Beclomethasone Dipropionate Inhaler is used in the treatment of allergic/ inflammatory airway diseases such as asthma and COPD.

Indications of Beclomethasone Dipropionate Inhaler:

• Asthma:

  • It is indicated for the maintenance and prophylactic treatment of asthma in patients  ≥4 years of age (QVAR RediHaler).
  • Limitations of use: Not for relief of acute bronchospasm.

Guideline recommendations:

• In children, adolescents, and adult patients with persistent asthma who are candidates for treatment according to a step-wise treatment approach, a low-dose inhaled corticosteroid (in addition to an as-needed short-acting beta -agonist) is the initial preferred long-term control medication.

• Off Label Use of Beclomethasone Dipropionate Inhaler in Adults:

  • Stable Chronic obstructive pulmonary disease.

Beclomethasone Dipropionate Inhaler dose in adults:

Note: Once asthma is controlled,titration to the lowest effective dose should be done.

Beclomethasone Dipropionate Inhaler dose in Asthma: Oral inhalation:

Note:

• In patients with mild to moderate asthma with a mild flare in symptoms,quadruple dose can be used temporarily in order to decrease the severity and duration of asthma exacerbation.
• Patients with good self-management and no prior history of fatal asthma exacerbations should be treated with this approach.
• Once symptoms are resolved or a maximum of 14 days of the quadrupled dose is given, dose should be titrated.

• US labeling: Metered-dose inhaler:

  • QVAR/ QVAR RediHaler:

Note: Dosing based on previous asthma therapy and asthma severity. In patients with uncontrolled symptoms despite 2 weeks of therapy, the dose should be increased.

• Patients not currently on inhaled corticosteroids:

  • Initial: 40 to 80 mcg twice daily.
  • maximum:320 mcg twice daily.

• Patients previously on inhaled corticosteroids:

  • Initial: 40 to 320 mcg twice daily.
  • Maximum: 320 mcg twice daily.

• Canadian labeling: Metered-dose inhaler:

  • Mild asthma:

    • 50 to 100 mcg twice daily.
    • maximum dose of 100 mcg twice daily.

  • Moderate asthma:

    • 100 to 250 mcg twice daily.
    • maximum dose of 250 mcg twice daily.

  • Severe asthma:

    • 300 to 400 mcg twice daily.
    • maximum dose of 400 mcg twice daily.

• Asthma Guidelines (Beclomethasone Dipropionate Inhaler dose):

  • National Asthma Education and Prevention Program guidelines: Metered dose inhaler:

    • Low-dose therapy: 80 to 240 mcg/day.
    • Medium-dose therapy: >240 to 480 mcg/day.
    • High-dose therapy: >480 mcg/day.

  • Global Initiative for Asthma guidelines: Metered-dose inhaler:

    • Low-dose therapy: 100 to 200 mcg/day.
    • Medium-dose therapy: >200 to 400 mcg/day.
    • High-dose therapy: >400 mcg/day.

Beclomethasone Dipropionate Inhaler dose in stable Chronic obstructive pulmonary disease (off label): Oral inhalation:

• 50 to 400 mcg daily in combination with a long-acting bronchodilator.

Beclomethasone Dipropionate Inhaler dose in children:

Note: Once symptoms are controlled, doses should be titrated to the lowest effective dose.

Beclomethasone Dipropionate Inhaler Dose in the maintenance therapy of Asthma:

Manufacturer's labeling (Qvar):

• Children 5 to 11 years:

  • Initial: 40 mcg twice daily.
  • maximum: 80 mcg twice daily.

• Children ≥12 years and Adolescents:

  • No previous inhaled corticosteroids:

    • Initial: 40 to 80 mcg twice daily.
    • maximum: 320 mcg twice daily.

  • Previous inhaled corticosteroid use:

    • Initial: 40 to 160 mcg twice daily.
    • maximum:320 mcg twice daily.

