Tyrvaya (varenicline tartrate)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

*One spray in each nostril twice daily (approximately 12 hours apart).

*Prime with seven (7) actuations before initial use. Re-prime with 1 actuation if not used for more than five (5) days.

*Do not shake.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most common adverse reaction reported in 82% of patients was sneezing. Events that were reported in 5-16% of patients were cough, throat irritation, and instillation-site (nose) irritation.

There are no severe adverse reactions for this drug.

More Frequent

• Sneezing

Less Frequent

• Cough
• Nasal passage irritation
• Pharyngitis

No enhanced messaging available.

Safety and efficacy of varenicline in pediatric patients have not been established.

There are no available data on varenicline use in pregnant women to inform any drug associated risks. In animal reproduction studies, varenicline did not produce malformations at clinically relevant doses. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the USgeneral population, the estimated background risk of major birth defects andmiscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%,respectively.

There are no data on the presence of varenicline in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies varenicline was present in milk of lactating rats. However, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk.

The lack of clinical data during lactation precludes a clear determination of the risk of varenicline to an infant during lactation; however, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for varenicline and any potential adverse effects on the breastfed child from varenicline.

No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.