No

Corticosteroid, Oral Inhaler; Corticosteroid, Nasal

Oral inhalation: Treatment of bronchial asthma in patients who require chronic administration of corticosteroids

Nasal aerosol: Symptomatic treatment of seasonal or perennial rhinitis and nasal polyposis

C

Data does not support an association between drug and congenital defects in humans

Breast-feeding/lactation: No data on crossing into breast milk or effects on the infant

Status asthmaticus; hypersensitivity to the drug or fluorocarbons, oleic acid in the formulation, systemic fungal infections

Not to be used in status asthmaticus; safety and efficacy in children <6 years of age have not been established; avoid using higher than recommended dosages since suppression of hypothalamic, pituitary, or adrenal function may occur

In studies involving inhaled corticosteroids, the average reduction in growth velocity was approximately 1 cm (about 1/3 of an inch) per year. It appears that the reduction is related to dose and how long the child takes the drug.

FDA's Pulmonary and Allergy Drugs and Metabolic and Endocrine Drugs advisory committees discussed this issue at a July 1998 meeting. They recommended that the agency develop class-wide labeling to inform healthcare providers so they would understand this potential side effect and monitor growth routinely in pediatric patients who are treated with inhaled corticosteroids, intranasal corticosteroids or both.

Long-term effects of this reduction in growth velocity on final adult height are unknown. Likewise, it also has not yet been determined whether patients' growth will "catch up" if treatment in discontinued. Drug manufacturers will continue to monitor these drugs to learn more about long-term effects. Children are prescribed inhaled corticosteroids to treat asthma. Intranasal corticosteroids are generally used to prevent and treat allergy-related nasal symptoms.

Patients are advised not to stop using their inhaled or intranasal corticosteroids without first speaking to their healthcare providers about the benefits of these drugs compared to their risks.

>10%:

Local: Growth of Candida in the mouth, irritation and burning of the nasal mucosa

Respiratory: Cough, hoarseness

1% to 10%:

Gastrointestinal: Xerostomia

Local: Nasal ulceration

Respiratory: Epistaxis

<1%: Headache, rash, dysphagia, bronchospasm, rhinorrhea, nasal congestion, sneezing, nasal septal perforations

Symptoms of overdose include irritation and burning of the nasal mucosa, sneezing, intranasal and pharyngeal Candida infections, nasal ulceration, epistaxis, rhinorrhea, nasal stuffiness, headache. When consumed in excessive quantities, systemic hypercorticism and adrenal suppression may occur, in those cases discontinuation and withdrawal of the corticosteroid should be done judiciously.

No data reported

Do not store near heat or open flame

Controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes, fibroblasts, reverses capillary permeability, and lysosomal stabilization at the cellular level to prevent or control inflammation

Therapeutic effect: Within 1-4 weeks of use

Inhalation:

Absorption: Readily absorbed; quickly hydrolyzed by pulmonary esterases prior to absorption

Distribution: 10% to 25% of dose reaches respiratory tract

Oral:

Absorption: 90%

Distribution: Secreted into breast milk

Protein binding: 87%

Metabolism: Hepatic

Half-life:

Initial: 3 hours

Terminal: 15 hours

Elimination: Renal

Nasal inhalation and oral inhalation dosage forms are not to be used interchangeably

Vancenase® AQ, Beconase® AQ: Children greater than or equal to 6 years and Adults: 1-2 inhalations each nostril twice daily

Vancenase® AQ 84 mcg: Children greater than or equal to 6 years and Adults: 1-2 inhalations in each nostril once daily

Intranasal (Vancenase®, Beconase®):

Children 6-12 years: 1 inhalation in each nostril 3 times/day

Children greater than or equal to 12 years and Adults: 1 inhalation in each nostril 2-4 times/day or 2 inhalations each nostril twice daily; usual maximum maintenance: 1 inhalation in each nostril 3 times/day

Oral inhalation (doses should be titrated to the lowest effective dose once asthma is controlled):

Beclovent®, Vanceril®:

Children 6-12 years: 1-2 inhalations 3-4 times/day (alternatively: 2-4 inhalations twice daily); maximum dose: 10 inhalations/day

Children greater than or equal to 12 years and Adults: 2 inhalations 3-4 times/day (alternatively: 4 inhalations twice daily); maximum dose: 20 inhalations/day; patients with severe asthma: Initial: 12-16 inhalations/day (divided 3-4 times/day); dose should be adjusted downward according to patient's response

Vanceril® 84 mcg double strength:

