Medication Safety Issues Sound-alike/look-alike issues:
Vanceril® may be confused with Vancenase®
Pronunciation (be kloe METH a sone)
U.S. Brand Names Beconase® AQ; QVAR®
Canadian Brand Names Apo-Beclomethasone®; Gen-Beclo; Nu-Beclomethasone; Propaderm®; QVAR®; Rivanase AQ; Vanceril® AEM
Pharmacologic Category Corticosteroid, Inhalant (Oral); Corticosteroid, Nasal
Use: Labeled Indications Oral inhalation: Maintenance and prophylactic treatment of asthma; includes those who require corticosteroids and those who may benefit from a dose reduction/elimination of systemically-administered corticosteroids. Not for relief of acute bronchospasm.
Nasal aerosol: Symptomatic treatment of seasonal or perennial rhinitis; prevent recurrence of nasal polyps following surgery.
Dosing: Adults Nasal inhalation and oral inhalation dosage forms are not to be used interchangeably.
Rhinitis, nasal polyps: Inhalation, nasal (Beconase® AQ): 1-2 inhalations each nostril twice daily; total dose 168-336 mcg/day
Asthma: Inhalation, oral (doses should be titrated to the lowest effective dose once asthma is controlled) (QVAR®):
Patients previously on bronchodilators only: Initial dose 40-80 mcg twice daily; maximum dose 320 mcg twice day
Patients previously on inhaled corticosteroids: Initial dose 40-160 mcg twice daily; maximum dose 320 mcg twice daily
NIH Asthma Guidelines (NIH, 2007): HFA formulation (eg, QVAR®): Administer in divided doses:
“Low†dose: 80-240 mcg/day
“Medium†dose: >240-480 mcg/day
“High†dose: >480 mcg/day
Dosing: Elderly Refer to adult dosing.
Dosing: Pediatric Nasal inhalation and oral inhalation dosage forms are not to be used interchangeably.
Rhinitis, nasal polyps: Inhalation, nasal (Beconase® AQ): Children ≥6 years: Refer to adult dosing
Asthma: Inhalation, oral (doses should be titrated to the lowest effective dose once asthma is controlled) (QVAR®):
Children 5-11 years: Initial: 40 mcg twice daily; maximum dose: 80 mcg twice daily
Children ≥12 years: Refer to adult dosing
NIH Asthma Guidelines (NIH, 2007): HFA formulation (eg, QVAR®): Administer in divided doses:
Children 5-11 years:
“Low†dose: 80-160 mcg/day
“Medium†dose: >160-320 mcg/day
“High†dose: >320 mcg/day
Children ≥12 years: Refer to adult dosing.
Administration: Inhalation Beconase AQ®: Shake well before use. Nasal applicator and dust cap may be washed in warm water and dry thoroughly.
QVAR®: Rinse mouth and throat after use to prevent Candida infection. Do not wash or put inhaler in water; mouth piece may be cleaned with a dry tissue or cloth. Prime canister before using.
Storage Do not store near heat or open flame. Do not puncture canisters. Store at room temperature. Rest QVAR® on concave end of canister with actuator on top.
Contraindications Hypersensitivity to beclomethasone or any component of the formulation; status asthmaticus
Allergy Considerations Corticosteroid Allergy
Warnings/Precautions Concerns related to adverse effects:
• Adrenal suppression: May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.
• Bronchospasm: May occur with wheezing after inhalation; if this occurs stop steroid and treat with a fast-acting bronchodilator.
• Delayed wound healing: Avoid nasal corticosteroid use in patients with recent nasal septal ulcers, nasal surgery or nasal trauma until healing has occurred.
• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Exposure to chickenpox should be avoided; corticosteroids should not be used to treat ocular herpes simplex. Corticosteroids should not be used for cerebral malaria. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only in conjunction with antituberculosis treatment).
• Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered.
• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Pre-existing psychiatric conditions may be exacerbated by corticosteroid use.
