Corticosteroids (Inhaled)

Beclomethasone dipropionate is NOT indicated for the relief of acute bronchospasm.

CONTRAINDICATIONS
QVAR is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to any of the ingredients of this preparation contraindicates its use.

DOSAGE AND ADMINISTRATION
Patients should prime QVAR by actuating into the air twice before using for the first time or if QVAR has not been used for over 10 days. Avoid spraying in the eyes or face when priming QVAR. QVAR is a solution aerosol, which does not require shaking. Consistent dose delivery is achieved, whether using the 40 or 80 mcg strengths, due to proportionality of the 2 products (i.e., 2 actuations of 40 mcg strength should provide a dose comparable to 1 actuation of the 80 mcg strength).

QVAR should be administered by the oral inhaled route in patients 5 years of age and older. Use of QVAR with a spacer device in children less than 5 years of age is not recommended (see package insert for  PRECAUTIONS, Pediatric Use). The onset and degree of symptom relief will vary in individual patients. Improvement in asthma symptoms should be expected within the first or second week of starting treatment, but maximum benefit should not be expected until 3 to 4 weeks of therapy. For patients who do not respond adequately to the starting dose after 3 to 4 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of QVAR when administered in excess of recommended doses has not been established.

Table 2: Recommended Dosing for Adults and Adolescents:

Table 3: Recommended Dosing for Children 5 to 11 Years:

As with any inhaled corticosteroid, physicians are advised to titrate the dose of QVAR downward over time to the lowest level that maintains proper asthma control. This is particularly important in children since a controlled study has shown that QVAR has the potential to affect growth in children. Patients should be instructed on the proper use of their inhaler.

Patients Not Receiving Systemic Corticosteroids
Patients who require maintenance therapy of their asthma may benefit from treatment with QVAR at the doses recommended above. In patients who respond to QVAR, improvement in pulmonary function is usually apparent within 1 to 4 weeks after the start of therapy. Once the desired effect is achieved, consideration should be given to tapering to the lowest effective dose.

Patients Maintained on Systemic Corticosteroids
QVAR may be effective in the management of asthmatics maintained on systemic corticosteroids and may permit replacement or significant reduction in the dosage of systemic corticosteroids.

The patient's asthma should be reasonably stable before treatment with QVAR is started. Initially, QVAR should be used concurrently with the patient's usual maintenance dose of systemic corticosteroids. After approximately one week, gradual withdrawal of the systemic corticosteroids is started by reducing the daily or alternate daily dose. Reductions may be made after an interval of one or two weeks, depending on the response of the patient. A slow rate of withdrawal is strongly recommended. Generally these decrements should not exceed 2.5 mg of prednisone or its equivalent. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g. joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with the inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly.

During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.

HOW SUPPLIED
QVAR is supplied in 2 strengths:

QVAR 40 mcg is supplied either in a 7.3 g canister containing 100 actuations with a beige plastic actuator and gray dust cap, and Patient's Instructions; box of one; 100 Actuations – NDC 59310-175-40 or in an 8.7 g canister containing 120 actuations with a beige plastic actuator and gray dust cap, and Patient's Instructions; box of one; 120 Actuations – NDC 59310-202-40.

QVAR 80 mcg is supplied either in a 4.2 g canister, for Institutional Use, containing 50 actuations with a dark mauve plastic actuator and gray dust cap, and Patient's Instructions; box of one; 50 actuations – NDC 59310-204-50, a 7.3 g canister containing 100 actuations with a dark mauve plastic actuator and gray dust cap, and Patient's Instructions; box of one; 100 Actuations – NDC 59310-177-80, or in an 8.7 g canister containing 120 actuations with a dark mauve plastic actuator and gray dust cap, and Patient's Instructions; box of one; 120 Actuations – NDC 59310-204-80.

The correct amount of medication in each inhalation cannot be assured after 50 actuations from the 4.2 g canister, 100 actuations from the 7.3 g canister or 120 actuations from the 8.7 g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.

Store QVAR Inhalation Aerosol when not being used, so that the product rests on the concave end of the canister with the plastic actuator on top.

Store at 25°C (77°F).

Excursions between 15° and 30°C (59° and 86°F) are permitted (see USP). For optimal results, the canister should be at room temperature when used. QVAR Inhalation Aerosol canister should only be used with the QVAR Inhalation Aerosol actuator and the actuator should not be used with any other inhalation drug product.

The recommended starting dose and the highest recommended dose of PULMICORT TURBUHALER, based on prior asthma therapy, are listed in the following table.

*In patients with mild to moderate asthma who are well controlled on inhaled corticosteroids, dosing with PULMICORT TURBUHALER 200 mcg or 400 mcg once daily may be considered. PULMICORT TURBUHALER can be administered once daily either in the morning or in the evening.

If the once-daily treatment with PULMICORT TURBUHALER does not provide adequate control of asthma symptoms, the total daily dose should be increased and/or administered as a divided dose.

 Patients Maintained on Chronic Oral Corticosteroids
Initially, PULMICORT TURBUHALER should be used concurrently with the patient’s usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. The next reduction is made after an interval of one or two weeks, depending on the response of the patient. Generally, these decrements should not exceed 2.5 mg of prednisone or its equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oral corticosteroids, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency (see WARNINGS). During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, eg, joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with PULMICORT TURBUHALER but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly. During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.

NOTE: In all patients it is desirable to titrate to the lowest effective dose once asthma stability is achieved.

