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RHINOCORT AQUA is a brand name for Budesonide, supplied as a spray, metered dose. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: RHINOCORT® AQUA (Budesonide Nasal Spray) is indicated for: • The treatment of seasonal allergic and allergic/non-allergic perennial and vasomotor rhinitis unresponsive to conventional therapy in patients 6 years and older • The treatment of nasal polyps and in the prevention of nasal polyps after polypectomy in…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Careful attention must be given to patients previously treated for prolonged periods with systemic corticosteroids when transferred to RHINOCORT® AQUA (budesonide) (see WARNINGS AND PRECAUTIONS). Initially, RHINOCORT® AQUA and the systemic corticosteroid must be given concomitantly, while the dose of the latter is gradually decreased.
5 mg of prednisone every four days if the patient is under close supervision. 5 mg of prednisone (or equivalent) every ten days. If withdrawal symptoms appear, the previous dose of the systemic steroid should be resumed for a week before further decrease is attempted.
Patients should be informed that the full effect of RHINOCORT® AQUA therapy may not become evident until 2 to 3 days of treatment have been completed. Full therapeutic benefit requires regular usage. Treatment of seasonal rhinitis should, if possible, start before exposure to the allergens.
Concomitant treatment may sometimes be necessary to counteract eye symptoms caused by the allergy. , every 6 months. Page 4 of 26 If the nasal passages are severely blocked, the drug may fail to reach the site of action. In such cases, decongestants may be required before initiating RHINOCORT® AQUA therapy.
Although systemic effects are negligible at recommended doses, RHINOCORT® AQUA treatment should not be continued beyond three weeks in the absence of significant symptomatic improvement. RHINOCORT® AQUA should not be used in the presence of untreated localized infections involving the nasal mucosa.
2 Recommended Dose and Dosage Adjustment Treatment of Rhinitis: Adults and Children (12 Years of Age and Older) Initial Dose The recommended starting dose is 4 sprays per day (total daily dose of 256 mcg). The dose can be administered as 2 sprays in each nostril once daily in the morning or divided into two administrations daily of 1 spray in each nostril in the morning and evening Maintenance Dose After the desired clinical effect is obtained and symptoms are controlled, the maintenance dose should be reduced to the smallest amount necessary to control the symptoms.
The dose can be reduced to 1 spray per nostril once daily in the morning (total daily dose of 128 mcg). Children (6 Years to Less Than 12 Years of Age) Initial Dose The recommended dose is 1 spray in each nostril (total dose 128 mcg) once daily in the morning.
1 Adverse Reaction Overview The adverse reactions reported with RHINOCORT® AQUA are consistent with those expected when applying a topical treatment to an already inflamed membrane. All side effects were transient. The most commonly reported side effects include: nasal and throat irritation, nasal bleeding and crusting.
Other adverse events reported are itching throat, sore throat, cough, fatigue, nausea/dizziness, and headache. When patients are transferred to RHINOCORT® AQUA from a systemic steroid, allergic conditions such as asthma or eczema may be unmasked.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The safety of budesonide from clinical trial data is based on data from 15 placebo-controlled randomized studies in the treatment of allergic rhinitis.
Tables 2 and 3 include adverse events that occurred where greater than one event was reported, and the incidence was greater than placebo and in 1% of patients or more. 5 Post-Market Adverse Reactions The following adverse reactions have been reported during post-approval use of RHINOCORT® AQUA.
Immune System Disorders:
Anaphylactic reaction (very rare), Type I hypersensitivity reaction, Type IV hypersensitivity reaction (immediate and delayed hypersensitivity reactions, including Erythema, Urticaria, Rash, Dermatitis, Angioedema, and Pruritus) (uncommon) Respiratory, Thoracic and Mediastinal Disorders: Hemorrhagic secretion and Epistaxis, Nasal discomfort (nasal irritation) (common), Nasal septum perforation (very rare) General Disorders and Administrative Site Conditions: Mucosal ulceration (ulcerations of the mucous membrane) (very rare)
, joint and/or muscular pain, lassitude, depression) may occur in spite of maintenance or improvement of respiratory functions (see DOSAGE AND ADMINISTRATION). In severe cases, adrenal insufficiency may occur necessitating a temporary resumption of systemic steroids.
Careful attention must be given to patients with asthma or other clinical conditions in whom a rapid decrease in systemic steroids may cause a severe exacerbation of their symptoms. Patients should be advised to inform subsequent physicians of the prior use of glucocorticosteroids.
Treatment with RHINOCORT® AQUA should not be stopped abruptly but tapered off gradually. Ear/Nose/Throat RHINOCORT® AQUA should not be used in the presence of untreated localized infection involving the nasal mucosa. Concomitant treatment (topical histamines or cromones) may sometimes be required, as an add-on therapy to nasal corticosteroids, to counteract eye symptoms caused by allergy.
