Rhinocort

Budesonide is a prescription medication used in a variety of inflammatory conditions. These include maintaining asthma control and preventing asthma attacks. Budesonide is also used to treat certain inflammatory bowel diseases, as well as symptoms of allergies. Budesonide belongs to a group of drugs called corticosteroids which help to decrease inflammation to relieve symptoms.

This medication comes in multiple forms. The capsule and extended-release tablet forms are usually taken once daily in the morning with or without food. The nasal spray may be used once per day, one to four sprays per nostril. The oral (by mouth) inhalation form is typically used twice daily.

Common side effects of budesonide tablets and capsules include headache, nausea, and stomach pain.

Oral:

Common side effects include:

• headache
• nausea
• stomach pain
• fatigue
• flatulence
• abdominal problems
• acne
• urinary tract infection
• joint pain
• constipation

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the side effects of budesonide inhalation. Ask your healthcare provider or pharmacist for more information.

Topical:

Common side effects of budesonide nasal spray include:

• nosebleeds
• soar throat
• bronchospasm (narrowing of air passageways)
• coughing
• nasal irritation

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the side effects of budesonide inhalation. Ask your healthcare provider or pharmacist for more information.

Inhalation:

Common side effects reported by patients using budesonide inhalation include:

• sore nose and throat
• stuffy nose
• runny nose
• nausea
• hay fever
• viral infections of the upper respiratory tract
• viral irritation and inflammation of the stomach and intestine (gastroenteritis). Symptoms may include stomach area pain, diarrhea, nausea and vomiting, loss of appetite, headaches, and weakness.
• ear infections

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the side effects of budesonide inhalation. Ask your healthcare provider or pharmacist for more information.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using Pulmicort Flexhaler with certain other medicines may affect each other causing side effects.

Especially tell your healthcare provider if you take:

• a corticosteroid medicine
• anti-seizure medicine (anticonvulsants)
• medicines that suppress your immune system (immunosuppressant)
• ketoconazale (Nizoral)
• clarithromycin (Biaxin)
• erythromycin (Ery-C, Ery Gel, Ery-Tab, PCE)
• indinavir (Crixivan)
• itraconazole (Sporanox, Onmel)
• nefazodone
• nelfinavir (Viracept)
• ritonavir (Norvir, Kaletra)
• telithromycin (Ketek)

This is not a complete list of budesonide drug interactions. Ask your doctor or pharmacist for more information.

Before using budesonide tell your healthcare provider if you:

• are allergic to any ingredients in budesonide
• have or had chicken pox or measles, or have recently been near anyone with chicken pox or measles. have or had tuberculosis of your respiratory tract. Have certain kinds of serious infections that have not been treated, including:
  • fungal infections
  • bacterial infections
  • viral infections
  • parasitic infections
• have recently had surgery or an injury to your nose
• herpes simplex infection of the eye (ocular herpes simplex)
• have eye problems such as increased pressure in the eye, glaucoma, or cataracts
• are planning to have surgery
• have liver problems
• have decreased bone mineral density

You are at risk for decreased bone mineral density if you:

• are inactive for a long period of time
• have a family history of osteoporosis
• are a woman going through menopause or are past menopause
• smoke or use tobacco
• do not eat well (poor nutrition)
• are elderly
• take bone thinning medicines (such as anticonvulsant medicines or corticosteroids) for a long time

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using budesonide with certain other medicines may affect each other causing side effects.

Tell your doctor if you are breastfeeding or plan to breastfeed. The active ingredient in budesonide is excreted in human breast milk. It is not known if budesonide will harm your nursing baby.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Oral:

• Store at room temperature.
• Dispense in a tight, light-resistant container using a child-resistant closure.
• Keep container tightly closed.
• Keep this and all medication out of the reach of children.

Topical:

• Store budesonide nasal spray at room temperature.
• Do not freeze budesonide nasal spray.
• Protect budesonide nasal spray from light.
• Do not use budesonide nasal spray after the labeled number of sprays have been used (does not include priming) or after the expiration date shown on the carton or bottle label.
• Keep the green protective cap on budesonide nasal spray when not in use.
• Keep budesonide nasal spray and all medications out of the reach of children.