Children 6-12 years: 2 inhalations twice daily; maximum dose: 5 inhalations/day

Children greater than or equal to 12 years and Adults: 2 inhalations twice daily; maximum dose: 10 inhalations/day; patients with severe asthma: Initial: 6-8 inhalations/day (divided twice daily); dose should be adjusted downward according to patient's response

NIH Guidelines (NIH, 1997) (give in divided doses):

Children:

"Low" dose: 84-336 mcg/day (42 mcg/puff: 2-8 puffs/day or 84 mcg/puff: 1-4 puffs/day)

"Medium" dose: 336-672 mcg/day (42 mcg/puff: 8-16 puffs/day or 84 mcg/puff: 4-8 puffs/day)

"High" dose: >672 mcg/day (42 mcg/puff: >16 puffs/day or 84 mcg/puff >8 puffs/day)

Adults:

"Low" dose: 168-504 mcg/day (42 mcg/puff: 4-12 puffs/day or 84 mcg/puff: 2-6 puffs/day)

"Medium" dose: 504-840 mcg/day (42 mcg/puff: 12-20 puffs/day or 84 mcg/puff: 6-10 puffs/day)

"High" dose: >840 mcg/day (42 mcg/puff: >20 puffs/day or 84 mcg/puff: >10 puffs/day)

Aerosol inhalation: Shake container thoroughly before using

Aerosol inhalation, oral: Consider use of a spacer device for children <8 years of age requiring a metered dose inhaler (MDI)

None reported

None reported

No information available to require special precautions

Localized infections with Candida albicans or Aspergillus niger have occurred frequently in the mouth and pharynx with repetitive use of oral inhaler of beclomethasone. Positive cultures for oral Candida may be present in up to 75% of patients. These infections may require treatment with appropriate antifungal therapy or discontinuance of treatment with beclomethasone inhaler.

Use as directed; do not increase dosage or discontinue abruptly without consulting prescriber. It may take 1-4 weeks for you to realize full effects of treatment. Review use of inhaler or spray with prescriber or follow package insert for directions. Keep oral inhaler clean and unobstructed. Always rinse mouth and throat after use of inhaler to prevent opportunistic infection. If you are also using an inhaled bronchodilator, wait 10 minutes before using this steroid aerosol. Report adverse effects such as skin redness, rash, or irritation; pain or burning of nasal mucosa; white plaques in mouth or fuzzy tongue; unresolved headache; or worsening of condition or lack of improvement. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Take drug history of patients with perennial rhinitis, may be drug related; check mucous membranes for signs of fungal infection

Nasal, as dipropionate:

Inhalation: (Beconase®, Vancenase®): 42 mcg/inhalation [200 metered doses] (16.8 g)

Spray, as dipropionate (Vancenase® AQ Nasal): 0.084% [120 actuations] (19 g)

Spray, aqueous, nasal, as dipropionate (Beconase® AQ, Vancenase® AQ): 42 mcg/inhalation [ greater than or equal to 200 metered doses] (25 g); 84 mcg/inhalation [ greater than or equal to 200 metered doses] (25 g)

Oral: Inhalation, as dipropionate:

Beclovent®, Vanceril®: 42 mcg/inhalation [200 metered doses] (16.8 g)

Vanceril® Double Strength: 84 mcg/inhalation (5.4 g - 40 metered doses, 12.2 g - 120 metered doses)

Demain JG and Goetz DW, "Pediatric Adenoidal Hypertrophy and Nasal Airway Obstruction: Reduction With Aqueous Nasal Beclomethasone," Pediatrics, 1995, 95(3):355-64.

Expert Panel Report 2, "Guidelines for the Diagnosis and Management of Asthma," Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 94-4051, April, 1997.

Kobayashi RH, Tinkelman DG, Reese ME, et al, "Beclomethasone Dipropionate Aqueous Nasal Spray for Seasonal Allergic Rhinitis in Children," Ann Allergy, 1989, 62(3):205-8.

Tinkelman DG, Reed CE, Nelson HS, et al, "Aerosol Beclomethasone Dipropionate Compared With Theophylline as Primary Treatment of Chronic, Mild to Moderately Severe Asthma in Children," Pediatrics, 1993, 92(1):64-77.

Wyatt R, Waschek J, Weinberger M, et al, "Effects of Inhaled Beclomethasone Dipropionate and Alternate-Day Prednisone on Pituitary-Adrenal Function in Children With Chronic Asthma," N Engl J Med, 1978, 299(25):1387-92.