Rhinocort Aqua is a nasal spray containing budesonide, a corticosteroid. It prevents the release of substances in the body that cause inflammation.

Rhinocort Aqua Nasal Spray is a prescription medicine used to treat stuffy nose, sneezing, itchy nose, and runny nose caused by seasonal or year-round allergies in adults and children 6 years of age and older.

The safety and effectiveness of Rhinocort Aqua Nasal Spray has not been shown in children under 6 years of age.

Before using Rhinocort Aqua, tell your doctor if you have been sick or had an infection of any kind. Also tell your doctor if you have liver disease, glaucoma or cataracts, herpes simplex infection of your eyes, tuberculosis, sores or ulcers in your nose, or if you have recently had injury of or surgery on your nose.

It may take up to 2 weeks of using Rhinocort Aqua before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a week of treatment.

Budesonide can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using Rhinocort Aqua.

Avoid getting Rhinocort Aqua in your eyes. If this does happen, rinse with water and call your doctor.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using Rhinocort Aqua.

Use Rhinocort Aqua exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Rhinocort Aqua is usually given in each nostril once per day. The usual dose is 1 to 4 sprays for adults, and 1 to 2 sprays for children. Carefully follow your doctor's dosing instructions.

Prime the Rhinocort Aqua nasal spray before your first use. Shake well and pump 8 test sprays into the air, away from your face. Pump the spray until a fine mist appears. Prime again whenever the inhaler has not been used in longer than 2 days, or if it has been dropped.

Shake the nasal spray well bottle just before each use.

To use the Rhinocort Aqua nasal spray:

• Blow your nose gently. Keep your head upright and insert the tip of the bottle into one nostril. Press your other nostril closed with your finger. Breathe in quickly and gently spray the medicine into your nose. Then use the spray in your other nostril.

• Do not blow your nose for at least a few minutes after using the nasal spray.

• Do not use the Rhinocort Aqua nasal spray more than once per day.

• If the spray gets in your eyes or mouth, rinse with water.

• If the nasal spray has not been used for longer than 14 days, rinse the applicator and prime with 2 test sprays.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

It may take up to 2 weeks before your symptoms improve. For best results, keep using the medication as directed, even if you feel fine. Call your doctor if your symptoms do not improve, or if they get worse while using Rhinocort Aqua.

Budesonide can weaken your immune system. Tell your doctor if you have signs of infection such as fever, chills, body aches, vomiting, or feeling tired.

If you use this medicine long-term, you may need frequent medical tests.

Store Rhinocort Aqua in an upright position at room temperature, away from moisture and heat.

Throw the medication away after you have used 120 sprays, even if there is still medicine left in the bottle.

Usual Adult Dose for Allergic Rhinitis:

64 mcg (32 mcg spray per nostril) once a day
Maximum dose: 256 mcg per day administered as 4 sprays per nostril once a day.

Usual Pediatric Dose for Allergic Rhinitis:

6 years or older:
64 mcg (32 mcg spray per nostril) once a day
Maximum dose: 6 to less than 12 years is 128 mcg per day administered as 2 sprays per nostril once a day; 12 years and older is 256 mcg per day administered as 4 sprays per nostril once a day

Comments:
-Titrating an individual patient to the minimum effective dosage is recommended to reduce the possibility of side effects.
-When the maximum benefit has been reached and symptoms have been controlled, reducing the dosage may be effective in maintaining control of the allergic rhinitis symptoms in patients who were controlled on higher dosages.

Use: Treatment of seasonal or perennial allergic rhinitis in adults and children 6 years or older

You should not use budesonide if you are allergic to budesonide.

Ask a doctor or pharmacist if Rhinocort Aqua is safe to use if you have ever had:

• glaucoma or cataracts (now or in the past);

• a weak immune system (caused by disease or by using certain medicines);

• sores or ulcers inside your nose;

• if you have an eye infection; or

• if you have recently had injury of or surgery on your nose.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using Rhinocort Aqua.

Rhinocort Aqua is not approved for use by anyone younger than 6 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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

An overdose of budesonide nasal is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have signs of an allergic reaction to Rhinocort Aqua: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Rhinocort Aqua and call your doctor at once if you have:

• come into contact with anyone who has chickenpox, measles or tuberculosis;

• severe or ongoing nosebleeds;

• vision problems; or

• fever, chills, body aches, flu symptoms.

Less serious Rhinocort Aqua side effects may be more likely, and you may have none at all.

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

Many drugs can affect budesonide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.