Disease-related concerns:
• Asthma: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Not to be used in status asthmaticus or for the relief of acute bronchospasm.
• Cardiovascular disease: Use with caution in patients with HF; long-term use has been associated with fluid retention and hypertension.
• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.
• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, peptic ulcer, ulcerative colitis) due to perforation risk.
• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred especially during initial treatment with corticosteroids.
• Myocardial infarct (MI): Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.
• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.
• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.
• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.
Special populations:
• Pediatrics: Orally-inhaled and intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter per year [range 0.3-1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally-inhaled and intranasal corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients. Safety and efficacy have not been established in children <5 years of age.
Other warnings/precautions:
• Discontinuation of therapy: Withdraw systemic therapy with gradual tapering of dose. There have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing oral inhalation therapy.
Geriatric Considerations Elderly patients may have difficulty with oral metered dose inhalers and may benefit from the use of a spacer or chamber device.
Pregnancy Risk Factor C
Pregnancy Considerations Teratogenic effects were observed in animal studies. No human data on beclomethasone crossing the placenta or effects on the fetus. A decrease in fetal growth has not been observed with inhaled corticosteroid use during pregnancy. Inhaled corticosteroids are recommended for the treatment of asthma (most information available using budesonide) and allergic rhinitis during pregnancy.
Lactation Excretion in breast milk unknown/use caution
Breast-Feeding Considerations Other corticosteroids have been found in breast milk; however, information for beclomethasone is not available. Inhaled corticosteroids are recommended for the treatment of asthma (most information available using budesonide) while breast-feeding.
Adverse Reactions Frequency not defined.
Central nervous system: Agitation, depression, dizziness, dysphonia, headache, lightheadedness, mental disturbances
Dermatologic: Acneiform lesions, angioedema, atrophy, bruising, pruritus, purpura, striae, rash, urticaria
Endocrine & metabolic: Cushingoid features, growth velocity reduction in children and adolescents, HPA function suppression, weight gain
Gastrointestinal: Dry/irritated nose, throat and mouth, hoarseness, localized Candida or Aspergillus infection, loss of smell, loss of taste, nausea, unpleasant smell, unpleasant taste, vomiting
Local: Nasal spray: Burning, epistaxis, localized Candida infection, nasal septum perforation (rare), nasal stuffiness, nosebleeds, rhinorrhea, sneezing, transient irritation, ulceration of nasal mucosa (rare)
Ocular: Cataracts, glaucoma, intraocular pressure increased
Respiratory: Cough, paradoxical bronchospasm, pharyngitis, sinusitis, wheezing
Miscellaneous: Anaphylactic/anaphylactoid reactions, death (due to adrenal insufficiency, reported during and after transfer from systemic corticosteroids to aerosol in asthmatic patients), immediate and delayed hypersensitivity reactions
Drug Interactions Amphotericin B: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Amphotericin B. Risk C: Monitor therapy
Antidiabetic Agents: Corticosteroids (Orally Inhaled) may diminish the hypoglycemic effect of Antidiabetic Agents. In some instances, corticosteroid-mediated HPA axis suppression has led to episodes of acute adrenal crisis, which may manifest as enhanced hypoglycemia, particularly in the setting of insulin or other antidiabetic agent use. Risk C: Monitor therapy
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy
Loop Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy
Thiazide Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Thiazide Diuretics. Risk C: Monitor therapy
Nursing: Physical Assessment/Monitoring Not to be used to treat status asthmaticus or fungal infections of nasal passages. Monitor therapeutic effectiveness and adverse reactions. When changing from systemic steroids to inhalational steroids, taper reduction of systemic medication slowly. Growth should be routinely monitored in pediatric patients. Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report.
Patient Education 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 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. Discard after date calculated by prescriber; the amount of medication in canister cannot be guaranteed after using the labeled number of actuations (sprays) even though it may not feel empty. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.
