Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV 1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Under standardized in vitro test conditions, Wixela™ Inhub™ delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per dose from Wixela™ Inhub™ 100/50, Wixela™ Inhub™ 250/50, and Wixela™ Inhub™ 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Each of the 60 doses contains a white to off white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). Wixela™ Inhub™ is a grey colored plastic inhaler containing two foil sealed discs, each disc containing 30 pre-metered doses. It is freely soluble in methanol slightly soluble in ethanol, chloroform, and isopropanol and sparingly soluble in water. Salmeterol xinafoate, USP is a white to almost white powder with a molecular weight of 603.8, and the empirical formula is C 25H 37NO 4 It has the chemical name (±)-4-Hydroxy-α 1-amino]methyl]-mxylene- α,α'-diol 1-hydroxy-2-naphthoate (salt) and the following chemical structure: Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The other active component of Wixela™ Inhub™ is salmeterol xinafoate, a beta 2-adrenergic bronchodilator. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. One active component of Wixela™ Inhub™ is fluticasone propionate, a corticosteroid having the chemical name S-Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α- propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure:įluticasone propionate, USP is a white to almost white powder with a molecular weight of 500.6, and the empirical formula is C 25H 31F 3O 5S. Wixela™ Inhub™ 100/50, Wixela™ Inhub™ 250/50, and Wixela™ Inhub™ 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. You may report side effects to FDA at 1-80. For more information, ask your doctor or pharmacist.Ĭall your doctor for medical advice about side effects. These are not all the possible side effects of Wixela Inhub. Tell the doctor if you have any side effect that bothers you or that does not go away.
It is not known if Wixela Inhub is safe and effective in children younger than 4 years of age. Wixela Inhub belongs to a class of drugs called Respiratory Inhalant Combos COPD Agents. Wixela Inhub may be used alone or with other medications.
Wixela Inhub is a prescription medicine used to treat the symptoms of Asthma and Chronic Obstructive Pulmonary Disease ( COPD).
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