Varenicline (nasal)

Varenicline (nasal) is used in adults to relieve symptoms of dry eye disease. Varenicline (nasal) helps to increase tear production in the eye when it is sprayed into the nose.

Varenicline (nasal) may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Varenicline nasal is for use in the nose.

Do not shake the bottle.

Varenicline nasal is usually sprayed once in each nostril twice per day (about 12 hours apart).

Read and carefully follow any Instructions for Use provided with your medicine. Be sure you understand how to properly prepare your first dose. Talk to your doctor or pharmacist if you do not understand these instructions or have any questions.

To use the nasal spray:

• Before your first use, prime it with 7 sprays into the air, away from your face.
• Tilt your head back slightly without lying down and insert the tip of the bottle into the nostril. Breathe in and spray the medicine into your nose. Use in your other nostril as directed.
• If the spray gets in your eyes or mouth or on your skin, rinse with water.
• Clean the nasal applicator after each use.
• Prime again whenever the inhaler has not been used in longer than 5 days.
• Do not use the second bottle until you are done with the first bottle. Each bottle has about 15 days of treatment.

Store at room temperature away from moisture and heat. Do not freeze. Once opened, throw away the medicine after 30 days.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had health problems or if you are taking other medications.

It is not known if varenicline (nasal) will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using varenicline (nasal).

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Common side effects of varenicline may include:

• sneezing;
• cough; or
• irritation in your nose or throat.

This is not a complete list of side effects, and others may happen. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Smoking Cessation:

Days 1 to 3: 0.5 mg orally once a dayDays 4 to 7: 0.5 mg orally 2 times a dayDays 8 to end of treatment: 1 mg orally 2 times a dayDuration of therapy: 12 weeksComments:-The patient should set a date to stop smoking. Dosing should start 1 to 2 weeks before this date OR the patient may begin treatment and quit smoking between Days 8 and 35.-Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support.-In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.Use: As an aid to smoking cessation treatment

Skip the missed dose and take your next dose at the usual time. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid priming varenicline (nasal) more than necessary. Priming will decrease the amount of medicine left in the bottle.

Other drugs may affect varenicline (nasal), including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.