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Neumoterol

Neumoterol

budesonide + formoterol

Manufacturer:

Laboratorios Liconsa

Distributor:

Multicare
Concise Prescribing Info
Contents
Per 200 mcg/6 mcg DPI Budesonide 200 mcg, formoterol fumarate dihydrate 6 mcg. Per 400 mcg/12 mcg DPI Budesonide 400 mcg, formoterol fumarate dihydrate 12 mcg
Indications/Uses
Regular treatment of asthma in adults & adolescents 12-17 yr where use of a combination (inhaled corticosteroid & long-acting β2-adrenoceptor agonist) is appropriate. Patients not adequately controlled w/ inhaled corticosteroids & "as needed" inhaled short-acting β2-adrenoceptor agonists, or patients already adequately controlled w/ both inhaled corticosteroids & long-acting β2-adrenoceptor agonists.
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Dosage/Direction for Use
Individualized dose. Maintenance therapy Adult ≥18 yr 1-2 inhalations bid. Max: 4 inhalations bid. Adolescent 12-17 yr 1-2 inhalations bid. When control of symptoms is achieved, titration to lowest effective dose could include once daily. Maintenance & reliever therapy Adult ≥18 yr 2 inhalations given either as 1 inhalation in morning & evening or 2 inhalations in either morning or evening. Take 1 additional inhalation as needed. If symptoms persist after a few min, an additional inhalation should be taken. Max: Not ≥6 inhalations on any single occasion. Total daily dose up to 12 inhalations could be used for a limited period.
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Overdosage
View Neumoterol overdosage for action to be taken in the event of an overdose.
Contraindications
Hypersensitivity to budesonide & formoterol.
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Special Precautions
Taper dose when discontinuing long-term treatment. Do not use to treat exacerbation. Monitor growth of childn & adolescents on long-term therapy. Patients transferring from oral steroids; those requiring high-dose emergency corticosteroid therapy or prolonged treatment; severe liver cirrhosis. Thyrotoxicosis, phaeochromocytoma, DM, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe HTN, aneurysm or other severe CV disorders eg, ischaemic heart disease tachyarrhythmias or severe heart failure. Pregnancy & lactation.
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Adverse Reactions
Candida infections in the oropharynx, pneumonia (in COPD patients); headache, tremor; palpitations; mild irritation in the throat, coughing, hoarseness.
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Drug Interactions
Plasma levels of budesonide may be markedly increase w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone & HIV PIs. Weakened or inhibited effect of formoterol w/ β2-adrenergic blockers (including eye drops). Prolonged QTc-interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine) & TCAs. Impaired cardiac tolerance towards β2-sympathomimetics w/ L-dopa, L-thyroxine, oxytocin & alcohol. May precipitate hypertensive reactions w/ MAOIs including agents w/ similar properties eg, furazolidone & procarbazine. Elevated risk of arrhythmias w/ anaesth w/ halogenated hydrocarbons. Potential additive bronchodilating effect w/ other β-adrenergic or anticholinergic drugs. Hypokalaemia may increase disposition towards arrhythmias in patients treated w/ digitalis glycosides.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Neumoterol detailed prescribing information
Storage
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Description
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Action
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MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03AK07 - formoterol and budesonide ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.
Patient Counseling Information
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Presentation/Packing
Form
Neumoterol DPI cap 200 mcg/6 mcg
Packing/Price
(+ inhaler) 1 × 60's
Form
Neumoterol DPI cap 400 mcg/1,200 mcg
Packing/Price
(+ inhaler) 1 × 60's
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