Budesonide

Budesonide is a white to off-white, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform.

Its partition coefficient between octanol and water at pH 5 is 1.6 x 10³.

Budesonide Nasal Spray is an unscented, metered-dose, manual-pump spray formulation containing a micronized suspension of budesonide in an aqueous medium. Microcrystalline cellulose and carboxymethyl cellulose sodium, dextrose anhydrous, polysorbate 80, disodium edetate, potassium sorbate, and purified water are contained in this medium; hydrochloric acid is added to adjust the pH to a target of 4.5.

Budesonide Nasal Spray delivers 32 mcg of budesonide per spray.

Each bottle of Budesonide Nasal Spray 32 mcg contains 120 metered sprays after initial priming.

Prior to initial use, the container must be shaken gently and the pump must be primed by actuating eight times. If used daily, the pump does not need to be reprimed. If not used for two consecutive days, reprime with one spray or until a fine spray appears. If not used for more than 14 days, rinse the applicator and reprime with two sprays or until a fine spray appears.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. In standard in vitro and animal models, budesonide has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol (rat croton oil ear edema assay). As a measure of systemic activity, budesonide is 40 times more potent than cortisol when administered subcutaneously and 25 times more potent when administered orally in the rat thymus involution assay. The clinical significance of this is unknown.

The activity of Budesonide Nasal Spray is due to the parent drug, budesonide. In glucocorticoid receptor affinity studies, the 22R form was two times as active as the 22S epimer. In vitro studies indicated that the two forms of budesonide do not interconvert.

The precise mechanism of corticosteroid actions on inflammation in seasonal and perennial allergic rhinitis is not well known. Inflammation is an important component in the pathogenesis of seasonal and perennial allergic rhinitis. Corticosteroids have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and non-allergic-mediated inflammation. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in seasonal and perennial allergic rhinitis.

12.2 Pharmacodynamics

A 3-week clinical study in seasonal rhinitis, comparing Budesonide Nasal Inhaler, orally ingested budesonide, and placebo in 98 patients with allergic rhinitis due to birch pollen, demonstrated that the therapeutic effect of Budesonide Nasal Inhaler can be attributed to the topical effects of budesonide.

HPA Axis Effects:

The effects of Budesonide Nasal Spray on adrenal function have been evaluated in several clinical trials. In a four-week clinical trial, 61 adult patients who received 256 mcg daily of Budesonide Nasal Spray demonstrated no significant differences from patients receiving placebo in plasma cortisol levels measured before and 60 minutes after 0.25 mg intramuscular cosyntropin. There were no consistent differences in 24-hour urinary cortisol measurements in patients receiving up to 400 mcg daily. Similar results were seen in a study of 150 children and adolescents aged 6 to 17 with perennial rhinitis who were treated with 256 mcg daily for up to 12 months.

After treatment with the recommended maximal daily dose of Budesonide Nasal Spray (256 mcg) for seven days, there was a small, but statistically significant decrease in the area under the plasma cortisol-time curve over 24 hours (AUC_0-24h) in healthy adult volunteers.

A dose-related suppression of 24-hour urinary cortisol excretion was observed after administration of Budesonide Nasal Spray doses ranging from 100-800 mcg daily for up to four days in 78 healthy adult volunteers. The clinical relevance of these results is unknown.

12.3 Pharmacokinetics

Absorption

After intranasal administration of a single dose of Budesonide Nasal Spray (128 mcg), the mean peak plasma concentration of approximately 0.3 nmol/L occurs about 0.5 hours post-dose. Compared to an intravenous dose, approximately 34% of the delivered intranasal dose reaches the systemic circulation, most of which is absorbed through the nasal mucosa. While budesonide is well absorbed from the GI tract, the oral bioavailability of budesonide is low (~10%) primarily due to extensive first pass metabolism in the liver.

Distribution

The volume of distribution of budesonide was approximately 2-3 L/kg. It was 85-90% bound to plasma proteins. The volume of distribution for the 22R epimer is almost twice that of the 22S epimer. Protein binding was constant over a concentration range (1-100 nmol/L) achieved with, and exceeding, recommended doses of Budesonide Nasal Spray. Budesonide showed little or no binding to corticosteroid binding globulin. Budesonide rapidly equilibrated with red blood cells in a concentration independent manner with a blood/plasma ratio of about 0.8.

