Budesonide Nasal

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If you or your child feel that your symptoms do not improve within a few days or if they become worse, check with your doctor.

budesonide may increase your risk of having some unwanted effects in the nose. Check with your doctor right away if you or your child have bloody mucus; sores inside the nose; unexplained nosebleeds; or a whistling sound when you breathe while you are using budesonide.

budesonide may cause thrush (a type of fungus infection) in the nose or throat. Tell your doctor right away if you or your child have white patches in the throat, or pain when you eat or swallow.

budesonide may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using budesonide.

You may get infections more easily while you are using budesonide. Avoid close contact with anyone who has chickenpox or measles if you have never had these infections. This is especially important for children. Tell your doctor right away if you think you have been exposed to chickenpox or measles.

Using too much of budesonide or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using budesonide: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or weight loss.

budesonide may slow down a child's growth if it is used for a long time. Talk to your child's doctor if you think your child is not growing properly or if you have any questions about this.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Controls the rate of protein synthesis; depresses the migration of polymorphonuclear leukocytes, fibroblasts; reverses capillary permeability and lysosomal stabilization at the cellular level to prevent or control inflammation. Has potent glucocorticoid activity and weak mineralocorticoid activity.

Distribution

~2 to 3 L/kg

Metabolism

Hepatic via CYP3A4 to two metabolites: 16 alpha-hydroxyprednisolone and 6 beta-hydroxybudesonide; both are <1% as active as parent

Excretion

Urine (~66%) and feces as metabolites

US labeling:

Rx: Allergic rhinitis: Management of symptoms of seasonal or perennial allergic rhinitis in adults and children ≥6 years.

OTC: Upper respiratory symptoms: Relief of symptoms of hay fever or other upper respiratory allergies (eg, nasal congestion, runny nose, itchy nose, sneezing) in adults and children ≥6 years.

Canadian labeling:

Nasal polyps: Treatment of nasal polyps; prevention of nasal polyps after polypectomy.

Rhinitis: Management of symptoms of seasonal allergic, perennial, and vasomotor rhinitis unresponsive to conventional therapy.

US labeling:

Rx: Allergic rhinitis: Intranasal: One spray (32 mcg) in each nostril once daily (total daily dose: 64 mcg/day). Some patients who do not achieve adequate control may benefit from increased dosage. A reduced dosage may be effective after initial control is achieved (maximum dose: 4 sprays [128 mcg] in each nostril once daily [total daily dose: 256 mcg/day]).

OTC: Upper respiratory symptoms: Intranasal: Two sprays (64 mcg) in each nostril once daily (total daily dosage: 128 mcg/day); once symptoms improve, reduce to 1 spray (32 mcg) in each nostril once daily (total daily dosage: 64 mcg/day)

Canadian labeling: Note: Discontinue therapy if significant improvement is not observed within 3 weeks

Nasal polyps: Intranasal:

Rhinocort Aqua: One spray (64 mcg) in each nostril twice daily; total daily dose: 256 mcg/day

Rhinocort Turbuhaler: One application (100 mcg) in each nostril twice daily; total daily dose: 400 mcg/day

Rhinitis: Intranasal: Note: If possible initiate therapy prior to allergen exposure.

Rhinocort Aqua: Initial: Two sprays (128 mcg) in each nostril once daily or 1 spray (64 mcg) in each nostril twice daily (total daily dose: 256 mcg/day); Maintenance: Individualize, use lowest effective dose.

Rhinocort Turbuhaler: Initial: Two applications (200 mcg) in each nostril once daily (total daily dose: 400 mcg/day); Maintenance: Individualize; use lowest effective dose.

There are no dosage adjustments provided in manufacturer’s labeling (has not been studied). Systemic availability of budesonide may be increased in patients with hepatic impairment; monitor closely for signs and symptoms of hypercortisolism.

US labeling: Store with valve up at 20°C to 25°C (68°F to 77°F); do not freeze. Protect from light.

Canadian labeling: Store at 15°C to 30°C (59°F to 86°F).

Monitor growth in pediatric patients; signs/symptoms of HPA axis suppression/adrenal insufficiency; ocular changes; signs/symptoms of Candida infection (long-term therapy)

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.

Budesonide nasal 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 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 medicine bottle well just before each use.

To use the 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 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 budesonide nasal.

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 this medicine 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.

Nose/throat dryness or irritation, cough, sneezing, nosebleeds, or unpleasant taste/smell may occur. If any of these side effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: loss of taste or smell, pain/sores in your nose.

Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

Corticosteroids may weaken the body's ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. This effect might also rarely occur with corticosteroids inhaled through the nose (such as budesonide). The risk may be increased if high doses are used, especially when used for a long time. Tell your doctor right away if you have any signs of infection (such as ear pain, persistent sore throat, fever, chills, white patches inside the nose or on the back of the throat).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, wheezing/trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Check all prescription medicine labels carefully since similar medications (other corticosteroids such as prednisone) may increase your risk of side effects if taken together with this drug. Ask your doctor or pharmacist if you have any questions about your medications.