
The following adverse reaction information is available for VARENICLINE TARTRATE (varenicline tartrate):
Adverse reaction overview.
In placebo-controlled studies, adverse effects reported in more than 5% of patients receiving varenicline and with an incidence twice the rate observed in those receiving placebo were nausea, abnormal (vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting.
In placebo-controlled studies, adverse effects reported in more than 5% of patients receiving varenicline and with an incidence twice the rate observed in those receiving placebo were nausea, abnormal (vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting.
There are 24 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Angina |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Accidental injury Acute myocardial infarction Acute pancreatitis Alcohol intolerance Anemia Angioedema Cardiac arrhythmia Cerebrovascular accident Diabetes mellitus Drug-induced psychosis Erythema multiforme Homicidal ideation Hypersensitivity drug reaction Hypertension Manic disorder Seizure disorder Stevens-johnson syndrome Suicidal Suicidal ideation Thrombotic disorder Transient cerebral ischemia Unconsciousness |
There are 76 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Constipation Dream disorder Flatulence Headache disorder Insomnia Nausea Vomiting |
Acute abdominal pain Anorexia Drowsy Dyspepsia Dyspnea Fatigue Gastroesophageal reflux disease General weakness Hyperhidrosis Increased appetite Lethargy Malaise Nightmares Pruritus of skin Rhinorrhea Skin rash Upper respiratory infection Xerostomia |
| Rare/Very Rare |
|---|
|
Acne vulgaris Aggressive behavior Agitation Allergic rhinitis Arthralgia Asthma Back pain Behavioral disorders Chest pain Concentration difficulty Cramps Delusional disorder Depression Diarrhea Disturbance of attention Dizziness Drug-induced hot flash Dry skin Dysgeusia Eczema Edema Epistaxis Erectile dysfunction Flu-like symptoms Flushing Hallucinations Hostility Hyperglycemia Increased urinary frequency Libido changes Lymphadenopathy Menstrual disorder Mood changes Myalgia Nocturia Palpitations Panic disorder Paranoid disorder Peripheral vascular disease Polyuria Psoriasis Skin photosensitivity Sleep disorder Sleep walking disorder Symptoms of anxiety Tinnitus Toothache Urticaria Vertigo Visual changes Weight gain |
The following precautions are available for VARENICLINE TARTRATE (varenicline tartrate):
Safety and efficacy of varenicline have not been established in patients younger than 18 years of age and use of the drug in this age group is not recommended. In a limited number of pediatric patients 12-17 years of age, systemic exposure to varenicline, as assessed by area under the concentration-time curve (AUC) and renal clearance of the drug, in pediatric patients weighing more than 55 kg was comparable to that of an adult population over the dosage range of 0.5-2 mg daily.
At a varenicline dosage of 0.5 mg twice daily, steady-state exposure was approximately 40% higher in adolescents 12-17 years of age weighing 55 kg or less when compared with that of an adult population.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
At a varenicline dosage of 0.5 mg twice daily, steady-state exposure was approximately 40% higher in adolescents 12-17 years of age weighing 55 kg or less when compared with that of an adult population.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Available human data are insufficient to determine whether varenicline is associated with a risk of major congenital malformations or miscarriage when used during pregnancy. In animal reproductive studies, varenicline did not produce any major malformations; however, there was some evidence of maternal toxicity, developmental toxicity, and decreased fetal weight when pregnant rats and rabbits were administered varenicline during the period of organogenesis at maternal exposures 36-50 times the exposure at the maximum recommended human dose. Smoking during pregnancy is associated with known risks to the mother, fetus, and newborn infant; however, it is not known whether smoking cessation with varenicline may reduce these risks.
Varenicline is distributed into milk in animals. It is not known whether the drug is distributed into human milk or if the drug has any effects on the breast-fed infant or on milk production. The known benefits of breast-feeding should be considered along with the mother's clinical need for varenicline and any potential adverse effects of the drug or underlying maternal condition on the infant.
The pharmacokinetic profile of varenicline in healthy male and female smokers (65-75 years of age) who received 1 mg of the drug once or twice daily for 7 consecutive days was similar to that of younger individuals in one study. No substantial differences in safety and efficacy were observed relative to younger adults in this study, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients; however, increased sensitivity cannot be ruled out. Varenicline is substantially excreted by the kidneys. Because geriatric patients are more likely to have decreased renal function, dosage should be selected cautiously; it may be useful to monitor renal function in such patients.
The following prioritized warning is available for VARENICLINE TARTRATE (varenicline tartrate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for VARENICLINE TARTRATE (varenicline tartrate)'s list of indications:
| Smoking cessation | |
| F17 | Nicotine dependence |
| F17.2 | Nicotine dependence |
| F17.20 | Nicotine dependence, unspecified |
| F17.200 | Nicotine dependence, unspecified, uncomplicated |
| F17.201 | Nicotine dependence, unspecified, in remission |
| F17.203 | Nicotine dependence unspecified, with withdrawal |
| F17.208 | Nicotine dependence, unspecified, with other nicotine-induced disorders |
| F17.209 | Nicotine dependence, unspecified, with unspecified nicotine-induced disorders |
| F17.21 | Nicotine dependence, cigarettes |
| F17.210 | Nicotine dependence, cigarettes, uncomplicated |
| F17.211 | Nicotine dependence, cigarettes, in remission |
| F17.213 | Nicotine dependence, cigarettes, with withdrawal |
| F17.218 | Nicotine dependence, cigarettes, with other nicotine-induced disorders |
| F17.219 | Nicotine dependence, cigarettes, with unspecified nicotine-induced disorders |
| O99.33 | Tobacco use disorder complicating pregnancy, childbirth, and the puerperium |
| O99.330 | Smoking (tobacco) complicating pregnancy, unspecified trimester |
| O99.331 | Smoking (tobacco) complicating pregnancy, first trimester |
| O99.332 | Smoking (tobacco) complicating pregnancy, second trimester |
| O99.333 | Smoking (tobacco) complicating pregnancy, third trimester |
| O99.334 | Smoking (tobacco) complicating childbirth |
| O99.335 | Smoking (tobacco) complicating the puerperium |
| Z87.891 | Personal history of nicotine dependence |
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