Inhalation: Sit when using. Take deep breaths for 3-5 minutes, and clear nasal passages before administration (use decongestant as needed). Hold breath for 5-10 seconds after use, and wait 1-3 minutes between inhalations. Follow package insert instructions for use. Do not exceed maximum dosage. If also using inhaled bronchodilator, use before beclomethasone. Rinse mouth and throat after use to reduce aftertaste and prevent candidiasis.
Dosage Forms Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol for oral inhalation, as dipropionate:
QVAR®: 40 mcg/inhalation [100 metered actuations] (7.3 g); 80 mcg/inhalation [100 metered actuations] (7.3 g)
Suspension, intranasal, as dipropionate [aqueous spray]:
Beconase® AQ: 42 mcg/inhalation [180 metered sprays (25 g)
Generic Available No
Pricing: U.S. (www.drugstore.com) Aerosol solution (Qvar)
40 mcg/ACT (7.3): $75.59
80 mcg/ACT (7.3): $92.87
Suspension (Beconase AQ)
42 mcg/spray (25): $149.32
Mechanism of Action 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
Pharmacodynamics/Kinetics Onset of action: Therapeutic effect: 1-4 weeks
Absorption: Readily; quickly hydrolyzed by pulmonary esterases prior to absorption
Distribution: Beclomethasone: 20 L; active metabolite: 424 L
Protein binding: 87%
Metabolism: Hepatic via CYP3A4 to active metabolites
Bioavailability: Of active metabolite, 44% following nasal inhalation (43% from swallowed portion)
Half-life elimination: Initial: 3 hours
Excretion: Feces (60%); urine (12%)
Related Information Asthma
Inhalant Agents
Status Epilepticus
Pharmacotherapy Pearls Effects of inhaled/intranasal steroids on growth have been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with orally-inhaled and intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch up†growth following discontinuation of treatment with inhaled corticosteroids has not been adequately studied.
Dental Health: Effects on Dental Treatment Key adverse event(s) related to dental treatment: Oral candidiasis, xerostomia (normal salivary flow resumes upon discontinuation), nasal dryness, and dry throat. Localized infections with Candida albicans or Aspergillus niger occur frequently in the mouth and pharynx with repetitive use of an oral inhaler; may require treatment with appropriate antifungal therapy or discontinuance of inhaler use.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions No information available to require special precautions
Mental Health: Effects on Mental Status May cause agitation, depression, dizziness, euphoria, insomnia, mood swings, and personality changes; may cause exacerbation of pre-existing psychiatric conditions
Mental Health: Effects on Psychiatric Treatment None reported
Anesthesia and Critical Care Concerns/Other Considerations Surgery: For patients who have received oral systemic corticosteroids during the past 6 months and for selected patients on long-term, high-dose, inhaled corticosteroid (ICS), give stress doses of hydrocortisone intravenously during the surgical period and reduce the dose rapidly within 24 hours after surgery (Expert Panel Report 3, 2007). Clinically important adrenal suppression has been reported in patients receiving high doses of an ICS, particularly children.
Index Terms Beclomethasone Dipropionate
References Bakhireva LN, Jones KL, Schatz M, et al, “Asthma Medication Use in Pregnancy and fetal Growth,†J Allergy Clin Immunol, 2005, 116(3):503-9.[PubMed 16159616]
Demain JG and Goetz DW, “Pediatric Adenoidal Hypertrophy and Nasal Airway Obstruction: Reduction With Aqueous Nasal Beclomethasone,†Pediatrics, 1995, 95(3):355-64. [PubMed 7862473]
Expert Panel Report 3, “Guidelines for the Diagnosis and Management of Asthma,†Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 08-4051, prepublication 2007. Available at http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm
Goedert JJ, Vitale F, Lauria C, et al, “Risk Factors for Classical Kaposi's Sarcoma,†J Natl Cancer Inst, 2002, 94(22):1712-8.[PubMed 12441327]
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. [PubMed 2646995]
Namazy J, Schatz M, Long L, et al, “Use of Inhaled Steroids by Pregnant Asthmatic Women Does Not Reduce Intrauterine Growth,†J Allergy Clin Immunol, 2004, 113(3):427-32.[PubMed 15007341]
“NAEPP Expert Panel Report. Managing Asthma During Pregnancy: Recommendations for Pharmacologic Treatment - 2004 Update,†J Allergy Clin Immunol, 2005, 115(1):34-46.[PubMed 15637545]
“National Asthma Education and Prevention Program. Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma Update on Selected Topics-2002,†J Allergy Clin Immunol, 2002, 110(5 Suppl):141-219.
