Beclomethasone (Oral Inhalation)

• If you have an allergy to beclomethasone or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This is not a list of all drugs or health problems that interact with beclomethasone.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Redness or white patches in mouth or throat.
• Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped beclomethasone (oral inhalation).
• Change in eyesight.
• This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using this medicine, use a rescue inhaler and get medical help right away.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about beclomethasone, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about beclomethasone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using beclomethasone.

Review Date: October 4, 2017

Within 1 to 2 days in some patients; usually within 1 to 2 weeks; Maximum effect: 3 to 4 weeks

Time to Peak

Plasma: Oral inhalation: BDP: 0.5 hours; 17-BMP: 0.7 hours

Half-Life Elimination

BDP: 0.5 hours; 17-BMP: 2.7 hours

Protein Binding

BDP 87%; 17-BMP: 94% to 96%

Chronic obstructive pulmonary disease (stable) (oral inhalation)

Based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 update to the guidelines for the management of chronic obstructive pulmonary disease (COPD), regular treatment with inhaled corticosteroids improves symptoms, lung function, and quality of life, and reduces frequency of exacerbations in COPD patients with a forced expiratory volume (FEV)1 <60% predicted. Long term treatment with inhaled corticosteroids added to long-acting bronchodilators is recommended for patients with severe and very severe COPD and frequent exacerbations that are not adequately controlled by long-acting bronchodilators. Long-term monotherapy with inhaled corticosteroids is not recommended.

Asthma: Inhalation, oral (doses should be titrated to the lowest effective dose once asthma is controlled):

US labeling:

Patients previously on bronchodilators only: Initial dose 40 to 80 mcg twice daily; maximum dose: 320 mcg twice daily

Patients previously on inhaled corticosteroids: Initial dose 40 to 160 mcg twice daily; maximum dose: 320 mcg twice daily

Canadian labeling:

Mild asthma: 50 to 100 mcg twice daily; maximum dose: 100 mcg twice daily

Moderate asthma: 100 to 250 mcg twice daily; maximum dose: 250 mcg twice daily

Severe asthma: 300 to 400 mcg twice daily; maximum dose: 400 mcg twice daily

Asthma Guidelines:

National Asthma Education and Prevention Program guidelines (NAEPP 2007): HFA inhaler (refers to Qvar 40 mcg and 80 mcg strengths available in US):

“Low” dose: 80 to 240 mcg daily

“Medium” dose: >240 to 480 mcg daily

“High” dose: >480 mcg daily

Global Initiative for Asthma guidelines (GINA 2016): HFA inhaler (refers to Qvar 50 mcg and 100 mcg strengths available in Canada):

“Low” dose: 100 to 200 mcg daily

“Medium” dose: >200 to 400 mcg daily

“High” dose: >400 mcg daily

Conversion: Conversion from oral systemic corticosteroid to orally inhaled corticosteroid: Initiation of oral inhalation therapy should begin in patients whose asthma is reasonably stabilized on oral corticosteroids (OCS). A gradual dose reduction of OCS should begin ~7 days after starting inhaled therapy. US labeling recommends reducing prednisone dose no more rapidly than ≤2.5 mg/day (or equivalent of other OCS) every 1 to 2 weeks. The Canadian labeling recommends decreasing the daily dose of prednisone by 1 mg (or equivalent of other OCS) every 7 days or more in closely monitored patients. If adrenal insufficiency occurs, temporarily increase the OCS dose and follow with a more gradual withdrawal. Note: When transitioning from systemic to inhaled corticosteroids, supplemental systemic corticosteroid therapy may be necessary during periods of stress or during severe asthma attacks.

Chronic obstructive pulmonary disease (stable) (off-label use): Inhalation, oral: 50 to 400 mcg daily in combination with a long-acting bronchodilator (GOLD, 2014).

Refer to adult dosing.

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

Growth (adolescents) and signs/symptoms of HPA axis suppression/adrenal insufficiency; signs/symptoms of oral candidiasis; ocular effects (eg, cataracts, increased intraocular pressure, glaucoma)