Neotison 100 Convicap

Indicated for maintenance treatment of, asthma, as prophylactic therapy

Inhaled Administration For oral inhalation only Rinse mouth with water and expectorate after each dose to prevent oral/esophageal candidiasis

Inhalation Asthma prophylaxis Adult: As fluticasone furoate dry powd inhaler: 100-200 mcg once daily. Starting dose is based on asthma severity Recommended starting dose: 100 mcg/day May increase to 200 mcg/day after 2 weeks if patient does not respond to 100 mcg/day Not to exceed 200 mcg qDay Hepatic impairment Mild: No dosage adjustment required Moderate-to-severe: Caution advised; monitor patients for corticosteroid-related adverse effects

Asthma Indicated for once-daily maintenance treatment of asthma as prophylactic therapy in children aged >5 years <5 years: Safety and efficacy not established 5-11 years: 50 mcg inhaled PO qDay >12 years 1 inhalation PO qDay; not to exceed 1 inhalation every 24 hr Starting dose is based on asthma severity Recommended starting dose: 100 mcg/day May increase to 200 mcg/day after 2 weeks if patient does not respond to 100 mcg/day Not to exceed 200 mcg qDay

Renal impairment (all severities): No dosage adjustment required

Status asthmaticus or other acute episodes of asthma Hypersensitivity, including severe allergy to milk protein

Fluticasone utilises a fluorocarbothioate ester linkage at the 17 carbon position. It has potent vasoconstrictive and anti-inflammatory activity, but weak hypothalamic-pituitary-adrenal (HPA) inhibitory effect when applied topically.

Localized infections of the mouth and pharynx with Candida albicans reported with inhaled corticosteroids Not indicated for use as rescue therapy for acute bronchospasm Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex; more serious or even fatal course of chickenpox or measles in susceptible patients; use caution because of potential for worsening of these infections; if exposed to chickenpox, prophylaxis with varicella-zoster immune globulin or pooled IV immunoglobulin may be indicated; if a patient is exposed to measles, prophylaxis with pooled IM immunoglobulin (IG) may be indicated Caution when withdrawing from systemic corticosteroids and transferring to inhaled corticosteroids; taper systemic corticosteroids gradually and monitor for symptoms of HPA axis suppression and adrenal insufficiency; prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy Systemic absorption from inhaled corticosteroids is low, but hypercorticism and adrenal suppression may occur with very high dosages or at regular dosage in susceptible individuals; if changes occur, discontinue therapy slowly Long-term use decreases bone mineral density; patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care May cause reduction in growth velocity when administered to children and adolescents Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, impaired wound healing; monitor patients periodically for signs of adverse effects on nasal mucosa; avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma Lactation No information is available on the presence of fluticasone furoate in human milk, the effects on the breastfed child, or the effects on milk production Low concentrations of other inhaled corticosteroids have been detected in human milk The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child from fluticasone furoate or from the underlying maternal condition

>10% Nasopharyngitis (8-13%) Headache (6-13%) 1-10% Bronchitis (4-7%) Sinusitis (4-7%) Influenza (4-7%) Pharyngitis (3-6%) URT infection (2-6%) Oropharyngeal pain (3-4%) Toothache (3%) Back pain (3%) Viral gastroenteritis (3%) Abdominal pain (3%) Cough (3%) Oropharyngeal candidiasis (3%) Dysphonia (2-3%) Oral candidiasis (<1-3%) Procedural pain (<1-3%) Rhinitis (<1-3%) Throat irritation (<1-3%)

Pregnancy Insufficient data on use in pregnant women Animal studies No fetal structural abnormalities were observed in animal (ie, rats, rabbits) reproduction studies during organogenesis at doses 4 times (rat) and 1 times (rabbit) the maximum recommended human daily inhalation dose Clinical considerations In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia 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 Lactation No information is available on the presence of fluticasone furoate in human milk, the effects on the breastfed child, or the effects on milk production Low concentrations of other inhaled corticosteroids have been detected in human milk The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child from fluticasone furoate or from the underlying maternal condition

Increased plasma concentration w/ potent CYP3A4 inhibitors (e.g. ritonavir).