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Beclomethasone Dipropionate

Pronunciation

Pronunciation: BE-kloe-METH-a-sone dye-PROE-pee-oh-nate
Class: Corticosteroid

Trade Names

Beconase AQ
- Suspension, intranasal 42 mcg/actuation

Qnasl
- Solution, intranasal 80 mcg/actuation

QVAR
- Aerosol, oral inhalation 40 mcg/actuation
- Aerosol, oral inhalation 80 mcg/actuation

Apo-Beclomethasone (Canada)
Gen-Beclo AQ (Canada)
Propaderm (Canada)
ratio-Beclomethasone AQ (Canada)
Rivanase AQ (Canada)

Pharmacology

Has potent anti-inflammatory effect on respiratory tract and in nasal passages.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Pharmacokinetics

Absorption

Rapidly absorbed.

Nasal inhalation

Primarily deposited in the nasal passage; majority of the drug is eventually swallowed. Bioavailability following administration is 44% ( Beconase AQ ).

Oral inhalation

Systemic bioavailability from lungs is about 20%.

Distribution

87% protein bound (94% to 96% for beclomethasone 17-monoprionate).

Metabolism

Metabolized to beclomethasone 17-monopropionate (active) and free beclomethasone (very weak activity).

Elimination

Primarily excreted in feces. Less than 10% excreted in urine. The half-life is 2.8 h for beclomethasone 17-monopropionate.

Onset

Within 24 h (oral inhalation). Within 3 days (nasal inhalation)

Indications and Usage

Nasal inhalation

Relief of symptoms of seasonal or perennial allergic and nonallergic rhinitis ( Beconase AQ ); for the treatment of the nasal symptoms associated with seasonal and perennial allergic rhinitis ( Qnasl ); prevention of recurrence of nasal polyps following surgical removal ( Beconase AQ ).

Oral inhalation ( QVAR )

Maintenance prophylactic treatment of asthma in patients 5 y and older; asthma patients who require systemic corticosteroid administration, where adding an inhaled corticosteroid may reduce or eliminate need for systemic corticosteroids.

Contraindications

Nasal inhalation

Hypersensitivity to any component of the product.

Oral inhalation

Primary treatment of status asthmaticus or acute episodes of asthma; hypersensitivity to any of the ingredients.

Dosage and Administration

Bronchial Asthma
Adults and children 12 y and older

PO Oral inhalation If previous therapy consisted of bronchodilators alone, start with 40 or 80 mcg twice daily (max dose, 320 mcg twice daily); if previous therapy consisted of inhaled corticosteroids, start with 40 to 160 mcg twice daily (max dosage, 320 mcg twice daily).

Children 5 to 11 y of age

PO Oral inhalation If previous therapy consisted of bronchodilators alone or inhaled corticosteroids, start with 40 mcg twice daily (max dosage, 80 mcg twice daily).

Nasal Polyps/Rhinitis ( Beconase AQ )
Adults and children 12 y and older

Nasal inhalation 1 or 2 inhalations in each nostril twice daily.

Children 6 to 12 y of age

Nasal inhalation 1 inhalation in each nostril twice daily. Patients not adequately responding or those with more severe symptoms may use 2 inhalations in each nostril twice daily. Once adequate control is achieved, decrease dose to 1 inhalation in each nostril twice daily. Maximum total daily dosage should not exceed 2 sprays in each nostril twice daily.

Rhinitis ( Qnasl )
Adults and children 12 y and older

Nasal inhalation 2 sprays in each nostril once daily; max of 4 sprays/day.

General Advice

  • If patient is also receiving a bronchodilator by inhalation, administer bronchodilator 5 min before beclomethasone to enhance penetration of latter drug into bronchial tree.
  • Nasal inhalation
  • For intranasal use only; avoid spraying in the eyes.
  • If excessive nasal mucous secretions or edema are present, nasal inhalation may not reach intended site of action. In such cases, it may be necessary to use a nasal vasoconstrictor during the first 2 or 3 days of therapy with nasal spray.
  • Beconase AQ should be shaken well before use.
  • Both products require priming prior to first use; see manufacturer package insert for instructions.
  • Oral inhalation
  • Have patient place inhaler in mouth and close lips around mouthpiece, keeping tongue below mouthpiece. Tilt patient's head back slightly. Instruct patient to take a slow, deep breath while inhaler is being activated and to hold breath for 5 to 10 sec, and then breathe out slowly. A spacing device (eg, Aerochamber ) may be used to enhance delivery of medication. Have patient rinse mouth after inhalations are complete.
  • The aerosol is for oral inhalation only. Avoid spraying into the nose or eyes.
  • Aerosol does not need to be shaken before use.
  • Test aerosol by spraying 2 times into the air before using the first time and/or when the inhaler has not been used for more than 10 days.

Storage/Stability

Nasal inhalation

Store between 59° and 86°F.

Oral inhalation

Store at 59° to 86°F on the concave end of the canister with the plastic actuator on top. For optimal results, canister should be at room temperature when used. Do not use actuator with any other inhalation drug product. Do not puncture canister or use near heat or open flame or discard into fire or incinerator.

Drug Interactions

None well documented.

Adverse Reactions

CNS

Nasal inhalation

Headache, light-headedness (less than 5%).

Oral inhalation

Headache (at least 3%).

