Turkey QVAR ® RediHaler™ differs from conventional metered-dose inhalers (MDIs) as it delivers medication via a breath-actuated MDI, eliminating the need for hand-breath coordination during inhalation. Latvia Slovenia 2001 Talk with your doctor if you think your child is not … Dedicated. South Korea %%EOF Chile Indicated for maintenance treatment of asthma as prophylactic therapyNo prior history of inhaled corticosteroid use: 40-80 mcg inhaled PO q12hr initially; may increase dose if needed; not to exceed 320 mcg BIDPrior history of inhaled corticosteroid use: 40-160 mcg inhaled PO q12hr based on previous inhaled corticosteroid product and disease severity; not to exceed 320 mcg BIDImprovement in pulmonary function is usually apparent within 1-4 weeks after initiation of treatmentLimitations of use: Not indicated for relief of acute bronchospasmIndicated for maintenance treatment of asthma as prophylactic therapy4-11 years: 40 mcg inhaled PO BID for patients with/without prior history of inhaled corticosteroid use; may increase dose for adequate response after ≥2 weeks therapy; not to exceed 80 mcg inhaled BIDMay cause growth velocity reduction with extended use; monitor closely if on prolonged therapy; advise downward dose titration over time to the lowest level that maintains proper asthma controlLimitations of use: Not indicated for relief of acute bronchospasmStart at lower end of dosing range due to increased risk of adverse effectsPsychiatric events and behavioral changes (eg, aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation [primarily in children])Primary treatment of status asthmaticus, acute bronchospasmImmediate hypersensitivity reactions may occur; discontinue beclomethasone inhaler if such reactions occurMay decrease growth velocity in children; titrate dose to the lowest effective dose to relieve signs/symptomsKaposi sarcoma associated with prolonged corticosteroid treatment; if observed, consider discontinuing therapyPsychiatric disturbances reported with corticosteroid use; psychiatric conditions, including depression, euphoria, personality changes, insomnia, and mood swings may be exacerbated by corticosteroid useFollowing initiation of inhaled corticosteroids, rare cases of vasculitis or eosinophilic conditions may occur after decrease and/or withdrawal of oral corticosteroid therapyUse caution in patients with heart failure (long-term use associated with fluid retention), diabetes mellitus (may lead to hyperglycemia), gastrointestinal disease (diverculitis, peptic ulcer, ulcerative colitis due to perforation risk), myasthenia gravis (exacerbation may occur), myocardial infarct (exacerbation of symptoms reported), myocardial infarct (corticosteroids associated with myocardial rupture), ocular disease (routine eye exam recommended), history of seizure disorder (seizures reported with adrenal crisis)Dosage adjustments may be necessary with changes in thyroid status; metabolic clearance of corticosteroids may increase in hyperthyroid patients and decreases in hypothyroid onesThere are no adequate and well-controlled in pregnant women; there are clinical considerations with use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women; available human data do not establish presence or absence of drug- associated risk to fetus; in animal reproduction studies, beclomethasone dipropionate resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or greater than approximately 0.75 times maximum recommended human daily inhalation dose (MRHDID) in adults (0.64 mg/day); in rats exposed to beclomethasone dipropionate by inhalation, dose-related gross injury to fetal adrenal glands was observed at doses greater than 180 times the MRHDID, but there was no evidence of external or skeletal malformations or embryo lethality at inhalation doses up to 440 times the MRHDIDThe risk of complications to mother and developing fetus from inadequate control of asthma must be balanced against risks from exposure to beclomethasone dipropionateThere are no data available on presence in human milk, effects on breastfed child, or on milk production; however, other inhaled corticosteroids have been detected in human milkThe developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from beclomethasone dipropionate or from underlying maternal conditionA: Generally acceptable.