Budesonide Intranasal

Budesonide Intranasal is a prescription medication used to treat the nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies 

• Budesonide Intranasal is available under the following different brand names: Rhinocort Allergy, Rhinocort Aqua (DSC)

Dosage Considerations – Should be Given as Follows:

Intranasal spray

• 32 mcg /actuation (Rhinocort Allergy [over the counter], generic [prescription])

Allergic Rhinitis (prescription medication)

Adult dosage

Prescription medication

• Initial dose: 1 spray/nostril once a day (64 mcg/day)
• Not to exceed 4 sprays/nostril once a day (256 mcg/day

Rhinocort Allergy (Over the counter)

• Children below 12 years: Safety and efficacy not established
• 2 sprays/nostril once a day (128 mcg/day); once allergy symptoms improve, reduce dose to 1 spray/nostril once a day (64 mcg/day)

Pediatric dosage

Prescription medication

• Children below 6 years: Safety and efficacy not established
• Initial dose: 1 spray/nostril once a day (64 mcg/day)
• 6-11 years: Not to exceed 2 sprays/nostril once a day (128 mcg/day)
• Children above 12 years: Not to exceed 4 sprays/nostril once a day (256 mcg/day)

Rhinocort allergy

• Children below 6 years: Safety and efficacy not established
• 6-12 years: 1 spray/nostril once a day (64 mcg/day); if allergy symptoms do not improve, may increase to 2 sprays/nostril once a day (128 mcg/day)
• Children above 12 years: 2 sprays/nostril once a day (128 mcg/day); once allergy symptoms improve, reduce dose to 1 spray/nostril once a day (64 mcg/day)

Common side effects of Budesonide Intranasal include:

• nose/throat dryness or irritation,
• sore throat,
• cough,
• sneezing,
• nosebleeds,
• unpleasant taste/smell,
• sores or white patches inside or around the nose, or
• pain, swelling, burning, itching, or irritation around the nose.

Serious side effects of Budesonide Intranasal include:

• loss of taste or smell, or
• pain or sores in the nose.

Rare side effects of Budesonide Intranasal include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Budesonide Intranasal has no noted severe interactions with any other drugs.
• Budesonide Intranasal has no noted serious interactions with any other drugs.
• Budesonide Intranasal has no noted moderate interactions with any other drugs.
• Budesonide Intranasal has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to drugs or excipients 

Effects of drug abuse

None

Short-Term Effects

• See “What Are Side Effects Associated with Using Budesonide Intranasal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Budesonide Intranasal?”

Cautions

• Anaphylaxis, urticaria, rash, dermatitis, angioedema, and pruritus may occur
• Epistaxis reported with the use
• Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred
• Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients; monitor growth routinely of pediatric patients receiving long-term treatment; to minimize systemic effects of Intranasal corticosteroids, titrate each patient’s dosage to the lowest one that effectively controls his/her symptoms
• Nasal septum perforation reported following Intranasal application
• Development of localized infections of the nose and pharynx with Candida albicans was reported; when such an infection develops, may require treatment with appropriate local or systemic therapy and discontinuation of treatment with this drug; patients receiving therapy over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa
• Glaucoma increased intraocular pressure, and cataracts were reported following the Intranasal application of corticosteroids, including budesonide; therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts
• Immunosuppression
  • Patients who are on drugs that suppress the immune system are more susceptible to infections than healthy individuals; chickenpox and measles can have a more serious or even fatal course in susceptible children or adults using corticosteroids; in such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure
  • How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known; the contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known
  • If exposed to chickenpox, therapy with varicella-zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated
  • If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated; if chickenpox develops, treatment with antiviral agents may be considered
  • Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral, or parasitic infections, or ocular herpes simplex
• Hypercorticism and adrenal suppression
  • When Intranasal steroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur; if such changes happen, therapy should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy
  • The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency, and in addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint and/or muscular pain, fatigue, weakness, nausea, vomiting, hypotension, lassitude, and depression
  • Patients previously treated for prolonged periods with systemic corticosteroids should be weaned off slowly when transferred to topical corticosteroids and carefully monitored for acute adrenal insufficiency in response to stress
  • In patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms
• Drug interactions overview
  • Caution should be exercised when considering the coadministration of this drug with ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to budesonide may occur

Pregnancy and Lactation

• Adverse events (e.g., hypoadrenalism) observed with systemic corticosteroids in animal reproduction studies
• Increased risk of abnormalities has not been demonstrated in pregnant women using Intranasal budesonide
• Clinical considerations: Intranasal corticosteroids are recommended for allergic rhinitis during pregnancy
• Lactation
  • Excreted in breast milk after oral inhalation (approximately 0.3-1 % of the maternal dose)
  • Plasma budesonide levels obtained from infants after breastfeeding were below the limit of quantification