Note: Therapeutic ratio between Qvar and other beclomethasone inhalers (eg, CFC formulations; however, none are currently available in US) has not been established.

The alternate dosing of Beclomethasone Dipropionate Inhaler: NIH Asthma Guideline: HFA formulation (Qvar):

• Children 5 to 11 years: Administer in divided doses:

  • "Low" dose: 80 to 160 mcg/day (40 mcg/puff: 2 to 4 puffs/day or 80 mcg/puff: 1 to 2 puffs/day).
  • "Medium" dose: >160 to 320 mcg/day (40 mcg/puff: 4 to 8 puffs/day or 80 mcg/puff: 2 to 4 puffs/day).
  • "High" dose: >320 mcg/day (40 mcg/puff: >8 puffs/day or 80 mcg/puff: >4 puff/day).

• Children ≥12 years and Adolescents:

  • "Low" dose: 80 to 240 mcg/day (40 mcg/puff: 2 to 6 puffs/day or 80 mcg/puff: 1 to 3 puffs/day).
  • "Medium" dose: >240 to 480 mcg/day (40 mcg/puff: 6 to 12 puffs/day or 80 mcg/puff: 3 to 6 puffs/day).
  • "High" dose: >480 mcg/day (40 mcg/puff: >12 puffs/day or 80 mcg/puff: 6 puffs/day).

Canadian labeling: Metered-dose inhaler:

• Children 5 to 11 years:

  • Initial: 50 mcg twice daily.
  • maximum:100 mcg twice daily.

• Children ≥12 years of age and Adolescents:

  • Mild asthma: 50 to 100 mcg twice daily to a maximum dose of 100 mcg twice daily.
  • Moderate asthma: 100 to 250 mcg twice daily to a maximum dose of 250 mcg twice daily.
  • Severe asthma: 300 to 400 mcg twice daily to a maximum dose of 400 mcg twice daily.

Conversion from oral systemic corticosteroid to orally inhaled corticosteroid:

• Patients whose asthma is controlled on oral corticosteroids can be switched to oral inhalation therapy
• Oral steroids should be reduced gradually 7 days after starting inhaled therapy.
• US labeling recommends reducing prednisone dose no more rapidly than ≤5 mg/day (or the equivalent of other OCS) every 1 to 2 weeks in adolescents or adults.
• Oral steroids should be increased temporarily and gradually withdrawn in case of adrenal insufficiency.

Note: Supplemental systemic corticosteroid therapy is required during stress or severe asthma attacks while switching from oral to inhalation therapy.

Beclomethasone Dipropionate Inhaler Pregnancy Risk Category: B3

• If asthma is not controlled, there are many adverse events that can happen during pregnancy.
• Poorly controlled asthma and asthma exacerbations increase the risk of maternal/fetal harm.
• Inhaled corticosteroids can be used to treat asthma in pregnant women.
• If symptoms are under control during pregnancy, beclomethasone may be continued.
• When starting treatment for pregnancy, it is preferable to use an agent who has more data on pregnant women.

Use of a Beclomethasone Dipropionate inhaler during breastfeeding

• It is unknown if beclomethasone secretion occurs in breast milk when it is administered via inhalation.
• Breastfeeding can be assisted by inhalational steroids
• According to the manufacturer's instructions, the decision about whether to continue or stop breastfeeding during therapy is based on the risks of infant exposure, the benefits to the infant and the benefits to the mother.
• Breastfeeding should be encouraged for women with asthma.

Dose adjustment in kidney disease:

There are no dosage adjustments provided in the manufacturer's labeling.

Dose adjustment in liver disease:

There are no dosage adjustments provided in the manufacturer's labeling.