Metabolism

In vitro studies with human liver homogenates have shown that budesonide is rapidly and extensively metabolized. Two major metabolites formed via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4)-catalyzed biotransformation have been isolated and identified as 16α-hydroxyprednisolone and 6β-hydroxybudesonide. The corticosteroid activity of each of these two metabolites is less than 1% of that of the parent compound. No qualitative difference between the in vitro and in vivo metabolic patterns have been detected. Negligible metabolic inactivation was observed in human lung and serum preparations.

Excretion/Elimination

The 22R form of budesonide was preferentially cleared by the liver with systemic clearance of 1.4 L/min vs. 1.0 L/min for the 22S form. The terminal half-life, 2 to 3 hours, was the same for both epimers and was independent of dose. Budesonide was excreted in urine and feces in the form of metabolites. Approximately 2/3 of an intranasal radiolabeled dose was recovered in the urine and the remainder in the feces. No unchanged budesonide was detected in the urine.

Specific Populations

Geriatric

The pharmacokinetics of Budesonide Nasal Spray in geriatric patients have not been specifically studied.

Pediatric

Following administration of Budesonide Nasal Spray, the time to reach peak drug concentrations and plasma half-life were similar in children and in adults. Children had plasma concentrations approximately twice those observed in adults due primarily to differences in weight between children and adults.

Gender

No specific pharmacokinetic study has been conducted to evaluate the effect of gender on budesonide pharmacokinetics. However, following administration of 400 mcg of Budesonide Nasal Spray to 7 male and 8 female volunteers in a pharmacokinetic study, no major gender differences in the pharmacokinetic parameters were found.

Race

No specific study has been undertaken to evaluate the effect of race on budesonide pharmacokinetics.

Nursing Mothers

The disposition of budesonide when delivered by oral inhalation from a dry powder inhaler at doses of 200 or 400 mcg twice daily for at least 3 months was studied in eight lactating women with asthma from 1 to 6 months postpartum. Systemic exposure to budesonide in these women appears to be comparable to that in non-lactating women with asthma from other studies. Breast milk obtained over eight hours post-dose revealed that the maximum concentration of budesonide for the 400 and 800 mcg doses was 0.39 and 0.78 nmol/L, respectively, and occurred within 45 minutes after dosing. The estimated oral daily dose of budesonide from breast milk to the infant was approximately 0.007 and 0.014 mcg/kg/day for the two dose regimens used in this study, which represents approximately 0.3% to 1% of the dose inhaled by the mother. Budesonide levels in plasma samples obtained from five infants at about 90 minutes after breastfeeding (and about 140 minutes after drug administration to the mother) were below quantifiable levels (<0.02 nmol/L in four infants and <0.04 nmol/L in one infant) [see Use in Specific Populations, Nursing Mothers (8.3) ].

Renal or Hepatic Impairment

The pharmacokinetics of budesonide have not been investigated in patients with renal impairment. Reduced liver function may affect the elimination of corticosteroids. The pharmacokinetics of budesonide were affected by compromised liver function as evidenced by a doubled systemic availability after oral ingestion. The relevance of this finding to intranasally administered budesonide has not been established.

Drug-Drug Interactions

Inhibitors of cytochrome P450 enzymes

Ketoconazole: Ketoconazole, a strong inhibitor of cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4), the main metabolic enzyme for corticosteroids, increased plasma levels of orally ingested budesonide [see Warnings and Precautions (5.5) and Drug Interactions (7.1) ].

Cimetidine: At recommended doses, cimetidine, a non-specific inhibitor of CYP enzymes, had a slight but clinically insignificant effect on the pharmacokinetics of oral budesonide.

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 104-week oral study in Sprague-Dawley rats, a statistically significant increase in the incidence of gliomas was observed in the male rats receiving an oral dose of budesonide 50 mcg/kg/day (approximately twice the maximum recommended daily intranasal dose in adults and children on a mcg/m² basis). No tumorigenicity was seen in male rats at oral doses up to 25 mcg/kg (approximately equal to the maximum recommended daily intranasal dose in adults and children on a mcg/m² basis, and in female rats at oral doses up to 50 mcg/kg approximately two times the maximum recommended daily intranasal dose in adults and children on a mcg/m² basis). In two additional two-year studies in male Fischer and Sprague-Dawley rats, budesonide caused no gliomas at an oral dose of 50 mcg/kg (approximately twice the maximum recommended daily intranasal dose in adults and children on a mcg/m² basis). However, in the male Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of hepatocellular tumors at an oral dose of 50 mcg/kg (approximately twice the maximum recommended daily intranasal dose in adults and children on a mcg/m² basis). The concurrent reference corticosteroids (prednisolone and triamcinolone acetonide) in these two studies showed similar findings.