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. [PubMed 8516087]
Todd GR, Acerini CL, Buck JJ, et al, "Acute Adrenal Crisis in Asthmatics Treated With High-Dose Fluticasone Propionate," Eur Respir J, 2002, 19(6):1207-9.[PubMed 12108877]
Todd GR, Acerini CL, Ross-Russell R, et al, "Survey of Adrenal Crisis Associated With Inhaled Corticosteroids in the United Kingdom," Arch Dis Child, 2002, 87(6):457-61.[PubMed 12456538]
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.[PubMed 362207]
International Brand Names Aerobec (SE); Afifon (IL); Alanase (NZ); Aldecin (AU, BG, MY); Atomase (MY, NZ); Beclate (IN, ZA); Beclazone (MX, MY, NZ); Beclo-Asma (HK); Beclo-Asma CFC Free (SG); Becloforte (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Beclomet (CH, MY, SE, TW); Beclomet Easyhaler (ID, TH); Beclomet Nasal Aqua (ID); Beclometasone (FR); Beclone (FR); Beclosol Aquoso (BR); Beclospin (FR); Beconase (AE, BB, BF, BH, BJ, BM, BS, BZ, CH, CI, CL, CO, CR, CY, DO, EE, EG, ET, FI, FR, GB, GH, GM, GN, GT, GY, HN, ID, IL, IQ, IR, JM, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, MX, MY, NE, NG, NI, NL, OM, PA, PE, PK, QA, SA, SC, SD, SL, SN, SR, SV, SY, TH, TN, TT, TZ, UG, VE, YE, ZA, ZM, ZW); Becotide (AE, AT, BB, BD, BE, BF, BG, BH, BJ, BM, BS, BZ, CH, CI, CL, CR, CY, CZ, DE, DK, DO, EE, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, GT, GY, HK, HN, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KP, KW, LB, LR, LY, MA, ML, MR, MU, MW, MX, MY, NE, NG, NI, NL, NO, OM, PA, PE, PH, PK, PT, QA, RU, SA, SC, SD, SE, SG, SL, SN, SR, SV, SY, TH, TN, TR, TT, TW, TZ, UG, UY, YE, ZA, ZM, ZW); Belax (TW); Bemase (TH); Bemedrex Easyhaler (FR); Bronconox (CO); Bronconox Forte (CO); Clenil (AE, AR, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, TW, YE); Clenil Forte (ID); Clenil HFA Modulate (MY); Clenil Modulite (GB); Clipper (BE, GB); Decomit (SG); Dobipro (MX); Easyhaler Beclomethasone (GB, IE); Ecobec (FR); Filair (CN); Miflasone (FR); Nasair (VE); Nasobec Aqueous (HK, KP); Nexxair (FR); Oxiplus (PY, UY); Propavent (AR); Q Var (CR, GT, HN, MY, NZ, PA, PH, SV, TH); Qvar (MX); Qvar Autohaler (AU, FR); Qvar Inhaler (AU); Respocort (MY, NZ, PH); Rhino Clenil (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Rino-Clenil (TH); Viarex (AE, BF, BH, BJ, CI, CY, EG, ET, GH, GM, GN, IL, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZA, ZM, ZW); Viarox (ZA)
Copyright (c) Lexi-Comp, Inc. 1978-2008 All Rights Reserved. Sources : Drug Information Handbook, 17th Edition
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