Common Side Effects Of Beclomethasone Dipropionate Inhaler:

• Central nervous system:

  • Headache

• Respiratory:

  • Pharyngitis

Rare Side Effects Of Beclomethasone Dipropionate Inhaler:

• Central Nervous System:

  • Pain
  • Voice Disorder

• Gastrointestinal:

  • Oral Candidiasis
  • Vomiting
  • Diarrhea
  • Nausea

• Genitourinary:

  • Dysmenorrhea
  • Viral Gastroenteritis

• Infection:

  • Influenza

• Neuromuscular & Skeletal:

  • Back Pain
  • Myalgia

• Otic:

  • Otitis

• Respiratory:

  • Nasopharyngitis
  • Upper Respiratory Tract Infection
  • Cough
  • Viral Upper Respiratory Tract Infection
  • Oropharyngeal Pain
  • Sinusitis
  • Allergic Rhinitis

• Miscellaneous:

  • Fever

Contraindications to Beclomethasone Dipropionate Inhaler:

• Hypersensitivity to beclomethasone and any component of the formulation
• Status asthmaticus or other acute episodes of asthma that require intensive treatment
• There is not much evidence of cross-reactivity between corticosteroids and allergenic corticosteroids. 
• Cross-sensitivity is possible due to similarities in chemical structure or pharmacologic effects.

Canadian labeling. Additional contraindications (not in US labels)

• Untreated fungal, tubercular, or bacterial infections of the respiratory system
• Intense treatment is required for moderate to severe bronchiectasis.

Warnings and precautions

• Suppression of the adrenals:

  • Patients using higher doses for longer duration and children can experience hypercortisolism or suppression of the hypothalamic-pituitary-adrenal (HPA) axis which can result in an adrenal crisis.
  • It is important to gradually discontinue corticosteroids with caution.
  • When patients are switched from systemic corticosteroids and inhaled products, which can lead to adrenal insufficiency, it can cause life-threatening complications.
  • During withdrawal from steroids, you may experience an increase in allergy symptoms.
  • Prednisone may make adult patients more susceptible if they are taking >=20mg of prednisone daily (or an equivalent).
  • Patients with trauma, surgery, infections (especially gastroenteritis), and other conditions that involve severe electrolyte loss, inhalational steroids, are not recommended for treatment.
  • Patients who have received prolonged inhalational steroids at high doses should receive intravenously administered hydrocortisone. The dose should be reduced within 24 hours.

• Bronchospasm

  • Inhalational steroids may cause fatal paradoxical bronchospasm. This should be distinguished from an inadequate response.
  • In such cases, beclomethasone withdrawal and alternative therapy initiation are required.

• Hypersensitivity reactions

  • Steroids can cause hypersensitivity reactions, such as angioedema and bronchospasm. It is important to stop using them.

• Immunosuppression:

  • Acute infections, such as fungal infections, might be concealed by secondary infections, and long-term steroid medication can lessen the immune system's reaction to vaccinations.
  • Patients with active or quiescent respiratory tubeerculosis, ocular herpes, or untreated viral or fungal, parasitic or bacterial systemic infections are not advised to use this medication.
  • If the patient has had chickenpox or the measles, varicella-zoster immunoglobulin prophylaxis (or pooled intramuscular immunoglobulin) may be advised.
  • In the event of chickenpox, antiviral therapy may be required.

• Oral candidiasis:

  • Inhalational steroids may cause local oropharyngeal Candida Albicansinfections. These should be treated as part of ongoing therapy.
  • It is recommended that you rinse your mouth with water after every use.

• Asthma

  • During severe asthma attacks or times of stress, additional oral or systemic steroid may be necessary.
  • Short-acting betaagonists can be used to manage acute symptoms or symptoms that occur between treatments.
  • In severe asthma episodes, or when there is a history of asthmaticus, it is not recommended to use this medication.

• Bone mineral density:

  • Long-term steroids can cause a decrease in bone mineral density.
  • Extended immobilization, family history and osteoporosis are all risk factors. Also, it is important to be cautious when using anticonvulsants or oral corticosteroids, which can lower bone mass.