The long-term effects of nasal corticosteroids in human subjects are still unknown, in particular, their local effects, and on developmental or immunologic processes. The nasal mucosa of those patients receiving long term, continuous therapy should be inspected at least twice a year.
The possibility of atrophic rhinitis and/or pharyngeal candidiasis should be kept in mind. Following the use of intranasal corticosteroids, instances of nasal septum perforation have been reported very rarely. Endocrine and Metabolism Use of excessive doses of, or long-term treatment with, glucocorticosteroids may lead to signs or symptoms of hypercorticism, suppression of HPA function and/or suppression of growth in children.
During long-term therapy, pituitary-adrenal function status should be periodically assessed. Glucocorticosteroid effects may be enhanced in patients with hypothyroidism. Dose-related suppression of plasma and urinary cortisol has been observed in healthy volunteers after short-term administration of RHINOCORT® AQUA Although no important changes in basal plasma cortisol levels were manifested in patients with rhinitis using RHINOCORT® AQUA at recommended doses, caution is advised.
RHINOCORT® AQUA is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
• Patients with active or quiescent tuberculosis; • Patients with untreated fungal, bacterial, or viral infections; • Children under 6 years of age.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If symptoms do not improve, the dose can be increased up to 2 sprays per nostril (up to 256 mcg total daily dose) once daily in the morning. Maintenance Dose Once allergy symptoms improve, the maintenance dose should be reduced to 1 spray in each nostril once daily in the morning.
Parents should talk to their child’s physician if the child needs to use the spray for longer than two months a year.
Treatment or Prevention of Nasal Polyps:
Adults and Children (12 Years of Age and Older) The recommended dose is 1 spray into each nostril morning and evening (total daily dose of 256 mcg). Children Under 6 Years Health Canada has not authorized an indication for children in this age group.
4 Administration RHINOCORT® AQUA should be administered by the intranasal route only. Before taking each dose, the bottle should be inverted 3 to 4 times. Prior to administration, the nasal spray must be prepared for first time use. The bottle should be inverted 3 to 4 times and the protective cap removed.
The pump should be actuated 5 to 10 times away from the face until a fine mist spray appears. If the spray was not used on the prior day, the pump should be prepared by pressing down once away from the face before administration.
Illustrated instructions for proper use appear in PART III:
PATIENT MEDICATION INFORMATION. 5 Missed Dose If a single dose is missed, instruct the patient to take the dose as soon as possible and then go back to their regular schedule. If it is almost time to take the next dose, instruct the patient to skip the missed dose and to take the next dose at the usual time.
The patient should not take a double dose of RHINOCORT® AQUA to make up for a missed dose.
g. acetylsalicylic acid) should be used cautiously in conjunction with glucocorticosteroids. During long-term therapy, hematological status should be periodically assessed. Hepatic/Biliary/Pancreatic Glucocorticosteroid effects may be enhanced in patients with cirrhosis.
Reduced liver function may affect the elimination of corticosteroids. The intravenous pharmacokinetics of budesonide however, are similar in cirrhotic patients and in healthy subjects. The pharmacokinetics after oral ingestion of budesonide were affected by compromised liver function as evidenced by increased systemic availability.
This is however, of limited clinical importance for RHINOCORT® AQUA as the oral contribution to the systemic availability is relatively small. Immune As with all medications containing a corticosteroid, RHINOCORT® AQUA should be administered with caution, and only if necessary, in patients with active or quiescent tuberculosis infections of the respiratory tract; chronic or untreated infections such as systemic fungal, bacterial, viral, or parasitic; or ocular herpes simplex.
Glucocorticosteroids may mask some signs of infections and new infections may appear during their use. A decreased resistance to localized infection has been observed during glucocorticosteroid therapy; this may require treatment with appropriate therapy or stopping the administration of RHINOCORT® AQUA.
Patients who are on immunosuppressant drugs are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or fatal course in children on immunosuppressant corticosteroids.
In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affects 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, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated.
If chicken pox develops, treatment with antiviral agents may be considered. Ophthalmologic Following the use of intranasal aerosolized corticosteroids, instances of increased intraocular pressure have been reported very rarely. Visual disturbance may be reported with systemic and topical (including intranasal, inhaled and intraocular) corticosteroid use.
The possible causes of visual disturbance may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which may have been reported after use of systemic and topical corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts.
Page 8 of 26 Peri-operative Considerations Because of the inhibitory effect of corticosteroids on wound healing in patients who have had recent nasal surgery or trauma, RHINOCORT® AQUA should be used with caution until healing has occurred.
Psychiatric Although very rare, there is a potential risk of psychological or behavioural effects (psychomotor hyperactivity, sleep disorders, anxiety, depression and aggression) that have been reported. 1 Pregnant Women In experimental animal studies, budesonide was found to cross the placental barrier.
Like other glucocorticosteroids, budesonide is teratogenic to rodent species. High doses of budesonide administered […]