HOW SUPPLIED
PULMICORT TURBUHALER consists of a number of assembled plastic details, the main parts being the dosing mechanism, the storage unit for drug substance and the mouthpiece. The inhaler is protected by a white outer tubular cover screwed onto the inhaler. The body of the inhaler is white and the turning grip is brown. The following wording is printed on the grip in raised lettering, “Pulmicort™ 200 mcg”. The TURBUHALER inhaler cannot be refilled and should be discarded when empty.

PULMICORT TURBUHALER is available as 200 mcg/dose, 200 doses

ALVESCO is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION
FOR ORAL INHALATION ONLY

DOSAGE FORMS AND STRENGTHS
Inhalation Aerosol 80 mcg /actuation or 160 mcg /actuation

Aerospan is NOT indicated for the relief of acute bronchospasm or in children less than 6 years of age.

DOSAGE AND ADMINISTRATION
For oral inhalation only. Inhaler includes a built-in spacer. Do not use with external spacers or holding chambers.

Adults and adolescents (≥ 12 years): The recommended starting dose is 160 mcg twice daily. Do not exceed 320 mcg twice daily.

Children (6 - 11 years): The recommended starting dose is 80 mcg twice daily. Do not exceed 160 mcg twice daily. Administer under adult supervision.

DOSAGE FORMS AND STRENGTHS
Inhalation Aerosol, 60 or 120 metered 80 mcg-doses

FLOVENT HFA is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

DOSAGE FORMS AND STRENGTHS
Inhalation aerosol with 44, 110, or 220 mcg per actuation.

Drug UPDATES:  ARNUITY™ ELLIPTA®  (fluticasone furoate inhalation powder) 100 mcg, 200 mcg
[Drug information  /  PDF]    Dosing:  Click links for more info.

Initial U.S. Approval:  2014

Mechanism of Action: Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate. The clinical relevance of these findings is unknown.

The precise mechanism of corticosteroid action on asthma is not known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma.
Though effective for the treatment of asthma, corticosteroids may not affect symptoms immediately. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. When corticosteroids are discontinued, asthma stability may persist for several days or longer.

Trials in subjects with asthma have shown a favorable ratio between topical anti-inflammatory activity and systemic corticosteroid effects with recommended doses of orally inhaled fluticasone furoate. This is explained by a combination of a relatively high local anti-inflammatory effect, negligible oral systemic bioavailability (approximately 1.3%), and the minimal pharmacological activity of the metabolites detected in man.

INDICATIONS AND USAGE:
1.1 Treatment of Asthma
ARNUITY™ ELLIPTA® is indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.

Important Limitation of Use: ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.

HOW SUPPLIED:
Inhalation Powder. Disposable light grey and orange plastic inhaler containing a foil blister strip of powder intended for oral inhalation only. Each blister contains fluticasone furoate 100 or 200 mcg.

INDICATIONS AND USAGE
Treatment of Asthma
ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older.

Important Limitations of Use
ASMANEX TWISTHALER is NOT indicated for the relief of acute bronchospasm.
ASMANEX TWISTHALER is NOT indicated in children less than 4 years of age.

DOSAGE AND ADMINISTRATION
Administer ASMANEX TWISTHALER by the orally inhaled route only. Instruct patients to inhale rapidly and deeply. Advise patients to rinse the mouth after inhalation. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after initiation of treatment. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients =12 years of age who do not respond adequately to the starting dose after 2 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of ASMANEX TWISTHALER when administered in excess of recommended doses have not been established.

Recommended Dosages in Patients 4 Years of Age and Older
The recommended starting doses and highest recommended daily dose for ASMANEX TWISTHALER treatment based on prior asthma therapy are provided in Table 1.

* When administered once daily, ASMANEX TWISTHALER should be taken only in the evening.

† The 440 mcg daily dose may be administered in divided doses of 220 mcg twice daily or as 440 mcg once daily.
‡ For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of ASMANEX TWISTHALER therapy. Monitor patients carefully for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy.

§ Recommended pediatric dosage is 110 mcg once daily in the evening regardless of prior therapy.

For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of ASMANEX TWISTHALER therapy. Patients should be carefully monitored for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency. Once prednisone reduction is complete, the dosage of mometasone furoate should be reduced to the lowest effective dosage.

Instructions for Use
Patients should be instructed to record the date of pouch opening on the cap label and discard the inhaler 45 days after opening the foil pouch or when the dose counter reads "00" and the final dose has been inhaled, whichever comes first. The inhaler should be held upright while removing the cap. The medication should be taken as directed, breathing rapidly and deeply, and patients should not breathe out through the inhaler. The mouthpiece should be wiped dry and the cap replaced immediately following each inhalation and rotated fully until the click is heard. Rinsing of mouth after inhalation is advised. Patients should store the unit as instructed. The dose counter displays the doses remaining. When the dose counter indicates zero, the cap will lock and the unit must be discarded. Patients should be advised that if the dose counter is not working correctly, the unit should not be used and it should be brought to their physician or pharmacist.

DOSAGE FORMS AND STRENGTHS
ASMANEX TWISTHALER is a dry powder for inhalation that is available in 2 strengths.

ASMANEX TWISTHALER 220 mcg delivers 200 mcg mometasone furoate per actuation from the mouthpiece.

ASMANEX TWISTHALER 110 mcg delivers 100 mcg mometasone furoate per actuation from the mouthpiece.