Inhalational:

• Store at room temperature.
• Keep the budesonide inhaler dry.
• Keep your budesonide inhaler with the cover tightly in place when not in use.
• Keep budesonide and all medicines out of the reach of children.

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 budesonide nasal spray in children younger than 6 years of age. 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 budesonide nasal spray in the elderly.

Breast Feeding

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.

Interactions with Medicines

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

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.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bemiparin
• Boceprevir
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Clonixin
• Cobicistat
• Conivaptan
• Darunavir
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Idelalisib
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pixantrone
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Ritonavir
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Telaprevir
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erythromycin
• Ketoconazole

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataracts, history of or
• Glaucoma, history of—Use with caution. May make these conditions worse.

• Chicken pox (includes recent exposure) or
• Herpes simplex infection of the eye or
• Infections (virus, bacteria, fungus, or parasite), any type and untreated or
• Measles (includes recent exposure) or
• Tuberculosis, active or history of—Can reduce the body's ability to fight off these infections.

• Injury to the nose, recent or
• Nose surgery, recent or
• Sores or ulcers in the nose, recent—This medicine may prevent proper healing of these conditions.

• Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

This section provides information on the proper use of a number of products that contain budesonide. It may not be specific to Rhinocort. Please read with care.

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 amount that is absorbed from the nose and the chance of unwanted effects. Do not change your dose or stop using this medicine without checking with your doctor first.

This medicine comes with a patient information leaflet. Read and follow the 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. If it does get in the eyes, rinse them with water right away and call your doctor.

In order for this medicine to help you, it must be used on a regular basis as ordered by your doctor. This medicine usually begins to work in about 2 days, but up to 2 weeks may pass before you feel its full effects.

Do not use this medicine for any other nose problem without checking with your doctor first.

To use the spray:

• Shake the bottle gently before each use.
• When you use the spray for the first time, you must prime the bottle. Pump the bottle 8 times or until a fine spray comes out.
• Gently blow your nose before using the spray. Insert the tip of the bottle into your nostril.
• Close the opposite nostril with a finger and lean your head slightly forward.
• Spray into your nostril and breathe gently inward. Lean your head backward for a few seconds.
• If a second dose is needed in the same nostril, lean the head slightly forward and repeat the same steps.
• Spray the opposite nostril using the same steps.
• Do not blow your nose for 15 minutes after using the spray.
• Wipe the tip of the bottle with a clean tissue and put the cap back on.
• If you do not use the bottle for 2 days, prime it again by releasing one spray.
• If you do not use the bottle for more than 14 days, clean the spray tip and prime it again by releasing two sprays.
• After you prime the bottle, there will only be 120 doses or sprays. Keep track of the number of sprays you use. Throw the bottle away after you use 120 sprays even if some liquid remains in the bottle.

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, teenagers, and children 12 years of age and older—At first, one spray in each nostril once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 4 sprays in each nostril per day.
    • Children 6 to 11 years of age—At first, one spray in each nostril once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 2 sprays in each nostril per day.
    • Children younger than 6 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 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.

After you prime the bottle, there will only be 120 doses or sprays. Keep track of the number of sprays you use. Throw the bottle away after you use 120 sprays even if some liquid remains in the bottle.

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.

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

• Bloody nose

• Body aches or pain
• congestion
• cough
• difficulty with breathing
• dryness or soreness of the throat
• fever
• hoarseness
• noisy breathing
• runny nose
• shortness of breath
• tender, swollen glands in the neck
• tightness in the chest
• trouble with swallowing
• voice changes
• wheezing

• Backache
• blistering, crusting, irritation, itching, or reddening of the skin
• bloody mucus
• blurred vision
• cracked, dry, or scaly skin
• darkening of the skin
• decreased vision
• diarrhea
• difficulty with swallowing
• dizziness
• eye pain
• facial hair growth in females
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• full or round face, neck, or trunk
• headache
• hives or welts
• increased thirst or urination
• irritability
• itching
• lack or slowing of normal growth in children
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• loss of sexual desire or ability
• menstrual irregularities
• mental depression
• muscle wasting
• nausea or vomiting
• nosebleeds
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• swelling
• tearing
• unusual tiredness or weakness

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:

• Burning, itching, swollen, or sore throat
• loss of sense of smell

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.