• Ocular disease:

  • Steroid therapy long-term can lead to cataracts, glaucoma and blurred vision.
  • It is important to exercise caution and have routine eye exams.

Monitoring parameters:

• Pulmonary function tests including FEV, peak flow
• Growth (adolescents and children via stadiometry)
• Signs/symptoms of HPA axis suppression/adrenal insufficiency
• Bone mineral density
• Symptoms of asthma
• Signs/symptoms of oral candidiasis
• Cataract, glaucoma
• Possible eosinophilic conditions (such as Churg-Strauss syndrome)

How to administer Beclomethasone Dipropionate Inhaler?

Oral inhalation:

• Metered-dose inhaler:
  • It should not be shaken before use.
  • Avoid spraying in the face or eyes.
  • The mouth should be rinsed with water (without swallowing) after each use.
  • The mouthpiece may be cleaned with a dry tissue or cloth, it should not be washed with water. Discard the inhaler when the dose counter displays "0".

QVAR:

• Prime canister by spraying twice into the air prior to initial use or if not in use for >10 days.
• Immediate inhalation is required in patients using a spacer due to the decreased amount of medication that is delivered with a delayed inspiration.

QVAR RediHaler:

• Inhaler device is breath-actuated;
• does not require priming before use.
• During storage, the white cap on the inhaler must remain closed.
• The white cap must be closed before the next inhalation if more than 1 inhalation is needed per dose.
• If the white cap has been opened for >2 minutes or left in the open position, it should be closed to prepare the inhaler, and the dose counter should be checked to make sure the inhaler is not empty.
• Never breathe out into the inhaler mouthpiece.
• It should not be used with a spacer or volume-holding chamber.

Mechanism of action of Beclomethasone Dipropionate:

• It can control the rate of protein synthesizing. 
• It reduces inflammation by inhibiting the migration polymorphonuclear lymphocytes and fibroblasts.
• This reverses the capillarypermeability and lysosomal stability at the cellular level.

The beginning of action:

• Some patients may be discharged within 1 to 2 days.
• Usually within one to two weeks
• Maximum effect: 3-4 weeks

Absorption:

• Readily; quickly hydrolyzed by pulmonary esterases to an active metabolite (beclomethasone-17-monopropionate [17-BMP]) during absorption.

Protein binding:

• BDP 87%; 17-BMP: 94% to 96%.

Metabolism:

• BDP is a pro-drug (inactive);
• It undergoes rapid conversion to 17-BMP during absorption; followed by additional metabolism via CYP3A4 to other, less active metabolites (beclomethasone-21-monopropionate [21-BMP] and beclomethasone [BOH]).

Half-life elimination:

• QVAR: BDP: 0.5 hours; 17-BMP: 2.8 hours.
• RediHaler: BDP: 2 minutes; 17-BMP: 4 hours.

Time to peak plasma: Inhalation:

• QVAR: BDP: 0.5 hours; 17-BMP: 0.7 hours.
• RediHaler: BDP: 2 minutes; 17-BMP: 10 minutes.

Excretion:

• Primary route of excretion is via feces (60%);
• <10% to 12% of the oral dose excreted in urine as metabolites.

International Brands of Beclomethasone Dipropionate Inhaler:

• AeroBec
• Aerocort
• Aerovent
• Asmabec Clickhaler
• Beclasone
• Beclate Aquanase
• Beclazone
• Beclo-Asma
• Beclod
• Becloforte
• Beclohale
• Beclomet
• Beclomin
• Beclone
• Beclophar
• Beclosone Forte
• Beclotis
• Beconase
• Becotide
• Beklofort Evohaler
• Bekotid Evohaler
• Bemedrex
• Bronconox
• Bronconox
• Forte
• Clenil
• Clenil Forte
• Destap FS
• Eclosynt
• Ecobec
• Ibicar
• Meclonate
• Propavent
• Qvar
• Respocort
• Steradin HFA
• Ventolair

Beclomethasone Dipropionate Brands in Pakistan: