Vancenase (Beclomethasone Dipropionate)



Beclomethasone Dipropionate

Rhinitis – Hay Fever Therapy

Indications And Clinical Uses: The treatment of perennial and seasonal rhinitis and hay fever symptoms when tolerance to, or effectiveness of, conventional treatment is unsatisfactory.

Contra-Indications: Active or quiescent untreated pulmonary tuberculosis; untreated bacterial, viral or fungal infections; hypersensitivity to any of the product’s components; children under 6 years of age.

Precautions: See Vanceril Oral Inhaler. Vancenase is not recommended for patients with a history of recurrent nasal bleeding.

Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs. This is of particular importance in children.

During Vancenase therapy, the possibility of pharyngeal candidiasis, atrophic rhinitis or other changes in nasal mucosa should be kept in mind.

Instruct patients to use Vancenase for several days as the onset of action and full therapeutic effect may be somewhat slower than for topical or oral sympathomimetic amines or antihistamines. Patients should be reevaluated after several days.

Pregnancy and Lactation: The use of this product during pregnancy and lactation has not been established and therefore the compound should be used only if the potential benefit justifies the potential risk to the fetus or infant.

If hypersensitivity reactions occur during therapy, discontinue the drug.

Adverse Reactions: The most frequently observed adverse effects are those consistent with what one would expect in applying a topical medication to an already inflamed membrane. These include mild transient burning and stinging which occasionally require discontinuance of therapy. Other possible adverse effects in patients treated with Vancenase are: nasal irritation, nosebleed, sneezing, throat irritation and sore throat.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Vancenase has the potential for causing hypercorticism and/or adrenal suppression which may respond to dosage reduction or symptomatic treatment respectively.

Dosage And Administration: The usual dose for adults and children over 6 years of age is 1 metered dose (50 g) into each nostril 3 to 4 times daily. Maximum daily dose should not exceed 20 metered doses (1 000 g) for adults and 10 doses (500 g) for children. Subsequent dosage may be modified according to patient response. Insufficient information is available to warrant the safe use in children under 6 years of age.

When Vancenase is used concurrently with Vanceril, the combined total daily dose should not exceed the maximum daily recommended dose of beclomethasone dipropionate.

Emphasize to patients the need for the regular use and proper operation of the pressurized canister. The nasal passages must be clear before using Vancenase. This may be done simply by blowing the nose or by taking other appropriate medical measures when necessary.

Careful attention must be given to patients previously treated for prolonged periods with systemic corticosteroids when transferring them to Vancenase. Initially, Vancenase and the systemic corticosteroid must be given concomitantly for 10 to 14 days, followed by a gradual withdrawal of the systemic corticosteroids. Dose reductions should be at a rate not to exceed 1 mg (prednisone) every 10 to 14 days if close continuous medical supervision is not feasible. It may be possible to withdraw systemic corticosteroids more rapidly if the initial dosage was 7.5 mg daily of prednisone (or equivalent) or less, or if the patient is under close continuous medical supervision. In patients who are not able to completely discontinue the use of systemic corticosteroids, a minimum maintenance dose should be continued in addition to Vancenase.

Availability And Storage: Each metered dose of nasal inhaler contains: beclomethasone dipropionate USP 50 g. Nonmedicinal ingredients: oleic acid, trichloromonofluoromethane and dichlorodifluoromethane. Aerosol canisters filled to provide a minimum of 100 or 200 doses depending on dosage regimen utilized.

VANCENASE® Schering Beclomethasone Dipropionate Rhinitis – Hay Fever Therapy

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