Chantix Continuing Month Box

Drug overview for CHANTIX CONTINUING MONTH BOX (varenicline tartrate):

Generic name: varenicline tartrate (var-EN-i-kleen)
Drug class: Smoking Deterrents - Nicotinic or Bupropion (NDRI)-Type
Therapeutic class:

Varenicline is a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist.

No enhanced Uses information available for this drug.

DRUG IMAGES

CHANTIX 1 MG CONT MONTH BOX

The following indications for CHANTIX CONTINUING MONTH BOX (varenicline tartrate) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

The following precautions are available for CHANTIX CONTINUING MONTH BOX (varenicline tartrate):

Pediatric
Pregnant
Lactation
Geriatric

Efficacy of varenicline was not established in patients <=16 years of age; its use in this age group is not recommended. Weight-adjusted varenicline dosages for 12 weeks did not improve abstinence rates versus placebo; safety was consistent with adult studies. In pediatric patients 12-17 years of age, varenicline pharmacokinetics were approximately dose-proportional over the 0.5-2

mg daily range. Systemic exposure in adolescents weighing >55 kg was comparable to that observed in adults, while exposure was approximately 40% higher in those weighing <=55 kg compared with adults, at a dosage of 0.5 mg twice daily.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

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.

Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.

Drug Name	Excretion Potential	Effect on Infant	Notes
Varenicline	Unknown. It is unknown whether the drug is excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Insufficient human data available

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.