Budesonide

Brand(s)

Manufacturer

• Cipla Limited

Disease(s)

• Allergy

Budesonide nasal spray

What is this medicine?

BUDESONIDE is a nasal spray containing budesonide, a corticosteroid. It prevents the release of substances in the body that cause inflammation. Budesonide is used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. Budesonide is also used to keep nasal polyps from coming back after surgery to remove them. Budesonide may also be used for purposes other than those listed in this medication guide.

What should I tell my health care provider before I take this medicine?

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

Before using Budesonide, tell your doctor if you have been sick or had an infection of any kind. You may not be able to use Budesonide until you are well.

Also tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;
• glaucoma or cataracts;
• herpes simplex virus of your eyes;
• tuberculosis or any other infection or illness;
• sores or ulcers inside your nose; or
• if you have recently had injury of or surgery on your nose.

FDA pregnancy category B. Budesonide is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether budesonide passes into breast milk or if it could harm a nursing baby. Do not use Budesonide without telling your doctor if you are breast-feeding a baby.

How should I use this medicine?

Use Budesonide exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Budesonide comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

The usual dose of Budesonide is 1 to 4 sprays into each nostril once per day. Follow your doctor's instructions.

Before using the spray for the first time, you must prime the spray pump. Shake the medicine well and spray 8 test sprays into the air and away from your face. Spray until a fine mist appears. Prime the spray pump any time you have not used your nasal spray for longer than 2 days. If longer than 2 weeks has passed, rinse the applicator and prime with 2 test sprays.

Shake the medicine bottle well just before each use. It may take up to 2 weeks of using this medicine 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.

To be sure Budesonide is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Store Budesonide 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.

What if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What may interact with this medicine?

Before using Budesonide, tell your doctor if you are using any of the following drugs:

• HIV /AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir);
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), troleandomycin (Tao);
• an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
• an "SSRI" antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil); or
• a tricyclic antidepressant such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

This list is not complete and here may be other drugs that can interact with Budesonide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What should I watch for while using this medicine?

To be sure Budesonide is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

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 Budesonide.

Avoid getting Budesonide 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 Budesonide.

What side effects may I notice from this medicine?

Get emergency medical help if you have any of these signs of an allergic reaction to Budesonide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• severe or ongoing nose bleed;
• sores in the nose that won't heal;
• wheezing, trouble breathing;
• vision problems; or
• fever, chills, body aches, flu symptoms.

Less serious Budesonide side effects may include:

• dry or sore throat, cough;
• irritation in your nose;
• pain, swelling, burning, itching, or irritation in your throat;
• sores or white patches inside or around your nose.

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.