EENT

Nasal inhalation

Nasopharyngeal irritation (24%); nasal discomfort (5%); sneezing attacks (4%); nasal stuffiness, nosebleeds, rhinorrhea, tearing eyes (less than 3%); dryness, irritation of the nose and throat, unpleasant taste and smell; cataracts, glaucoma, loss of taste and smell, nasal septal perforation (postmarketing).

Oral inhalation

Pharyngitis, rhinitis, sinusitis (at least 3%).

GI

Nasal inhalation

Nausea (less than 5%).

Oral inhalation

Nausea (at least 3%).

Genitourinary

Oral inhalation

Dysmenorrhea (1% to 3%).

Metabolic

Suppression of hypothalamic-pituitary-adrenal (HPA) function.

Respiratory

Oral inhalation

Increased asthma symptoms, upper respiratory tract infections (at least 3%); coughing (1% to 3%).

Miscellaneous

Growth velocity reduction in children; rare cases of immediate and delayed hypersensitivity reaction with angioedema, bronchospasm, rash, and urticaria; weight gain.

Oral inhalation

Back pain, dysphonia, oral symptoms, pain (at least 3%).

Precautions

Monitor

If change is made from systemic (oral) corticosteroids to inhaled or intranasal corticosteroids, observe patient carefully for signs of adrenal insufficiency (eg, depression, dizziness, fatigue, hypotension, nausea, or abdominal, joint, or muscle pain). If nasal spray is used for several months or longer, periodically examine for changes in the nasal mucosa and for evidence of Candida albicans infection. Routinely monitor growth of pediatric patients. Closely monitor patients with a change in vision or with a history of increased IOP, glaucoma, or cataracts.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy in children younger than 5 y not established (oral inhalation). Safety and efficacy in children younger than 6 y not established ( Beconase AQ ). Safety and efficacy in children younger than 12 y not established ( Qnasl ). Corticosteroids may suppress growth in children and adolescents, particularly with higher doses over extended periods.

Hypersensitivity

Hypersensitivity reactions, including anaphylaxis, urticaria, angioedema, and rash, have been reported.

Special Risk Patients

Use with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex.

Acute asthma

Not indicated for relief of bronchospasm.

Fungal infections

Antifungal treatment or discontinuance of corticosteroid therapy may be necessary.

Immunosuppression

Patients receiving immunosuppressant agents are more susceptible to infections than healthy adults. If a patient is exposed to measles or chickenpox, appropriate prophylaxis and treatment may be indicated.

Local effects

Candida infection of the nose and pharynx, epistaxis, nasal septum perforation, and nasal ulceration have been reported with the use of beclomethasone nasal inhalation.

Ophthalmic effects

Glaucoma and/or cataracts may occur.

Systemic effects

Use cautiously in patients taking daily or alternate-day prednisone; may increase likelihood of HPA function suppression. Exceeding recommended dose may cause systemic effects.

Transfer

Use extreme caution when transferring patient from a systemic corticosteroid to a less systemically available inhaled corticosteroid because death caused by adrenal insufficiency has occurred in asthmatic patients.

Wheezing

Reported rarely with intranasal use.

Wound healing

Patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

Overdosage

Symptoms

Adrenal suppression, hypercorticism.

Patient Information

  • Advise patients to read the patient information leaflet before starting therapy and again with each refill.
  • Warn patients that QVAR is an asthma controller and is not to be used to treat an acute asthma attack. Patients must use rescue medication (bronchodilator) to obtain rapid relief of asthma symptoms.
  • Instruct patients to carry medical identification (eg, card, bracelet) if experiencing acute, severe asthma attacks requiring rapid systemic treatment.
  • Advise patients to continue taking other medications for asthma as prescribed by health care provider.
  • Review proper administration technique. Have patient demonstrate technique.
  • Advise patients to rinse mouth with water after inhalations are complete. Instruct patients to spit rinse water out and not to swallow it.
  • Advise patients to report the following symptoms to health care provider: cough, dry mouth, facial swelling, rash, sore throat or mouth, worsening asthma symptoms (increasing need for bronchodilator).
  • Advise patients to notify health care provider if oral, nasal, or pharyngeal irritation occurs, or if symptoms worsen.
  • Advise patients that dose may be changed periodically depending on how well symptoms are controlled.
  • Instruct patients not to exceed prescribed dose.
  • Explain that effects of drug are not immediate. Benefit requires daily use as instructed and usually occurs after 1 to 2 days, but full relief may take 1 to 2 wk.
  • Instruct patients not to stop the medication once symptoms have been controlled. Continued daily use is necessary to control symptoms.
  • Advise patients to use nasal spray at regular intervals because effectiveness depends on regular use.
  • Advise patients not to increase dose on their own and to inform health care provider if symptoms do not improve or if they worsen.
  • If patient is being converted from oral corticosteroids to inhaled corticosteroids, review signs and symptoms of adrenal insufficiency, which may occur days or weeks after conversion is complete. Advise patient to carry medical identification (eg, card, bracelet) indicating that supplemental systemic corticosteroids may be needed during periods of stress or a severe asthma attack.
  • Advise patients to discard the aerosol canister when the labeled number of doses has been used.
  • Advise patients to avoid exposure to chickenpox and measles and to seek medical advice immediately if exposed. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
  • Advise patients to inform health care provider if there are any changes in vision during treatment.

Copyright © 2009 Wolters Kluwer Health.

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