There was no evidence of a carcinogenic effect when budesonide was administered orally for 91-weeks to mice at doses up to 200 mcg/kg/day (approximately 3 times the maximum recommended daily intranasal dose in adults and children on a mcg/m² basis).

Budesonide was not mutagenic or clastogenic in six different test systems: Ames Salmonella/microsome plate test, mouse micronucleus test, mouse lymphoma test, chromosome aberration test in human lymphocytes, sex-linked recessive lethal test in Drosophila melanogaster, and DNA repair analysis in rat hepatocyte culture.

In rats, budesonide had no effect on fertility at subcutaneous doses up to 80 mcg/kg (approximately 3 times the maximum recommended daily intranasal dose in adults on mcg/m² basis).

At a subcutaneous dose of 20 mcg/kg/day (less than the maximum recommended daily intranasal dose in adults on a mcg/m² basis), decreases in maternal body weight gain, prenatal viability, and viability of the young at birth and during lactation were observed. No such effects were noted at 5 mcg/kg (less than the maximum recommended daily intranasal dose in adults on a mcg/m² basis).

13.2 Animal Toxicology and/or Pharmacology

Budesonide was teratogenic and embryocidal in rabbits and rats. Budesonide produced fetal loss, decreased pup weights, and skeletal abnormalities at a subcutaneous dose of 25 mcg/kg in rabbits (approximately 2 times the maximum recommended daily intranasal dose in adults on a mcg/m² basis) and at a subcutaneous dose of 500 mcg/kg in rats (approximately 16 times the maximum recommended daily intranasal dose in adults on a mcg/m² basis). No teratogenic or embryocidal effects were observed in rats when budesonide was administered by inhalation doses up to 250 mcg/kg (approximately 8 times the maximum recommended daily intranasal dose in adults on a mcg/m² basis).

14 CLINICAL STUDIES

The therapeutic efficacy of Budesonide Nasal Spray has been evaluated in placebo-controlled clinical trials of seasonal and perennial allergic rhinitis of 3-6 weeks duration.

The number of patients treated with budesonide in these studies was 90 males and 51 females aged 6-12 years and 691 males and 694 females 12 years and above. The patients were predominantly Caucasian.

Overall, the results of these clinical trials showed that Budesonide Nasal Spray administered once daily provides statistically significant reduction in the severity of nasal symptoms of seasonal and perennial allergic rhinitis including runny nose, sneezing, and nasal congestion.

An improvement in nasal symptoms may be noted in patients within 10 hours of first using Budesonide Nasal Spray. This time to onset is supported by an environmental exposure unit study in seasonal allergic rhinitis patients that demonstrated that Budesonide Nasal Spray led to a statistically significant improvement in nasal symptoms compared to placebo by 10 hours. Further support comes from a clinical study of patients with perennial allergic rhinitis which demonstrated a statistically significant improvement in nasal symptoms for both Budesonide Nasal Spray and for the active comparator (mometasone furoate) compared to placebo by 8 hours. Onset was also assessed in this study with peak nasal inspiratory flow rate and this endpoint failed to show efficacy for either active treatment. Although statistically significant improvements in nasal symptoms compared to placebo were noted within 8-10 hours in these studies, about one half to two thirds of the ultimate clinical improvement with Budesonide Nasal Spray occurs over the first 1-2 days, and maximum benefit may not be achieved until approximately 2 weeks after initiation of treatment.

15 REFERENCES

¹ Kallen B, Rydhstroem H, Aberg A. Congenital malformations after the use of inhaled budesonide in early pregnancy. Obstet Gynecol 1999; 93:392-395.

² Ericson A, Kallen B. Use of drugs during pregnancy: unique Swedish registration method that can be improved. Swedish Medical Products Agency 1999;1:8-11.

³ Norjavaara E, Gerhardsson de Verdier M. Normal pregnancy outcomes in a population-based study including 2968 pregnant women exposed to budesonide. J Allergy Clin Immunol 2003;111:736-742.

16 HOW SUPPLIED/STORAGE AND HANDLING

Budesonide Nasal Spray 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a green protection cap. Budesonide Nasal Spray 32 mcg (NDC 0186-1073-08) provides 120 metered sprays after initial priming; net fill weight 8.6 g. The Budesonide Nasal Spray 32 mcg bottle has been filled with an excess to accommodate the priming activity. The bottle should be discarded after 120 sprays following initial priming, since the amount of budesonide delivered per spray thereafter may be substantially less than the labeled dose. Each spray delivers 32 mcg of budesonide to the patient.

