Cesonide 80 HFA Inhaler

Cesonide 80 HFA Inhaler is used for: Asthma, seasonal allergic rhinitis, perennial allergic rhinitis

Inhalation Asthma, Prophylaxis Adult: Who received bronchodilators alone Recommended Starting Dose 80 mcg twice daily Highest Recommended Dose 160 mcg twice daily Who received inhaled corticosteroids Recommended Starting Dose 80 mcg twice daily Highest Recommended Dose 320 mcg twice daily Who received oral corticosteroids (oral corticosteroids prednisone should be reduced gradually, no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with Ciclesonide.) Recommended Starting Dose 320 mcg twice daily Highest Recommended Dose 320 mcg twice daily Nasal Spray: 1 spray (50 micrograms/spray) in each nostril once a day. The maximum total daily dosage should not exceed 2 sprays in each nostril (200 micrograms/day).

Inhalation Asthma, Prophylaxis Adult: Patients > 12 years who received bronchodilators alone Recommended Starting Dose 80 mcg twice daily Highest Recommended Dose 160 mcg twice daily Patients > 12 years who received inhaled corticosteroids Recommended Starting Dose 80 mcg twice daily Highest Recommended Dose 320 mcg twice daily Patients >12 years who received oral corticosteroids (oral corticosteroids prednisone should be reduced gradually, no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with Ciclesonide.) Recommended Starting Dose 320 mcg twice daily Highest Recommended Dose 320 mcg twice daily Nasal Spray: 1 spray (50 micrograms/spray) in each nostril once a day. The maximum total daily dosage should not exceed 2 sprays in each nostril (200 micrograms/day).

Gently shake and prime nasal spray by actuating 3 times before using for the first time or when not in use for 4 consecutive days

Patients with status asthmaticus or other acute episodes of asthma where intensive measures are required. Patients with a known hypersensitivity to ciclesonide or any of the ingredients

Candida albicans infection of the mouth and pharynx. Advise patients to rinse mouth following inhalation. Potential worsening of existing tuberculosis: fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with above because of the potential for worsening of these infections. Risk of impaired adrenal function when transferring from oral steroids to inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Ciclesonide. Hypercorticism, suppression of hypothalamic-pituitary-adrenal (HPA) function with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Ciclesonide slowly Suppression of growth in children. Monitor growth routinely in pediatric patients receiving Ciclesonide. Development of glaucoma, increased intraocular pressure and posterior subcapsular cataracts. Monitoring Parameters Monitor patients periodically for signs of adverse effects on the oral cavity. Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely. Monitor growth of pediatric patients receiving this medication routinely (eg, via stadiometry); to minimize systemic effects of orally inhaled corticosteroids, including this medication, titrate each patient’s dose to lowest dosage that effectively controls his/her symptoms.

Pregnancy There are no available data on use in pregnant women to assess drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there is low systemic exposure following administration at recommended dose In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control Animal data In animal reproduction studies, drug administered by oral route to pregnant rats during period of organogenesis did not cause any evidence of fetal harm at doses up to 15 times maximum recommended human daily oral inhalation dose (MRHDOID) Teratogenicity, characteristic of corticosteroids, decreased body weight, and/or skeletal variations were observed in rabbit fetuses following administration of ciclesonide to pregnant rabbits by subcutaneous route during period of organogenesis at doses 0.15 times MRHDOID and higher on mcg/m2 basis; no evidence of fetal harm observed in rabbits at doses of 0.03 times MRHDOID Lactation There are no data on presence of the drug or its metabolite in human milk, effects on breastfed infant, or milk production; not known whether oral inhalation administration of this drug at recommended dose could result in sufficient systemic absorption to produce detectable quantities in human milk The molecular weight of the prodrug ciclesonide (approximately 541 g/mol) is small enough to be excreted into breast milk; however, its high plasma protein binding affinity and very short half-life suggests that minimal amounts will be present within the milk Conversely, the half-life of the active metabolite des-ciclesonide (approximately 471 g/mol) suggests that exposure to the nursing infant will be greater than that of the prodrug ciclesonide; although ciclesonide and des-ciclesonide have negligible oral bioavailability (both less than 1% for each) due to low gastrointestinal absorption and high first-pass metabolism, the relative anti-inflammatory activity of des-ciclesonide is 120 times greater than that of ciclesonide and 12 times greater than that of dexamethasone; the effects of this exposure on a nursing infant are unknown, however, like all corticosteroids, suppression of HPA function is a potential complication Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy, and any potential adverse effects on breastfed infant from therapy, or from underlying maternal condition

Increased ciclesonide concentrations with concomitant ketoconazole, itraconazole, ritonavir, nelfinavir or other potent CYP3A4 inhibitors. Contraindicated (0) Serious (3) apalutamide lonafarnib tucatinib

Side effects of Ciclesonide : Inhalation >10% Headache (11%),Nasopharyngitis (11%) 1-10% Epistaxis (4.9%),Ear pain (2.2%),Facial edema (3%),Urticaria (3%),Oral candidiasis (3%),Back pain (3%),Extremety pain (3%),Conjunctivitis (3%),Upper respiratory infection (9%),Gastroenteritis (3%),Sinusitis (3%) Nasal spray 1-10% Headache (3.1-6.6%),Epistaxis (2.9-6%),Nasopharyngitis (3.7%),Nasal discomfort (3.2%),Ear pain (2.2%)

Ciclesonide, an inhaled corticosteriod, is converted by esterases in the lungs to the active metabolite, desisobutyryl-ciclesonide, which has anti-inflammatory activity.

Cesonide 80 HFA 80mcg Inhaler manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Ciclesonide. Cesonide 80 HFA is availble in Bangladesh. Farmaco BD drug index information on Cesonide 80 HFA Inhaler is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.