Vancenase AQ (Nasal)

Beclomethasone nasal spray is used to treat an itchy or runny nose, sneezing, or other symptoms caused by perennial (year-round) or seasonal hay fever (allergic rhinitis). It is a steroid (cortisone-like medicine) that helps stop the inflammation that happens during allergic reactions.

You can get this medicine only with your doctor's prescription.

It is very important for your doctor to check how you or your child are doing at regular visits. This will help your doctor see if the medicine is working well and if you or your child should keep using it.

If your or your child's symptoms do not get better within a few days or if they get worse, talk to your doctor.

This medicine may raise the chance of having some unwanted effects in the nose. Contact your doctor right away if you or your child experience bloody mucus, sores inside the nose, unexplained nosebleeds, or a whistling sound when breathing while using this medicine.

This medicine may lead to thrush (a type of fungal infection) in the nose or throat. Inform your doctor immediately if you or your child notice white patches in the throat, or have pain when eating or swallowing.

If you or your child have blurred vision, trouble reading, or any other change in vision during or after treatment, contact your doctor right away. Your doctor might want you or your child to see an ophthalmologist (eye doctor).

This medicine can cause serious allergic reactions, such as angioedema and anaphylaxis. Call your doctor immediately if you notice swelling of the face, lips, tongue, throat, arms, or legs, or if you have trouble swallowing or breathing while using this medicine.

You may be more prone to infections while using this medicine. Try to avoid close contact with people who are sick or have infections like chickenpox or measles, especially if you or your child have never had these infections. This is especially important for children. Contact your doctor right away if you think you or your child have been exposed to chickenpox or measles.

This medicine may increase the risk of having a less active adrenal gland. The adrenal gland produces steroids for your body. This is more likely in people who use steroids for a long time or at high doses. Contact your doctor immediately if you or your child experience any of the following symptoms: dark skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may happen while taking this medicine.

This medicine may cause children to grow more slowly than normal. This means a child might not gain weight or grow taller. Talk to your doctor if you think your child is not growing properly or if you have any questions about this.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. Here are some important points to think about:

Allergies

Inform your doctor if you have had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

Studies done so far have not shown any specific problems that would limit the use of beclomethasone nasal spray in children aged 4 years and older. However, safety and effectiveness have not been established in children younger than 4 years old.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of beclomethasone nasal spray. However, older patients are more likely to have liver, kidney, or heart issues related to aging, which may require caution when using beclomethasone nasal spray.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together despite potential interactions. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The interactions listed are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to prescribe this medication or may change other medicines you are taking.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Aspirin
• Bemiparin
• Lutetium Lu 177 Dotatate
• Macimorelin
• Nadroparin
• Sargramostim
• Somatrogon-ghla

Using this medicine with any of the following medicines may increase the risk of certain side effects, but it may still be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Auranofin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Asthma or wheezing or
• Cataracts, history of or
• Chicken pox (including recent exposure) or
• Glaucoma, history of or
• Herpes simplex infection of the eye or
• Infections (bacterial, fungal, viral, or parasitic), active or untreated or
• Measles (including recent exposure) or
• Tuberculosis, active or history of—Use with caution. May worsen these conditions.

• Injury to the nose or
• Recent nose surgery or
• Recent sores or ulcers in the nose—May hinder proper healing of these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Chills
• Dizziness
• Fast heartbeat
• Lightheadedness
• Rapid, shallow breathing
• Rash
• Unusual bleeding or bruising

Less common

• Change in vision
• Eye pain
• Headache
• Nausea or vomiting
• Tearing
• Unexplained nosebleeds

Incidence not known

• Bloody mucus
• Cough or hoarseness
• Difficulty with breathing
• Dizziness
• Hives or welts, itching
• Loss of taste and smell
• Sores inside the nose

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.

In the U.S.

• Beconase
• Beconase AQ
• QNASL
• Vancenase
• Vancenase AQ
• Vancenase AQ Double Strength

Available Dosage Forms:

• Aerosol Liquid
• Spray

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Use this medicine only as directed. 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 comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is only used in the nose. Do not get it in your eyes or on your skin. If it does get on these areas, rinse it off right away and call your doctor.

To use the spray:

• When you use the medicine for the first time or if you have not used this medicine for 7 days in a row, you must prime the spray. Press down fully on the top of the canister four times or until a fine spray comes out.
• After you prime the nasal spray, there will only be 120 doses or sprays.
• Gently blow your nose before using the spray. Tilt your head back slightly and insert the tip of the nose piece into your nostril.
• Close the opposite nostril with a finger. Release 1 spray and at the same time, breathe in gently through the nostril.
• Hold your breath for a few seconds then breathe out slowly through your mouth.
• Spray the opposite nostril using the same steps.
• Do not blow your nose after using the spray.
• Wipe the tip of the outside of the nose piece with a clean, dry tissue or cloth and put the cap back on.
• Do not remove the canister from the actuator. Qnasl™ nasal aerosol canister should only be used with the Qnasl™ nasal aerosol actuator.
• Throw this medicine away after you use 120 sprays or when the dose indicator read zero "0".

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 allergic rhinitis: Adults and children 12 years of age and older—2 sprays in each nostril once a day. Each spray contains 80 micrograms (mcg). Adults and children 4 to 11 years of age—1 spray in each nostril once a day. Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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.