Budesonide Nasal Spray should be stored at controlled room temperature, 20 to 25°C (68 to 77°F) with the valve up. Do not freeze. Protect from light. Shake gently before use. Do not spray in eyes.

17 PATIENT COUNSELING INFORMATION

[See FDA-Approved Patient Labeling]

Patients being treated with Budesonide Nasal Spray should receive the following information and instructions. This information is intended to aid the patient in the safe and effective use of the medication. It is not a disclosure of all possible adverse or intended effects. For proper use of Budesonide Nasal Spray and to attain maximum improvement, the patient should read and follow the accompanying FDA Approved Patient Labeling.

17.1 Local Nasal Effects

Patients should be advised that epistaxis and localized infections with Candida albicans occurred in the nose and pharynx in some patients. If candidiasis develops, it should be treated with appropriate local or systemic therapy and discontinue treatment with Budesonide Nasal spray. In addition, nasal corticosteroids are associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use Budesonide Nasal Spray until healing has occurred [ see Warnings and Precautions (5.1) ].

17.2 Hypersensitivity including Anaphylaxis

Patients should be advised that hypersensitivity reactions including anaphylactic reaction, urticaria, rash, dermatitis, angioedema and pruritus have been reported with use of Budesonide Nasal Spray. Discontinue Budesonide Nasal Spray if such reactions occur [see Contraindications (4) Warnings and Preacautions(5.2) and Adverse Reactions (6) ].

17.3 Immunosuppression

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection, or ocular herpes simplex [see Warnings and Precautions (5.3) ].

17.4 Reduced Growth Velocity

Patients should be advised that intranasal corticosteroids, including budesonide, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route [see Warnings and Precautions (5.7) ].

17.5 Glaucoma and Cataracts

Patients should be advised that long-term use of intranasal corticosteroids, including budesonide, may increase the risk of some eye problems (cataracts and glaucoma). Patients should inform his/her healthcare provider if a change in vision is noted while using Budesonide Nasal Spray [see Warnings and Precautions (5.7) ].

17.6 Use Daily

Patients should use Budesonide Nasal Spray at regular intervals since its effectiveness depends on its regular use. Patients may note an improvement in nasal symptoms within 10 hours of first using Budesonide Nasal Spray. Maximum benefit may not be achieved until approximately 2 weeks after initiation of treatment [see Dosage and Administration (2) ].

Patients should take the medication as directed and should not exceed the prescribed dosage. The patient should contact the physician if symptoms do not improve after two weeks, or if the condition worsens. Patients who experience recurrent episodes of epistaxis (nosebleeds) or nasal septum discomfort while taking this medication should contact their physician. For proper use of Budesonide Nasal Spray and to attain maximum improvement, the patient should read and follow the accompanying patient information carefully. 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.

17.7 How to use Budesonide Nasal Spray

Patients should be carefully instructed on the use of this drug product to assure optimal dose delivery [see Patient Information].

All trademarks are the property of the AstraZeneca group of companies

©AstraZeneca 2011

Distributed by:

AstraZeneca LP, Wilmington, DE 19850

Rev. 10/2011

Patient Information

Budesonide^®

(bew DEH so nide)

Nasal Spray

For use in your nose only

Read the Patient Information that comes with Budesonide Nasal Spray before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have questions about Budesonide Nasal Spray, ask your healthcare provider or pharmacist.

What is Budesonide Nasal Spray?

Budesonide Nasal Spray is a prescription medicine used to treat seasonal and year-round allergy symptoms in adults and children 6 years of age and older.

Budesonide Nasal Spray contains budesonide, which is a man-made (synthetic) corticosteroid. Intranasal corticosteroids are natural hormones found in the body that reduce swelling of the lining of your nose. When you spray Budesonide Nasal Spray into your nose, it helps reduce the nasal symptoms of allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, runny nose, itching and sneezing.

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

Who should not use Budesonide Nasal Spray?

Do not use Budesonide Nasal Spray:

• •if you are allergic to budesonide or any of the ingredients in Budesonide Nasal Spray. See the end of this leaflet for a complete list of the ingredients in Budesonide Nasal Spray.

What should I tell my healthcare provider before using Budesonide Nasal Spray?

