Vancenase aq nasal spray 0.084%

Beclomethasone 17,21-dipropionate is a diester of beclomethasone, a synthetic halogenated corticosteroid. Animal studies show that beclomethasone dipropionate has potent glucocorticosteroid and weak mineralocorticosteroid activity. The mechanisms for the anti-inflammatory action of beclomethasone dipropionate are unknown. The precise mechanism of the aerosolized drug's action in the nose is also unknown. Biopsies of nasal mucosa obtained during clinical studies (duration of treatment from 1 to 6 years at doses up to 336 mcg/day) showed no histopathologic changes when beclomethasone dipropionate was administered intranasally.

In a study evaluating the hypothalamic-pituitary-adrenal (HPA) effects of 336 mcg/day beclomethasone dipropionate administered intranasally for 36 consecutive days via aqueous suspension, there was no statistically significant difference in cortisol suppression between beclomethasone dipropionate 336 mcg once daily, beclomethasone dipropionate 168 mcg twice daily, and placebo. Plasma cortisol response to 6-hour cosyntropin stimulation was attenuated in control patients who received oral prednisone 10 mg daily.

The effects of beclomethasone dipropionate on HPA function have also been evaluated in adult volunteers by other routes of administration. There was no suppression of early morning plasma cortisol concentrations when beclomethasone dipropionate was administered in a dose of 1000 mcg/day for 1 month as an oral aerosol or for 3 days by intramuscular injection. However, partial suppression of plasma cortisol concentration was observed when beclomethasone dipropionate was administered in doses of 2000 mcg/day either by oral aerosol or intramuscular injection. Immediate suppression of plasma cortisol concentrations was observed after single doses of 4000 mcg of beclomethasone dipropionate. Suppression of HPA function (reduction of early morning plasma cortisol levels) has been reported in adult patients who received 1600 mcg daily doses of oral beclomethasone dipropionate for 1 month.

In one study of pediatric patients with asthma, the administration of inhaled beclomethasone dipropionate at recommended daily doses for at least 1 year was associated with a reduction in nocturnal cortisol secretion. The clinical significance of this finding is not clear. It reinforces other evidence, however, that topical beclomethasone dipropionate may be absorbed in amounts that can have systemic effects and that physicians should be alert for evidence of systemic effects, especially in chronically treated patients (see PRECAUTIONS ).

Beclomethasone dipropionate is sparingly soluble. When given by nasal inhalation in the form of an aqueous or aerosolized suspension, the drug is deposited primarily in the nasal passages. A portion of the drug is swallowed. Absorption occurs rapidly from all respiratory and gastrointestinal tissues. There is no evidence of tissue storage of beclomethasone dipropionate or its metabolites. In vitro studies have shown that tissue other than the liver (lung slices) can rapidly metabolize beclomethasone dipropionate to beclomethasone 17-monopropionate and more slowly to free beclomethasone (which has very weak anti-inflammatory activity). However, irrespective of the route of entry, the principal route of excretion is the feces. In humans, 12% to 15% of an orally administered dose of beclomethasone dipropionate is excreted in the urine. The drug is excreted in both urine and feces as free and conjugated polar metabolites.

Studies have shown that the degree of binding to plasma proteins is 87%.

In clinical trials with VANCENASE AQ 84 mcg Nasal Spray in patients with seasonal allergic rhinitis, 336 mcg of beclomethasone dipropionate once daily was superior to placebo with respect to effects on nasal symptoms. In a study comparing VANCENASE AQ 84 mcg Nasal Spray once daily with beclomethasone dipropionate 42 mcg nasal spray twice daily, each delivering a total daily dose of 336 mcg beclomethasone dipropionate, both regimens were comparable with respect to effects on physician-rated nasal symptoms. In this study, a significant advantage over placebo was observed for both regimens within 3 days of the start of treatment.

VANCENASE AQ 84 mcg Nasal Spray is indicated for the relief of symptoms of allergic and nonallergic (vasomotor) rhinitis. Results from clinical trials of intranasal beclomethasone dipropionate in patients with seasonal allergic rhinitis have shown that significant symptom relief was obtained in most patients within 3 days. However, symptom relief may not occur in some patients for as long as 2 weeks. VANCENASE AQ 84 mcg Nasal Spray should not be continued beyond 3 weeks in the absence of significant symptom improvement. VANCENASE AQ 84 mcg Nasal Spray should not be used in the presence of untreated localized infection involving the nasal mucosa.

VANCENASE AQ 84 mcg Nasal Spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal.

Clinical studies with beclomethasone dipropionate 42 mcg nasal spray have shown that treatment of the symptoms associated with nasal polyps may have to be continued for several weeks or more before a therapeutic result can be fully assessed. Recurrence of symptoms due to polyps can occur after stopping treatment, depending on the severity of the disease.

Hypersensitivity to any of the ingredients of this preparation contraindicates its use.

In clinical studies with intranasally administered beclomethasone dipropionate, adverse effects have primarily been related to irritation of the nasal mucous membranes. Rarely, immediate hypersensitivity reactions may occur after intranasal administration of beclomethasone dipropionate.

Clinical trials of VANCENASE AQ 84 mcg Nasal Spray included 187 patients who received VANCENASE AQ 84 mcg Nasal Spray, 127 patients who received beclomethasone dipropionate 42 mcg nasal spray, and 192 patients who received vehicle placebo. The incidence and nature of adverse events with VANCENASE AQ 84 mcg Nasal Spray (336 mcg beclomethasone dipropionate once daily) was comparable to that seen with beclomethasone dipropionate 42 mcg nasal spray (168 mcg beclomethasone dipropionate twice daily) and with vehicle placebo. Adverse events reported by 2% or more of patients (regardless of relationship to treatment) who received VANCENASE AQ 84 mcg Nasal Spray in clinical trials and that were more common with VANCENASE AQ 84 mcg Nasal Spray than with placebo are displayed in the table below.

Rare cases of ulceration of the nasal mucosa and instances of nasal septum perforation have been reported following the intranasal administration of beclomethasone dipropionate (see PRECAUTIONS ).

Rare instances of wheezing and increased intraocular pressure have been reported following the intranasal administration of aerosolized corticosteroids (see PRECAUTIONS ).

Single cases each of aseptic necrosis of the femoral head and of nasal fungal infection with erosion through the cribriform plate have been reported after long-term administration of beclomethasone dipropionate nasal spray.

When used at excessive doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, VANCENASE AQ 84 mcg Nasal Spray should be discontinued slowly consistent with accepted procedures for discontinuing oral steroid therapy. The oral median lethal dose of beclomethasone dipropionate is greater than 1 g/kg in mice and rats (approximately 7000 times and 14,000 times, respectively, the maximum recommended human daily intranasal dose on a mg/m 2 basis). One bottle of VANCENASE AQ 84 mcg Nasal Spray contains beclomethasone dipropionate, monohydrate equivalent to 16.0 mg of beclomethasone dipropionate; therefore, acute overdosage is unlikely.