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Rhinocort Aqua (budesonide)

THERAPEUTIC CLASS

Corticosteroid

DEA CLASS

RX

INDICATIONS

Treatment of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children ≥6 yrs of age.

ADULT DOSAGE

Seasonal/Perennial Allergic Rhinitis

Initial: 1 spray/nostril qd (64mcg/day)
Max: 4 sprays/nostril qd (256mcg/day)

PEDIATRIC DOSAGE

Seasonal/Perennial Allergic Rhinitis

6 to <12 Years:
Initial: 1 spray/nostril qd (64mcg/day)
Max: 2 sprays/nostril qd (128mcg/day)

≥12 Years:
Initial: 1 spray/nostril qd (64mcg/day)
Max: 4 sprays/nostril qd (256mcg/day)

ADMINISTRATION

Intranasal route

Shake gently before each use.
Do not spray in eyes.

Priming
Prior to initial use, container must be shaken gently and pump must be primed by actuating 8 times.
If used daily, the pump does not need to be reprimed.
If not used for 2 consecutive days, reprime w/ 1 spray or until a fine spray appears.
If not used for >14 days, rinse applicator and reprime w/ 2 sprays or until a fine spray appears.

HOW SUPPLIED

Nasal Spray: 32mcg/spray [120 sprays]

WARNINGS/PRECAUTIONS

Local nasal effects (eg, epistaxis, Candida infections of the nose and pharynx, nasal septal perforation, impaired wound healing) may occur. May need to d/c therapy and institute appropriate therapy if Candida infections develop. Avoid w/ recent nasal septal ulcers/surgery/trauma until healing has occurred. Hypersensitivity reactions may occur. May increase susceptibility to infections. May lead to serious/fatal course of chickenpox or measles; avoid exposure and, if exposed, consider prophylaxis/treatment. Use w/ caution, if at all, in patients w/ active or quiescent tuberculosis (TB), untreated fungal, bacterial, systemic viral, or parasitic infections, or ocular herpes simplex. Systemic corticosteroid effects (eg, hypercorticism, adrenal suppression) may appear; d/c slowly if such changes occur. Risk of adrenal insufficiency and withdrawal symptoms when replacing systemic corticosteroids w/ topical corticosteroids. May reduce growth velocity in pediatric patients. Glaucoma, increased intraocular pressure (IOP), and cataracts reported; closely monitor patients w/ a change in vision or w/ a history of increased IOP, glaucoma, and/or cataracts. Closely monitor patients w/ hepatic disease.

ADVERSE REACTIONS

Pharyngitis, epistaxis, cough, bronchospasm, nasal irritation.

DRUG INTERACTIONS

Concomitant CYP3A4 inhibitors may increase exposure; caution w/ long-term ketoconazole and other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, itraconazole, nefazodone).

PREGNANCY AND LACTATION

Category B, caution in nursing.

MECHANISM OF ACTION

Corticosteroid; not established. Possesses a wide range of inhibitory activities against multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and non-allergic-mediated inflammation.

PHARMACOKINETICS

Absorption: Absolute bioavailability (34%); Cmax=0.3nmol/L; Tmax=0.5 hr. Distribution: Vd=2-3L/kg, plasma protein binding (85-90%), found in breast milk. Metabolism: Liver (rapid, extensive) via CYP3A4; 16α-hydroxyprednisolone and 6β-hydroxybudesonide (major metabolites). Elimination: Urine (2/3 metabolites), feces; T1/2=2-3 hrs.

ASSESSMENT

Assess for drug hypersensitivity, active/quiescent TB, untreated fungal/bacterial infections, systemic viral/parasitic infections, ocular herpes simplex, history of increased IOP, history of glaucoma or cataracts, recent nasal ulcers/surgery/trauma, hepatic impairment, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for acute adrenal insufficiency and withdrawal symptoms when replacing systemic corticosteroid w/ topical corticosteroid. Monitor for hypercorticism, epistaxis, nasal ulceration, nasal septal perforation, reduction of growth velocity in pediatric patients, vision changes, glaucoma, cataracts, increased IOP, hypersensitivity reactions, infections, and for other adverse reactions. Patients on therapy for several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.

PATIENT COUNSELING

Inform about risks of local nasal effects, cataracts, glaucoma, immunosuppression, and hypersensitivity reactions. Advise not to use w/ recent nasal ulcers/surgery/trauma until healing has occurred. Instruct to inform physician if a change in vision is noted. Instruct to d/c if hypersensitivity reactions occur. Warn to avoid exposure to chickenpox or measles and, if exposed, to consult physician w/o delay. Advise parents that therapy may slow growth in children. Instruct to take ud at regular intervals and not to exceed the prescribed dosage. Advise to contact physician if symptoms do not improve after 2 weeks or if condition worsens. Advise to avoid spraying into eyes. Instruct to contact physician if recurrent episodes of epistaxis (nosebleeds) or nasal septum discomfort are experienced while taking this medication.

STORAGE

20-25°C (68-77°F) w/ the valve up. Do not freeze. Protect from light.

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