Before you use Budesonide Nasal Spray, tell your healthcare provider or pharmacist if you:

• •have recently been around anyone with chicken pox or measles
• •have liver problems
• •have any untreated infections
• •have ever had an infection called tuberculosis
• •have an eye infection
• •have recently had surgery or an injury to your nose
• •have any other medical conditions
• •are pregnant or plan to become pregnant. It is not known if Budesonide Nasal Spray will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• •are breastfeeding or plan to breastfeed. Budesonide Nasal Spray can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take Budesonide Nasal Spray.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Budesonide Nasal Spray may affect the way other medicines work, and other medicines may affect how Budesonide Nasal Spray works.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Budesonide Nasal Spray?

• •Budesonide Nasal Spray is for use in your nose only. Do not spray it in your eyes or mouth.
• •Use Budesonide Nasal Spray exactly as your healthcare provider tells you to use it.
• •It is very important that you use Budesonide Nasal Spray regularly. Do not stop using Budesonide Nasal Spray or change your dose without talking to your healthcare provider, even if you are feeling better.
• •Talk to your healthcare provider if your symptoms do not improve after taking Budesonide Nasal Spray for 2 weeks or if your symptoms get worse.
• •An adult should help a young child use this medicine.
• •See the “Patient Instructions for Use” at the end of this leaflet for complete information on how to use Budesonide Nasal Spray.

What are the possible side effects of Budesonide Nasal Spray?

Budesonide Nasal Spray may cause serious side effects including:

• • hole in the cartilage inside the nose (nasal septal perforation). Tell your healthcare provider if you have a whistling sound from your nose when you breathe.
• • slow wound healing. You should not use Budesonide Nasal Spray until your nose has healed if you have a sore in your nose, if you have had surgery on your nose, or if your nose has been injured.
• • fungal infection in your nose.
• • allergic reactions. Tell your healthcare provider or get medical help right away if you have:
  • ∘ skin rash, redness or swelling
  • ∘ severe itching
  • ∘ swelling of the face, mouth and tongue
• • immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that weaken your body’s ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while using Budesonide Nasal Spray. Symptoms of infection may include fever, pain, aches, chills, feeling tired, nausea and vomiting.
• • adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency may include tiredness, weakness, nausea, vomiting and low blood pressure.
• • slowed or delayed growth in children. A child’s growth should be checked regularly while using Budesonide Nasal Spray.
• • eye problems, such as glaucoma and cataracts. Tell your healthcare provider if you have a change in vision or have a history of increased intraocular pressure, glaucoma, and/or cataracts.

Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.

The most common side effects of Budesonide Nasal Spray include:

• •nose bleeds
• •sore throat
• •breathing difficulties such as wheezing, or chest tightening
• •cough
• •irritation of your nose

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

These are not all of the possible side effects of Budesonide Nasal Spray. For more information, ask your healthcare provider or pharmacist.

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

You may report side effects to AstraZeneca at 1-800-236-9933.

What should I know about allergic rhinitis?

“Rhinitis” means inflammation of the lining of the nose. It is sometimes called “hay fever.” Allergic rhinitis can be caused by allergies to pollen, animal dander, house dust mite, and mold spores. If you have allergic rhinitis, your nose becomes stuffy, runny, and itchy. You may also sneeze a lot. You may have red, itchy, watery eyes; itchy throat; or blocked, itchy ears.

Budesonide Nasal Spray helps to relieve your nasal symptoms.

If you also have itchy, watery eyes, you should tell your healthcare provider. He or she can prescribe additional medication to treat these symptoms.

How should I store Budesonide Nasal Spray?

• •Store Budesonide Nasal Spray at 68°F to 77°F (20°C to 25°C).
• •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. (Please see Prior to Use on reverse side).
• •Keep Budesonide Nasal Spray and all medications out of the reach of children.

General Information about the safe and effective use of Budesonide Nasal Spray:

Do not use Budesonide Nasal Spray for a condition for which it was not prescribed. Do not give Budesonide Nasal Spray to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Budesonide Nasal Spray. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Budesonide Nasal Spray that is written for health professionals.

For more information, go to www.astrazenca-us.com or call AstraZeneca at 1-800-236-9933.

What are the Ingredients of Budesonide Nasal Spray?

Active ingredient: budesonide

Inactive ingredients:

Microcrystalline cellulose and carboxymethyl cellulose sodium, dextrose anhydrous, polysorbate 80, disodium edetate, potassium sorbate, purified water and hydrochloric acid.

Patient Instructions for Use

For use in your nose only. Do not spray in your eyes or mouth.

Read the Patient Instructions for Use carefully before you start to use Budesonide Nasal Spray. If you have any questions, ask your healthcare provider.