CHANTIX STARTING MONTH BOX (varenicline tartrate)

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

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

Available data do not indicate an increased risk of major congenital malformations or miscarriage when varenicline is used during pregnancy, compared to women who smoke. In a population-based cohort study from Denmark and Sweden, 335 pregnancies exposed to varenicline (317 during the first trimester) were compared with over 78,000 pregnancies in women who smoked and over 800,000 pregnancies in non-smokers. The rate of major congenital malformations was similar across all groups (3.6% varenicline versus 4.3% smokers versus 4.2% non-smokers).

Rates of adverse perinatal outcomes (stillbirth, small for gestational age, preterm birth, and premature rupture of membranes) in the varenicline-exposed group were similar to or lower than those observed in women who smoked during pregnancy and were generally comparable to rates in non-smokers. Available studies cannot confirm or rule out varenicline-related risks during pregnancy. In animal reproductive studies, varenicline therapy did not result in 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.

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. Because data on varenicline excretion in human milk and its effects on infants are lacking, breastfeeding women should monitor their infants for seizures or excessive vomiting; these are adverse effects reported in adults that may also be relevant in infants.

In a combined single- and multiple-dose study of 16 healthy male and female smokers (65-75 years of age) who received varenicline 1 mg once or twice daily for 7 consecutive days, the pharmacokinetic profile was similar to that observed in younger adults. No differences in safety or effectiveness were observed between elderly and younger patients, and other clinical experience has not identified differences in response; however, increased sensitivity in some older patients 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.