Description
Varenicline nasal spray is used to treat signs and symptoms of dry eye disease. It works by increasing the tear production in the eye.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Spray
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of varenicline nasal spray in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of varenicline nasal spray in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Bupropion
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.
This medicine usually comes with patient information insert and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away. Do not shake the bottle.
To use the spray:
- When you use the varenicline nasal spray for the first time, you must prime the spray. Press down fully 7 times into the air away from the face.
- Prime the spray if you have not used it for more than 5 days, by spraying the medicine 1 time into the air. Do not prime it for more than needed.
- Gently blow your nose to clear the nostrils before you use this medicine. Remove the cap and clip. Do not throw away the cap or the clip.
- Tilt your head back, without lying down, and insert the spray tip into your nostril. Hold the bottle upright and aim the spray tip towards the top of the ear on the same side as your nostril. Do not spray it against the wall of the inside of your nose.
- Place your tongue on the roof of your mouth. Press the pump 1 time and breath gently at the same time.
- Repeat in your other nostril using the same steps.
- Wipe the spray tip with a clean tissue and put the clip and the cap back on.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For nasal dosage form (spray):
- For treatment of the signs and symptoms of dry eye disease:
- Adults—1 spray in each nostril 2 times a day (at least 12 hours apart). Each spray contains 0.03 milligrams (mg) of varenicline.
- Children—Use and dose must be determined by your doctor.
- For treatment of the signs and symptoms of dry eye disease:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw this medicine away 30 days after opening the bottle.
Precautions
It is very important that your eye doctor (ophthalmologist) check your progress at regular visits to make sure the medicine is working properly and to check for unwanted effects.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Burning, redness, or swelling around or inside the nose
- cough
- sneezing
- sore throat
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20524751
