Varenicline Tartrate (EENT)

Brand names: Tyrvaya
Drug class: Antineoplastic Agents

Usage of Varenicline Tartrate (EENT)

Varenicline has the following uses:

Varenicline (nasal solution) is a cholinergic agonist indicated for the treatment of the signs and symptoms of dry eye disease.

Relate drugs

How to use Varenicline Tartrate (EENT)

General

Varenicline is available in the following dosage form(s) and strength(s):

Nasal spray delivering 0.03 mg of varenicline in each spray (0.05 mL).

Dosage

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

Adults

Dosage and Administration

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.

Warnings

Contraindications

None.

Warnings/Precautions

Specific Populations

Pregnancy

Risk Summary: 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.

Animal Data: Pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. While no fetal structural abnormalities occurred in either species, maternal toxicity, characterized by reduced body weight gain, and reduced fetal weights occurred in rabbits at the highest dose (4864 times the MRHD on a mg/m2 basis). In a pre- and postnatal development study, pregnant rats received up to 15 mg/kg/day of oral varenicline succinate from organogenesis through lactation. Maternal toxicity, characterized by a decrease in body weight gain, was observed at 15 mg/kg/day (1216 times the MRHD on a mg/m2 basis). Decreased fertility and increased auditory startle response occurred in offspring at the highest maternal dose of 15 mg/kg/day.

Lactation

Risk Summary: 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.

Pediatric Use

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

Geriatric Use

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

Common Adverse Effects

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.

What other drugs will affect Varenicline Tartrate (EENT)

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

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